CELEX ID: 32017R0745

--- ENGLISH ---

Document:
5.5.2017
EN
Official Journal of the European Union
L 117/1
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee 
(
1
)
,
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure 
(
2
)
,
Whereas:
(1)
Council Directive 90/385/EEC 
(
3
)
 and Council Directive 93/42/EEC 
(
4
)
 constitute the Union regulatory framework for medical devices, other than 
in vitro
 diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.
(2)
This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods. As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.
(3)
This Regulation does not seek to harmonise rules relating to the further making available on the market of medical devices after they have already been put into service such as in the context of second-hand sales.
(4)
Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety.
(5)
To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical investigations.
(6)
For historical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments. In the interest of simplification, both directives, which have been amended several times, should be replaced by a single legislative act applicable to all medical devices other than 
in vitro
 diagnostic medical devices.
(7)
The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as 
in vitro
 diagnostic medical devices, medicinal products, cosmetics and food. Therefore, Regulation (EC) No 178/2002 of the European Parliament and of the Council 
(
5
)
 should be amended to exclude medical devices from its scope.
(8)
It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant.
(9)
Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of taking a Union-wide decision regarding the regulatory status of a product should also be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council 
(
6
)
.
(10)
Products which combine a medicinal product or substance and a medical device are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. 
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7
)
 The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market assessment, and of exchange of information in the context of vigilance activities involving such combination products. For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements laid down in this Regulation for the device part should be adequately assessed in the context of the marketing authorisation for such medicinal products. Directive 2001/83/EC should therefore be amended.
(11)
Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council 
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8
)
 and Directive 2004/23/EC of the European Parliament and of the Council 
(
9
)
, is incomplete in respect of certain products manufactured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered non-viable. Such products should come under the scope of this Regulation, provided they comply with the definition of a medical device or are covered by this Regulation.
(12)
Certain groups of products for which a manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation. In order for manufacturers to be able to demonstrate the conformity of such products, the Commission should adopt common specifications at least with regard to application of risk management and, where necessary, clinical evaluation regarding safety. Such common specifications should be developed specifically for a group of products without an intended medical purpose and should not be used for conformity assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical intended purpose should fulfil both the requirements applicable to devices with, and to devices without, an intended medical purpose.
(13)
As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly excluded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that products that contain or consist of viable biological materials or viable organisms of another origin in order to achieve or support the intended purpose of those products are not covered by this Regulation either.
(14)
The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council 
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10
)
 should continue to apply.
(15)
There is scientific uncertainty about the risks and benefits of nanomaterials used for devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU 
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11
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, with the necessary flexibility to adapt that definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of devices, manufacturers should take special care when using nanoparticles for which there is a high or medium potential for internal exposure. Such devices should be subject to the most stringent conformity assessment procedures. In preparation of implementing acts regulating the practical and uniform application of the corresponding requirements laid down in this Regulation, the relevant scientific opinions of the relevant scientific committees should be taken into account.
(16)
Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council 
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12
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 are an integral part of the general safety and performance requirements laid down in this Regulation for devices. Consequently, this Regulation should be considered a 
lex specialis
 in relation to that Directive.
(17)
This Regulation should include requirements regarding the design and manufacture of devices emitting ionizing radiation without affecting the application of Council Directive 2013/59/Euratom 
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13
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 which pursues other objectives.
(18)
This Regulation should include requirements for devices' design, safety and performance characteristics which are developed in such a way as to prevent occupational injuries, including protection from radiation.
(19)
It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.
(20)
The definitions in this Regulation, regarding devices themselves, the making available of devices, economic operators, users and specific processes, the conformity assessment, clinical investigations and clinical evaluations, post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should be aligned with well-established practice in the field at Union and international level in order to enhance legal certainty.
(21)
It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council 
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14
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 and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.
(22)
To recognise the important role of standardisation in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council 
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15
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 should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation.
(23)
Directive 98/79/EC of the European Parliament and of the Council 
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16
)
 allows the Commission to adopt common technical specifications for specific categories of 
in vitro
 diagnostic medical devices. In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance requirements, and the requirements for clinical investigations and clinical evaluation and/or post-market clinical follow-up, laid down in this Regulation.
(24)
Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and taking account of European and international standards.
(25)
The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the Council 
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17
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 and Decision No 768/2008/EC of the European Parliament and of the Council 
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18
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.
(26)
The rules on Union market surveillance and control of products entering the Union market laid down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks.
(27)
It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors, building on the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the various parts of this Regulation, to enhance understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators.
(28)
For the purpose of this Regulation, the activities of distributors should be deemed to include acquisition, holding and supplying of devices.
(29)
Several of the obligations on manufacturers, such as clinical evaluation or vigilance reporting, that were set out only in the Annexes to Directives 90/385/EEC and 93/42/EEC, should be incorporated into the enacting provisions of this Regulation to facilitate its application.
(30)
Health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby address, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market. In that context, it is appropriate to provide that certain rules of this Regulation, as regards medical devices manufactured and used only within health institutions, including hospitals as well as institutions, such as laboratories and public health institutes that support the healthcare system and/or address patient needs, but which do not treat or care for patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner. It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption applicable to health institutions does not apply to such establishments.
(31)
In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC 
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19
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. Such measures should be proportionate to the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device.
(32)
To ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question. In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions.
(33)
The risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the clinical risks to be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical evaluation processes should be inter-dependent and should be regularly updated.
(34)
It should be ensured that supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
(35)
For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance.
(36)
To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify when a distributor, importer or other person is to be considered the manufacturer of a device.
(37)
Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety and from the need for protection of intellectual property rights provided for under Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different interpretations in the Member States. The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the Court of Justice 
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20
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 in other relevant sectors and existing good practice in the field of medical devices.
(38)
The reprocessing and further use of single-use devices should only take place where permitted by national law and while complying with the requirements laid down in this Regulation. The reprocessor of a single-use device should be considered to be the manufacturer of the reprocessed device and should assume the obligations incumbent on manufacturers under this Regulation. Nevertheless, Member States should have the possibility of deciding that the obligations relating to reprocessing and re-use of single-use devices within a health institution or by an external reprocessor acting on its behalf may differ from the obligations on a manufacturer described in this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of single-use devices within a health institution or by an external reprocessor are compliant with CS that have been adopted, or, in the absence of such CS, with relevant harmonised standards and national provisions. The reprocessing of such devices should ensure an equivalent level of safety and performance to that of the corresponding initial single-use device.
(39)
Patients who are implanted with a device should be given clear and easily accessible essential information allowing the implanted device to be identified and other relevant information about the device, including any necessary health risk warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.
(40)
Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to the placing on the market or putting into service of devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.
(41)
The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those settings.
(42)
The UDI system should apply to all devices placed on the market except custom-made devices, and be based on internationally recognised principles including definitions that are compatible with those used by major trade partners. In order for the UDI system to become functional in time for the application of this Regulation, detailed rules should be laid down in this Regulation.
(43)
Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
(44)
One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission. Within the internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices set up by Commission Decision 2010/227/EU 
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.
(45)
To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably practicable, free of charge also to other stakeholders.
(46)
Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on clinical investigations should serve as a tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and to report serious adverse events, device deficiencies and related updates. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of the evaluation of such incidents and events by competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities.
(47)
In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the European Parliament and of the Council 
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 applies to the processing of personal data carried out in the Member States, under the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council 
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23
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 applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. In accordance with Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems.
(48)
For implantable devices and for class III devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.
(49)
The summary of safety and clinical performance for a device should include in particular the place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when compared to the diagnostic or therapeutic alternatives and the specific conditions under which that device and its alternatives can be considered.
(50)
The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.
(51)
Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on clinical evaluation, should be critically evaluated by the authority responsible for notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities of notified bodies and should be based on sampling of the relevant documentation.
(52)
The position of notified bodies vis-à-vis manufacturers should be strengthened, including with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification.
(53)
To increase transparency with regard to the oversight of notified bodies by national authorities, the authorities responsible for notified bodies should publish information on the national measures governing the assessment, designation and monitoring of notified bodies. In accordance with good administrative practice, this information should be kept up to date by those authorities in particular to reflect relevant, significant or substantive changes to the procedures in question.
(54)
The Member State in which a notified body is established should be responsible for enforcing the requirements of this Regulation with regard to that notified body.
(55)
In view, in particular, of the responsibility of Member States for the organisation and delivery of health services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for the conformity assessment of devices and established on their territory as far as issues that are not regulated in this Regulation are concerned. Any such additional requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal treatment of notified bodies.
(56)
For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert panels to scrutinise their clinical evaluation assessment report. Competent authorities should be informed about devices that have been granted a certificate following a conformity assessment procedure involving an expert panel. The consultation of expert panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and developing CS on categories of devices that have undergone that consultation process.
(57)
For class III devices and for certain class IIb devices, a manufacturer should be able to consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or investigation, on its clinical development strategy and on proposals for clinical investigations.
(58)
It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the division of devices into four product classes in line with international practice. The classification rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC, active implantable devices should be in the highest risk class.
(59)
Rules under the old regime applied to invasive devices do not sufficiently take account of the level of invasiveness and potential toxicity of certain devices which are introduced into the human body. In order to obtain a suitable risk-based classification of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body, it is necessary to introduce specific classification rules for such devices. The classification rules should take into account the place where the device performs its action in or on the human body, where it is introduced or applied, and whether a systemic absorption of the substances of which the device is composed, or of the products of metabolism in the human body of those substances occurs.
(60)
The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.
(61)
The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field.
(62)
It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity.
(63)
To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical data that, for class III devices and implantable devices should, as a general rule, be sourced from clinical investigations that have been carried out under the responsibility of a sponsor. It should be possible both for the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the clinical investigation.
(64)
The rules on clinical investigations should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of clinical investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of clinical investigations conducted outside the Union in accordance with international guidelines to be accepted within the Union. In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65)
It should be left to the Member State where a clinical investigation is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a clinical investigation and to organise the involvement of ethics committees within the timelines for the authorisation of that clinical investigation as set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that context, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the necessary expertise is available.
(66)
Where, in the course of a clinical investigation, harm caused to a subject leads to the civil or criminal liability of the investigator or the sponsor being invoked, the conditions for liability in such cases, including issues of causality and the level of damages and sanctions, should remain governed by national law.
(67)
An electronic system should be set up at Union level to ensure that every clinical investigation is recorded and reported in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68)
Where a clinical investigation is to be conducted in more than one Member State, the sponsor should have the possibility of submitting a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the investigational device and of the scientific design of that clinical investigation, the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a clinical investigation, including informed consent. For an initial period of seven years from the date of application of this Regulation, Member States should be able to participate on a voluntary basis in the coordinated assessment. After that period, all Member States should be obliged to participate in the coordinated assessment. The Commission, based on the experience gained from the voluntary coordination between Member States, should draw up a report on the application of the relevant provisions regarding the coordinated assessment procedure. In the event that the findings of the report are negative, the Commission should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment procedure.
(69)
Sponsors should report certain adverse events and device deficiencies that occur during clinical investigations to the Member States in which those clinical investigations are being conducted. Member States should have the possibility of terminating or suspending the investigations or revoking the authorisation for those investigations, if considered necessary to ensure a high level of protection of the subjects participating in a clinical investigation. Such information should be communicated to the other Member States.
(70)
The sponsor of a clinical investigation should submit a summary of results of the clinical investigation that is easily understandable for the intended user together with the clinical investigation report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results will be submitted.
(71)
This Regulation should cover clinical investigations intended to gather clinical evidence for the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and scientific assessments for other types of clinical investigations of medical devices.
(72)
Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection measures. However, it should be left to Member States to determine the legally designated representatives of incapacitated subjects and minors.
(73)
The principles of replacement, reduction and refinement in the area of animal experimentation laid down in the Directive 2010/63/EU of the European Parliament and of the Council 
(
24
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 should be observed. In particular, the unnecessary duplication of tests and studies should be avoided.
(74)
Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set up under their quality management system and based on a post-market surveillance plan. Relevant data and information gathered through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the purpose of transparency.
(75)
In order to better protect health and safety regarding devices on the market, the electronic system on vigilance for devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions.
(76)
Member States should take appropriate measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be encouraged and enabled to report suspected serious incidents at national level using harmonised formats. The national competent authorities should inform manufacturers of any suspected serious incidents and, where a manufacturer confirms that such an incident has occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents.
(77)
The evaluation of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective action.
(78)
In the context of the investigation of incidents, the competent authorities should take into account, where appropriate, the information provided by and views of relevant stakeholders, including patient and healthcare professionals' organisations and manufacturers' associations.
(79)
The reporting of serious adverse events or device deficiencies during clinical investigations and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.
(80)
Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures.
(81)
Any statistically significant increase in the number or severity of incidents that are not serious or in expected side-effects that could have a significant impact on the benefit-risk analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to permit their assessment and the adoption of appropriate measures.
(82)
An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices including 
in vitro
 diagnostic medical devices, should be established to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/746 of the European Parliament and of the Council 
(
25
)
, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation. The MDCG should be able to establish subgroups in order to have access to necessary in-depth technical expertise in the field of medical devices including 
in vitro
 diagnostic medical devices. When establishing subgroups, appropriate consideration should be given to the possibility of involving existing groups at Union level in the field of medical devices.
(83)
Expert panels and expert laboratories should be designated by the Commission on the basis of their up-to-date clinical, scientific or technical expertise, with the aim of providing scientific, technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this Regulation. Moreover, expert panels should fulfil the tasks of providing an opinion on clinical evaluation assessment reports of notified bodies in the case of certain high-risk devices.
(84)
Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is essential for ensuring a consistently high level of health and safety protection within the internal market, in particular in the areas of clinical investigations and vigilance. The principle of coordinated exchange and assessment should also apply across other authority activities described in this Regulation, such as the designation of notified bodies and should be encouraged in the area of market surveillance of devices. Joint working, coordination and communication of activities should also lead to more efficient use of resources and expertise at national level.
(85)
The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly implemented at Union level based on sound scientific evidence.
(86)
The Union and, where appropriate, the Member States should actively participate in international regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related information regarding medical devices and to foster the further development of international regulatory guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that set by this Regulation.
(87)
Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement.
(88)
Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should, in order to ensure transparency, inform the Commission and the other Member States before they decide on the level and structure of such fees. In order to further ensure transparency, the structure and level of the fees should be publicly available on request.
(89)
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should be applied by the Member States in accordance with those rights and principles.
(90)
The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in order to amend certain non-essential provisions of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making 
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26
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. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with preparation of delegated acts.
(91)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 
(
27
)
.
(92)
The advisory procedure should be used for implementing acts that set out the form and presentation of the data elements of manufacturers' summaries of safety and clinical performance, and that establish the model for certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an impact on health and safety at Union level.
(93)
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures, imperative grounds of urgency so require.
(94)
In order to enable it to designate issuing entities, expert panels and expert laboratories, implementing powers should be conferred on the Commission.
(95)
To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements that are to be made. However, certain parts of the Regulation that directly affect Member States and the Commission should be implemented as soon as possible. It is also particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be designated in accordance with the new requirements so as to avoid any shortage of medical devices on the market. Nonetheless, it is necessary that any designation of a notified body in accordance with the requirements of this Regulation prior to the date of its application be without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and 93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of application of this Regulation.
(96)
In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the obligation to submit the relevant information to the electronic systems set up at Union level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to plan, only become fully effective from 18 months after the date of application of this Regulation. During this transitional period, certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However, in order to avoid multiple registrations, economic operators and notified bodies who register in the relevant electronic systems set up at Union level pursuant to this Regulation should be considered to be in compliance with the registration requirements adopted by the Member States pursuant to those provisions.
(97)
In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned.
(98)
Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to those Directives should however continue to apply. While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting incidents related to devices placed on the market pursuant to the Directives using the same tools as those for reporting on devices placed on the market pursuant to this Regulation. It is furthermore appropriate, in order to ensure a smooth transition from the old regime to the new regime, to provide that Commission Regulation (EU) No 207/2012 
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28
)
 and Commission Regulation (EU) No 722/2012 
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29
)
 should remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.
Decision 2010/227/EU adopted in implementation of those Directives and Directive 98/79/EC should also remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely, no such maintenance in force is required for Commission Directives 2003/12/EC 
(
30
)
 and 2005/50/EC 
(
31
)
 and Commission Implementing Regulation (EU) No 920/2013 
(
32
)
.
(99)
The requirements of this Regulation should be applicable to all devices placed on the market or put into service from the date of application of this Regulation. However, in order to provide for a smooth transition it should be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100)
The European Data Protection Supervisor has given an opinion 
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33
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 pursuant to Article 28(2) of Regulation (EC) No 45/2001.
(101)
Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal market as regards medical devices and to ensure high standards of quality and safety for medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1.   This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
2.   This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety.
The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.
Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.
This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.
3.   Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.
4.   For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.
5.   Where justified on account of the similarity between a device with an intended medical purpose placed on the market and a product without an intended medical purpose in respect of their characteristics and risks, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list in Annex XVI, by adding new groups of products, in order to protect the health and safety of users or other persons or other aspects of public health.
6.   This Regulation does not apply to:
(a)
in vitro
 diagnostic medical devices covered by Regulation (EU) 2017/746;
(b)
medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;
(c)
advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;
(d)
human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;
(e)
cosmetic products covered by Regulation (EC) No 1223/2009;
(f)
transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable;
(g)
transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable;
(h)
products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;
(i)
food covered by Regulation (EC) No 178/2002.
7.   Any device which, when placed on the market or put into service, incorporates as an integral part an 
in vitro
 diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by this Regulation. The requirements of Regulation (EU) 2017/746 shall apply to the 
in vitro
 diagnostic medical device part of the device.
8.   Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.
However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council 
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34
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, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.
9.   Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.
However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.
10.   Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to that of the device shall be assessed and authorised in accordance with this Regulation. In that case, the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply.
However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.
11.   This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
12.   Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council 
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35
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 shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation.
13.   This Regulation shall not affect the application of Directive 2013/59/Euratom.
14.   This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation.
15.   This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or healthcare institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling.
16.   Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
—
diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
—
diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
—
investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
—
providing information by means of 
in vitro
 examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
—
devices for the control or support of conception;
—
products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
(2)
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
(3)
‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
(4)
‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
Software shall also be deemed to be an active device;
(5)
‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
—
to be totally introduced into the human body, or
—
to replace an epithelial surface or the surface of the eye,
by clinical intervention and which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;
(6)
‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;
(7)
‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
(8)
‘single-use device’ means a device that is intended to be used on one individual during a single procedure;
(9)
‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;
(10)
‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;
(11)
‘system’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;
(12)
‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;
(13)
‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;
(14)
‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;
(15)
‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;
(16)
‘non-viable’ means having no potential for metabolism or multiplication;
(17)
‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues;
(18)
‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;
(19)
‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries;
(20)
‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;
(21)
‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;
(22)
‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;
(23)
‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
(24)
‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;
(25)
‘compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
(a)
perform without losing or compromising the ability to perform as intended, and/or
(b)
integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
(c)
be used together without conflict/interference or adverse reaction.
(26)
‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
(a)
exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or
(b)
communicate with each other, and/or
(c)
work together as intended.
(27)
‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(28)
‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;
(29)
‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;
(30)
‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;
(31)
‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;
(32)
‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
(33)
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
(34)
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
(35)
‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);
(36)
‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
(37)
‘user’ means any healthcare professional or lay person who uses a device;
(38)
‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
(39)
‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;
(40)
‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
(41)
‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;
(42)
‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
(43)
‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;
(44)
‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;
(45)
‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;
(46)
‘investigational device’ means a device that is assessed in a clinical investigation;
(47)
‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;
(48)
‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
—
clinical investigation(s) of the device concerned,
—
clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
—
reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
—
clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;
(49)
‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation;
(50)
‘subject’ means an individual who participates in a clinical investigation;
(51)
‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;
(52)
‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;
(53)
‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;
(54)
‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;
(55)
‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;
(56)
‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;
(57)
‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;
(58)
‘serious adverse event’ means any adverse event that led to any of the following:
(a)
death,
(b)
serious deterioration in the health of the subject, that resulted in any of the following:
(i)
life-threatening illness or injury,
(ii)
permanent impairment of a body structure or a body function,
(iii)
hospitalisation or prolongation of patient hospitalisation,
(iv)
medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
(v)
chronic disease,
(c)
foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
(59)
‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer;
(60)
‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
(61)
‘market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
(62)
‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;
(63)
‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;
(64)
‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;
(65)
‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
(a)
the death of a patient, user or other person,
(b)
the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
(c)
a serious public health threat;
(66)
‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;
(67)
‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;
(68)
‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;
(69)
‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;
(70)
‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
(71)
‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
Article 3
Amendment of certain definitions
The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.
Article 4
Regulatory status of products
1.   Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3) of this Regulation.
2.   The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
3.   The Commission shall ensure that Member States share expertise in the fields of medical devices, 
in vitro
 diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products.
4.   When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), as relevant.
CHAPTER II
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT
Article 5
Placing on the market and putting into service
1.   A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
2.   A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.
3.   Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.
4.   Devices that are manufactured and used within health institutions shall be considered as having been put into service.
5.   With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:
(a)
the devices are not transferred to another legal entity,
(b)
manufacture and use of the devices occur under appropriate quality management systems,
(c)
the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,
(d)
the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;
(e)
the health institution draws up a declaration which it shall make publicly available, including:
(i)
the name and address of the manufacturing health institution;
(ii)
the details necessary to identify the devices;
(iii)
a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,
(f)
the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;
(g)
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and
(h)
the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.
This paragraph shall not apply to devices that are manufactured on an industrial scale.
6.   In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 6
Distance sales
1.   A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation.
2.   Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation.
3.   Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned.
4.   A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
Article 7
Claims
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
(a)
ascribing functions and properties to the device which the device does not have;
(b)
creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c)
failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
(d)
suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
Article 8
Use of harmonised standards
1.   Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the 
Official Journal of the European Union
, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).
References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the 
Official Journal of the European Union
.
2.   References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the 
Official Journal of the European Union
.
Article 9
Common specifications
1.   Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
2.   Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.
3.   Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.
4.   Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products.
Article 10
General obligations of manufacturers
1.   When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.
2.   Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.
3.   Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.
4.   Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III.
The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III.
5.   Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII.
6.   Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.
7.   Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31.
8.   Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.
Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof.
A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.
9.   Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.
The quality management system shall address at least the following aspects:
(a)
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
(b)
identification of applicable general safety and performance requirements and exploration of options to address those requirements;
(c)
responsibility of the management;
(d)
resource management, including selection and control of suppliers and sub-contractors;
(e)
risk management as set out in in Section 3 of Annex I;
(f)
clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
(g)
product realisation, including planning, design, development, production and service provision;
(h)
verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;
(i)
setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;
(j)
handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
(k)
processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
(l)
management of corrective and preventive actions and verification of their effectiveness;
(m)
processes for monitoring and measurement of output, data analysis and product improvement.
10.   Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83.
11.   Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.
12.   Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly.
Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken.
13.   Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.
14.   Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned. The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service.
If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information.
If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.
The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings.
15.   Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 30(1).
16.   Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.
Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
Article 11
Authorised representative
1.   Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
2.   The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
3.   The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
(a)
verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
(b)
keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
(c)
comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
(d)
in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
(e)
forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
(f)
cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
(g)
immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
(h)
terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
4.   The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).
5.   Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
6.   An authorised representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.
7.   Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.
Article 12
Change of authorised representative
The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:
(a)
the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
(b)
the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
(c)
the transfer of documents, including confidentiality aspects and property rights;
(d)
the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.
Article 13
General obligations of importers
1.   Importers shall place on the Union market only devices that are in conformity with this Regulation.
2.   In order to place a device on the market, importers shall verify that:
(a)
the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b)
a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
(c)
the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
(d)
where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
3.   Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
4.   Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31.
5.   Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.
6.   Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.
7.   Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.
8.   Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.
9.   Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56.
10.   Importers shall cooperate with competent authorities, at the latters' request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.
Article 14
General obligations of distributors
1.   When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.
2.   Before making a device available on the market, distributors shall verify that all of the following requirements are met:
(a)
the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b)
the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
(c)
for imported devices, the importer has complied with the requirements set out in Article 13(3);
(d)
that, where applicable, a UDI has been assigned by the manufacturer.
In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
3.   Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.
4.   Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.
5.   Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
6.   Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.
Article 15
Person responsible for regulatory compliance
1.   Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
(a)
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b)
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
2.   Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC 
(
36
)
 shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.
3.   The person responsible for regulatory compliance shall at least be responsible for ensuring that:
(a)
the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b)
the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c)
the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d)
the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e)
in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
4.   If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.
5.   The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.
6.   Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:
(a)
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b)
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Article 16
Cases in which obligations of manufacturers apply to importers, distributors or other persons
1.   A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a)
makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
(b)
changes the intended purpose of a device already placed on the market or put into service;
(c)
modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
2.   For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
(a)
provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;
(b)
changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
3.   A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.
Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, 
inter alia
, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
4.   At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
Article 17
Single-use devices and their reprocessing
1.   Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article.
2.   Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC.
3.   By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a health institution, Member States may decide not to apply all of the rules relating to manufacturers' obligations laid down in this Regulation provided that they ensure that:
(a)
the safety and performance of the reprocessed device is equivalent to that of the original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied with;
(b)
the reprocessing is performed in accordance with CS detailing the requirements concerning:
—
risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing,
—
the validation of procedures for the entire process, including cleaning steps,
—
the product release and performance testing,
—
the quality management system,
—
the reporting of incidents involving devices that have been reprocessed, and
—
the traceability of reprocessed devices.
Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information on the reprocessed devices that patients are treated with.
Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available.
4.   Member States may choose to apply the provisions referred to in paragraph 3 also as regards single-use devices that are reprocessed by an external reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is returned to that health institution and the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3.
5.   The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point (b) of paragraph 3 by 26 May 2020. Those CS shall be consistent with the latest scientific evidence and shall address the application of the general requirements on safety and performance laid down in in this Regulation. In the event that those CS are not adopted by 26 May 2020, reprocessing shall be performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and national provisions, shall be certified by a notified body.
6.   Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2020 in accordance with Directive 93/42/EEC, may be reprocessed.
7.   Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out.
8.   The name and address of the legal or natural person referred to in paragraph 2 and the other relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device.
The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
9.   A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following:
(a)
the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing;
(b)
the making available or further use of reprocessed single-use devices.
Member States shall notify the Commission and the other Member States of those national provisions. The Commission shall make such information publicly available.
10.   The Commission shall by 27 May 2024 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. On the basis of that report, the Commission shall, if appropriate, make proposals for amendments to this Regulation.
Article 18
Implant card and information to be supplied to the patient with an implanted device
1.   The manufacturer of an implantable device shall provide together with the device the following:
(a)
information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;
(b)
any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;
(c)
any information about the expected lifetime of the device and any necessary follow-up;
(d)
any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.
In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.
2.   Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.
3.   The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom.
Article 19
EU declaration of conformity
1.   The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
2.   Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device. The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates.
3.   By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.
4.   The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
Article 20
CE marking of conformity
1.   Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.
2.   The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
3.   The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.
4.   The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
5.   Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.
6.   Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.
Article 21
Devices for special purposes
1.   Member States shall not create obstacles to:
(a)
investigational devices being supplied to an investigator for the purpose of a clinical investigation if they meet the conditions laid down in Articles 62 to 80 and Article 82, in the implementing acts adopted pursuant to Article 81 and in Annex XV;
(b)
custom-made devices being made available on the market if Article 52(8) and Annex XIII have been complied with.
The devices referred to in the first subparagraph shall not bear the CE marking, with the exception of the devices referred to in Article 74.
2.   Custom-made devices shall be accompanied by the statement referred to in Section 1 of Annex XIII, which shall be made available to the particular patient or user identified by name, an acronym or a numerical code.
Member States may require that the manufacturer of a custom-made device submit to the competent authority a list of such devices which have been made available in their territory.
3.   At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.
Article 22
Systems and procedure packs
1.   Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
(a)
other devices bearing the CE marking;
(b)
in vitro
 diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
(c)
other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.
2.   In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
(a)
they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers' instructions and have carried out their activities in accordance with those instructions;
(b)
they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;
(c)
the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.
3.   Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market shall, at their choice, apply one of the procedures set out in Annex IX or the procedure set out in Part A of Annex XI. The application of those procedures and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions.
4.   Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.
5.   The systems or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trade mark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can be contacted, so that the person's location can be established. Systems or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I. The statement referred to in paragraph 2 of this Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable under Article 10(8) to the devices that have been combined. Where those periods differ, the longest period shall apply.
Article 23
Parts and components
1.   Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States.
2.   An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation.
Article 24
Free movement
Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation.
CHAPTER III
IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
Article 25
Identification within the supply chain
1.   Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.
2.   Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8):
(a)
any economic operator to whom they have directly supplied a device;
(b)
any economic operator who has directly supplied them with a device;
(c)
any health institution or healthcare professional to which they have directly supplied a device.
Article 26
Medical devices nomenclature
To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable.
Article 27
Unique Device Identification system
1.   The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:
(a)
production of a UDI that comprises the following:
(i)
a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;
(ii)
a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;
(b)
placing of the UDI on the label of the device or on its packaging;
(c)
storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively;
(d)
establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28.
2.   The Commission shall, by means of implementing acts, designate one or several entities to operate a system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or those entities shall satisfy all of the following criteria:
(a)
the entity is an organisation with legal personality;
(b)
its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation;
(c)
its system for the assignment of UDIs conforms to the relevant international standards;
(d)
the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions;
(e)
the entity undertakes to do the following:
(i)
operate its system for the assignment of UDIs for at least 10 years after its designation;
(ii)
make available to the Commission and to the Member States, upon request, information concerning its system for the assignment of UDIs;
(iii)
remain in compliance with the criteria for designation and the terms of designation.
When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to minimising financial and administrative burdens for economic operators and health institutions.
3.   Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.
Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.
4.   UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers.
5.   The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87.
6.   The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appear on the EU declaration of conformity referred to in Article 19.
7.   As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned.
8.   Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to:
—
class III implantable devices;
—
the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11.
9.   Health institutions shall store and keep preferably by electronic means the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to class III implantable devices.
For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.
Member States shall encourage, and may require, healthcare professionals to store and keep preferably by electronic means, the UDI of the devices with which they have been supplied with.
10.   The Commission is empowered to adopt delegated acts in accordance with Article 115:
(a)
amending the list of information set out in Part B of Annex VI in the light of technical progress; and
(b)
amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification.
11.   The Commission may, by means of implementing acts, specify the detailed arrangements and the procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the following:
(a)
determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply;
(b)
specifying the data to be included in the UDI-PI of specific devices or device groups;
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
12.   When adopting the measures referred to in paragraph 11, the Commission shall take into account all of the following:
(a)
confidentiality and data protection as referred to in Articles 109 and 110 respectively;
(b)
the risk-based approach;
(c)
the cost-effectiveness of the measures;
(d)
the convergence of UDI systems developed at international level;
(e)
the need to avoid duplications in the UDI system;
(f)
the needs of the healthcare systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders.
Article 28
UDI database
1.   The Commission, after consulting the MDCG shall set up and manage a UDI database to validate, collate, process and make available to the public the information mentioned in Part B of Annex VI.
2.   When designing the UDI database, the Commission shall take into account the general principles set out in Section 5 of Part C of Annex VI. The UDI database shall be designed in particular such that no UDI-PIs and no commercially confidential product information can be included therein.
3.   The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be accessible to the public free of charge.
4.   The technical design of the UDI database shall ensure maximum accessibility to information stored therein, including multi-user access and automatic uploads and downloads of that information. The Commission shall provide for technical and administrative support to manufacturers and other users of the UDI database.
Article 29
Registration of devices
1.   Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
2.   Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom-made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack.
3.   For devices that are the subject of a conformity assessment as referred to in Article 52(3) and in the second and third subparagraphs of Article 52(4), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.
For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Chapter I of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
4.   Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and shall thereafter keep the information updated.
Article 30
Electronic system for registration of economic operators
1.   The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 31(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative and the importer. The details regarding the information to be provided to that electronic system by the economic operators are laid down in Section 1 of Part A of Annex VI.
2.   Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.
3.   Within two weeks of placing a device, other than a custom-made device, on the market, importers shall verify that the manufacturer or authorised representative has provided to the electronic system the information referred to in paragraph 1.
Where applicable, importers shall inform the relevant authorised representative or manufacturer if the information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the relevant entry/entries.
Article 31
Registration of manufacturers, authorised representatives and importers
1.   Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body.
2.   After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer.
3.   The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29.
4.   Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.
5.   Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.
6.   Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.
7.   The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 30 shall be accessible to the public.
8.   The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 111.
Article 32
Summary of safety and clinical performance
1.   For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.
The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.
The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available.
2.   The summary of safety and clinical performance shall include at least the following aspects:
(a)
the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
(b)
the intended purpose of the device and any indications, contraindications and target populations;
(c)
a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;
(d)
possible diagnostic or therapeutic alternatives;
(e)
reference to any harmonised standards and CS applied;
(f)
the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;
(g)
suggested profile and training for users;
(h)
information on any residual risks and any undesirable effects, warnings and precautions.
3.   The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).
Article 33
European database on medical devices
1.   The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) for the following purposes:
(a)
to enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators;
(b)
to enable unique identification of devices within the internal market and to facilitate their traceability;
(c)
to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81;
(d)
to enable manufacturers to comply with the information obligations laid down in Articles 87 to 90 or in any acts adopted pursuant to Article 91;
(e)
to enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them.
2.   Eudamed shall include the following electronic systems:
(a)
the electronic system for registration of devices referred to in Article 29(4);
(b)
the UDI-database referred to in Article 28;
(c)
the electronic system on registration of economic operators referred to in Article 30;
(d)
the electronic system on notified bodies and on certificates referred to in Article 57;
(e)
the electronic system on clinical investigations referred to in Article 73;
(f)
the electronic system on vigilance and post-market surveillance referred to in Article 92;
(g)
the electronic system on market surveillance referred to in Article 100.
3.   When designing Eudamed the Commission shall give due consideration to compatibility with national databases and national web-interfaces to allow for import and export of data.
4.   The data shall be entered into Eudamed by the Member States, notified bodies, economic operators and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall provide for technical and administrative support to users of Eudamed.
5.   All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2.
The Commission shall ensure that public parts of Eudamed are presented in a user-friendly and easily-searchable format.
6.   Eudamed shall contain personal data only insofar as necessary for the electronic systems referred to in paragraph 2 of this Article to collate and process information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of data subjects for periods no longer than those referred to in Article 10(8).
7.   The Commission and the Member States shall ensure that data subjects may effectively exercise their rights to information, of access, to rectification and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also ensure that data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject.
8.   The Commission shall, by means of implementing acts, lay down the detailed arrangements necessary for the setting up and maintenance of Eudamed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). When adopting those implementing acts, the Commission shall ensure that, as far as possible, the system is developed in such a way as to avoid having to enter the same information twice within the same module or in different modules of the system.
9.   In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems.
Article 34
Functionality of Eudamed
1.   The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2020 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met.
2.   The Commission shall, on the basis of an independent audit report, inform the MDCG when it has verified that Eudamed has achieved full functionality and Eudamed meets the functional specifications drawn up pursuant to paragraph 1.
3.   The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the 
Official Journal of the European Union
.
CHAPTER IV
NOTIFIED BODIES
Article 35
Authorities responsible for notified bodies
1.   Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities under national law and shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors and subsidiaries of those bodies.
2.   The authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with conformity assessment bodies.
3.   The authority responsible for notified bodies shall be organised in a manner such that each decision relating to designation or notification is taken by personnel different from those who carried out the assessment.
4.   The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis.
5.   The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains. However, it shall exchange information on notified bodies with other Member States, the Commission and, when required, with other regulatory authorities.
6.   The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks.
Where the authority responsible for notified bodies is a different authority from the national competent authority for medical devices, it shall ensure that the national authority responsible for medical devices is consulted on relevant matters.
7.   Member States shall make publicly available general information on their measures governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and on changes which have a significant impact on such tasks.
8.   The authority responsible for notified bodies shall participate in the peer-review activities provided for in Article 48.
Article 36
Requirements relating to notified bodies
1.   Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex VII.
In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII and personnel with relevant clinical expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself.
The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors.
2.   Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter.
3.   In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 37
Subsidiaries and subcontracting
1.   Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly.
2.   Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries.
3.   Notified bodies shall make publicly available a list of their subsidiaries.
4.   Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly.
5.   Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
Article 38
Application by conformity assessment bodies for designation
1.   Conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies.
2.   The application shall specify the conformity assessment activities as defined in this Regulation, and the types of devices for which the body is applying to be designated, and shall be supported by documentation demonstrating compliance with Annex VII.
In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 39. However, the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request.
3.   The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements set out in Annex VII.
Article 39
Assessment of the application
1.   The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 38 is complete and shall request the applicant to provide any missing information. Once the application is complete that authority shall send it to the Commission.
The authority responsible for notified bodies shall review the application and supporting documentation in accordance with its own procedures and shall draw up a preliminary assessment report.
2.   The authority responsible for notified bodies shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the MDCG.
3.   Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific circumstances require a different number of experts, chosen from the list referred to in Article 40(2). One of the experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team. The other two experts shall come from Member States other than the one in which the applicant conformity assessment body is established.
The joint assessment team shall be comprised of experts who are competent to assess the conformity assessment activities and the types of devices which are the subject of the application or, in particular when the assessment procedure is initiated in accordance with Article 47(3), to ensure that the specific concern can be appropriately assessed.
4.   Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 38. The joint assessment team may provide feedback to, or require clarification from, the authority responsible for notified bodies on the application and on the planned on-site assessment.
The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to be involved in the conformity assessment process.
The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.
5.   Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VII shall be raised during the assessment process and discussed between the authority responsible for notified bodies and the joint assessment team with a view to reaching consensus and resolving any diverging opinions, with respect to the assessment of the application.
At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant conformity assessment body the non-compliances resulting from the assessment and summarise the assessment by the joint assessment team.
Within a specified timeframe, the applicant conformity assessment body shall submit to the national authority a corrective and preventive action plan to address the non-compliances.
6.   The joint assessment team shall document any remaining diverging opinions with respect to the assessment within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies.
7.   The authority responsible for notified bodies shall following receipt of a corrective and preventive action plan from the applicant body assess whether non-compliances identified during the assessment have been appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein.
The authority responsible for notified bodies shall having confirmed the corrective and preventive action plan forward it and its opinion thereon to the joint assessment team. The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications.
The authority responsible for notified bodies shall draw up its final assessment report which shall include:
—
the result of the assessment,
—
confirmation that the corrective and preventive actions have been appropriately addressed and, where required, implemented,
—
any remaining diverging opinion with the joint assessment team, and, where applicable,
—
the recommended scope of designation.
8.   The authority responsible for notified bodies shall submit its final assessment report and, if applicable, the draft designation to the Commission, the MDCG and the joint assessment team.
9.   The joint assessment team shall provide a final opinion regarding the assessment report prepared by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those documents to the Commission, which shall immediately submit that final opinion to the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft designation, which the authority responsible for notified bodies shall duly take into consideration for its decision on the designation of the notified body.
10.   The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements specifying procedures and reports for the application for designation referred to in Article 38 and the assessment of the application set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 40
Nomination of experts for joint assessment of applications for notification
1.   The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of medical devices to participate in the activities referred to in Articles 39 and 48.
2.   The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise. That list shall be made available to Member States competent authorities through the electronic system referred to in Article 57.
Article 41
Language requirements
All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned.
Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned.
The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 39(3).
Article 42
Designation and notification procedure
1.   Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 39 was completed and which comply with Annex VII.
2.   Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool within the database of notified bodies developed and managed by the Commission (NANDO).
3.   The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope of the designation indicating the conformity assessment activities as defined in this Regulation and the types of devices which the notified body is authorised to assess and, without prejudice to Article 44, any conditions associated with the designation.
4.   The notification shall be accompanied by the final assessment report of the authority responsible for notified bodies, the final opinion of the joint assessment team referred to in Article 39(9) and the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification.
5.   The notifying Member State shall, without prejudice to Article 44, inform the Commission and the other Member States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set out in Annex VII.
6.   Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission may raise written objections, setting out its arguments, with regard either to the notified body or to its monitoring by the authority responsible for notified bodies. Where no objection is raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in paragraph 2.
7.   When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter having been brought before it. Where the MDCG is of the opinion that the notification can be accepted, the Commission shall publish in NANDO the notification within 14 days.
8.   Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40 days of its receipt. The response shall address the objections raised in the opinion, and set out the reasons for the notifying Member State's decision to designate or not designate the conformity assessment body.
9.   Where the notifying Member State decides to uphold its decision to designate the conformity assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notification within 14 days of being informed thereof.
10.   When publishing the notification in NANDO, the Commission shall also add to the electronic system referred to in Article 57 the information relating to the notification of the notified body along with the documents mentioned in paragraph 4 of this Article and the opinion and responses referred to in paragraphs 7 and 8 of this Article.
11.   The designation shall become valid the day after the notification is published in NANDO. The published notification shall state the scope of lawful conformity assessment activity of the notified body.
12.   The conformity assessment body concerned may perform the activities of a notified body only after the designation has become valid in accordance with paragraph 11.
13.   The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). The Commission, after consulting the MDCG, may update this list based, 
inter alia
, on information arising from the coordination activities described in Article 48.
Article 43
Identification number and list of notified bodies
1.   The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11). It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them pursuant to those Directives.
2.   The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in Article 57. The Commission shall ensure that the list is kept up to date.
Article 44
Monitoring and re-assessment of notified bodies
1.   Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated.
2.   The authorities responsible for notified bodies shall monitor the notified bodies established on their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its obligations set out in this Regulation. Notified bodies shall, upon request by their authority responsible for notified bodies, supply all relevant information and documents, required to enable the authority, the Commission and other Member States to verify compliance.
3.   Where the Commission or the authority of a Member State submits a request to a notified body established on the territory of another Member State relating to a conformity assessment carried out by that notified body, it shall send a copy of that request to the authority responsible for notified bodies of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The authority responsible for notified bodies of the Member State in which the body is established shall ensure that requests submitted by authorities of any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason for not doing so in which case the matter may be referred to the MDCG.
4.   At least once a year, the authorities responsible for notified bodies shall re-assess whether the notified bodies established on their respective territory and, where appropriate, the subsidiaries and subcontractors under the responsibility of those notified bodies still satisfy the requirements and fulfil their obligations set out in Annex VII. That review shall include an on-site audit of each notified body and, where necessary, of its subsidiaries and subcontractors.
The authority responsible for notified bodies shall conduct its monitoring and assessment activities according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular, associated subsidiaries and subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission.
5.   The monitoring of notified bodies by the authority responsible for notified bodies shall include observed audits of notified body personnel, including where necessary any personnel from subsidiaries and subcontractors, as that personnel is in the process of conducting quality management system assessments at a manufacturer's facility.
6.   The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider data arising from market surveillance, vigilance and post-market surveillance to help guide its activities.
The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and other information, including from other Member States, which may indicate non-fulfilment of the obligations by a notified body or its deviation from common or best practice.
7.   The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify compliance.
8.   The authority responsible for notified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in Article 45.
9.   The authority responsible for notified bodies shall document and record any findings regarding non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective and preventive actions.
10.   Three years after notification of a notified body, and again every fourth year thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team appointed for the purpose of the procedure described in Articles 38 and 39.
11.   The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend paragraph 10 to modify the frequency at which the complete re-assessment referred to in that paragraph is to be carried out.
12.   The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however it shall contain a summary which shall be made publicly available.
The summary of the report shall be uploaded to the electronic system referred to in Article 57.
Article 45
Review of notified body assessment of technical documentation and clinical evaluation documentation
1.   The authority responsible for notified bodies, as part of its ongoing monitoring of notified bodies, shall review an appropriate number of notified body assessments of manufacturers' technical documentation, in particular the clinical evaluation documentation as referred to in points (c) and (d) of Section 6.1 of Annex II to verify the conclusions drawn by the notified body based on the information presented by the manufacturer. The reviews by the authority responsible for notified bodies shall be conducted both off-site and on-site.
2.   The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the types and risk of devices certified by the notified body, in particular high-risk devices, and be appropriately justified and documented in a sampling plan, which shall be made available by the authority responsible for notified bodies to the MDCG upon request.
3.   The authority responsible for notified bodies shall review whether the assessment by the notified body was conducted appropriately and shall check the procedures used, associated documentation and the conclusions drawn by the notified body. Such checking shall include the technical documentation and clinical evaluation documentation of the manufacturer upon which the notified body has based its assessment. Such reviews shall be conducted utilising CS.
4.   Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 44(10) and the joint assessment activities referred to in Article 47(3). The reviews shall be conducted utilising appropriate expertise.
5.   Based on the reports of the reviews and assessments by the authority responsible for notified bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market surveillance activities described in Chapter VII, on the continuous monitoring of technical progress, or on the identification of concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that the sampling, carried out under this Article, cover a greater or lesser proportion of the technical documentation and clinical evaluation documentation assessed by a notified body.
6.   The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and clinical evaluation documentation, as referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 46
Changes to designations and notifications
1.   The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body.
The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.
For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.
2.   The Commission shall immediately publish the amended notification in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57.
3.   Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation.
4.   Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period.
The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation.
5.   Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days.
6.   In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request.
7.   In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall:
(a)
assess the impact on the certificates issued by the notified body;
(b)
submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
(c)
require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market;
(d)
enter into the electronic system referred to in Article 57 information in relation to certificates of which it has required their suspension or withdrawal;
(e)
inform the competent authority for medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 57 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others.
8.   With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances:
(a)
the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or
(b)
the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
9.   With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances:
(a)
where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and
(b)
another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation.
In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months.
The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
Article 47
Challenge to the competence of notified bodies
1.   The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in Annex VII or the obligations to which they are subject. It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns.
2.   The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned.
3.   The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described in Article 39(3) and (4), where there is reasonable concern about the ongoing compliance of a notified body or a subsidiary or subcontractor of the notified body with the requirements set out in Annex VII and where the investigation by the authority responsible for notified bodies is not deemed to have fully addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome of that assessment shall follow the principles of Article 39. Alternatively, depending on the severity of the issue, the Commission, in conjunction with the MDCG, may request that the authority responsible for notified bodies allow the participation of up to two experts from the list established pursuant to Article 40 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 44 and as outlined in the annual assessment plan described in Article 44(4).
4.   Where the Commission ascertains that a notified body no longer meets the requirements for its designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the designation if necessary.
Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the designation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 57.
5.   The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly.
Article 48
Peer review and exchange of experience between authorities responsible for notified bodies
1.   The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements including:
(a)
development of best practice documents relating to the activities of the authorities responsible for notified bodies;
(b)
development of guidance documents for notified bodies in relation to the implementation of this Regulation;
(c)
training and qualification of the experts referred to in Article 40;
(d)
monitoring of trends relating to changes to notified body designations and notifications and trends in certificate withdrawals and transfers between notified bodies;
(e)
monitoring of the application and applicability of scope codes referred to in Article 42(13);
(f)
development of a mechanism for peer reviews between authorities and the Commission;
(g)
methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.
2.   The authorities responsible for notified bodies shall participate in a peer review every third year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 39. Alternatively, an authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 44.
3.   The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism.
4.   The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available.
5.   The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanism and training and qualification as referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 49
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including 
in vitro
 diagnostic medical devices. This group shall meet on a regular basis and at least annually.
The bodies notified under this Regulation shall participate in the work of that group.
The Commission may establish the specific arrangements for the functioning of the coordination group of notified bodies.
Article 50
List of standard fees
Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.
CHAPTER V
CLASSIFICATION AND CONFORMITY ASSESSMENT
SECTION 1
Classification
Article 51
Classification of devices
1.   Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII.
2.   Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body.
The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request.
3.   At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following:
(a)
application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices;
(b)
that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII.
4.   The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3.
5.   In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
6.   The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 114(3).
SECTION 2
Conformity assessment
Article 52
Conformity assessment procedures
1.   Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
2.   Prior to putting into service a device that is not placed on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
3.   Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.
4.   Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.
However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.
Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.
5.   Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom.
6.   Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device for each category of devices.
Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The assessment of the technical documentation shall apply for at least one representative device for each category of devices.
7.   Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited:
(a)
in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions;
(b)
in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements;
(c)
in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
8.   Manufacturers of custom-made devices shall follow the procedure set out in Annex XIII and draw up the statement set out in Section 1 of that Annex before placing such devices on the market.
In addition to the procedure applicable pursuant to the first subparagraph, manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment as specified in Chapter I of Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Part A of Annex XI.
9.   In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of devices referred to in the first subparagraph of Article 1(8), the procedure specified in Section 5.2 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
10.   In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of devices that are covered by this Regulation in accordance with point (f) or (g) of Article 1(6) and with the first subparagraph of Article 1(10), the procedure specified in Section 5.3 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
11.   In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7, in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the procedure specified in Section 5.4 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
12.   The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body.
13.   Investigational devices shall be subject to the requirements set out in Articles 62 to 81.
14.   The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects:
(a)
the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in the third paragraph of Section 2.3 and in Section 3.5 of Annex IX in the case of class IIa and class IIb devices, and in Section 10.2 of Annex XI in the case of class IIa devices;
(b)
the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;
(c)
the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of the technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX, Section 3 of Annex X and Section 15 of Annex XI.
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 53
Involvement of notified bodies in conformity assessment procedures
1.   Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.
2.   The notified body concerned shall, by means of the electronic system referred to in Article 57, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body's decision regarding the conformity assessment.
3.   When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn an application with another notified body prior to the decision of that notified body and provide information about any previous application for the same conformity assessment that has been refused by another notified body.
4.   The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure.
5.   Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities.
Article 54
Clinical evaluation consultation procedure for certain class III and class IIb devices
1.   In addition to the procedures applicable pursuant to Article 52, a notified body shall also follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the following devices:
(a)
class III implantable devices, and
(b)
class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12).
2.   The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
(a)
in the case of renewal of a certificate issued under this Regulation;
(b)
where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or
(c)
where the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
3.   The notified body shall notify the competent authorities, the authority responsible for notified bodies and the Commission through the electronic system referred to in Article 57 of whether or not the procedure referred to in paragraph 1 of this Article is to be applied. That notification shall be accompanied by the clinical evaluation assessment report.
4.   The Commission shall draw up an annual overview of devices which have been subject to the procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of Annex X. The annual overview shall include the notifications in accordance with paragraph 3 of this Article and point (e) of Section 5.1 of Annex IX and a listing of the cases where the notified body did not follow the advice from the expert panel. The Commission shall submit this overview to the European Parliament, to the Council and to the MDCG.
5.   The Commission shall by 27 May 2025 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. The report shall take into account the annual overviews and any available relevant recommendations from the MDCG. On the basis of that report the Commission shall, if appropriate, make proposals for amendments to this Regulation.
Article 55
Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
1.   A notified body shall notify the competent authorities of certificates it has granted to devices for which the conformity assessment has been performed pursuant to Article 54(1). Such notification shall take place through the electronic system referred to in Article 57 and shall include the summary of safety and clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the case of divergent views between the notified body and the expert panels, a full justification shall also be included.
2.   A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate measures in accordance with Articles 95 and 97.
3.   The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device.
Article 56
Certificates of conformity
1.   The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates shall be as set out in Annex XII.
2.   The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
3.   Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or require manufacturers to undertake specific PMCF studies pursuant to Part B of Annex XIV.
4.   Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision.
5.   The notified body shall enter in the electronic system referred to in Article 57 any information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. Such information shall be accessible to the public.
6.   In the light of technical progress, the Commission is empowered to adopt delegated acts in accordance with Article 115 amending the minimum content of the certificates set out in Annex XII.
Article 57
Electronic system on notified bodies and on certificates of conformity
1.   The Commission, after consulting the MDCG, shall set up and manage an electronic system to collate and process the following information:
(a)
the list of subsidiaries referred to in Article 37(3);
(b)
the list of experts referred to in Article 40(2);
(c)
the information relating to the notification referred to in Article 42(10) and the amended notifications referred to in Article 46(2);
(d)
the list of notified bodies referred to in Article 43(2);
(e)
the summary of the report referred to in Article 44(12);
(f)
the notifications for conformity assessments and certificates referred to in Articles 54(3) and 55(1);
(g)
withdrawal or refusals of applications for the certificates as referred to in Article 53(2) and Section 4.3 of Annex VII;
(h)
the information regarding certificates referred to in Article 56(5);
(i)
the summary of safety and clinical performance referred to in Article 32.
2.   The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission, where appropriate to the notified bodies and where provided elsewhere in this regulation or in Regulation (EU) 2017/746 to the public.
Article 58
Voluntary change of notified body
1.   In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:
(a)
the date on which the certificates issued by the outgoing notified body become invalid;
(b)
the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material;
(c)
the transfer of documents, including confidentiality aspects and property rights;
(d)
the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body;
(e)
the last serial number or lot number for which the outgoing notified body is responsible.
2.   The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.
Article 59
Derogation from the conformity assessment procedures
1.   By way of derogation from Article 52, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety or health.
2.   The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient.
3.   Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 114(4).
Article 60
Certificate of free sale
1.   For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE marking in accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 29. Where a notified body has issued a certificate pursuant to Article 56, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII.
2.   The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).
CHAPTER VI
CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
Article 61
Clinical evaluation
1.   Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.
The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.
To that end, manufacturers shall plan, conduct and document a clinical evaluation in accordance with this Article and Part A of Annex XIV.
2.   For all class III devices and for the class IIb devices referred to in point (b) of Article 54(1), the manufacturer may, prior to its clinical evaluation and/or investigation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer's intended clinical development strategy and proposals for clinical investigation. The manufacturer shall give due consideration to the views expressed by the expert panel. Such consideration shall be documented in the clinical evaluation report referred to in paragraph 12 of this Article.
The manufacturer may not invoke any rights to the views expressed by the expert panel with regard to any future conformity assessment procedure.
3.   A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
(a)
a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied:
—
it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, in accordance with Section 3 of Annex XIV, and
—
the data adequately demonstrate compliance with the relevant general safety and performance requirements;
(b)
a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and
(c)
a consideration of currently available alternative treatment options for that purpose, if any.
4.   In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:
—
the device has been designed by modifications of a device already marketed by the same manufacturer,
—
the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
—
the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.
In this case, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.
In addition, clinical investigations need not be performed in the cases referred to in paragraph 6.
5.   A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:
—
the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis, and
—
the original clinical evaluation has been performed in compliance with the requirements of this Regulation,
and the manufacturer of the second device provides clear evidence thereof to the notified body.
6.   The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices:
(a)
which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
—
is based on sufficient clinical data, and
—
is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available; or
(b)
that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available.
7.   Cases in which paragraph 4 is not applied by virtue of paragraph 6 shall be justified in the clinical evaluation report by the manufacturer and in the clinical evaluation assessment report by the notified body.
8.   Where justified in view of well-established technologies, similar to those used in the exempted devices listed in point (b) of paragraph 6 of this Article, being used in other devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list of exempted devices referred to in the second subparagraph of Article 52(4) and in point (b) of paragraph 6 of this Article, by adding other types of implantable or class III devices to that list or removing devices therefrom.
9.   In the case of the products without an intended medical purpose listed in Annex XVI, the requirement to demonstrate a clinical benefit in accordance with this Chapter and Annexes XIV and XV shall be understood as a requirement to demonstrate the performance of the device. Clinical evaluations of those products shall be based on relevant data concerning safety, including data from post-market surveillance, PMCF, and, where applicable, specific clinical investigation. Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.
10.   Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate.
11.   The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.
For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with such data.
12.   The clinical evaluation, its results and the clinical evidence derived from it shall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device concerned.
13.   Where necessary to ensure the uniform application of Annex XIV, the Commission may, having due regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 62
General requirements regarding clinical investigations conducted to demonstrate conformity of devices
1.   Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment purposes, for one or more of the following purposes:
(a)
to establish and verify that, under normal conditions of use, a device is designed, manufactured and packaged in such a way that it is suitable for one or more of the specific purposes listed in point (1) of Article 2, and achieves the performance intended as specified by its manufacturer;
(b)
to establish and verify the clinical benefits of a device as specified by its manufacturer;
(c)
to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.
2.   Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor.
Member States may choose not to apply the first subparagraph to clinical investigations to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical investigation who shall be the addressee for all communications with the sponsor provided for in this Regulation.
3.   Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in a clinical investigation are protected and prevail over all other interests and the clinical data generated are scientifically valid, reliable and robust.
Clinical investigations shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a clinical investigation. At least one lay person shall participate in the ethical review.
4.   A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
(a)
the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;
(b)
an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law;
(c)
the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the Union;
(d)
vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;
(e)
the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
(f)
the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent in accordance with Article 63;
(g)
the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;
(h)
the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
(i)
the clinical investigation has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the clinical investigation plan and constantly monitored;
(j)
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner or any other person entitled by national law to provide the relevant patient care under clinical investigation conditions;
(k)
no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the clinical investigation;
(l)
the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, technical and biological safety testing and pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;
(m)
the requirements of Annex XV are fulfilled.
5.   Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the clinical investigation at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal.
6.   The investigator shall be a person exercising a profession which is recognised in the Member State concerned as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care. Other personnel involved in conducting a clinical investigation shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.
7.   The facilities where the clinical investigation is to be conducted shall be suitable for the clinical investigation and shall be similar to the facilities where the device is intended to be used.
Article 63
Informed consent
1.   Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2. Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent document. The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent has been given. The informed consent shall be documented. Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the clinical investigation.
2.   Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
(a)
enable the subject or his or her legally designated representative to understand:
(i)
the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigations;
(ii)
the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the clinical investigation at any time without any resulting detriment and without having to provide any justification;
(iii)
the conditions under which the clinical investigations is to be conducted, including the expected duration of the subject's participation in the clinical investigation; and
(iv)
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation is discontinued;
(b)
be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;
(c)
be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law;
(d)
include information about the applicable damage compensation system referred to in Article 69; and
(e)
include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and information about the availability of the clinical investigation results in accordance with paragraph 6 of this Article.
3.   The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.
4.   In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information.
5.   In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.
6.   The subject shall be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be made available pursuant to Article 77(5) in the electronic system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical investigation, and shall be informed, to the extent possible, when they have become available.
7.   This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a clinical investigation.
Article 64
Clinical investigations on incapacitated subjects
1.   In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical investigation may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
(a)
the informed consent of their legally designated representative has been obtained;
(b)
the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in view of their capacity to understand it;
(c)
the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;
(d)
no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;
(e)
the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
(f)
the clinical investigation relates directly to a medical condition from which the subject suffers;
(g)
there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
2.   The subject shall as far as possible take part in the informed consent procedure.
Article 65
Clinical investigations on minors
A clinical investigation on minors may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
(a)
the informed consent of their legally designated representative has been obtained;
(b)
the minors have received the information referred to in Article 63(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;
(c)
the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;
(d)
no incentives or financial inducements are given to the subject or his or her legally designated representative except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;
(e)
the clinical investigation is intended to investigate treatments for a medical condition that only occurs in minors or the clinical investigation is essential with respect to minors to validate data obtained in clinical investigations on persons able to give informed consent or by other research methods;
(f)
the clinical investigation either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;
(g)
there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the minor subject outweighing the risks and burdens involved;
(h)
the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity;
(i)
if during a clinical investigation the minor reaches the age of legal competence to give informed consent as defined in national law, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical investigation.
Article 66
Clinical investigations on pregnant or breastfeeding women
A clinical investigation on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
(a)
the clinical investigation has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
(b)
where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child;
(c)
no incentives or financial inducements are given to the subject except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation.
Article 67
Additional national measures
Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical investigations, or persons in residential care institutions.
Article 68
Clinical investigations in emergency situations
1.   By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical investigation may be obtained, and information on the clinical investigation may be given, after the decision to include the subject in the clinical investigation, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical investigation plan for that clinical investigation and that all of the following conditions are fulfilled:
(a)
due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the clinical investigation;
(b)
there are scientific grounds to expect that participation of the subject in the clinical investigation will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition;
(c)
it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative;
(d)
the investigator certifies that he or she is not aware of any objections to participate in the clinical investigation previously expressed by the subject;
(e)
the clinical investigation relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the clinical investigation is of such a nature that it may be conducted exclusively in emergency situations;
(f)
the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.
2.   Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article 63 shall be sought to continue the participation of the subject in the clinical investigation, and information on the clinical investigation shall be given, in accordance with the following requirements:
(a)
regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 63(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
(b)
regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever can be done sooner, and the information referred to in Article 63(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable.
For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent.
3.   If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object to the use of data obtained from the clinical investigation.
Article 69
Damage compensation
1.   Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical investigation conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.
2.   The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State in which the clinical investigation is conducted.
Article 70
Application for clinical investigations
1.   The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the clinical investigation is to be conducted (referred to for the purposes of this Article as ‘Member State concerned’) accompanied by the documentation referred to in Chapter II of Annex XV.
The application shall be submitted by means of the electronic system referred to in Article 73, which shall generate a Union-wide unique single identification number for the clinical investigation, which shall be used for all relevant communication in relation to that clinical investigation. Within 10 days of it receiving the application, the Member State concerned shall notify the sponsor as to whether the clinical investigation falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter II of Annex XV.
2.   Within one week of any change occurring in relation to the documentation referred to in Chapter II of Annex XV, the sponsor shall update the relevant data in the electronic system referred to in Article 73 and make that change to the documentation clearly identifiable. The Member State concerned shall be notified of the update by means of that electronic system.
3.   Where the Member State concerned finds that the clinical investigation applied for does not fall within the scope of this Regulation or that the application dossier is not complete, it shall inform the sponsor thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 73. The Member State concerned may extend this period by a maximum of 20 days where appropriate.
Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers the application does fall under the scope of this Regulation and/or is complete but the Member State concerned does not, the application shall be considered to have been rejected. The Member State concerned shall provide for an appeal procedure in respect of such refusal.
The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the clinical investigation is considered as falling within the scope of this Regulation and the application is complete.
4.   The Member State concerned may also extend the period referred to in paragraph 1 and 3 each by a further five days.
5.   For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively.
6.   During the period when the application is being assessed, the Member State may request additional information from the sponsor. The expiry of the period laid down in point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received.
7.   The sponsor may start the clinical investigation in the following circumstances:
(a)
in the case of investigational class I devices or in the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation;
(b)
in the case of investigational devices, other than those referred to in point (a), as soon as the Member State concerned has notified the sponsor of its authorisation, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.
8.   The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter II of Annex XV.
9.   In order to ensure the uniform application of the requirements laid down in Chapter II of Annex XV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 71
Assessment by Member States
1.   Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons financing the clinical investigation, as well as free of any other undue influence.
2.   Member States shall ensure that the assessment is done jointly by an appropriate number of persons who collectively have the necessary qualifications and experience.
3.   Member States shall assess whether the clinical investigation is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected. They shall, while taking into account applicable CS or harmonised standards, examine in particular:
(a)
the demonstration of compliance of the investigational device(s) with the applicable general safety and performance requirements, apart from the aspects covered by the clinical investigation, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, assurance of technical and biological safety testing and pre-clinical evaluation;
(b)
whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by harmonised standards;
(c)
whether the measures planned for the safe installation, putting into service and maintenance of the investigational device are adequate;
(d)
the reliability and robustness of the data generated in the clinical investigation, taking account of statistical approaches, design of the investigation and methodological aspects, including sample size, comparator and endpoints;
(e)
whether the requirements of Annex XV are met;
(f)
in the case of devices for sterile use, evidence of the validation of the manufacturer's sterilisation procedures or information on the reconditioning and sterilisation procedures which have to be conducted by the investigation site;
(g)
the demonstration of the safety, quality and usefulness of any components of animal or human origin or of substances, which may be considered medicinal products in accordance with Directive 2001/83/EC.
4.   Member States shall refuse the authorisation of the clinical investigation if:
(a)
the application dossier submitted pursuant to Article 70(1) remains incomplete;
(b)
the device or the submitted documents, especially the investigation plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the clinical investigation, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients,
(c)
the requirements of Article 62 are not met, or
(d)
any assessment under paragraph 3 is negative.
Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph.
Article 72
Conduct of a clinical investigation
1.   The sponsor and the investigator shall ensure that the clinical investigation is conducted in accordance with the approved clinical investigation plan.
2.   In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical investigation is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a clinical investigation. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the clinical investigation including the following:
(a)
the objective and methodology of the clinical investigation; and
(b)
the degree of deviation of the intervention from normal clinical practice.
3.   All clinical investigation information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.
4.   Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network.
5.   Member States shall inspect, at an appropriate level, investigation site(s) to check that clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
6.   The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the investigation.
Article 73
Electronic system on clinical investigations
1.   The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system:
(a)
to create the single identification numbers for clinical investigations referred to in Article 70(1);
(b)
to be used as an entry point for the submission of all applications or notifications for clinical investigations referred to in Articles 70, 74, 75 and 78 and for all other submission of data, or processing of data in this context;
(c)
for the exchange of information relating to clinical investigations in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in Articles 70 and 76;
(d)
for information to be provided by the sponsor in accordance with Article 77, including the clinical investigation report and its summary as required in paragraph 5 of that Article;
(e)
for reporting on serious adverse events and device deficiencies and related updates referred to in Article 80.
2.   When setting up the electronic system referred in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council 
(
37
)
 as concerns combined clinical investigations of devices with a clinical trial under that Regulation.
3.   The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission. The information referred to in the other points of that paragraph shall be accessible to the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds:
(a)
protection of personal data in accordance with Regulation (EC) No 45/2001;
(b)
protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an overriding public interest in disclosure;
(c)
effective supervision of the conduct of the clinical investigation by the Member State(s) concerned.
4.   No personal data of subjects shall be publicly available.
5.   The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union.
Article 74
Clinical investigations regarding devices bearing the CE marking
1.   Where a clinical investigation is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), (‘PMCF investigation’), and where the investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 73. The sponsor shall include the documentation referred to in Chapter II of Annex XV as part of the notification. Points (b) to (k) and (m) of Article 62(4), Article 75, Article 76, Article 77, Article 80(5) and the relevant provisions of Annex XV shall apply to PMCF investigations.
2.   Where a clinical investigation is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), Articles 62 to 81 shall apply.
Article 75
Substantial modifications to clinical investigations
1.   If a sponsor intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, it shall notify, within one week, by means of the electronic system referred to in Article 73 the Member State(s) in which the clinical investigation is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Chapter II of Annex XV as part of the notification. Changes to the relevant documentation shall be clearly identifiable.
2.   The Member State shall assess any substantial modification to the clinical investigation in accordance with the procedure laid down in Article 71.
3.   The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in that paragraph, unless:
(a)
the Member State in which the clinical investigation is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 71(4) or on considerations of public health, subject and user safety or health, of public policy, or
(b)
an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the clinical investigation, which, in accordance with national law, is valid for that entire Member State.
4.   The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts.
Article 76
Corrective measures to be taken by Member States and information exchange between Member States
1.   Where a Member State in which a clinical investigation is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures on its territory:
(a)
revoke the authorisation for the clinical investigation;
(b)
suspend or terminate the clinical investigation;
(c)
require the sponsor to modify any aspect of the clinical investigation.
2.   Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion. That opinion shall be delivered within seven days.
3.   Where a Member State has taken a measure referred to in paragraph 1 of this Article or has refused a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds, that Member State shall communicate the corresponding decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 73.
4.   Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 73 to all Member States and the Commission.
Article 77
Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
1.   If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation early, it shall inform within 15 days the Member State in which that clinical investigation has been temporarily halted or terminated early, through the electronic system referred to in Article 73, of the temporary halt or early termination, providing a justification. In the event that the sponsor has temporarily halted or terminated early the clinical investigation on safety grounds, it shall inform all Member States in which that clinical investigation is being conducted thereof within 24 hours.
2.   The end of a clinical investigation shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the clinical investigation plan.
3.   The sponsor shall notify each Member State in which a clinical investigation was being conducted of the end of that clinical investigation in that Member State. That notification shall be made within 15 days of the end of the clinical investigation in relation to that Member State.
4.   If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation was conducted of the end of the clinical investigation in all Member States. That notification shall be made within 15 days of that end of the clinical investigation.
5.   Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a clinical investigation was conducted a clinical investigation report as referred to in Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV.
The clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 73.
Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year of the end of the investigation, it shall be submitted as soon as it is available. In such case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XV shall specify when the results of the clinical investigation are going to be available, together with a justification.
6.   The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.
In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.
7.   The summary and the clinical investigation report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 73, at the latest when the device is registered in accordance with Article 29 and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission.
If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time.
Article 78
Coordinated assessment procedure for clinical investigations
1.   By means of the electronic system referred to in Article 73, the sponsor of a clinical investigation to be conducted in more than one Member State may submit, for the purpose of Article 70, a single application that, upon receipt, is transmitted electronically to all Member States in which the clinical investigation is to be conducted.
2.   The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States in which the clinical investigation is to be conducted acts as coordinating Member State. The Member States in which the clinical investigation is to be conducted shall, within six days of submission of the application, agree on one of them taking the role of the coordinating Member State. If they do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that role.
3.   Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shall coordinate their assessment of the application, in particular of the documentation referred to in Chapter II of Annex XV.
However, the completeness of the documentation referred to in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV shall be assessed separately by each Member State concerned in accordance with Article 70(1) to (5).
4.   With regard to documentation other than that referred to in the second subparagraph of paragraph 3, the coordinating Member State shall:
(a)
within six days of receipt of the single application, notify the sponsor that it is the coordinating Member State (‘notification date’);
(b)
for the purpose of the validation of the application, take into account any considerations submitted within seven days of the notification date by any Member State concerned;
(c)
within 10 days of the notification date, assess whether the clinical investigation falls within the scope of this Regulation and whether the application is complete, and shall notify the sponsor accordingly. Article 70(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment;
(d)
establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the validation date to the Member States concerned. By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned.
The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's application in accordance with Article 70(7).
5.   As regards the assessment of the documentation referred to in the second subparagraph of paragraph 3, each Member State concerned may request, on a single occasion, additional information from the sponsor. The sponsor shall submit the requested additional information within the period set by the Member State concerned, which shall not exceed 12 days from the receipt of the request. The expiry of the last deadline pursuant to point (d) of paragraph 4 shall be suspended from the date of the request until such time as the additional information has been received.
6.   For class IIb and class III devices, the coordinating Member State may also extend the periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts.
7.   The Commission may, by means of implementing acts, further specify the procedures and timescales for coordinated assessments to be taken into account by Member States concerned when deciding on the sponsor's application. Such implementing acts may also set out the procedures and timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of this Article, in the case of reporting of adverse events pursuant to Article 80(4) and in the case of clinical investigations of combination products between medical devices and medicinal products, where the latter are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
8.   Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the conduct of the clinical investigation is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member States concerned.
Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds:
(a)
when it considers that participation in the clinical investigation would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned;
(b)
infringement of national law; or
(c)
considerations as regards subject safety and data reliability and robustness submitted under point (b) of paragraph 4.
Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed justification, through the electronic system referred to in Article 73, to the Commission, to all other Member States concerned and to the sponsor.
9.   Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the clinical investigation is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.
10.   A Member State concerned shall refuse to authorise a clinical investigation if it disagrees with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV are not complied with, or where an ethics committee has issued a negative opinion in relation to that clinical investigation, which is valid, in accordance with national law, for that entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal.
11.   Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 73 as to whether the clinical investigation is authorised, whether it is authorised subject to conditions, or whether authorisation has been refused. Notification shall be done by way of one single decision within five days of the transmission, pursuant to point (d) of paragraph 4, by the coordinating Member State of the final assessment report. Where an authorisation of a clinical investigation is subject to conditions, those conditions may only be such that, by their nature, they cannot be fulfilled at the time of that authorisation.
12.   Any substantial modifications as referred to in Article 75 shall be notified to the Member States concerned by means of the electronic system referred to in Article 73. Any assessment as to whether there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State, except for substantial modifications concerning Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by each Member State concerned.
13.   The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter.
14.   The procedure set out in this Article shall, until 27 May 2027, be applied only by those of the Member States in which the clinical investigation is to be conducted which have agreed to apply it. After 27 May 2027, all Member States shall be required to apply that procedure.
Article 79
Review of coordinated assessment procedure
By 27 May 2026, the Commission shall submit to the European Parliament and to the Council a report on experience gained from the application of Article 78 and, if necessary, propose a review of Article 78(14) and point (h) of Article 123(3).
Article 80
Recording and reporting of adverse events that occur during clinical investigations
1.   The sponsor shall fully record all of the following:
(a)
any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;
(b)
any serious adverse event;
(c)
any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
(d)
any new findings in relation to any event referred to in points (a) to (c).
2.   The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in Article 73:
(a)
any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;
(b)
any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
(c)
any new findings in relation to any event referred to in points (a) and (b).
The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
Upon request by any Member State in which the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1.
3.   The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a clinical investigation is performed under the same clinical investigation plan as the one applying to a clinical investigation covered by this Regulation by means of the electronic system referred to in Article 73.
4.   In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 78, the sponsor shall report any event as referred to in paragraph 2 of this Article by means of the electronic system referred to in Article 73. Upon receipt, this report shall be transmitted electronically to all Member States in which the clinical investigation is being conducted.
Under the direction of the coordinating Member State referred to in Article 78(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate the clinical investigation or whether to revoke the authorisation for that clinical investigation.
This paragraph shall not affect the rights of the other Member States to perform their own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any such measures.
5.   In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply instead of this Article.
6.   Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding investigational procedure has been established.
Article 81
Implementing acts
The Commission may, by means of implementing acts, establish the detailed arrangements and procedural aspects necessary for the implementation of this Chapter as regards the following:
(a)
harmonised electronic forms for the application for clinical investigations and their assessment as referred to in Articles 70 and 78, taking into account specific categories or groups of devices;
(b)
the functioning of the electronic system referred to in Article 73;
(c)
harmonised electronic forms for the notification of PMCF investigations as referred to in Article 74(1), and of substantial modifications as referred to in Article 75;
(d)
the exchange of information between Member States as referred to in Article 76;
(e)
harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 80;
(f)
the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in Article 80;
(g)
uniform application of the requirements regarding the clinical evidence or data needed to demonstrate compliance with the general safety and performance requirements set out in Annex I.
The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 82
Requirements regarding other clinical investigations
1.   Clinical investigations, not performed pursuant to any of the purposes listed in Article 62(1), shall comply with the provisions of Article 62 (2) and (3), points (b), (c), (d), (f), (h), and (l) of Article 62(4) and Article 62(6).
2.   In order to protect the rights, safety, dignity and well-being of subjects and the scientific and ethical integrity of clinical investigations not performed for any of the purposes listed in Article 62(1), each Member State shall define any additional requirements for such investigations, as appropriate for each Member State concerned.
CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
SECTION 1
Post-market surveillance
Article 83
Post-market surveillance system of the manufacturer
1.   For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(9).
2.   The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.
3.   Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
(a)
to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
(b)
to update the design and manufacturing information, the instructions for use and the labelling;
(c)
to update the clinical evaluation;
(d)
to update the summary of safety and clinical performance referred to in Article 32;
(e)
for the identification of needs for preventive, corrective or field safety corrective action;
(f)
for the identification of options to improve the usability, performance and safety of the device;
(g)
when relevant, to contribute to the post-market surveillance of other devices; and
(h)
to detect and report trends in accordance with Article 88.
The technical documentation shall be updated accordingly.
4.   If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87.
Article 84
Post-market surveillance plan
The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.
Article 85
Post-market surveillance report
Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.
Article 86
Periodic safety update report
1.   Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
(a)
the conclusions of the benefit-risk determination;
(b)
the main findings of the PMCF; and
(c)
the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.
Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.
For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.
2.   For class III devices or implantable devices, manufacturers shall submit PSURs by means of the electronic system referred to in Article 92 to the notified body involved in the conformity assessment in accordance with Article 52. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
3.   For devices other than those referred to in paragraph 2, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
SECTION 2
Vigilance
Article 87
Reporting of serious incidents and field safety corrective actions
1.   Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:
(a)
any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88;
(b)
any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.
The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 92.
2.   As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident.
3.   Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.
4.   Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.
5.   Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.
6.   Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report.
7.   If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it shall nevertheless submit a report within the timeframe required in accordance with paragraphs 2 to 5.
8.   Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being undertaken.
9.   For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the coordinating competent authority referred to in Article 89(9), in consultation with the competent authorities referred to in point (a) of Article 92(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent authority is referred to in points (a) and (b) of Article 92(8), the manufacturer may provide periodic summary reports following agreement with that competent authority.
10.   The Member States shall take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities suspected serious incidents referred to in point (a) of paragraph 1.
The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients.
11.   Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.
Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 89.
Where the manufacturer of the device concerned considers that the incident is not a serious incident or is an expected undesirable side-effect, which will be covered by trend reporting in accordance with Article 88, it shall provide an explanatory statement. If the competent authority does not agree with the conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance with Article 89.
Article 88
Trend reporting
1.   Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.
The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.
2.   The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures.
Article 89
Analysis of serious incidents and field safety corrective actions
1.   Following the reporting of a serious incident pursuant to Article 87(1), the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned. This shall include a risk assessment of the incident and field safety corrective action taking into account criteria as referred to in paragraph 3 of this Article as appropriate.
The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned during the investigations referred to in the first subparagraph and shall not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
2.   Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory, or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 87 is evaluated centrally at national level by their competent authority, if possible together with the manufacturer, and, where relevant, the notified body concerned.
3.   In the context of the evaluation referred to in paragraph 2, the competent authority shall evaluate the risks arising from the reported serious incident and evaluate any related field safety corrective actions, taking into account the protection of public health and criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of direct or indirect harm, the severity of that harm, the clinical benefit of the device, intended and potential users, and population affected. The competent authority shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other corrective action, in particular taking into account the principle of inherent safety contained in Annex I.
Upon request by the national competent authority, manufacturers shall provide all documents necessary for the risk assessment.
4.   The competent authority shall monitor the manufacturer's investigation of a serious incident. Where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent investigation.
5.   The manufacturer shall provide a final report to the competent authority setting out its findings from the investigation by means of the electronic system referred to in Article 92. The report shall set out conclusions and where relevant indicate corrective actions to be taken.
6.   In the case of devices referred to in the first subparagraph of Article 1(8) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall, inform the national competent authority or the EMA, depending on which issued the scientific opinion on that substance under Article 52(9), of that serious incident or field safety corrective action.
In the case of devices covered by this Regulation in accordance with point (g) of Article 1(6) and where the serious incident or field safety corrective action may be related to the derivatives of tissues or cells of human origin utilised for the manufacture of the device, and in the case of devices falling under this Regulation pursuant to Article 1(10), the competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall inform the competent authority for human tissues and cells that was consulted by the notified body in accordance with Article 52(10).
7.   After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating competent authority shall, through the electronic system referred to in Article 92, inform, without delay, the other competent authorities of the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident, including information on the underlying events and the outcome of its assessment.
8.   The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice. The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph 9, to the coordinating competent authority to allow it to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.
The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular, by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action. The field safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons, and shall clearly indicate all the actions to be taken by users.
The manufacturer shall enter the field safety notice in the electronic system referred to in Article 92 through which that notice shall be accessible to the public.
9.   The competent authorities shall actively participate in a procedure in order to coordinate their assessments referred to in paragraph 3 in the following cases:
(a)
where there is concern regarding a particular serious incident or cluster of serious incidents relating to the same device or type of device of the same manufacturer in more than one Member State;
(b)
where the appropriateness of a field safety corrective action that is proposed by a manufacturer in more than one Member State is in question.
That coordinated procedure shall cover the following:
—
designation of a coordinating competent authority on a case by case basis, when required;
—
defining the coordinated assessment process, including the tasks and responsibilities of the coordinating competent authority and the involvement of other competent authorities.
Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the competent authority of the Member State in which the manufacturer has its registered place of business.
The coordinating competent authority shall, through the electronic system referred to in Article 92, inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority.
10.   The designation of a coordinating competent authority shall not affect the rights of the other competent authorities to perform their own assessment and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating competent authority and the Commission shall be kept informed of the outcome of any such assessment and the adoption of any such measures.
11.   The Commission shall provide administrative support to the coordinating competent authority in the accomplishment of its tasks under this Chapter.
Article 90
Analysis of vigilance data
The Commission shall, in collaboration with the Member States, put in place systems and processes to actively monitor the data available in the electronic system referred to in Article 92, in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns.
Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating competent authority shall inform the manufacturer, or where applicable the authorised representative, which shall then take the necessary corrective actions.
Article 91
Implementing acts
The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the detailed arrangements and procedural aspects necessary for the implementation of Articles 85 to 90 and 92 as regards the following:
(a)
the typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices;
(b)
the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 85, 86, 87, 88 and 89 respectively;
(c)
standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting of suspected serious incidents by healthcare professionals, users and patients;
(d)
timelines for the reporting of field safety corrective actions, and for the provision by manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be reported as referred to in Article 87;
(e)
harmonised forms for the exchange of information between competent authorities as referred to in Article 89;
(f)
procedures for the designation of a coordinating competent authority; the coordinated evaluation process, including tasks and responsibilities of the coordinating competent authority and involvement of other competent authorities in this process.
The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 92
Electronic system on vigilance and on post-market surveillance
1.   The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information:
(a)
the reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 87(1) and Article 89(5);
(b)
the periodic summary reports by manufacturers referred to in Article 87(9);
(c)
the reports by manufacturers on trends referred to in Article 88;
(d)
the PSURs referred to in Article 86;
(e)
the field safety notices by manufacturers referred to in Article 89(8);
(f)
the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 89(7) and (9).
That electronic system shall include relevant links to the UDI database.
2.   The information referred to in paragraph 1 of this Article shall be made available through the electronic system to the competent authorities of the Member States and to the Commission. The notified bodies shall also have access to that information to the extent that it relates to devices for which they issued a certificate in accordance with Article 53.
3.   The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system referred to in paragraph 1.
4.   On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the electronic system referred to in paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union.
5.   The reports on serious incidents referred to in point (a) of Article 87(1) shall be automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the Member State in which the incident occurred.
6.   The trend reports referred to in Article 88(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the Member State in which the incidents occurred.
7.   The reports on field safety corrective actions referred to in point (b) of Article 87(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the following Member States:
(a)
the Member States in which the field safety corrective action is being or is to be undertaken;
(b)
the Member State in which the manufacturer has its registered place of business.
8.   The periodic summary reports referred to in Article 87(9) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of:
(a)
the Member State or Member States participating in the coordination procedure in accordance with Article 89(9) and which have agreed on the periodic summary report;
(b)
the Member State in which the manufacturer has its registered place of business.
9.   The information referred to in paragraphs 5 to 8 of this Article shall be automatically transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this Article, to the notified body that issued the certificate for the device in question in accordance with Article 56.
SECTION 3
Market surveillance
Article 93
Market surveillance activities
1.   The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples. The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints.
2.   The competent authorities shall draw up annual surveillance activity plans and allocate a sufficient number of material and competent human resources in order to carry out those activities taking into account the European market surveillance programme developed by the MDCG pursuant to Article 105 and local circumstances.
3.   In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
(a)
may require economic operators to, 
inter alia
, make available the documentation and information necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of devices or access to devices free of charge; and
(b)
shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users.
4.   The competent authorities shall prepare an annual summary of the results of their surveillance activities and make it accessible to other competent authorities by means of the electronic system referred to in Article 100.
5.   The competent authorities may confiscate, destroy or otherwise render inoperable devices that present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the protection of public health.
6.   Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority shall draw up a report on the findings of the inspection that concern compliance with the legal and technical requirements applicable under this Regulation. The report shall set out any corrective actions needed.
7.   The competent authority which carried out the inspection shall communicate the content of the report referred to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before adopting the final report, the competent authority shall give that economic operator the opportunity to submit comments. That final inspection report shall be entered in the electronic system provided for in Article 100.
8.   The Member States shall review and assess the functioning of their market surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. Each Member State shall make a summary of the results accessible to the public by means of the electronic system referred to in Article 100.
9.   The competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof, to provide for a harmonised and high level of market surveillance in all Member States.
Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint market surveillance activities and specialisation.
10.   Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions.
11.   Where appropriate, the competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance.
Article 94
Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
Where the competent authorities of a Member State, based on data obtained by vigilance or market surveillance activities or on other information, have reason to believe that a device:
(a)
may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or
(b)
otherwise does not comply with the requirements laid down in this Regulation,
they shall carry out an evaluation of the device concerned covering all requirements laid down in this Regulation relating to the risk presented by the device, or to any other non-compliance of the device.
The relevant economic operators shall cooperate with the competent authorities.
Article 95
Procedure for dealing with devices presenting an unacceptable risk to health and safety
1.   Where, having performed an evaluation pursuant to Article 94, the competent authorities find that the device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall without delay require the manufacturer of the devices concerned, its authorised representative and all other relevant economic operators to take all appropriate and duly justified corrective action to bring the device into compliance with the requirements of this Regulation relating to the risk presented by the device and, in a manner that is proportionate to the nature of the risk, to restrict the making available of the device on the market, to subject the making available of the device to specific requirements, to withdraw the device from the market, or to recall it, within a reasonable period that is clearly defined and communicated to the relevant economic operator.
2.   The competent authorities shall, without delay, notify the Commission, the other Member States and, where a certificate has been issued in accordance with Article 56 for the device concerned, the notified body that issued that certificate, of the results of the evaluation and of the actions which they have required the economic operators to take, by means of the electronic system referred to in Article 100.
3.   The economic operators as referred to in paragraph 1 shall, without delay, ensure that all appropriate corrective action is taken throughout the Union in respect of all the devices concerned that they have made available on the market.
4.   Where the economic operator as referred to in paragraph 1 does not take adequate corrective action within the period referred to in paragraph 1, the competent authorities shall take all appropriate measures to prohibit or restrict the making available of the device on their national market, to withdraw the device from that market or to recall it.
The competent authorities shall notify the Commission, the other Member States and the notified body referred to in paragraph 2 of this Article, without delay, of those measures, by means of the electronic system referred to in Article 100.
5.   The notification referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification and tracing of the non-compliant device, the origin of the device, the nature of and the reasons for the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
6.   Member States other than the Member State initiating the procedure shall, without delay, inform the Commission and the other Member States, by means of the electronic system referred to in Article 100, of any additional relevant information at their disposal relating to the non-compliance of the device concerned and of any measures adopted by them in relation to the device concerned.
In the event of disagreement with the notified national measure, they shall, without delay, inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 100.
7.   Where, within two months of receipt of the notification referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of any measures taken by a Member State, those measures shall be deemed to be justified.
In that case, all Member States shall ensure that corresponding appropriate restrictive or prohibitive measures, including withdrawing, recalling or limiting the availability of the device on their national market, are taken without delay in respect of the device concerned.
Article 96
Procedure for evaluating national measures at Union level
1.   Where, within two months of receipt of the notification referred to in Article 95(4), objections are raised by a Member State against a measure taken by another Member State, or where the Commission considers the measure to be contrary to Union law, the Commission shall, after consulting the competent authorities concerned and, where necessary, the economic operators concerned, evaluate that national measure. On the basis of the results of that evaluation, the Commission may decide, by means of implementing acts, whether or not the national measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
2.   Where the Commission considers the national measure to be justified as referred to in paragraph 1 of this Article, the second subparagraph of Article 95(7) shall apply. If the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure.
Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt of the notification referred to in Article 95(4), the national measure shall be considered to be justified.
3.   Where a Member State or the Commission considers that the risk to health and safety emanating from a device cannot be mitigated satisfactorily by means of measures taken by the Member State or Member States concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of implementing acts, the necessary and duly justified measures to ensure the protection of health and safety, including measures restricting or prohibiting the placing on the market and putting into service of the device concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 97
Other non-compliance
1.   Where, having performed an evaluation pursuant to Article 94, the competent authorities of a Member State find that a device does not comply with the requirements laid down in this Regulation but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance.
2.   Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph 1 of this Article, the Member State concerned shall, without delay, take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market. That Member State shall inform the Commission and the other Member States, without delay, of those measures, by means of the electronic system referred to in Article 100.
3.   In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 98
Preventive health protection measures
1.   Where a Member State, after having performed an evaluation which indicates a potential risk related to a device or a specific category or group of devices, considers that, in order to protect the health and safety of patients, users or other persons or other aspects of public health, the making available on the market or putting into service of a device or a specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled, it may take any necessary and justified measures.
2.   The Member State referred to in paragraph 1 shall immediately notify the Commission and all other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 100.
3.   The Commission, in consultation with the MDCG and, where necessary, the economic operators concerned, shall assess the national measures taken. The Commission may decide, by means of implementing acts, whether the national measures are justified or not. In the absence of a Commission decision within six months of their notification, the national measures shall be considered to be justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
4.   Where the assessment referred to in paragraph 3 of this Article demonstrates that the making available on the market or putting into service of a device, specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in all Member States in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission may adopt implementing acts to take the necessary and duly justified measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 99
Good administrative practice
1.   Any measure adopted by the competent authorities of the Member States pursuant to Articles 95 to 98 shall state the exact grounds on which it is based. Where such a measure is addressed to a specific economic operator, the competent authority shall notify without delay the economic operator concerned of that measure, and shall at the same time inform that economic operator of the remedies available under the law or the administrative practice of the Member State concerned and of the time limits to which such remedies are subject. Where the measure is of general applicability, it shall be appropriately published.
2.   Except in cases where immediate action is necessary for reasons of unacceptable risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time that is clearly defined before any measure is adopted.
Where action has been taken without the economic operator having had the opportunity to make submissions as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter.
3.   Any measure adopted shall be immediately withdrawn or amended upon the economic operator's demonstrating that it has taken effective corrective action and that the device is in compliance with the requirements of this Regulation.
4.   Where a measure adopted pursuant to Articles 95 to 98 concerns a device for which a notified body has been involved in the conformity assessment, the competent authorities shall by means of the electronic system referred to in Article 100 inform the relevant notified body and the authority responsible for the notified body of the measure taken.
Article 100
Electronic system on market surveillance
1.   The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
(a)
summaries of the results of the surveillance activities referred to in Article 93(4);
(b)
the final inspection report referred to in Article 93(7);
(c)
information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 95(2), (4) and (6);
(d)
information in relation to non-compliance of products as referred to in Article 97(2);
(e)
information in relation to the preventive health protection measures referred to in Article 98(2);
(f)
summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in 93(8).
2.   The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with Article 56 for the device concerned and be accessible to the Member States and to the Commission.
3.   Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States.
CHAPTER VIII
COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS
Article 101
Competent authorities
The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States shall communicate the names and contact details of the competent authorities to the Commission which shall publish a list of competent authorities.
Article 102
Cooperation
1.   The competent authorities of the Member States shall cooperate with each other and with the Commission. The Commission shall provide for the organisation of exchanges of information necessary to enable this Regulation to be applied uniformly.
2.   Member States shall, with the support of the Commission, participate, where appropriate, in initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical devices.
Article 103
Medical Device Coordination Group
1.   A Medical Device Coordination Group (‘MDCG’) is hereby established.
2.   Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one member and one alternate each with expertise in the field of medical devices, and one member and one alternate with expertise in the field of 
in vitro
 diagnostic medical devices. A Member State may choose to appoint only one member and one alternate, each with expertise in both fields.
The members of the MDCG shall be chosen for their competence and experience in the field of medical devices and 
in vitro
 diagnostic medical devices. They shall represent the competent authorities of the Member States. The names and affiliation of members shall be made public by the Commission.
The alternates shall represent and vote for the members in their absence.
3.   The MDCG shall meet at regular intervals and, where the situation requires, upon request by the Commission or a Member State. The meetings shall be attended either by the members appointed for their role and expertise in the field of medical devices, or by the members appointed for their expertise in the field of 
in vitro
 diagnostic medical devices, or by the members appointed for their expertise in both fields, or their alternates, as appropriate.
4.   The MDCG shall use its best endeavours to reach consensus. If such consensus cannot be reached, the MDCG shall decide by a majority of its members. Members with diverging positions may request that their positions and the grounds on which they are based be recorded in the MDCG's position.
5.   The MDCG shall be chaired by a representative of the Commission. The chair shall not take part in votes of the MDCG.
6.   The MDCG may invite, on a case-by-case basis, experts and other third parties to attend meetings or provide written contributions.
7.   The MDCG may establish standing or temporary sub-groups. Where appropriate, organisations representing the interests of the medical device industry, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to such sub-groups in the capacity of observers.
8.   The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
—
the adoption of opinions or recommendations or other positions, including in cases of urgency;
—
the delegation of tasks to reporting and co-reporting members;
—
the implementation of Article 107 regarding conflict of interests;
—
the functioning of sub-groups.
9.   The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99 of Regulation (EU) 2017/746.
Article 104
Support by the Commission
The Commission shall support the functioning of the cooperation between national competent authorities. It shall, in particular, provide for the organisation of exchanges of experience between the competent authorities and provide technical, scientific and logistic support to the MDCG and its sub-groups. It shall organise the meetings of the MDCG and its sub-groups, participate in those meetings and ensure the appropriate follow-up.
Article 105
Tasks of the MDCG
Under this Regulation, the MDCG shall have the following tasks:
(a)
to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV;
(b)
to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 49;
(c)
to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of clinical evaluations and investigations by manufacturers, assessment by notified bodies and vigilance activities;
(d)
to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and performance requirements laid down in this Regulation and Regulation (EU) 2017/746 are adequate to ensure safety and performance of devices, and thereby contribute to identifying whether there is a need to amend Annex I to this Regulation;
(e)
to contribute to the development of device standards, of CS and of scientific guidelines, including product specific guidelines, on clinical investigation of certain devices in particular implantable devices and class III devices;
(f)
to assist the competent authorities of the Member States in their coordination activities in particular in the fields of classification and the determination of the regulatory status of devices, clinical investigations, vigilance and market surveillance including the development and maintenance of a framework for a European market surveillance programme with the objective of achieving efficiency and harmonisation of market surveillance in the Union, in accordance with Article 93;
(g)
to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue related to the implementation of this Regulation;
(h)
to contribute to harmonised administrative practice with regard to devices in the Member States.
Article 106
Provision of scientific, technical and clinical opinions and advice
1.   The Commission shall, by means of implementing acts and in consultation with the MDCG, make provision for expert panels to be designated for the assessment of the clinical evaluation in relevant medical fields as referred to in paragraph 9 of this Article and to provide views in accordance with Article 48(6) of Regulation (EU) 2017/746 on the performance evaluation of certain 
in vitro
 diagnostic medical devices and, where necessary, for categories or groups of devices, or for specific hazards relating to categories or groups of devices, observing the principles of highest scientific competence, impartiality, independence and transparency. The same principles shall apply where the Commission decides to appoint expert laboratories in accordance with paragraph 7 of this Article.
2.   Expert panels and expert laboratories may be designated in areas where the Commission, in consultation with the MDCG, has identified a need for the provision of consistent scientific, technical and/or clinical advice or laboratory expertise in relation to the implementation of this Regulation. Expert panels and expert laboratories may be appointed on a standing or temporary basis.
3.   Expert panels shall consist of advisors appointed by the Commission on the basis of up-to-date clinical, scientific or technical expertise in the field and with a geographical distribution that reflects the diversity of scientific and clinical approaches in the Union. The Commission shall determine the number of members of each panel in accordance with the requisite needs.
The members of expert panels shall perform their tasks with impartiality and objectivity. They shall neither seek nor take instructions from notified bodies or manufacturers. Each member shall draw up a declaration of interests, which shall be made publicly available.
The Commission shall establish systems and procedures to actively manage and prevent potential conflicts of interest.
4.   Expert panels shall take into account relevant information provided by stakeholders including patients' organisations and healthcare professionals when preparing their scientific opinions.
5.   The Commission, following consultation with the MDCG, may appoint advisors to expert panels following publication in the 
Official Journal of the European Union
 and on the Commission website following a call for expressions of interest. Depending on the type of task and the need for specific expertise, advisors may be appointed to the expert panels for a maximum period of three years and their appointment may be renewed.
6.   The Commission, following consultation with the MDCG, may include advisors on a central list of available experts who, whilst not being formally appointed to a panel, are available to provide advice and to support the work of the expert panel as needed. That list shall be published on the Commission website.
7.   The Commission may, by means of implementing acts and following consultation with the MDCG, designate expert laboratories, on the basis of their expertise in:
—
physico-chemical characterisation, or
—
microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical biological and toxicological testing
of specific devices, categories or groups of devices.
The Commission shall only designate expert laboratories for which a Member State or the Joint Research Centre has submitted an application for designation.
8.   Expert laboratories shall satisfy the following criteria:
(a)
have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the devices for which they are designated;
(b)
possess the necessary equipment to carry out the tasks assigned to them;
(c)
have the necessary knowledge of international standards and best practices;
(d)
have an appropriate administrative organisation and structure;
(e)
ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks.
9.   Expert panels appointed for clinical evaluation in relevant medical fields shall fulfil the tasks provided for in Article 54(1) and Article 61(2) and Section 5.1 of Annex IX or Section 6 of Annex X, as applicable.
10.   Expert panels and expert laboratories may have the following tasks, depending on the requisite needs:
(a)
to provide scientific, technical and clinical assistance to the Commission and the MDCG in relation to the implementation of this Regulation;
(b)
to contribute to the development and maintenance of appropriate guidance and CS for:
—
clinical investigations,
—
clinical evaluation and PMCF,
—
performance studies,
—
performance evaluation and post-market performance follow-up,
—
physico-chemical characterisation, and
—
microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical toxicological testing
for specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices;
(c)
to develop and review clinical evaluation guidance and performance evaluation guidance for performance of conformity assessment in line with the state of the art with regard to clinical evaluation, performance evaluation, physico-chemical characterisation, and microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical toxicological testing;
(d)
to contribute to the development of standards at international level, ensuring that such standards reflect the state of the art;
(e)
to provide opinions in response to consultations by manufacturers in accordance with Article 61(2), notified bodies and Member States in accordance with paragraphs 11 to 13 of this Article.
(f)
to contribute to identification of concerns and emerging issues on the safety and performance of medical devices;
(g)
to provide views in accordance with Article 48(4) of Regulation (EU) 2017/746 on the performance evaluation of certain 
in vitro
 diagnostic medical devices.
11.   The Commission, shall facilitate the access of Member States and notified bodies and manufacturers to advice provided by expert panels and expert laboratories concerning, 
inter alia
, the criteria for an appropriate data set for assessment of the conformity of a device, in particular with regard to the clinical data required for clinical evaluation, with regard to physico-chemical characterisation, and with regard to microbiological, biocompatibility, mechanical, electrical, electronic and non-clinical toxicological testing.
12.   When adopting its scientific opinion in accordance with paragraph 9, the members of the expert panels shall use their best endeavours to reach consensus. If consensus cannot be reached, the expert panels shall decide by a majority of their members, and the scientific opinion shall mention the divergent positions and the grounds on which they are based.
The Commission shall publish the scientific opinion and advice delivered in accordance with paragraphs 9 and 11 of this Article, ensuring consideration of aspects of confidentiality as set out in Article 109. The clinical evaluation guidance referred to in point (c) of paragraph 10 shall be published following consultation with the MDCG.
13.   The Commission may require manufacturers and notified bodies to pay fees for the advice provided by expert panels and expert laboratories. The structure and the level of fees as well as the scale and structure of recoverable costs shall be adopted by the Commission by means of implementing acts, taking into account the objectives of the adequate implementation of this Regulation, protection of health and safety, support of innovation and cost-effectiveness and the necessity to achieve active participation in the expert panels. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
14.   The fees payable to the Commission in accordance with the procedure under paragraph 13 of this Article shall be set in a transparent manner and on the basis of the costs for the services provided. The fees payable shall be reduced in the case of a clinical evaluation consultation procedure initiated in accordance with point (c) of Section 5.1 of Annex IX involving a manufacturer who is a micro, small or medium-sized enterprise within the meaning of Recommendation 2003/361/EC.
15.   The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the tasks of expert panels and expert laboratories referred to in paragraph 10 of this Article.
Article 107
Conflict of interests
1.   Members of the MDCG, its sub-groups, and members of expert panels and expert laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner. They shall declare any direct or indirect interests they may have in the medical device industry and update that declaration whenever a relevant change occurs. The declaration of interests shall be made publicly available on the Commission website. This Article shall not apply to the representatives of stakeholder organisations participating in the sub-groups of the MDCG.
2.   Experts and other third parties invited by the MDCG on a case-by-case basis shall declare any interests they may have in the issue in question.
Article 108
Device registers and databanks
The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices, or the traceability of implantable devices, or all of such characteristics.
CHAPTER IX
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
Article 109
Confidentiality
1.   Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:
(a)
personal data, in accordance with Article 110;
(b)
commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights; unless disclosure is in the public interest;
(c)
the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.
2.   Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities and between competent authorities and the Commission shall not be disclosed without the prior agreement of the originating authority.
3.   Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
4.   The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Article 110
Data protection
1.   Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
2.   Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
Article 111
Levying of fees
1.   This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost-recovery principles.
2.   Member States shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted. The structure and level of fees shall be made publicly available on request.
Article 112
Funding of activities related to designation and monitoring of notified bodies
The costs associated with joint assessment activities shall be covered by the Commission. The Commission shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other necessary implementing rules. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 113
Penalties
The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those measures by 25 February 2020 and shall notify it, without delay, of any subsequent amendment affecting them.
CHAPTER X
FINAL PROVISIONS
Article 114
Committee procedure
1.   The Commission shall be assisted by a Committee on Medical Devices. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2.   Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
4.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or 5 thereof, as appropriate, shall apply.
Article 115
Exercise of the delegation
1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2.   The power to adopt delegated acts referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) shall be conferred on the Commission for a period of five years from 25 May 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3.   The delegation of power referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the 
Official Journal of the European Union
 or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6.   A delegated act adopted pursuant to Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Article 116
Separate delegated acts for different delegated powers
The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation.
Article 117
Amendment to Directive 2001/83/EC
In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
‘(12)
Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council
 (
*1
)
, a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.
If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.
Article 118
Amendment to Regulation (EC) No 178/2002
In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:
‘(i)
medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council
 (
*2
)
.
Article 119
Amendment to Regulation (EC) No 1223/2009
In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
‘4.   The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition ‘cosmetic product’. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).’.
Article 120
Transitional provisions
1.   From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
2.   Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022.
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024.
3.   By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.
Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified.
4.   Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.
5.   By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market prior to 26 May 2020.
6.   By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified prior 26 May 2020. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2020.
7.   As regards devices subject to the consultation procedure laid down in Article 54, paragraph 5 of this Article shall apply provided that the necessary appointments to the MDCG and expert panels have been made.
8.   By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to point (d) of Article 123(3) and ending 18 months later, comply with Article 29(4) and Article 56(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and with, respectively, point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of Directive 93/42/EEC as specified in Decision 2010/227/EU.
9.   Authorisations granted by the competent authorities of the Member States in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in the authorisation.
10.   Devices falling within the scope of this Regulation in accordance with points (f) and (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2020 may continue to be placed on the market and put into service in the Member States concerned.
11.   Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2020 may continue to be conducted. As of 26 May 2020, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.
12.   Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.
Article 121
Evaluation
By 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation report on the progress towards achievement of the objectives contained herein including an assessment of the resources required to implement this Regulation. Special attention shall be given to the traceability of medical devices through the storage, pursuant to Article 27, of the UDI by economic operators, health institutions and health professionals.
Article 122
Repeal
Without prejudice to Articles 120(3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2020, with the exception of:
—
Articles 8 and 10, points (b) and (c) of Article 10b(1), Article 10b(2) and Article 10b(3) of Directive 90/385/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
—
Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
—
Article 10, points (c) and (d) of Article 14a(1), Article 14a(2), Article 14a(3) and Article 15 of Directive 93/42/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation; and
—
Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in point (d) of Article 123(3) of this Regulation.
As regards the devices referred to in Article 120 (3) and (4) of this Regulation, the Directives referred to in the first paragraph shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs.
Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.
References to the repealed Directives shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XVII to this Regulation.
Article 123
Entry into force and date of application
1.   This Regulation shall enter into force on the twentieth day following that of its publication in the 
Official Journal of the European Union
.
2.   It shall apply from 26 May 2020.
3.   By way of derogation from paragraph 2:
(a)
Articles 35 to 50 shall apply from 26 November 2017. However, from that date until 26 May 2020, the obligations on notified bodies pursuant to Articles 35 to 50 shall apply only to those bodies which submit an application for designation in accordance with Article 38;
(b)
Articles 101 and 103 shall apply from 26 November 2017;
(c)
Article 102 shall apply from 26 May 2018;
(d)
without prejudice to the obligations on the Commission pursuant to Article 34, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1), Eudamed is not fully functional on 26 May 2020, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3). The provisions referred to in the preceding sentence are:
—
Article 29,
—
Article 31,
—
Article 32,
—
Article 33(4),
—
the second sentence of Article 40(2),
—
Article 42(10),
—
Article 43(2),
—
the second subparagraph of Article 44(12),
—
points (d) and (e) of Article 46(7),
—
Article 53(2),
—
Article 54(3),
—
Article 55(1),
—
Articles 70 to 77,
—
paragraphs 1 to 13 of Article 78,
—
Articles 79 to 82,
—
Article 86(2),
—
Articles 87 and 88,
—
Article 89(5) and (7), and the third subparagraph of Article 89(8),
—
Article 90,
—
Article 93(4), (7) and (8),
—
Article 95(2) and (4),
—
the last sentence of Article 97(2),
—
Article 99(4),
—
the second sentence of the first subparagraph of Article 120(3).
Until Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications.
(e)
Article 29(4) and Article 56(5) shall apply from 18 months after the later of the dates referred to in point (d);
(f)
for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices Article 27(4) shall apply from 26 May 2025;
(g)
for reusable devices that shall bear the UDI carrier on the device itself, Article 27(4) shall apply from two years after the date referred to in point (f) of this paragraph for the respective class of devices in that point;
(h)
The procedure set out in Article 78 shall apply from 26 May 2027, without prejudice to Article 78(14);
(i)
Article 120(12) shall apply from 26 May 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 5 April 2017.
For the European Parliament
The President
A. TAJANI
For the Council
The President
I. BORG
(
1
)
  Opinion of 14 February 2013 (
OJ C 133, 9.5.2013, p. 52
).
(
2
)
  Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of the Council at first reading of 7 March 2017 (not yet published in the Official Journal).
(
3
)
  Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (
OJ L 189, 20.7.1990, p. 17
).
(
4
)
  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (
OJ L 169, 12.7.1993, p. 1
).
(
5
)
  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (
OJ L 31, 1.2.2002, p. 1
).
(
6
)
  Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (
OJ L 342, 22.12.2009, p. 59
).
(
7
)
  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (
OJ L 311, 28.11.2001, p. 67
).
(
8
)
  Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (
OJ L 324, 10.12.2007, p. 121
).
(
9
)
  Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (
OJ L 102, 7.4.2004, p. 48
).
(
10
)
  Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (
OJ L 33, 8.2.2003, p. 30
).
(
11
)
  Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial (
OJ L 275, 20.10.2011, p. 38
).
(
12
)
  Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (
OJ L 96, 29.3.2014. p. 79
).
(
13
)
  Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (
OJ L 13, 17.1.2014, p. 1
).
(
14
)
  Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (
OJ L 241, 17.9.2015, p. 1
).
(
15
)
  Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (
OJ L 316, 14.11.2012, p. 12
).
(
16
)
  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on 
in vitro
 diagnostic medical devices (
OJ L 331, 7.12.1998, p. 1
).
(
17
)
  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (
OJ L 218, 13.8.2008, p. 30
).
(
18
)
  Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (
OJ L 218, 13.8.2008, p. 82
).
(
19
)
  Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (
OJ L 210, 7.8.1985, p. 29
).
(
20
)
  Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C-400/09 and C-207/10, ECLI:EU:C:2011:519.
(
21
)
  Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (
OJ L 102, 23.4.2010, p. 45
).
(
22
)
  Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (
OJ L 281, 23.11.1995, p. 31
).
(
23
)
  Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (
OJ L 8, 12.1.2001, p. 1
).
(
24
)
  Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (
OJ L 276, 20.10.2010, p. 33
).
(
25
)
  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on 
in vitro
 diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Official Journal).
(
26
)
  
            
OJ L 123, 12.5.2016, p. 1
.
(
27
)
  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (
OJ L 55, 28.2.2011, p. 13
).
(
28
)
  Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (
OJ L 72, 10.3.2012, p. 28
).
(
29
)
  Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (
OJ L 212, 9.8.2012, p. 3
).
(
30
)
  Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (
OJ L 28, 4.2.2003, p. 43
).
(
31
)
  Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (
OJ L 210, 12.8.2005, p. 41
).
(
32
)
  Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (
OJ L 253, 25.9.2013, p. 8
).
(
33
)
  
            
OJ C 358, 7.12.2013, p. 10
.
(
34
)
  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (
OJ L 136, 30.4.2004, p. 1
).
(
35
)
  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (
OJ L 157, 9.6.2006, p. 24
).
(
36
)
  Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (
OJ L 124, 20.5.2003, p. 36
).
(
37
)
  Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (
OJ L 158, 27.5.2014, p. 1
).
ANNEXES
I
General safety and performance requirements
II
Technical documentation
III
Technical documentation on post-market surveillance
IV
EU declaration of conformity
V
CE marking of conformity
VI
Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the UDI system
VII
Requirements to be met by notified bodies
VIII
Classification rules
IX
Conformity assessment based on a quality management system and assessment of the technical documentation
X
Conformity assessment based on type examination
XI
Conformity assessment based on product conformity verification
XII
Certificates issued by a notified body
XIII
Procedure for custom-made devices
XIV
Clinical evaluation and post-market clinical follow-up
XV
Clinical investigations
XVI
List of groups of products without an intended medical purpose referred to in Article 1(2)
XVII
Correlation table
ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I
GENERAL REQUIREMENTS
1.   Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.
2.   The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.
3.   Manufacturers shall establish, implement, document and maintain a risk management system.
Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall:
(a)
establish and document a risk management plan for each device;
(b)
identify and analyse the known and foreseeable hazards associated with each device;
(c)
estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;
(d)
eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
(e)
evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and
(f)
based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4.
4.   Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
(a)
eliminate or reduce risks as far as possible through safe design and manufacture;
(b)
where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
(c)
provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.
Manufacturers shall inform users of any residual risks.
5.   In eliminating or reducing risks related to use error, the manufacturer shall:
(a)
reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b)
give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
6.   The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
7.   Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.
8.   All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.
9.   For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons.
CHAPTER II
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
10.   Chemical, physical and biological properties
10.1.   Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled. Particular attention shall be paid to:
(a)
the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability;
(b)
the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;
(c)
the compatibility between the different parts of a device which consists of more than one implantable part;
(d)
the impact of processes on material properties;
(e)
where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;
(f)
the mechanical properties of the materials used, reflecting, where appropriate, matters such as strength, ductility, fracture resistance, wear resistance and fatigue resistance;
(g)
surface properties; and
(h)
the confirmation that the device meets any defined chemical and/or physical specifications.
10.2.   Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.
10.3.   Devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with the medicinal products concerned in accordance with the provisions and restrictions governing those medicinal products and that the performance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use.
10.4.   Substances
10.4.1.   Design and manufacture of devices
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.
Devices, or those parts thereof or those materials used therein that:
—
are invasive and come into direct contact with the human body,
—
(re)administer medicines, body liquids or other substances, including gases, to/from the body, or
—
transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,
shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified pursuant to Section 10.4.2:
(a)
substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council 
(
1
)
, or
(b)
substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council 
(
2
)
 or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council 
(
3
)
, in accordance with the criteria that are relevant to human health amongst the criteria established therein.
10.4.2.   Justification regarding the presence of CMR and/or endocrine-disrupting substances
The justification for the presence of such substances shall be based upon:
(a)
an analysis and estimation of potential patient or user exposure to the substance;
(b)
an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives;
(c)
argumentation as to why possible substance and/ or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product; including taking into account if the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials; and
(d)
where applicable and available, the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. and 10.4.4.
10.4.3.   Guidelines on phthalates
For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The benefit-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every five years, the guidelines shall be updated.
10.4.4.   Guidelines on other CMR and endocrine-disrupting substances
Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1., where appropriate.
10.4.5.   Labelling
Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
10.5.   Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.
10.6.   Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked to the size and the properties of particles which are or can be released into the patient's or user's body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.
11.   Infection and microbial contamination
11.1.   Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:
(a)
reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries,
(b)
allow easy and safe handling,
(c)
reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and
(d)
prevent microbial contamination of the device or its content such as specimens or fluids.
11.2.   Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation.
11.3.   Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer.
11.4.   Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user.
11.5.   Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods.
11.6.   Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities.
11.7.   Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.
11.8.   The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile.
12.   Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.
12.1.   In the case of devices referred to in the first subparagraph of Article 1(8), the quality, safety and usefulness of the substance which, if used separately, would be considered to be a medicinal product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC, as required by the applicable conformity assessment procedure under this Regulation.
12.2.   Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation.
13.   Devices incorporating materials of biological origin
13.1.   For devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable covered by this Regulation in accordance with point (g) of Article 1(6), the following shall apply:
(a)
donation, procurement and testing of the tissues and cells shall be done in accordance with Directive 2004/23/EC;
(b)
processing, preservation and any other handling of those tissues and cells or their derivatives shall be carried out so as to provide safety for patients, users and, where applicable, other persons. In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process;
(c)
the traceability system for those devices shall be complementary and compatible with the traceability and data protection requirements laid down in Directive 2004/23/EC and in Directive 2002/98/EC.
13.2.   For devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable the following shall apply:
(a)
where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives, shall originate from animals that have been subjected to veterinary controls that are adapted to the intended use of the tissues. Information on the geographical origin of the animals shall be retained by manufacturers;
(b)
sourcing, processing, preservation, testing and handling of tissues, cells and substances of animal origin, or their derivatives, shall be carried out so as to provide safety for patients, users and, where applicable, other persons. In particular safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process, except when the use of such methods would lead to unacceptable degradation compromising the clinical benefit of the device;
(c)
in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply.
13.3.   For devices manufactured utilising non-viable biological substances other than those referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of those substances shall be carried out so as to provide safety for patients, users and, where applicable, other persons, including in the waste disposal chain. In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.
14.   Construction of devices and interaction with their environment
14.1.   If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system shall be safe and shall not impair the specified performance of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. Connections which the user has to handle, such as fluid, gas transfer, electrical or mechanical coupling, shall be designed and constructed in such a way as to minimise all possible risks, such as misconnection.
14.2.   Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
(a)
the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features;
(b)
risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences;
(c)
the risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use;
(d)
the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts;
(e)
the risks of accidental ingress of substances into the device;
(f)
the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given; and
(g)
risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism.
14.3.   Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention shall be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion.
14.4.   Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.
14.5.   Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
14.6   Any measurement, monitoring or display scale shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used.
14.7.   Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by the user, patient or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.
15.   Devices with a diagnostic or measuring function
15.1.   Diagnostic devices and devices with a measuring function, shall be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate scientific and technical methods. The limits of accuracy shall be indicated by the manufacturer.
15.2.   The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC 
(
4
)
.
16.   Protection against radiation
16.1.   General
(a)
Devices shall be designed, manufactured and packaged in such a way that exposure of patients, users and other persons to radiation is reduced as far as possible, and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.
(b)
The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the patient and the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified.
16.2.   Intended radiation
(a)
Where devices are designed to emit hazardous, or potentially hazardous, levels of ionizing and/or non-ionizing radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent to the emission, it shall be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance.
(b)
Where devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall be fitted, where possible, with visual displays and/or audible warnings of such emissions.
16.3.   Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible. Where possible and appropriate, methods shall be selected which reduce the exposure to radiation of patients, users and other persons who may be affected.
16.4.   Ionising radiation
(a)
Devices intended to emit ionizing radiation shall be designed and manufactured taking into account the requirements of the Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation.
(b)
Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that, where possible, taking into account the intended use, the quantity, geometry and quality of the radiation emitted can be varied and controlled, and, if possible, monitored during treatment.
(c)
Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve an image and/or output quality that are appropriate to the intended medical purpose whilst minimising radiation exposure of the patient and user.
(d)
Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type, energy and, where appropriate, the quality of radiation.
17.   Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
17.1.   Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks or impairment of performance.
17.2.   For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.
17.3.   Software referred to in this Section that is intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise).
17.4.   Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.
18.   Active devices and devices connected to them
18.1.   For non-implantable active devices, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
18.2.   Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming critical.
18.3.   Devices where the safety of the patient depends on an external power supply shall include an alarm system to signal any power failure.
18.4.   Devices intended to monitor one or more clinical parameters of a patient shall be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health.
18.5.   Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment.
18.6.   Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electromagnetic interference such that is adequate to enable them to operate as intended.
18.7.   Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the patient, user or any other person, both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer.
18.8.   Devices shall be designed and manufactured in such a way as to protect, as far as possible, against unauthorised access that could hamper the device from functioning as intended.
19.   Particular requirements for active implantable devices
19.1.   Active implantable devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:
(a)
risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
(b)
risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment, and
(c)
risks which may arise where maintenance and calibration are impossible, including:
—
excessive increase of leakage currents,
—
ageing of the materials used,
—
excess heat generated by the device,
—
decreased accuracy of any measuring or control mechanism.
19.2.   Active implantable devices shall be designed and manufactured in such a way as to ensure
—
if applicable, the compatibility of the devices with the substances they are intended to administer, and
—
the reliability of the source of energy.
19.3.   Active implantable devices and, if appropriate, their component parts shall be identifiable to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices or their component parts.
19.4.   Active implantable devices shall bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and its year of manufacture); it shall be possible to read this code, if necessary, without the need for a surgical operation.
20.   Protection against mechanical and thermal risks
20.1.   Devices shall be designed and manufactured in such a way as to protect patients and users against mechanical risks connected with, for example, resistance to movement, instability and moving parts.
20.2.   Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.
20.3.   Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.
20.4.   Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible risks.
20.5.   Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings.
The same information shall be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.
20.6.   Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use.
21.   Protection against the risks posed to the patient or user by devices supplying energy or substances
21.1.   Devices for supplying the patient with energy or substances shall be designed and constructed in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of the patient and of the user.
21.2.   Devices shall be fitted with the means of preventing and/or indicating any inadequacies in the amount of energy delivered or substances delivered which could pose a danger. Devices shall incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source.
21.3.   The function of the controls and indicators shall be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.
22.   Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
22.1.   Devices for use by lay persons shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can be reasonably anticipated in the lay person's technique and environment. The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply.
22.2.   Devices for use by lay persons shall be designed and manufactured in such a way as to:
—
ensure that the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary after appropriate training and/or information,
—
reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries, and
—
reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, in the interpretation of the results.
22.3.   Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:
—
can verify that, at the time of use, the device will perform as intended by the manufacturer, and
—
if applicable, is warned if the device has failed to provide a valid result.
CHAPTER III
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
23.   Label and instructions for use
23.1.   General requirements regarding the information supplied by the manufacturer
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:
(a)
The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
(b)
The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
(c)
Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.
(d)
Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section.
(e)
Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
(f)
Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
(g)
Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
(h)
Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.
23.2.   Information on the label
The label shall bear all of the following particulars:
(a)
the name or trade name of the device;
(b)
the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
(c)
the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
(d)
if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;
(e)
where applicable, an indication that the device contains or incorporates:
—
a medicinal substance, including a human blood or plasma derivative, or
—
tissues or cells, or their derivatives, of human origin, or
—
tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012;
(f)
where applicable, information labelled in accordance with Section 10.4.5.;
(g)
the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;
(h)
the UDI carrier referred to in Article 27(4) and Part C of Annex VII;
(i)
an unambiguous indication of t the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
(j)
where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;
(k)
an indication of any special storage and/or handling condition that applies;
(l)
if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
(m)
warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users;
(n)
if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union;
(o)
if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
(p)
if the device is custom-made, the words ‘custom-made device’;
(q)
an indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;
(r)
in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action;
(s)
for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.
23.3.   Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)
The following particulars shall appear on the sterile packaging:
(a)
an indication permitting the sterile packaging to be recognised as such,
(b)
a declaration that the device is in a sterile condition,
(c)
the method of sterilisation,
(d)
the name and address of the manufacturer,
(e)
a description of the device,
(f)
if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,
(g)
if the device is custom-made, the words ‘custom-made device’,
(h)
the month and year of manufacture,
(i)
an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month, and
(j)
an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.
23.4.   Information in the instructions for use
The instructions for use shall contain all of the following particulars:
(a)
the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2;
(b)
the device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate;
(c)
where applicable, a specification of the clinical benefits to be expected.
(d)
where applicable, links to the summary of safety and clinical performance referred to in Article 32;
(e)
the performance characteristics of the device;
(f)
where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories;
(g)
any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard;
(h)
specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it;
(i)
details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection;
(j)
any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons;
(k)
the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:
—
details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory cleaning or disinfection,
—
identification of any consumable components and how to replace them,
—
information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime, and
—
methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices;
(l)
if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;
(m)
if the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation;
(n)
if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses;
(o)
an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements;
(p)
if the device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. This information shall be based on a specific section of the manufacturer's risk management documentation, where such characteristics and technical factors shall be addressed in detail. If in accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be made available to the user upon request;
(q)
for devices intended for use together with other devices and/or general purpose equipment:
—
information to identify such devices or equipment, in order to obtain a safe combination, and/or
—
information on any known restrictions to combinations of devices and equipment;
(r)
if the device emits radiation for medical purposes:
—
detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation,
—
the means of protecting the patient, user, or other person from unintended radiation during use of the device;
(s)
information that allows the user and/or patient to be informed of any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. The information shall cover, where appropriate:
—
warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety,
—
warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature,
—
warnings, precautions and/or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment,
—
if the device is intended to administer medicinal products, tissues or cells of human or animal origin, or their derivatives, or biological substances, any limitations or incompatibility in the choice of substances to be delivered,
—
warnings, precautions and/or limitations related to the medicinal substance or biological material that is incorporated into the device as an integral part of the device; and
—
precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the patient or user;
(t)
in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contra-indications, undesirable side-effects and risks relating to overdose;
(u)
in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;
(v)
warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information shall cover, where appropriate:
—
infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin, and
—
physical hazards such as from sharps.
If in accordance with the point (d) of Section 23.1 no instructions for use are required, this information shall be made available to the user upon request;
(w)
for devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional;
(x)
for the devices covered by this Regulation pursuant to Article 1(2), information regarding the absence of a clinical benefit and the risks related to use of the device;
(y)
date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use;
(z)
a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established;
(aa)
information to be supplied to the patient with an implanted device in accordance with Article 18;
(ab)
for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.
(
1
)
  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( 
OJ L 353, 31.12.2008, p. 1
).
(
2
)
  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (
OJ L 396, 30.12.2006, p. 1
).
(
3
)
  Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making available on the market of and use of biocidal products (
OJ L 167, 27.6.2012, p. 1
).
(
4
)
  Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (
OJ L 39, 15.2.1980, p. 40
).
ANNEX II
TECHNICAL DOCUMENTATION
The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex.
1.   DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
1.1.   Device description and specification
(a)
product or trade name and a general description of the device including its intended purpose and intended users;
(b)
the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;
(c)
the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;
(d)
principles of operation of the device and its mode of action, scientifically demonstrated if necessary;
(e)
the rationale for the qualification of the product as a device;
(f)
the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;
(g)
an explanation of any novel features;
(h)
a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;
(i)
a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;
(j)
a general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams;
(k)
a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;
(l)
technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.
1.2.   Reference to previous and similar generations of the device
(a)
an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;
(b)
an overview of identified similar devices available on the Union or international markets, where such devices exist.
2.   INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
A complete set of:
—
the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and
—
the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.
3.   DESIGN AND MANUFACTURING INFORMATION
(a)
information to allow the design stages applied to the device to be understood;
(b)
complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation;
(c)
identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.
4.   GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:
(a)
the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;
(b)
the method or methods used to demonstrate conformity with each applicable general safety and performance requirement;
(c)
the harmonised standards, CS or other solutions applied; and
(d)
the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.
5.   BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
The documentation shall contain information on:
(a)
the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and
(b)
the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.
6.   PRODUCT VERIFICATION AND VALIDATION
The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.
6.1.   Pre-clinical and clinical data
(a)
results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;
(b)
detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:
—
the biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user;
—
physical, chemical and microbiological characterisation;
—
electrical safety and electromagnetic compatibility;
—
software verification and validation (describing the software design and development process and evidence of the validation of the software, as used in the finished device. This information shall typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the information supplied by the manufacturer);
—
stability, including shelf life; and
—
performance and safety.
Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council 
(
1
)
 shall be demonstrated.
Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service;
(c)
the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;
(d)
the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.
6.2.   Additional information required in specific cases
(a)
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8), a statement indicating this fact. In this case, the documentation shall identify the source of that substance and contain the data of the tests conducted to assess its safety, quality and usefulness, taking account of the intended purpose of the device.
(b)
Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, and is covered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a device incorporates, as an integral part, tissues or cells of human origin or their derivatives that have an action ancillary to that of the device and is covered by this Regulation in accordance with the first subparagraph of Article 1(10), a statement indicating this fact. In such a case, the documentation shall identify all materials of human or animal origin used and provide detailed information concerning the conformity with Sections 13.1. or 13.2., respectively, of Annex I.
(c)
In the case of devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, detailed information, including test design, complete test or study protocols, methods of data analysis, and data summaries and test conclusions, regarding studies in relation to:
—
absorption, distribution, metabolism and excretion;
—
possible interactions of those substances, or of their products of metabolism in the human body, with other devices, medicinal products or other substances, considering the target population, and its associated medical conditions;
—
local tolerance; and
—
toxicity, including single-dose toxicity, repeat-dose toxicity, genotoxicity, carcinogenicity and reproductive and developmental toxicity, as applicable depending on the level and nature of exposure to the device.
In the absence of such studies, a justification shall be provided.
(d)
In the case of devices containing CMR or endocrine-disrupting substances referred to in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.
(e)
In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.
(f)
In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.
(g)
If the device is to be connected to other device(s) in order to operate as intended, a description of this combination/configuration including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer.
(
1
)
  Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (
OJ L 50, 20.2.2004, p. 44
).
ANNEX III
TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.
1.1.   The post-market surveillance plan drawn up in accordance with Article 84.
The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.
(a)
The post-market surveillance plan shall address the collection and utilization of available information, in particular:
—
information concerning serious incidents, including information from PSURs, and field safety corrective actions;
—
records referring to non-serious incidents and data on any undesirable side-effects;
—
information from trend reporting;
—
relevant specialist or technical literature, databases and/or registers;
—
information, including feedbacks and complaints, provided by users, distributors and importers; and
—
publicly available information about similar medical devices.
(b)
The post-market surveillance plan shall cover at least:
—
a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
—
effective and appropriate methods and processes to assess the collected data;
—
suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
—
effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
—
methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
—
methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
—
reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
—
systematic procedures to identify and initiate appropriate measures including corrective actions;
—
effective tools to trace and identify devices for which corrective actions might be necessary; and
—
a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
1.2.   The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.
ANNEX IV
EU DECLARATION OF CONFORMITY
The EU declaration of conformity shall contain all of the following information:
1.
Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
2.
A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
3.
The Basic UDI-DI as referred to in Part C of Annex VI;
4.
Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
5.
Risk class of the device in accordance with the rules set out in Annex VIII;
6.
A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
7.
References to any CS used and in relation to which conformity is declared;
8.
Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
9.
Where applicable, additional information;
10.
Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.
ANNEX V
CE MARKING OF CONFORMITY
1.
The CE marking shall consist of the initials ‘CE’ taking the following form:
2.
If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.
3.
The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
ANNEX VI
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM
PART A
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31
Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party.
1.   Information relating to the economic operator
1.1.
type of economic operator(manufacturer, authorised representative, or importer),
1.2.
name, address and contact details of the economic operator,
1.3.
where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,
1.4.
name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.
2.   Information relating to the device
2.1.
Basic UDI-DI,
2.2.
type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
2.3.
Member State in which the device is to or has been placed on the market in the Union,
2.4.
in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,
2.5.
risk class of the device,
2.6.
reprocessed single-use device (y/n),
2.7.
presence of a substance which, if used separately, may be considered to be a medicinal product and name of that substance,
2.8.
presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma and name of this substance,
2.9.
presence of tissues or cells of human origin, or their derivatives (y/n),
2.10.
presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n),
2.11.
where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation registration in the electronic system on clinical investigations,
2.12.
in the case of devices listed in Annex XVI, specification as to whether the intended purpose of the device is other than a medical purpose,
2.13.
in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(15), the name, address and contact details of that legal or natural person,
2.14.
in the case of class III or implantable devices, the summary of safety and clinical performance,
2.15.
status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).
PART B
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29
The manufacturer shall provide to the UDI database the UDI-DI and all of the following information relating to the manufacturer and the device:
1.
quantity per package configuration,
2.
the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,
3.
the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number),
4.
if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use, a ‘unit of use’ DI shall be assigned so as to associate the use of a device with a patient),
5.
name and address of the manufacturer (as indicated on the label),
6.
the SRN issued in accordance with Article 31(2),
7.
if applicable, name and address of the authorised representative (as indicated on the label),
8.
the medical device nomenclature code as provided for in Article 26,
9.
risk class of the device,
10.
if applicable, name or trade name,
11.
if applicable, device model, reference, or catalogue number,
12.
if applicable, clinical size (including volume, length, gauge, diameter),
13.
additional product description (optional),
14.
if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
15.
if applicable, additional trade names of the device,
16.
labelled as a single-use device (y/n),
17.
if applicable, the maximum number of reuses,
18.
device labelled sterile (y/n),
19.
need for sterilisation before use (y/n),
20.
containing latex (y/n),
21.
where applicable, information labelled in accordance with Section 10.4.5 of Annex I,
22.
URL for additional information, such as electronic instructions for use (optional),
23.
if applicable, critical warnings or contra-indications,
24.
status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).
PART C
THE UDI SYSTEM
1.   Definitions
Automatic identification and data capture (‘AIDC’)
AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID.
Basic UDI-DI
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
Unit of Use DI
The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
Configurable device
A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.
Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).
Configuration
Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs.
Configurations include 
inter alia
:
—
gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography.
—
ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.
UDI-DI
The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
Human Readable Interpretation (‘HRI’)
HRI is a legible interpretation of the data characters encoded in the UDI carrier.
Packaging levels
Packaging levels means the various levels of device packaging that contain a defined quantity of devices, such as a carton or case.
UDI-PI
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.
Radio Frequency Identification RFID
RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.
Shipping containers
A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems.
Unique Device Identifier (‘UDI’)
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
The word ‘Unique’ does not imply serialisation of individual production units.
UDI carrier
The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI.
UDI carriers include, 
inter alia
, ID/linear bar code, 2D/Matrix bar code, RFID.
2.   General requirements
2.1.   The affixing of the UDI is an additional requirement — it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation.
2.2.   The manufacturer shall assign and maintain unique UDIs for its devices.
2.3.   Only the manufacturer may place the UDI on the device or its packaging.
2.4.   Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2) may be used.
3.   The UDI
3.1.   A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.
3.2.   Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.
3.3.   The UDI shall contain two parts: a UDI-DI and a UDI-PI.
3.4.   The UDI-DI shall be unique at each level of device packaging.
3.5.   If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.
3.6.   Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.
3.7.   Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.
3.8.   The manufacturer shall assign the UDI to a device following the relevant coding standard.
3.9.   A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
(a)
name or trade name,
(b)
device version or model,
(c)
labelled as single use,
(d)
packaged sterile,
(e)
need for sterilization before use,
(f)
quantity of devices provided in a package,
(g)
critical warnings or contra-indications: e.g. containing latex or DEHP.
3.10.   Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI.
4.   UDI carrier
4.1.   The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.
4.2.   In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.
4.3.   For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.
4.4.   For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.
4.5.   When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable.
4.6.   If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
4.7.   If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.
4.8.   The HRI format shall follow the rules of the UDI code-issuing entity.
4.9.   If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label.
4.10.   Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances:
(a)
any type of direct marking would interfere with the safety or performance of the device;
(b)
the device cannot be directly marked because it is not technologically feasible.
4.11.   The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
4.12.   If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the placing of the UDI carrier on the packaging shall not be required.
4.13.   In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.
4.14.   The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage.
4.15.   Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.
5.   General principles of the UDI database
5.1.   The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex.
5.2.   Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database.
5.3.   Appropriate methods/procedures for validation of the data provided shall be implemented.
5.4.   Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market.
5.5.   The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation.
5.6.   The database shall allow for the linking of all the packaging levels of the device.
5.7.   The data for new UDI-DIs shall be available at the time the device is placed on the market.
5.8.   Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI.
5.9.   Internationally-accepted standards for data submission and updates shall, wherever possible, be used by the UDI database.
5.10.   The user interface of the UDI database shall be available in all official languages of the Union. The use of free-text fields shall, however, be minimized in order to reduce translations.
5.11.   Data relating to devices that are no longer available on the market shall be retained in the UDI database.
6.   Rules for specific device types
6.1.   Implantable devices:
6.1.1.
Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);
6.1.2.
The UDI-PI shall have at least the following characteristics:
(a)
the serial number for active implantable devices,
(b)
the serial number or lot number for other implantable devices.
6.1.3.
The UDI of the implantable device shall be identifiable prior to implantation.
6.2.   Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses
6.2.1.   The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.
6.2.2.   The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
6.3.   Systems and procedure packs as referred to in Article 22
6.3.1.   The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.
6.3.2.   Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.
Exemptions:
(a)
individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier;
(b)
devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.
6.3.3.   Placement of the UDI carrier on systems or procedure packs
(a)
The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
(b)
The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.
6.4.   Configurable devices:
6.4.1.   A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.
6.4.2.   The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.
6.4.3.   A configurable device UDI-PI shall be assigned to each individual configurable device.
6.4.4.   The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI.
6.4.5.   Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.
6.5.   Device Software
6.5.1.   UDI assignment Criteria
The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement.
The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.
6.5.2.   A new UDI-DI shall be required whenever there is a modification that changes:
(a)
the original performance;
(b)
the safety or the intended use of the software;
(c)
interpretation of data.
Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.
6.5.3.   Minor software revisions shall require a new UDI-PI and not a new UDI-DI.
Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency.
Minor software revisions shall be identified by a manufacturer-specific form of identification.
6.5.4.   UDI placement criteria for software
(a)
where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software;
(b)
the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an ‘about’ file, or included on the start-up screen;
(c)
software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API);
(d)
only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays, such as ‘about’ menu, splash screen etc.;
(e)
the human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.
ANNEX VII
REQUIREMENTS TO BE MET BY NOTIFIED BODIES
1.   ORGANISATIONAL AND GENERAL REQUIREMENTS
1.1.   Legal status and organisational structure
1.1.1.   Each notified body shall be established under the national law of a Member State, or under the law of a third country with which the Union has concluded an agreement in this respect. Its legal personality and status shall be fully documented. Such documentation shall include information about ownership and the legal or natural persons exercising control over the notified body.
1.1.2.   If the notified body is a legal entity that is part of a larger organisation, the activities of that organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable to both the notified body and the organisation to which it belongs.
1.1.3.   If a notified body wholly or partly owns legal entities established in a Member State or in a third country or is owned by another legal entity, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented. Personnel of those entities performing conformity assessment activities under this Regulation shall be subject to the applicable requirements of this Regulation.
1.1.4.   The organisational structure, allocation of responsibilities, reporting lines and operation of the notified body shall be such that they ensure that there is confidence in the performance by the notified body and in the results of the conformity assessment activities it conducts.
1.1.5.   The notified body shall clearly document its organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel who may have an influence upon the performance by the notified body and upon the results of its conformity assessment activities.
1.1.6.   The notified body shall identify the persons in top-level management that have overall authority and responsibility for each of the following:
—
the provision of adequate resources for conformity assessment activities;
—
the development of procedures and policies for the operation of the notified body;
—
the supervision of implementation of the procedures, policies and quality management systems of the notified body;
—
the supervision of the notified body's finances;
—
the activities and decisions taken by the notified body, including contractual agreements;
—
the delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities;
—
the interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent authorities, the Commission and other notified bodies.
1.2.   Independence and impartiality
1.2.1.   The notified body shall be a third-party body that is independent of the manufacturer of the device in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does not preclude the notified body from carrying out conformity assessment activities for competing manufacturers.
1.2.2.   The notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities. The notified body shall document and implement a structure and procedures for safeguarding impartiality and for promoting and applying the principles of impartiality throughout its organisation, personnel and assessment activities. Such procedures shall provide for the identification, investigation and resolution of any case in which a conflict of interest may arise, including involvement in consultancy services in the field of devices prior to taking up employment with the notified body. The investigation, outcome and its resolution shall be documented.
1.2.3.   The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not:
(a)
be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess, nor the authorised representative of any of those parties. Such restriction shall not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes;
(b)
be involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which they are designated, nor represent the parties engaged in those activities;
(c)
engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated;
(d)
offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity. In particular, they shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment, and
(e)
be linked to any organisation which itself provides consultancy services as referred to in point (d). Such restriction does not preclude general training activities that are not client specific and that relate to regulation of devices or to related standards.
1.2.4.   Involvement in consultancy services in the field of devices prior to taking up employment with a notified body shall be fully documented at the time of employment and potential conflicts of interest shall be monitored and resolved in accordance with this Annex. Personnel who were formerly employed by a specific client, or provided consultancy services in the field of devices to that specific client prior to taking up employment with a notified body, shall not be assigned for conformity assessment activities for that specific client or companies belonging to the same group for a period of three years.
1.2.5.   The impartiality of notified bodies, of their top-level management and of the assessment personnel shall be guaranteed. The level of the remuneration of the top-level management and assessment personnel of a notified body and subcontractors, involved in assessment activities shall not depend on the results of the assessments. Notified bodies shall make publicly available the declarations of interest of their top-level management.
1.2.6.   If a notified body is owned by a public entity or institution, independence and absence of any conflict of interest shall be ensured and documented between, on the one hand, the authority responsible for notified bodies and/or the competent authority and, on the other hand, the notified body.
1.2.7.   The notified body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, including the activities of its owners do not affect its independence, impartiality or the objectivity of its conformity assessment activities.
1.2.8.   The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined in Recommendation 2003/361/EC in relation to fees.
1.2.9.   The requirements laid down in this Section in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment.
1.3.   Confidentiality
1.3.1.   The notified body shall have documented procedures in place ensuring that its personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect the confidentiality of the information which comes into its possession during the performance of conformity assessment activities, except when disclosure is required by law.
1.3.2.   The personnel of a notified body shall observe professional secrecy in carrying out their tasks under this Regulation or any provision of national law giving effect to it, except in relation to the authorities responsible for notified bodies, competent authorities for medical devices in the Member States or the Commission. Proprietary rights shall be protected. The notified body shall have documented procedures in place in respect of the requirements of this Section.
1.4.   Liability
1.4.1.   The notified body shall take out appropriate liability insurance for its conformity assessment activities, unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for the conformity assessment.
1.4.2.   The scope and overall financial value of the liability insurance shall correspond to the level and geographic scope of activities of the notified body and be commensurate with the risk profile of the devices certified by the notified body. The liability insurance shall cover cases where the notified body may be obliged to withdraw, restrict or suspend certificates.
1.5.   Financial requirements
The notified body shall have at its disposal the financial resources required to conduct its conformity assessment activities within its scope of designation and related business operations. It shall document and provide evidence of its financial capacity and its long-term economic viability, taking into account, where relevant, any specific circumstances during an initial start-up phase.
1.6.   Participation in coordination activities
1.6.1.   The notified body shall participate in, or ensure that its assessment personnel is informed of, any relevant standardisation activities and in the activities of the notified body coordination group referred to in Article 49 and that its assessment and decision-making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation.
1.6.2.   The notified body shall take into consideration guidance and best practice documents.
2.   QUALITY MANAGEMENT REQUIREMENTS
2.1.   The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation.
2.2.   The quality management system of the notified body shall address at least the following:
—
management system structure and documentation, including policies and objectives for its activities;
—
policies for assignment of activities and responsibilities to personnel;
—
assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management;
—
the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
—
control of documents;
—
control of records;
—
management reviews;
—
internal audits;
—
corrective and preventive actions;
—
complaints and appeals; and
—
continuous training.
Where documents are used in various languages, the notified body shall ensure and control that they have the same content.
2.3.   The top-level management of the notified body shall ensure that the quality management system is fully understood, implemented and maintained throughout the notified body organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this Regulation.
2.4.   The notified body shall require all personnel to formally commit themselves by a signature or equivalent to comply with the procedures defined by the notified body. That commitment shall cover aspects relating to confidentiality and to independence from commercial and other interests, and any existing or prior association with clients. The personnel shall be required to complete written statements indicating their compliance with confidentiality, independence and impartiality principles.
3.   RESOURCE REQUIREMENTS
3.1.   General
3.1.1.   Notified bodies shall be capable of carrying out all the tasks falling to them under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.
In particular, notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated.
Such requirement presupposes at all times and for each conformity assessment procedure and each type of devices in relation to which they have been designated, that the notified body has permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant devices and the corresponding technologies. Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, clinical evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular, those set out in Annex I.
A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is designated. The notified body shall have sufficient internal competence to critically evaluate assessments conducted by external expertise. Tasks which a notified body is precluded from subcontracting are set out in Section 4.1.
Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices shall have appropriate knowledge to set up and operate a system for the selection of assessment and verification staff, for verification of their competence, for authorisation and allocation of their tasks, for organisation of their initial and ongoing training and for the assignment of their duties and the monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification operations are competent to fulfil the tasks required of them.
The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices.
3.1.2.   The notified body shall ensure that personnel involved in conformity assessment activities maintain their qualification and expertise by implementing a system for exchange of experience and a continuous training and education programme.
3.1.3.   The notified body shall clearly document the extent and limits of duties and responsibilities and the level of authorisation of the personnel, including any subcontractors and external experts, involved in conformity assessment activities and inform those personnel accordingly.
3.2.   Qualification criteria in relation to personnel
3.2.1.   The Notified Body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training. The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review and decision-making, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, tissues and cells of human and animal origin and clinical evaluation, covered by the scope of designation.
3.2.2.   The qualification criteria referred to in Section 3.2.1 shall refer to the scope of a notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 42(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description.
Specific qualification criteria shall be defined at least for the assessment of:
—
the pre-clinical evaluation,
—
clinical evaluation,
—
tissues and cells of human and animal origin,
—
functional safety,
—
software,
—
packaging,
—
devices that incorporate as an integral part a medicinal product,
—
devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body and
—
the different types of sterilisation processes.
3.2.3.   The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted. They shall have proven knowledge and experience in all of the following:
—
Union devices legislation and relevant guidance documents;
—
the conformity assessment procedures provided for in this Regulation;
—
a broad base of knowledge of device technologies and the design and manufacture of devices;
—
the notified body's quality management system, related procedures and the required qualification criteria;
—
training relevant to personnel involved in conformity assessment activities in relation to devices;
—
adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body.
3.2.4.   The notified body shall have permanent availability of personnel with relevant clinical expertise and where possible such personnel shall be employed by the notified body itself. Such personnel shall be integrated throughout the notified body's assessment and decision-making process in order to:
—
identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts;
—
appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonised standards and ensure that the external clinical experts are fully aware of the context and implications of their assessment and the advice they provide;
—
be able to review and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations, and appropriately guide external clinical experts in the assessment of the clinical evaluation presented by the manufacturer;
—
be able to scientifically evaluate and, if necessary, challenge the clinical evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation;
—
be able to ascertain the comparability and consistency of the assessments of clinical evaluations conducted by clinical experts;
—
be able to make an assessment of the manufacturer's clinical evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body's decision maker; and
—
be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
3.2.5.   The personnel responsible for carrying out product-related reviews (product reviewers), such as technical documentation reviews or type examination, including aspects such as clinical evaluation, biological safety, sterilisation and software validation, shall have all of the following proven qualifications:
—
successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences;
—
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
—
knowledge of device legislation, including the general safety and performance requirements set out in Annex I;
—
appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
—
appropriate knowledge and experience of risk management and related device standards and guidance documents;
—
appropriate knowledge and experience of clinical evaluation;
—
appropriate knowledge of the devices which they are assessing;
—
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments;
—
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
3.2.6.   The personnel responsible for carrying out audits of the manufacturer's quality management system (site auditors) shall have all of the following proven qualifications:
—
successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
—
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management;
—
appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
—
appropriate knowledge and experience of risk management and related device standards and guidance documents;
—
appropriate knowledge of quality management systems and related standards and guidance documents;
—
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits;
—
training in auditing techniques enabling them to challenge quality management systems;
—
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
3.2.7.   The personnel with overall responsibility for final reviews and decision-making on certification shall be employed by the notified body itself and shall not be external experts or be subcontracted. Those personnel shall, as a group, have proven knowledge and comprehensive experience of all of the following:
—
devices legislation and relevant guidance documents;
—
the device conformity assessments relevant to this Regulation;
—
the types of qualifications, experience and expertise relevant to device conformity assessment;
—
a broad base of knowledge of device technologies, including sufficient experience of conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
—
the notified body's quality management system, related procedures and the required qualifications for personnel involved;
—
the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out.
3.3.   Documentation of qualification, training and authorisation of personnel
3.3.1.   The notified body shall have a procedure in place to fully document the qualification of each member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where in exceptional circumstances the fulfilment of the qualification criteria set out in Section 3.2. cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities.
3.3.2.   For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and maintain up to date:
—
a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment activities; and
—
records attesting to the required knowledge and experience for the conformity assessment activity for which they are authorised. The records shall contain a rationale for defining the scope of the responsibilities for each of the assessment personnel and records of the conformity assessment activities carried out by each of them.
3.4.   Subcontractors and external experts
3.4.1.   Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined component parts of a conformity assessment activity.
The subcontracting of the auditing of quality management systems or of product related reviews as a whole shall not be permitted; nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts working on behalf of the notified body. The notified body in question shall retain full responsibility for being able to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific tasks, for making a decision based on a subcontractor's assessment and for the work conducted by subcontractors and experts on its behalf.
The following activities may not be subcontracted by notified bodies:
—
review of the qualifications and monitoring of the performance of external experts;
—
auditing and certification activities where the subcontracting in question is to auditing or certification organisations;
—
allocation of work to external experts for specific conformity assessment activities; and
—
final review and decision making functions.
3.4.2.   Where a notified body subcontracts certain conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place, and shall ensure that:
—
the subcontractor meets the relevant requirements of this Annex;
—
subcontractors and external experts do not further subcontract work to organisations or personnel; and
—
the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent.
Any subcontracting or consultation of external personnel shall be properly documented, shall not involve any intermediaries and shall be subject to a written agreement covering, among other things, confidentiality and conflicts of interest. The notified body in question shall take full responsibility for the tasks performed by subcontractors.
3.4.3.   Where subcontractors or external experts are used in the context of a conformity assessment, in particular regarding novel, invasive and implantable devices or technologies, the notified body in question shall have internal competence in each product area for which it is designated that is adequate for the purpose of leading the overall conformity assessment, verifying the appropriateness and validity of expert opinions and making decisions on certification.
3.5.   Monitoring of competences, training and exchange of experience
3.5.1.   The notified body shall establish procedures for the initial evaluation and on-going monitoring of the competence, conformity assessment activities and performance of all internal and external personnel, and subcontractors, involved in conformity assessment activities.
3.5.2.   Notified bodies shall review at regular intervals, the competence of their personnel, identify training needs and draw up a training plan to maintain the required level of qualification and knowledge of individual personnel. That review shall at a minimum, verify that personnel:
—
are aware of Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities referred to in Section 1.6; and
—
take part in the internal exchange of experience and the continuous training and education programme referred to in Section 3.1.2.
4.   PROCESS REQUIREMENTS
4.1.   General
The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of each conformity assessment activity for which it is designated, comprising the individual steps from pre-application activities up to decision making and surveillance and taking into account, when necessary, the respective specificities of the devices.
The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the internal activities of notified bodies and shall not be subcontracted.
4.2.   Notified body quotations and pre-application activities
The notified body shall:
(a)
publish a publicly available description of the application procedure by which manufacturers can obtain certification from it. That description shall include which languages are acceptable for submission of documentation and for any related correspondence;
(b)
have documented procedures relating to, and documented details about, fees charged for specific conformity assessment activities and any other financial conditions relating to notified bodies' assessment activities for devices;
(c)
have documented procedures in relation to advertising of their conformity assessment services. Those procedures shall ensure that advertising or promotional activities in no way imply or are capable of leading to an inference that their conformity assessment will offer manufacturers earlier market access or be quicker, easier or less stringent than that of other notified bodies;
(d)
have documented procedures requiring the review of pre-application information, including the preliminary verification that the product is covered by this Regulation and its classification, prior to issuing any quotation to the manufacturer relating to a specific conformity assessment; and
(e)
ensure that all contracts relating to the conformity assessment activities covered by this Regulation are concluded directly between the manufacturer and the notified body and not with any other organisation.
4.3.   Application review and contract
The notified body shall require a formal application signed by a manufacturer or an authorised representative containing all of the information and the manufacturer's declarations required by the relevant conformity assessment as referred to in Annexes IX to XI.
The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both parties. It shall be kept by the notified body. This contract shall have clear terms and conditions and contain obligations that enable the notified body to act as required under this Regulation, including an obligation on the manufacturer to inform the notified body of vigilance reports, the right of the notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its information obligations.
The notified body shall have documented procedures to review applications, addressing:
(a)
the completeness of those applications with respect to the requirements of the relevant conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought,
(b)
the verification of the qualification of products covered by those applications as devices and their respective classifications,
(c)
whether the conformity assessment procedures chosen by the applicant are applicable to the device in question under this Regulation,
(d)
the ability of the notified body to assess the application based on its designation, and
(e)
the availability of sufficient and appropriate resources.
The outcome of each review of an application shall be documented. Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 57 and shall be accessible to other notified bodies.
4.4.   Allocation of resources
The notified body shall have documented procedures to ensure that all conformity assessment activities are conducted by appropriately authorised and qualified personnel who are sufficiently experienced in the evaluation of the devices, systems and processes and related documentation that are subject to conformity assessment.
For each application, the notified body shall determine the resources needed and identify one individual responsible for ensuring that the assessment of that application is conducted in accordance with the relevant procedures and for ensuring that the appropriate resources including personnel are utilised for each of the tasks of the assessment. The allocation of tasks required to be carried out as part of the conformity assessment and any changes subsequently made to this allocation shall be documented.
4.5.   Conformity assessment activities
4.5.1.   General
The notified body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific fields.
The notified body shall have expertise, facilities and documented procedures that are sufficient to effectively conduct the conformity assessment activities for which the notified body in question is designated, taking account of the relevant requirements set out in Annexes IX to XI, and in particular all of the following requirements:
—
appropriately plan the conduct of each individual project,
—
ensure that the composition of the assessment teams is such that there is sufficient experience in relation to the technology concerned, and that there is continuous objectivity and independence, and to provide for rotation of the members of the assessment team at appropriate intervals,
—
specify the rationale for fixing time limits for completion of conformity assessment activities,
—
assess the manufacturer's technical documentation and the solutions adopted to meet the requirements laid down in Annex I,
—
review the manufacturer's procedures and documentation relating to the evaluation of pre-clinical aspects,
—
review the manufacturer's procedures and documentation relating to clinical evaluation,
—
address the interface between the manufacturer's risk management process and its appraisal and analysis of the pre-clinical and clinical evaluation and to evaluate their relevance for the demonstration of conformity with the relevant requirements in Annex I,
—
carry out the specific procedures referred to in Sections 5.2 to 5.4 of Annex IX,
—
in the case of class IIa or class IIb devices, assess the technical documentation of devices selected on a representative basis,
—
plan and periodically carry out appropriate surveillance audits and assessments, carry out or request certain tests to verify the proper functioning of the quality management system and to perform unannounced on site audits,
—
relating to the sampling of devices, verify that the manufactured device is in conformity with the technical documentation; such requirements shall define the relevant sampling criteria and testing procedure prior to sampling,
—
evaluate and verify a manufacturer's compliance with relevant Annexes.
The notified body shall, where relevant, take into consideration available CS, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance.
4.5.2.   Quality management system auditing
(a)
As part of the assessment of the quality management system, a notified body shall prior to an audit and in accordance with its documented procedures:
—
assess the documentation submitted in accordance with the relevant conformity assessment Annex, and draw up an audit programme which clearly identifies the number and sequence of activities required to demonstrate complete coverage of a manufacturer's quality management system and to determine whether it meets the requirements of this Regulation,
—
identify links between, and allocation of responsibilities among, the various manufacturing sites, and identify relevant suppliers and/or subcontractors of the manufacturer, and consider the need to specifically audit any of those suppliers or subcontractors or both,
—
clearly define, for each audit identified in the audit programme, the objectives, criteria and scope of the audit, and draw up an audit plan that adequately addresses and takes account of the specific requirements for the devices, technologies and processes involved,
—
draw up and keep up to date, for class IIa and class IIb devices, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer's application. That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate, and
—
select and assign appropriately qualified and authorised personnel for conducting the individual audits. The respective roles, responsibilities and authorities of the team members shall be clearly defined and documented.
(b)
Based on the audit programme it has drawn up, the notified body shall, in accordance with its documented procedures:
—
audit the manufacturer's quality management system, in order to verify that the quality management system ensures that the devices covered conform to the relevant provisions of this Regulation which apply to devices at every stage, from design through final quality control to ongoing surveillance, and shall determine whether the requirements of this Regulation are met,
—
based on relevant technical documentation and in order to determine whether the manufacturer meets the requirements referred to in the relevant conformity assessment Annex, review and audit the manufacturer's processes and subsystems, in particular for:
—
design and development,
—
production and process controls,
—
product documentation,
—
purchasing controls including verification of purchased devices,
—
corrective and preventive actions, including for post-market surveillance, and
—
PMCF,
and review and audit requirements and provisions adopted by the manufacturer, including those in relation to fulfilling the general safety and performance requirements set out in Annex I.
The documentation shall be sampled in such a manner as to reflect the risks associated with the intended use of the device, the complexity of the manufacturing technologies, the range and classes of devices produced and any available post-market surveillance information,
—
if not already covered by the audit programme, audit the control of processes on the premises of the manufacturer's suppliers, when the conformity of finished devices is significantly influenced by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient control over its suppliers,
—
conduct assessments of the technical documentation based on its sampling plan and taking account of Sections 4.5.4. and 4.5.5. for pre-clinical and clinical evaluations, and
—
the notified body shall ensure that audit findings are appropriately and consistently classified in accordance with the requirements of this Regulation and with relevant standards, or with best practice documents developed or adopted by the MDCG.
4.5.3.   Product verification
Assessment of the technical documentation
For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX, notified bodies shall have sufficient expertise, facilities and documented procedures for:
—
the allocation of appropriately qualified and authorised personnel for the examination of individual aspects such as use of the device, biocompatibility, clinical evaluation, risk management, and sterilisation, and
—
the assessment of conformity of the design with this Regulation, and for taking account of Sections 4.5.4. to 4.5.6. That assessment shall include examination of the implementation by manufacturers of incoming, in-process and final checks and the results thereof. If further tests or other evidence is required for the assessment of conformity with the requirements of this Regulation, the notified body in question shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests.
Type-examinations
The notified body shall have documented procedures, sufficient expertise and facilities for the type-examination of devices in accordance with Annex X including the capacity to:
—
examine and assess the technical documentation taking account of Sections 4.5.4. to 4.5.6., and verify that the type has been manufactured in conformity with that documentation;
—
establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility;
—
document its rationale for the selection of those parameters;
—
carry out the appropriate examinations and tests in order to verify that the solutions adopted by the manufacturer meet the general safety and performance requirements set out in Annex I. Such examinations and tests shall include all tests necessary to verify that the manufacturer has in fact applied the relevant standards it has opted to use;
—
agree with the applicant as to where the necessary tests will be performed if they are not to be carried out directly by the notified body; and
—
assume full responsibility for test results. Test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer.
Verification by examination and testing of every product
The notified body shall:
(a)
have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product in accordance with Part B of Annex XI;
(b)
establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility in order to:
—
verify, for class IIb devices, the conformity of the device with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to those devices,
—
confirm, for class IIa devices, the conformity with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to those devices;
(c)
document its rationale for the selection of the parameters referred to in point (b);
(d)
have documented procedures to carry out the appropriate assessments and tests in order to verify the conformity of the device with the requirements of this Regulation by examining and testing every product as specified in Section 15 of Annex XI;
(e)
have documented procedures providing for the reaching of an agreement with the applicant concerning when and where necessary tests that are not to be carried out by the notified body itself are to be performed; and
(f)
assume full responsibility for test results in accordance with documented procedures; test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer.
4.5.4.   Pre-clinical evaluation assessment
The notified body shall have documented procedures in place for the review of the manufacturer's procedures and documentation relating to the evaluation of pre-clinical aspects. The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address:
(a)
the planning, conduct, assessment, reporting and, where appropriate, updating of the pre-clinical evaluation, in particular of
—
the scientific pre-clinical literature search, and
—
the pre-clinical testing, for example laboratory testing, simulated use testing, computer modelling, the use of animal models,
(b)
the nature and duration of body contact and the specific associated biological risks,
(c)
the interface with the risk management process, and
(d)
the appraisal and analysis of the available pre-clinical data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I.
The notified body's assessment of pre-clinical evaluation procedures and documentation shall address the results of literature searches and all validation, verification and testing performed and conclusions drawn, and shall typically include considering the use of alternative materials and substances and take account of the packaging, stability, including shelf life, of the finished device. Where no new testing has been undertaken by a manufacturer or where there are deviations from procedures, the notified body in question shall critically examine the justification presented by the manufacturer.
4.5.5.   Clinical evaluation assessment
The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to clinical evaluation both for initial conformity assessment and on an ongoing basis. The notified body shall examine, validate and verify that manufacturers' procedures and documentation adequately address:
—
the planning, conduct, assessment, reporting and updating of the clinical evaluation as referred to in Annex XIV,
—
post-market surveillance and PMCF,
—
the interface with the risk management process,
—
the appraisal and analysis of the available data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I, and
—
the conclusions drawn with regard to the clinical evidence and drawing up of the clinical evaluation report.
These procedures referred to in the first paragraph shall take into consideration available CS, guidance and best practice documents.
The notified body's assessment of clinical evaluations as referred to in Annex XIV shall cover:
—
the intended use specified by the manufacturer and claims for the device defined by it,
—
the planning of the clinical evaluation,
—
the methodology for the literature search,
—
relevant documentation from the literature search,
—
the clinical investigation,
—
validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability and conclusions data from equivalent and similar devices,
—
post-market surveillance and PMCF,
—
the clinical evaluation report, and
—
justifications in relation to non-performance of clinical investigations or PMCF.
In relation to clinical data from clinical investigations included within the clinical evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved clinical investigation plan.
The notified body shall ensure that the clinical evaluation adequately addresses the relevant safety and performance requirements provided for in Annex I, that it is appropriately aligned with the risk management requirements, that it is conducted in accordance with Annex XIV and that it is appropriately reflected in the information provided relating to the device.
4.5.6.   Specific Procedures
The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to in Sections 5 and 6 of Annex IX, Section 6 of Annex X and Section 16 of Annex XI, for which they are designated.
In the case of devices manufactured utilising tissues or cells of animal origin or their derivatives, such as from TSE susceptible species, as referred to in Regulation (EU) No 722/2012, the notified body shall have documented procedures in place that fulfil the requirements laid down in that Regulation, including for the preparation of a summary evaluation report for the relevant competent authority.
4.6.   Reporting
The notified body shall:
—
ensure that all steps of the conformity assessment are documented so that the conclusions of the assessment are clear and demonstrate compliance with the requirements of this Regulation and can represent objective evidence of such compliance to persons that are not themselves involved in the assessment, for example personnel in designating authorities,
—
ensure that records that are sufficient to provide a discernible audit trail are available for quality management system audits,
—
clearly document the conclusions of its assessment of clinical evaluation in a clinical evaluation assessment report, and
—
for each specific project, provide a detailed report which shall be based on a standard format containing a minimum set of elements determined by the MDCG.
The report of the notified body shall:
—
clearly document the outcome of its assessment and draw clear conclusions from the verification of the manufacturer's conformity with the requirements of this Regulation,
—
make a recommendation for a final review and for a final decision to be taken by the notified body; this recommendation shall be signed off by the member of personnel responsible in the notified body, and
—
be provided to the manufacturer in question.
4.7.   Final review
The notified body shall prior to making a final decision:
—
ensure that the personnel assigned for the final review and decision-making on specific projects are appropriately authorised and are different from the personnel who have conducted the assessments,
—
verify that the report or reports and supporting documentation needed for decision making, including concerning resolution of non-conformities noted during assessment, are complete and sufficient with respect to the scope of the application, and
—
verify whether there are any unresolved non-conformities preventing issuance of a certificate.
4.8.   Decisions and Certifications
The notified body shall have documented procedures for decision-making including as regards the allocation of responsibilities for the issuance, suspension, restriction and withdrawal of certificates. Those procedures shall include the notification requirements laid down in Chapter V of this Regulation. The procedures shall allow the notified body in question to:
—
decide, based on the assessment documentation and additional information available, whether the requirements of this Regulation are fulfilled,
—
decide, based on the results of its assessment of the clinical evaluation and risk management, whether the post-market surveillance plan, including the PMCF plan, is adequate,
—
decide on specific milestones for further review by the notified body of the up to date clinical evaluation,
—
decide whether specific conditions or provisions need to be defined for the certification,
—
decide, based on the novelty, risk classification, clinical evaluation and conclusions from the risk analysis of the device, on a period of certification not exceeding five years,
—
clearly document decision making and approval steps including approval by signature of the members of personnel responsible,
—
clearly document responsibilities and mechanisms for communication of decisions, in particular, where the final signatory of a certificate differs from the decision maker or decision makers or does not fulfil the requirements laid down in Section 3.2.7,
—
issue a certificate or certificates in accordance with the minimum requirements laid down in Annex XII for a period of validity not exceeding five years and shall indicate whether there are specific conditions or limitations associated with the certification,
—
issue a certificate or certificates for the applicant alone and shall not issue certificates covering multiple entities, and
—
ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that they are entered into the electronic system referred to in Article 57.
4.9.   Changes and modifications
The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to the manufacturers' information obligations and the assessment of changes to:
—
the approved quality management system or systems or to the product-range covered,
—
the approved design of a device,
—
the intended use of or claims made for the device,
—
the approved type of a device, and
—
any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.6.
The procedures and contractual arrangements referred to in the first paragraph shall include measures for checking the significance of the changes referred to in the first paragraph.
In accordance with its documented procedures, the notified body in question shall:
—
ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and relevant information relating to such changes,
—
assess the changes proposed and verify whether, after these changes, the quality management system, or the design of a device or type of a device, still meets the requirements of this Regulation, and
—
notify the manufacturer of its decision and provide a report or as applicable a supplementary report, which shall contain the justified conclusions of its assessment.
4.10.   Surveillance activities and post-certification monitoring
The notified body shall have documented procedures:
—
defining how and when surveillance activities of manufacturers are to be conducted. Those procedures shall include arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at defined intervals,
—
for screening relevant sources of scientific and clinical data and post-market information relating to the scope of their designation. Such information shall be taken into account in the planning and conduct of surveillance activities, and
—
to review vigilance data to which they have access under Article 92(2) in order to estimate its impact, if any, on the validity of existing certificates. The results of the evaluation and any decisions taken shall be thoroughly documented.
The notified body in question shall, upon receipt of information about vigilance cases from a manufacturer or competent authorities, decide which of the following options to apply:
—
not to take action on the basis that the vigilance case is clearly not related to the certification granted,
—
observe the manufacturer's and competent authority's activities and the results of the manufacturer's investigation so as to determine whether the certification granted is at risk or whether adequate corrective action has been taken,
—
perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits and product testing, where it is likely that the certification granted is at risk,
—
increase the frequency of surveillance audits,
—
review specific products or processes on the occasion of the next audit of the manufacturer, or
—
take any other relevant measure.
In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to:
—
conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned and conducted in line with the relevant requirements in Section 4.5,
—
ensure adequate assessment of the manufacturer's documentation on, and application of the provisions on, vigilance, the post-market surveillance, and PMCF,
—
sample and test devices and technical documentation, during audits, according to pre-defined sampling criteria and testing procedures to ensure that the manufacturer continuously applies the approved quality management system,
—
ensure that the manufacturer complies with the documentation and information obligations laid down in the relevant Annexes and that its procedures take into account best practices in the implementation of quality management systems,
—
ensure that the manufacturer does not use quality management system or device approvals in a misleading manner,
—
gather sufficient information to determine if the quality management system continues to comply with the requirements of this Regulation,
—
ask the manufacturer, if non-conformities are detected, for corrections, corrective actions and, where applicable, preventive actions, and
—
where necessary, impose specific restrictions on the relevant certificate, or suspend or withdraw it.
The notified body shall, if listed as part of the conditions for certification:
—
conduct an in-depth review of the clinical evaluation as most recently updated by the manufacturer based on the manufacturer's post-market surveillance, on its PMCF and on clinical literature relevant to the condition being treated with the device or on clinical literature relevant to similar devices,
—
clearly document the outcome of the in-depth review and address any specific concerns to the manufacturer or impose any specific conditions on it, and
—
ensure that the clinical evaluation as most recently updated, is appropriately reflected in the instructions for use and, where applicable, the summary of safety and performance.
4.11.   Re-certification
The notified body shall have documented procedures in place relating to the re-certification reviews and the renewal of certificates. Re-certification of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates shall occur at least every five years.
The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including:
(a)
all changes to the originally approved device, including changes not yet notified,
(b)
experience gained from post-market surveillance,
(c)
experience from risk management,
(d)
experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I,
(e)
experience from reviews of the clinical evaluation, including the results of any clinical investigations and PMCF,
(f)
changes to the requirements, to components of the device or to the scientific or regulatory environment,
(g)
changes to applied or new harmonised standards, CS or equivalent documents, and
(h)
changes in medical, scientific and technical knowledge, such as:
—
new treatments,
—
changes in test methods,
—
new scientific findings on materials and components, including findings on their biocompatibility,
—
experience from studies on comparable devices,
—
data from registers and registries,
—
experience from clinical investigations with comparable devices.
The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMCF activities undertaken since the previous certification or re-certification, including appropriate updates to manufacturers' clinical evaluation reports.
For the decision on re-certification, the notified body in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps taken for certification such as application and application review.
ANNEX VIII
CLASSIFICATION RULES
CHAPTER I
DEFINITIONS SPECIFIC TO CLASSIFICATION RULES
1.   DURATION OF USE
1.1.   
                     ‘Transient’ means normally intended for continuous use for less than 60 minutes.
1.2.   
                     ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
1.3.   
                     ‘Long term’ means normally intended for continuous use for more than 30 days.
2.   INVASIVE AND ACTIVE DEVICES
2.1.   
                     ‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.
2.2.   
                     ‘Surgically invasive device’ means:
(a)
an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
(b)
a device which produces penetration other than through a body orifice.
2.3.   
                     ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.
2.4.   
                     ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.
2.5.   
                     ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.
2.6.   
                     ‘Central circulatory system’ means the following blood vessels: 
arteriae pulmonales
, 
aorta ascendens
, 
arcus aortae, aorta descendens
 to the 
bifurcatio aortae
, 
arteriae coronariae
, 
arteria carotis communis
, 
arteria carotis externa
, 
arteria carotis interna
, 
arteriae cerebrales
, 
truncus brachiocephalicus
, 
venae cordis
, 
venae pulmonales
, 
vena cava superior
 and 
vena cava inferior
.
2.7.   
                     ‘Central nervous system’ means the brain, meninges and spinal cord.
2.8.   
                     ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.
CHAPTER II
IMPLEMENTING RULES
3.1.   Application of the classification rules shall be governed by the intended purpose of the devices.
3.2.   If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right separately from the device with which they are used.
3.3.   Software, which drives a device or influences the use of a device, shall fall within the same class as the device.
If the software is independent of any other device, it shall be classified in its own right.
3.4.   If the device is not intended to be used solely or principally in a specific part of the body, it shall be considered and classified on the basis of the most critical specified use.
3.5.   If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply.
3.6.   In calculating the duration referred to in Section 1, continuous use shall mean:
(a)
the entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device. Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed; and
(b)
the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type.
3.7.   A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis.
CHAPTER III
CLASSIFICATION RULES
4.   NON-INVASIVE DEVICES
4.1.   Rule 1
All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
4.2.   Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
—
if they may be connected to a class IIa, class IIb or class III active device; or
—
if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
In all other cases, such devices are classified as class I.
4.3.   Rule 3
All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.
All non-invasive devices consisting of a substance or a mixture of substances intended to be used 
in vitro
 in direct contact with human cells, tissues or organs taken from the human body or used 
in vitro
 with human embryos before their implantation or administration into the body are classified as class III.
4.4.   Rule 4
All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
—
class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
—
class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;
—
class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and
—
class IIa in all other cases.
This rule applies also to the invasive devices that come into contact with injured mucous membrane.
5.   INVASIVE DEVICES
5.1.   Rule 5
All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:
—
class I if they are intended for transient use;
—
class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and
—
class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.
5.2.   Rule 6
All surgically invasive devices intended for transient use are classified as class IIa unless they:
—
are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;
—
are reusable surgical instruments, in which case they are classified as class I;
—
are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;
—
are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;
—
have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or
—
are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.
5.3.   Rule 7
All surgically invasive devices intended for short-term use are classified as class IIa unless they:
—
are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;
—
are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;
—
are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;
—
have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;
—
are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or
—
are intended to administer medicines, in which case they are classified as class IIb.
5.4.   Rule 8
All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
—
are intended to be placed in the teeth, in which case they are classified as class IIa;
—
are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III;
—
have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;
—
are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth;
—
are intended to administer medicinal products, in which case they are classified as class III;
—
are active implantable devices or their accessories, in which cases they are classified as class III;
—
are breast implants or surgical meshes, in which cases they are classified as class III;
—
are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or
—
are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments.
6.   ACTIVE DEVICES
6.1.   Rule 9
All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.
All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.
All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.
6.2.   Rule 10
Active devices intended for diagnosis and monitoring are classified as class IIa:
—
if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;
—
if they are intended to image 
in vivo
 distribution of radiopharmaceuticals; or
—
if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.
Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
6.3.   Rule 11
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
—
death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
—
a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
6.4.   Rule 12
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.
6.5.   Rule 13
All other active devices are classified as class I.
7.   SPECIAL RULES
7.1.   Rule 14
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III.
7.2.   Rule 15
All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.
7.3.   Rule 16
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.
All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.
This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.
7.4.   Rule 17
Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.
7.5.   Rule 18
All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.
7.6.   Rule 19
All devices incorporating or consisting of nanomaterial are classified as:
—
class III if they present a high or medium potential for internal exposure;
—
class IIb if they present a low potential for internal exposure; and
—
class IIa if they present a negligible potential for internal exposure.
7.7.   Rule 20
All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class IIb.
7.8.   Rule 21
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:
—
class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose;
—
class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;
—
class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and
—
class IIb in all other cases.
7.9.   Rule 22
Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.
ANNEX IX
CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
CHAPTER I
QUALITY MANAGEMENT SYSTEM
1.   The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the devices concerned. The manufacturer shall ensure the application of the quality management system as specified in Section 2 and shall be subject to audit, as laid down in Sections 2.3 and 2.4, and to surveillance as specified in Section 3.
2.   Quality management system assessment
2.1.   The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include:
—
the name of the manufacturer and address of its registered place of business and any additional manufacturing site covered by the quality management system, and, if the manufacturer's application is lodged by its authorised representative, the name of the authorised representative and the address of the authorised representative's registered place of business,
—
all relevant information on the device or group of devices covered by the quality management system,
—
a written declaration that no application has been lodged with any other notified body for the same device-related quality management system, or information about any previous application for the same device-related quality management system,
—
a draft of an EU declaration of conformity in accordance with Article 19 and Annex IV for the device model covered by the conformity assessment procedure,
—
the documentation on the manufacturer's quality management system,
—
a documented description of the procedures in place to fulfil the obligations arising from the quality management system and required under this Regulation and the undertaking by the manufacturer in question to apply those procedures,
—
a description of the procedures in place to ensure that the quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures,
—
the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92,
—
a description of the procedures in place to keep up to date the post-market surveillance system, and, where applicable, the PMCF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92, as well as the undertaking by the manufacturer to apply those procedures,
—
documentation on the clinical evaluation plan, and
—
a description of the procedures in place to keep up to date the clinical evaluation plan, taking into account the state of the art.
2.2.   Implementation of the quality management system shall ensure compliance with this Regulation. All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures such as quality programmes, quality plans and quality records.
Moreover, the documentation to be submitted for the assessment of the quality management system shall include an adequate description of, in particular:
(a)
the manufacturer's quality objectives;
(b)
the organisation of the business and in particular:
—
the organisational structures with the assignment of staff responsibilities in relation to critical procedures, the responsibilities of the managerial staff and their organisational authority,
—
the methods of monitoring whether the operation of the quality management system is efficient and in particular the ability of that system to achieve the desired design and device quality, including control of devices which fail to conform,
—
where the design, manufacture and/or final verification and testing of the devices, or parts of any of those processes, is carried out by another party, the methods of monitoring the efficient operation of the quality management system and in particular the type and extent of control applied to the other party, and
—
where the manufacturer does not have a registered place of business in a Member State, the draft mandate for the designation of an authorised representative and a letter of intention from the authorised representative to accept the mandate;
(c)
the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices and the corresponding documentation as well as the data and records arising from those procedures and techniques. Those procedures and techniques shall specifically cover:
—
the strategy for regulatory compliance, including processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, choice of and compliance with conformity assessment procedures,
—
identification of applicable general safety and performance requirements and solutions to fulfil those requirements, taking applicable CS and, where opted for, harmonised standards or other adequate solutions into account,
—
risk management as referred to in Section 3 of Annex I,
—
the clinical evaluation, pursuant to Article 61 and Annex XIV, including post-market clinical follow-up,
—
solutions for fulfilling the applicable specific requirements regarding design and construction, including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I,
—
solutions for fulfilling the applicable specific requirements regarding the information to be supplied with the device, in particular the requirements of Chapter III of Annex I,
—
the device identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture, and
—
management of design or quality management system changes; and
(d)
the verification and quality assurance techniques at the manufacturing stage and in particular the processes and procedures which are to be used, particularly as regards sterilisation and the relevant documents; and
(e)
the appropriate tests and trials which are to be carried out before, during and after manufacture, the frequency with which they are to take place, and the test equipment to be used; it shall be possible to trace back adequately the calibration of that test equipment.
In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annexes II and III.
2.3.   Audit
The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 2.2. Where the manufacturer uses a harmonised standard or CS related to a quality management system, the notified body shall assess conformity with those standards or CS. The notified body shall assume that a quality management system which satisfies the relevant harmonised standards or CS conforms to the requirements covered by those standards or CS, unless it duly substantiates not doing so.
The audit team of the notified body shall include at least one member with past experience of assessments of the technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such experience is not immediately obvious or applicable, the notified body shall provide a documented rationale for the composition of that team. The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to verify the manufacturing and other relevant processes.
Moreover, in the case of class IIa and class IIb devices, the quality management system assessment shall be accompanied by the assessment of technical documentation for devices selected on a representative basis in accordance with Sections 4.4 to 4.8. In choosing representative samples, the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 105 and in particular the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended purpose and the results of any previous relevant assessments such as with regard to physical, chemical, biological or clinical properties, that have been carried out in accordance with this Regulation. The notified body in question shall document its rationale for the samples taken.
If the quality management system conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality management system certificate. The notified body shall notify the manufacturer of its decision to issue the certificate. The decision shall contain the conclusions of the audit and a reasoned report.
2.4.   The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered. The notified body shall assess the changes proposed, determine the need for additional audits and verify whether after those changes the quality management system still meets the requirements referred to in Section 2.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits. The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate.
3.   Surveillance assessment applicable to class IIa, class IIb and class III devices
3.1.   The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality management system.
3.2.   The manufacturer shall give authorisation to the notified body to carry out all the necessary audits, including on-site audits, and supply it with all relevant information, in particular:
—
the documentation on its quality management system,
—
documentation on any findings and conclusions resulting from the application of the post-market surveillance plan, including the PMCF plan, for a representative sample of devices, and of the provisions on vigilance set out in Articles 87 to 92,
—
the data stipulated in the part of the quality management system relating to design, such as the results of analyses, calculations, tests and the solutions adopted regarding the risk-management as referred to in Section 4 of Annex I, and
—
the data stipulated in the part of the quality management system relating to manufacture, such as quality control reports and test data, calibration data, and records on the qualifications of the personnel concerned.
3.3.   Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. At the time of such on-site audits, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report.
3.4.   The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment. The notified body shall establish a plan for such unannounced on-site audits but shall not disclose it to the manufacturer.
Within the context of such unannounced on-site audits, the notified body shall test an adequate sample of the devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation, with the exception of the devices referred to in the second subparagraph of Article 52(8). Prior to unannounced on-site audits, the notified body shall specify the relevant sampling criteria and testing procedure.
Instead of, or in addition to, sampling referred to in the second paragraph, the notified body shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation, with the exception of the devices referred to in the second subparagraph of Article 52(8). Prior to the sampling, the notified body in question shall specify the relevant sampling criteria and testing procedure.
The notified body shall provide the manufacturer in question with an on-site audit report which shall include, if applicable, the result of the sample test.
3.5.   In the case of class IIa and class IIb devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the second paragraph of Section 2.3.
In the case of class III devices, the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices.
3.6.   The notified body shall ensure that the composition of the assessment team is such that there is sufficient experience with the evaluation of the devices, systems and processes concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals. As a general rule, a lead auditor shall neither lead nor attend audits for more than three consecutive years in respect of the same manufacturer.
3.7.   If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it.
CHAPTER II
ASSESSMENT OF THE TECHNICAL DOCUMENTATION
4.   Assessment of the technical documentation applicable to class III devices and to the class IIb devices referred to in the second subparagraph of Article 52(4)
4.1.   In addition to the obligations laid down in Section 2, the manufacturer shall lodge with the notified body an application for assessment of the technical documentation relating to the device which it plans to place on the market or put into service and which is covered by the quality management system referred to in Section 2.
4.2.   The application shall describe the design, manufacture and performance of the device in question. It shall include the technical documentation as referred to in Annexes II and III.
4.3.   The notified body shall examine the application by using staff, employed by it, with proven knowledge and experience regarding the technology concerned and its clinical application. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of the Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests.
4.4.   The notified body shall review the clinical evidence presented by the manufacturer in the clinical evaluation report and the related clinical evaluation that was conducted. The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the device in question or the clinical condition in which it is utilised, for the purposes of that review.
4.5.   The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity. For any characteristic of the device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.
4.6.   The notified body shall verify that the clinical evidence and the clinical evaluation are adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety and performance requirements. That verification shall include consideration of the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training and the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the PMCF plan proposed, where applicable.
4.7.   Based on its assessment of the clinical evidence, the notified body shall consider the clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMCF data.
4.8.   The notified body shall clearly document the outcome of its assessment in the clinical evaluation assessment report.
4.9.   The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a clinical evaluation assessment report. If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate. The certificate shall contain the conclusions of the technical documentation assessment, the conditions of the certificate's validity, the data needed for identification of the approved design, and, where appropriate, a description of the intended purpose of the device.
4.10.   Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 52 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate.
5.   Specific additional procedures
5.1.   Assessment procedure for certain class III and class IIb devices
(a)
For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product as referred to in Section 6.4. of Annex VIII (Rule 12), the notified body shall, having verified the quality of clinical data supporting the clinical evaluation report of the manufacturer referred to in Article 61(12), prepare a clinical evaluation assessment report which sets out its conclusions concerning the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication or indications and the PMCF plan referred to in Article 10(3) and Part B of Annex XIV.
The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer's clinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to the Commission.
The Commission shall immediately transmit those documents to the relevant expert panel referred to in Article 106.
(b)
The notified body may be requested to present its conclusions as referred to in point (a) to the expert panel concerned.
(c)
The expert panel shall decide, under the supervision of the Commission, on the basis of all of the following criteria:
(i)
the novelty of the device or of the related clinical procedure involved, and the possible major clinical or health impact thereof;
(ii)
a significantly adverse change in the benefit-risk profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in the case of failure of the device;
(iii)
a significantly increased rate of serious incidents reported in accordance with Article 87 in respect of a specific category or group of devices,
whether to provide a scientific opinion on the clinical evaluation assessment report of the notified body based on the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the medical indication or indications and the PMCF plan. That scientific opinion shall be provided within a period of 60 days, starting on the day of receipt of the documents from the Commission as referred to in point (a). The reasons for the decision to provide a scientific opinion on the basis of the criteria in points (i), (ii) and (iii) shall be included in the scientific opinion. Where the information submitted is not sufficient for the expert panel to reach a conclusion, this shall be stated in the scientific opinion.
(d)
The expert panel may decide, under the supervision of the Commission, on the basis of the criteria laid down in point (c) not to provide a scientific opinion, in which case it shall inform the notified body as soon as possible and in any event within 21 days of receipt of the documents as referred to in point (a) from the Commission. The expert panel shall within that time limit provide the notified body and the Commission with the reasons for its decision, whereupon the notified body may proceed with the certification procedure of that device.
(e)
The expert panel shall within 21 days of receipt of the documents from the Commission notify the Commission, through Eudamed whether it intends to provide a scientific opinion, pursuant to point (c), or whether it intends not to provide a scientific opinion, pursuant to point (d).
(f)
Where no opinion has been delivered within a period of 60 days, the notified body may proceed with the certification procedure of the device in question.
(g)
The notified body shall give due consideration to the views expressed in the scientific opinion of the expert panel. Where the expert panel finds that the level of clinical evidence is not sufficient or otherwise gives rise to serious concerns about the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication(s), and with the PMCF plan, the notified body shall, if necessary, advise the manufacturer to restrict the intended purpose of the device to certain groups of patients or certain medical indications and/or to impose a limit on the duration of validity of the certificate, to undertake specific PMCF studies, to adapt the instructions for use or the summary of safety and performance, or to impose other restrictions in its conformity assessment report, as appropriate. The notified body shall provide a full justification where it has not followed the advice of the expert panel in its conformity assessment report and the Commission shall without prejudice to Article 109 make both the scientific opinion of the expert panel and the written justification provided by the notified body publicly available via Eudamed.
(h)
The Commission, after consultation with the Member States and relevant scientific experts shall provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020.
5.2.   Procedure in the case of devices incorporating a medicinal substance
(a)
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.
(b)
Before issuing an EU technical documentation assessment certificate, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the substance into the device. Where the device incorporates a human blood or plasma derivative or a substance that, if used separately, may be considered to be a medicinal product falling exclusively within the scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
(c)
When issuing its opinion, the medicinal products authority consulted shall take into account the manufacturing process and the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body.
(d)
The medicinal products authority consulted shall provide its opinion to the notified body within 210 days of receipt of all the necessary documentation.
(e)
The scientific opinion of the medicinal products authority consulted, and any possible update of that opinion, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable and shall convey its final decision to the medicinal products authority consulted.
(f)
Before any change is made with respect to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the manufacturer shall inform the notified body of the changes. That notified body shall seek the opinion of the medicinal products authority consulted, in order to confirm that the quality and safety of the ancillary substance remain unchanged. The medicinal products authority consulted shall take into account the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the risk or benefit previously established concerning the incorporation of the substance into the device. The medicinal products authority consulted shall provide its opinion within 60 days after receipt of all the necessary documentation regarding the changes. The notified body shall not deliver the supplement to the EU technical documentation assessment certificate if the scientific opinion provided by the medicinal products authority consulted is unfavourable. The notified body shall convey its final decision to the medicinal products authority consulted.
(g)
Where the medicinal products authority consulted obtains information on the ancillary substance, which could have an impact on the risk or benefit previously established concerning the incorporation of the substance into the device, it shall advise the notified body as to whether this information has an impact on the risk or benefit previously established concerning the incorporation of the substance into the device. The notified body shall take that advice into account in reconsidering its assessment of the conformity assessment procedure.
5.3.   Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable
5.3.1.   Tissues or cells of human origin or their derivatives
(a)
For devices manufactured utilising derivatives of tissues or cells of human origin that are covered by this Regulation in accordance with point (g) of Article 1(6) and for devices that incorporate, as an integral part, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, that have an action ancillary to that of the device, the notified body shall, prior to issuing an EU technical documentation assessment certificate, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2004/23/EC (‘human tissues and cells competent authority’) on the aspects relating to the donation, procurement and testing of tissues or cells of human origin or their derivatives. The notified body shall submit a summary of the preliminary conformity assessment which provides, among other things, information about the non-viability of the human tissues or cells in question, their donation, procurement and testing and the risk or benefit of the incorporation of the tissues or cells of human origin or their derivatives into the device.
(b)
Within 120 days of receipt of all the necessary documentation, the human tissues and cells competent authority shall provide to the notified body its opinion.
(c)
The scientific opinion of the human tissues and cells competent authority, and any possible update, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion of the human tissues and cells competent authority when making its decision. The notified body shall not deliver the certificate if that scientific opinion is unfavourable. It shall convey its final decision to the human tissues and cells competent authority concerned.
(d)
Before any change is made with respect to non-viable tissues or cells of human origin or their derivatives incorporated in a device, in particular relating to their donation, testing or procurement, the manufacturer shall inform the notified body of the intended changes. The notified body shall consult the authority that was involved in the initial consultation, in order to confirm that the quality and safety of the tissues or cells of human origin or their derivatives incorporated in the device are maintained. The human tissues and cells competent authority concerned shall take into account the data relating to the usefulness of incorporation of the tissues or cells of human origin or their derivatives into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of the addition of the tissues or cells of human origin or their derivatives in the device. It shall provide its opinion within 60 days of receipt of all the necessary documentation regarding the intended changes. The notified body shall not deliver a supplement to the EU technical documentation assessment certificate if the scientific opinion is unfavourable and shall convey its final decision to the human tissues and cells competent authority concerned.
5.3.2.   Tissues or cells of animal origin or their derivatives
In the case of devices manufactured utilising animal tissue which is rendered non-viable or utilising non-viable products derived from animal tissue, as referred to in Regulation (EU) No 722/2012, the notified body shall apply the relevant requirements laid down in that Regulation.
5.4.   Procedure in the case of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body
(a)
The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable and only in respect of the requirements not covered by this Regulation, in accordance with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions.
(b)
In addition, for devices, or their products of metabolism, that are systemically absorbed by the human body in order to achieve their intended purpose, the notified body shall seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the compliance of the device with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
(c)
The opinion of the medicinal products authority consulted shall be drawn up within 150 days of receipt of all the necessary documentation.
(d)
The scientific opinion of the medicinal products authority consulted, and any possible update, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision and shall convey its final decision to the medicinal products authority consulted.
6.   Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma as referred to in Article 1(8)
Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma as referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
CHAPTER III
ADMINISTRATIVE PROVISIONS
7.   The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the EU declaration of conformity,
—
the documentation referred to in the fifth indent of Section 2.1 and in particular the data and records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2,
—
information on the changes referred to in Section 2.4,
—
the documentation referred to in Section 4.2, and
—
the decisions and reports from the notified body as referred to in this Annex.
8.   Each Member State shall require that the documentation referred to in Section 7 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period.
ANNEX X
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
1.   EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentation and relevant life cycle processes and a corresponding representative sample of the device production envisaged, fulfils the relevant provisions of this Regulation.
2.   Application
The manufacturer shall lodge an application for assessment with a notified body. The application shall include:
—
the name of the manufacturer and address of the registered place of business of the manufacturer and, if the application is lodged by the authorised representative, the name of the authorised representative and the address of its registered place of business,
—
the technical documentation referred to in Annexes II and III. The applicant shall make a representative sample of the device production envisaged (‘type’) available to the notified body. The notified body may request other samples as necessary, and
—
a written declaration that no application has been lodged with any other notified body for the same type, or information about any previous application for the same type that was refused by another notified body or was withdrawn by the manufacturer or its authorised representative before that other notified body made its final assessment.
3.   Assessment
The notified body shall:
(a)
examine the application by using staff with proven knowledge and experience regarding the technology concerned and its clinical application. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests;
(b)
examine and assess the technical documentation for conformity with the requirements of this Regulation that are applicable to the device and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable standards referred to in Article 8 or with applicable CS, and record the items not designed on the basis of the relevant standards referred to in Article 8 or of the relevant CS;
(c)
review the clinical evidence presented by the manufacturer in the clinical evaluation report in accordance with Section 4 of Annex XIV. The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the device in question or to the clinical condition in which it is utilised, for the purposes of that review;
(d)
in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity;
(e)
clearly document the outcome of its assessment in a pre-clinical and clinical evaluation assessment report as part of the EU type examination report referred to in point (i);
(f)
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements laid down in this Regulation, in the event that the standards referred to in Article 8 or the CS have not been applied. Where the device has to be connected to another device or devices in order to operate as intended, proof shall be provided that it conforms to the general safety and performance requirements when connected to any such device or devices having the characteristics specified by the manufacturer;
(g)
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised standards, those standards have actually been applied;
(h)
agree with the applicant on the place where the necessary assessments and tests are to be carried out; and
(i)
draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to (g).
4.   Certificate
If the type conforms to this Regulation, the notified body shall issue an EU type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the type examination assessment, the conditions of the certificate's validity and the data needed for identification of the type approved. The certificate shall be drawn up in accordance with Annex XII. The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body.
5.   Changes to the type
5.1.   The applicant shall inform the notified body which issued the EU type-examination certificate of any planned change to the approved type or of its intended purpose and conditions of use.
5.2.   Changes to the approved device including limitations of its intended purpose and conditions of use shall require approval from the notified body which issued the EU type-examination certificate where such changes may affect conformity with the general safety and performance requirements or with the conditions prescribed for use of the product. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU type-examination report. The approval of any change to the approved type shall take the form of a supplement to the EU type-examination certificate.
5.3.   Changes to the intended purpose and conditions of use of the approved device, with the exception of limitations of the intended purpose and conditions of use, shall necessitate a new application for a conformity assessment.
6.   Specific additional procedures
Section 5 of Annex IX shall apply with the proviso that any reference to an EU technical documentation assessment certificate shall be understood as a reference to an EU type-examination certificate.
7.   Administrative provisions
The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the documentation referred to in the second indent of Section 2,
—
information on the changes referred to in Section 5, and
—
copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements.
Section 8 of Annex IX shall apply.
ANNEX XI
CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
1.   The objective of the conformity assessment based on product conformity verification is to ensure that devices conform to the type for which an EU type-examination certificate has been issued, and that they meet the provisions of this Regulation which apply to them.
2.   Where an EU type-examination certificate has been issued in accordance with Annex X, the manufacturer may either apply the procedure set out in Part A (production quality assurance) or the procedure set out in Part B (product verification) of this Annex.
3.   By way of derogation from Sections 1 and 2 above, the procedures in this Annex coupled with the drawing up of technical documentation as set out in Annexes II and III may also be applied by manufacturers of class IIa devices.
PART A
PRODUCTION QUALITY ASSURANCE
4.   The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out a final verification, as specified in Section 6, and shall be subject to the surveillance referred to in Section 7.
5.   When the manufacturer fulfils the obligations laid down in Section 4, it shall draw up and keep an EU declaration of conformity in accordance with Article 19 and Annex IV for the device covered by the conformity assessment procedure. By issuing an EU declaration of conformity, the manufacturer shall be deemed to ensure and to declare that the device concerned conforms to the type described in the EU type-examination certificate and meets the requirements of this Regulation which apply to the device.
6.   Quality management system
6.1.   The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include:
—
all elements listed in Section 2.1 of Annex IX,
—
the technical documentation referred to in Annexes II and III for the types approved, and
—
a copy of the EU type-examination certificates referred to in Section 4 of Annex X; if the EU type-examination certificates have been issued by the same notified body with which the application is lodged, a reference to the technical documentation and its updates and the certificates issued shall also be included in the application.
6.2.   Implementation of the quality management system shall be such as to ensure that there is compliance with the type described in the EU type-examination certificate and with the provisions of this Regulation which apply to the devices at each stage. All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records.
That documentation shall, in particular, include an adequate description of all elements listed in points (a), (b), (d) and (e) of Section 2.2 of Annex IX.
6.3.   The first and second paragraph of Section 2.3 of Annex IX shall apply.
If the quality management system is such that it ensures that the devices conform to the type described in the EU type-examination certificate and that it conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality assurance certificate. The notified body shall notify the manufacturer of its decision to issue the certificate. That decision shall contain the conclusions of the notified body's audit and a reasoned assessment.
6.4.   Section 2.4 of Annex IX shall apply.
7.   Surveillance
Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of Annex IX shall apply.
In the case of class III devices, surveillance shall also include a check that the quantities of produced or purchased raw material or crucial components approved for the type and correspond to the quantities of finished devices.
8.   Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(8).
Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
9.   Administrative provisions
The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the EU declaration of conformity,
—
the documentation referred to in the fifth indent of Section 2.1 of Annex IX,
—
the documentation referred to in the eighth indent of Section 2.1 of Annex IX, including the EU type-examination certificate referred to in Annex X,
—
information on the changes referred to in Section 2.4 of Annex IX, and
—
the decisions and reports from the notified body as referred to in Sections 2.3, 3.3 and 3.4 of Annex IX.
Section 8 of Annex IX shall apply.
10.   Application to class IIa devices
10.1.   By way of derogation from Section 5, by virtue of the EU declaration of conformity the manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are manufactured in conformity with the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them.
10.2.   For class IIa devices the notified body shall assess, as part of the assessment referred to in Section 6.3, whether the technical documentation as referred to in Annexes II and III for the devices selected on a representative basis is compliant with this Regulation.
In choosing a representative sample or samples of devices, the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical, biological or clinical properties) that have been carried out in accordance with this Regulation. The notified body shall document its rationale for the sample or samples of devices taken.
10.3.   Where the assessment under Section 10.2. confirms that the class IIa devices in question conform to the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them, the notified body shall issue a certificate pursuant to this Part of this Annex.
10.4.   Samples additional to those taken for the initial conformity assessment of devices shall be assessed by the notified body as part of the surveillance assessment referred to in Section 7.
10.5.   By way of derogation from Section 6, the manufacturer or its authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the EU declaration of conformity,
—
the technical documentation referred to in Annexes II and III, and
—
the certificate referred to in Section 10.3.
Section 8 of Annex IX shall apply.
PART B
PRODUCT VERIFICATION
11.   Product verification shall be understood to be the procedure whereby after examination of every manufactured device, the manufacturer, by issuing an EU declaration of conformity in accordance with Article 19 and Annex IV, shall be deemed to ensure and to declare that the devices which have been subject to the procedure set out in Sections 14 and 15 conform to the type described in the EU type-examination certificate and meet the requirements of this Regulation which apply to them.
12.   The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which conform to the type described in the EU type-examination certificate and to the requirements of the Regulation which apply to them. Prior to the start of manufacture, the manufacturer shall prepare documents defining the manufacturing process, in particular as regards sterilisation where necessary, together with all routine, pre-established procedures to be implemented to ensure homogeneous production and, where appropriate, conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them.
In addition, for devices placed on the market in a sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer shall apply the provisions of Sections 6 and 7.
13.   The manufacturer shall undertake to institute and keep up to date a post-market surveillance plan, including a PMCF plan, and the procedures ensuring compliance with the obligations of the manufacturer resulting from the provisions on vigilance and post-market surveillance system set out in Chapter VII.
14.   The notified body shall carry out the appropriate examinations and tests in order to verify the conformity of the device with the requirements of the Regulation by examining and testing every product as specified in Section 15.
The examinations and tests referred to in the first paragraph of this Section shall not apply to aspects of the manufacturing process designed to secure sterility.
15.   Verification by examination and testing of every product
15.1.   Every device shall be examined individually and the appropriate physical or laboratory tests as defined in the relevant standard or standards referred to in Article 8, or equivalent tests and assessments, shall be carried out in order to verify, where appropriate, the conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them.
15.2.   The notified body shall affix, or have affixed, its identification number to each approved device and shall draw up an EU product verification certificate relating to the tests and assessments carried out.
16.   Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(8).
Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
17.   Administrative provisions
The manufacturer or its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the EU declaration of conformity,
—
the documentation referred to in Section 12,
—
the certificate referred to in Section 15.2, and
—
the EU type-examination certificate referred to in Annex X.
Section 8 of Annex IX shall apply.
18.   Application to class IIa devices
18.1.   By way of derogation from Section 11, by virtue of the EU declaration of conformity the manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are manufactured in conformity with the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them.
18.2.   The verification conducted by the notified body in accordance with Section 14 is intended to confirm the conformity of the class IIa devices in question with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to them.
18.3.   If the verification referred to in Section 18.2 confirms that the class IIa devices in question conform to the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them, the notified body shall issue a certificate pursuant to this Part of this Annex.
18.4.   By way of derogation from Section 17, the manufacturer or its authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the EU declaration of conformity,
—
the technical documentation referred to in Annexes II and III, and
—
the certificate referred to in Section 18.3.
Section 8 of Annex IX shall apply.
ANNEX XII
CERTIFICATES ISSUED BY A NOTIFIED BODY
CHAPTER I
GENERAL REQUIREMENTS
1.
Certificates shall be drawn up in one of the official languages of the Union.
2.
Each certificate shall refer to only one conformity assessment procedure.
3.
Certificates shall only be issued to one manufacturer. The name and address of the manufacturer included in the certificate shall be the same as that registered in the electronic system referred to in Article 30.
4.
The scope of the certificates shall unambiguously identify the device or devices covered:
(a)
EU technical documentation assessment certificates, EU type-examination certificates and EU product verification certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI as referred to in Article 27(6);
(b)
EU quality management system certificates and EU quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification, and, for class IIb devices, the intended purpose.
5.
The notified body shall be able to demonstrate on request, which (individual) devices are covered by the certificate. The notified body shall set up a system that enables the determination of the devices, including their classification, covered by the certificate.
6.
Certificates shall contain, if applicable, a note that, for the placing on the market of the device or devices it covers, another certificate issued in accordance with this Regulation is required.
7.
EU quality management system certificates and EU quality assurance certificates for class I devices for which the involvement of a notified body is required pursuant to Article 52(7) shall include a statement that the audit by the notified body of the quality management system was limited to the aspects required under that paragraph.
8.
Where a certificate is supplemented, modified or re-issued, the new certificate shall contain a reference to the preceding certificate and its date of issue with identification of the changes.
CHAPTER II
MINIMUM CONTENT OF THE CERTIFICATES
1.
name, address and identification number of the notified body;
2.
name and address of the manufacturer and, if applicable, of the authorised representative;
3.
unique number identifying the certificate;
4.
if already issued, the SRN of the manufacturer referred to in to Article 31(2);
5.
date of issue;
6.
date of expiry;
7.
data needed for the unambiguous identification of the device or devices where applicable as specified in Section 4 of Part I;
8.
if applicable, reference to any previous certificate as specified in Section 8 of Chapter I;
9.
reference to this Regulation and the relevant Annex in accordance with which the conformity assessment has been carried out;
10.
examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test reports and audit report(s);
11.
if applicable, reference to the relevant parts of the technical documentation or other certificates required for the placing on the market of the device or devices covered;
12.
if applicable, information about the surveillance by the notified body;
13.
conclusions of the notified body's conformity assessment with regard to the relevant Annex;
14.
conditions for or limitations to the validity of the certificate;
15.
legally binding signature of the notified body in accordance with the applicable national law.
ANNEX XIII
PROCEDURE FOR CUSTOM-MADE DEVICES
1.
For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:
—
the name and address of the manufacturer, and of all manufacturing sites,
—
if applicable, the name and address of the authorised representative,
—
data allowing identification of the device in question,
—
a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code,
—
the name of the person who made out the prescription and who is authorised by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned,
—
the specific characteristics of the product as indicated by the prescription,
—
a statement that the device in question conforms to the general safety and performance requirements set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been fully met, together with the grounds,
—
where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin, or of animal origin as referred to in Regulation (EU) No 722/2012.
2.
The manufacturer shall undertake to keep available for the competent national authorities documentation that indicates its manufacturing site or sites and allows an understanding to be formed of the design, manufacture and performance of the device, including the expected performance, so as to allow assessment of conformity with the requirements of this Regulation.
3.
The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which are manufactured in accordance with the documentation referred to in Section 2.
4.
The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.
Section 8 of Annex IX shall apply.
5.
The manufacturer shall review and document experience gained in the post-production phase, including from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective action, In that context, it shall report in accordance with Article 87(1) to the competent authorities any serious incidents or field safety corrective actions or both as soon as it learns of them.
ANNEX XIV
CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
PART A
CLINICAL EVALUATION
1.   To plan, continuously conduct and document a clinical evaluation, manufacturers shall:
(a)
establish and update a clinical evaluation plan, which shall include at least:
—
an identification of the general safety and performance requirements that require support from relevant clinical data;
—
a specification of the intended purpose of the device;
—
a clear specification of intended target groups with clear indications and contra-indications;
—
a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;
—
a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects;
—
an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device;
—
an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and
—
a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria;
(b)
identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review;
(c)
appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device;
(d)
generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues; and
(e)
analyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.
2.   The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.
3.   A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:
—
Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
—
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
—
Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. Considerations of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.
4.   The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation for the device in question.
Both favourable and unfavourable data considered in the clinical evaluation shall be included in the technical documentation.
PART B
POST-MARKET CLINICAL FOLLOW-UP
5.   PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.
6.   PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
6.1.   The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:
(a)
confirming the safety and performance of the device throughout its expected lifetime,
(b)
identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
(c)
identifying and analysing emergent risks on the basis of factual evidence,
(d)
ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
(e)
identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
6.2.   The PMCF plan shall include at least:
(a)
the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
(b)
the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
(c)
a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
(d)
a reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I;
(e)
the specific objectives to be addressed by the PMCF;
(f)
an evaluation of the clinical data relating to equivalent or similar devices;
(g)
reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF; and
(h)
a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.
7.   The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.
8.   The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
ANNEX XV
CLINICAL INVESTIGATIONS
CHAPTER I
GENERAL REQUIREMENTS
1.   Ethical principles
Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles.
2.   Methods
2.1.   Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. The rationale for the design and chosen statistical methodology shall be presented as further described in Section 3.6 of Chapter II of this Annex.
2.2.   The procedures used to perform the clinical investigation shall be appropriate to the device under investigation.
2.3.   The research methodologies used to perform the clinical investigation shall be appropriate to the device under investigation.
2.4.   Clinical investigations shall be performed in accordance with the clinical investigation plan by a sufficient number of intended users and in a clinical environment that is representative of the intended normal conditions of use of the device in the target patient population. Clinical investigations shall be in line with the clinical evaluation plan as referred to in Part A of Annex XIV.
2.5.   All the appropriate technical and functional features of the device, in particular those involving safety and performance, and their expected clinical outcomes shall be appropriately addressed in the investigational design. A list of the technical and functional features of the device and the related expected clinical outcomes shall be provided.
2.6.   The endpoints of the clinical investigation shall address the intended purpose, clinical benefits, performance and safety of the device. The endpoints shall be determined and assessed using scientifically valid methodologies. The primary endpoint shall be appropriate to the device and clinically relevant.
2.7.   Investigators shall have access to the technical and clinical data regarding the device. Personnel involved in the conduct of an investigation shall be adequately instructed and trained in the proper use of the investigational device, and as regards the clinical investigation plan and good clinical practice. This training shall be verified and where necessary arranged by the sponsor and documented appropriately.
2.8.   The clinical investigation report, signed by the investigator, shall contain a critical evaluation of all the data collected during the clinical investigation, and shall include any negative findings.
CHAPTER II
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanied by the following documents:
1.   Application form
The application form shall be duly filled in, containing information regarding:
1.1.
name, address and contact details of the sponsor and, if applicable, name, address and contact details of its contact person or legal representative in accordance with Article 62(2) established in the Union;
1.2.
if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for clinical investigation and, if applicable, of its authorised representative;
1.3.
title of the clinical investigation;
1.4.
status of the clinical investigation application (i.e. first submission, resubmission, significant amendment);
1.5.
details and/or reference to the clinical evaluation plan;
1.6.
If the application is a resubmission with regard to a device for which an application has been already submitted, the date or dates and reference number or numbers of the earlier application or in the case of significant amendment, reference to the original application. The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
1.7.
if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
1.8.
identification of the Member States and third countries in which the clinical investigation is to be conducted as part of a multicentre or multinational study at the time of application;
1.9.
a brief description of the investigational device, its classification and other information necessary for the identification of the device and device type;
1.10.
information as to whether the device incorporates a medicinal substance, including a human blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives;
1.11.
summary of the clinical investigation plan including the objective or objectives of the clinical investigation, the number and gender of subjects, criteria for subject selection, whether there are subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies, planned dates of commencement and of completion of the clinical investigation;
1.12.
if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;
1.13.
evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical investigation in accordance with the clinical investigation plan;
1.14.
details of the anticipated start date and duration of the investigation;
1.15.
details to identify the notified body, if already involved at the stage of application for a clinical investigation;
1.16.
confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application; and
1.17.
the statement referred to in Section 4.1.
2.   Investigator's Brochure
The investigator's brochure (IB) shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. Any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner. The IB shall be clearly identified and contain in particular the following information:
2.1.
Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule pursuant to Annex VIII, design and manufacturing of the device and reference to previous and similar generations of the device.
2.2.
Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use, including storage and handling requirements, as well as, to the extent that such information is available, information to be placed on the label, and instructions for use to be provided with the device when placed on the market. In addition, information relating to any relevant training required.
2.3.
Pre-clinical evaluation based on relevant pre-clinical testing and experimental data, in particular regarding in-design calculations, 
in vitro
 tests, 
ex vivo
 tests, animal tests, mechanical or electrical tests, reliability tests, sterilisation validation, software verification and validation, performance tests, evaluation of biocompatibility and biological safety, as applicable.
2.4.
Existing clinical data, in particular:
—
from relevant scientific literature available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of the device and/or of equivalent or similar devices;
—
other relevant clinical data available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of equivalent or similar devices of the same manufacturer, including length of time on the market and a review of performance, clinical benefit and safety-related issues and any corrective actions taken.
2.5.
Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks, any undesirable effects, contraindications and warnings.
2.6.
In the case of devices that incorporate a medicinal substance, including a human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the medicinal substance or on the tissues, cells or their derivatives, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the substance or tissues, cells or their derivatives, as well as evidence for the added value of incorporation of such constituents in relation to the clinical benefit and/or safety of the device.
2.7.
A list detailing the fulfilment of the relevant general safety and performance requirements set out in Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or have only been partly fulfilled or are lacking.
2.8.
A detailed description of the clinical procedures and diagnostic tests used in the course of the clinical investigation and in particular information on any deviation from normal clinical practice.
3.   Clinical Investigation Plan
The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology, monitoring, conduct, record-keeping and the method of analysis for the clinical investigation. It shall contain in particular the information as laid down in this Annex. If part of this information is submitted in a separate document, it shall be referenced in the CIP.
3.1.   General
3.1.1.   Single identification number of the clinical investigation, as referred to in Article 70(1).
3.1.2.   Identification of the sponsor — name, address and contact details of the sponsor and, where applicable, the name, address and contact details of the sponsor's contact person or legal representative in accordance with Article 62(2) established in the Union.
3.1.3.   Information on the principal investigator at each investigational site, the coordinating investigator for the investigation, the address details for each investigational site and the emergency contact details for the principal investigator at each site. The roles, responsibilities and qualifications of the various kinds of investigators shall be specified in the CIP.
3.1.4.   A brief description of how the clinical investigation is financed and a brief description of the agreement between the sponsor and the site.
3.1.5.   Overall synopsis of the clinical investigation, in an official Union language determined by the Member State concerned.
3.2.   Identification and description of the device, including its intended purpose, its manufacturer, its traceability, the target population, materials coming into contact with the human body, the medical or surgical procedures involved in its use and the necessary training and experience for its use, background literature review, the current state of the art in clinical care in the relevant field of application and the proposed benefits of the new device.
3.3.   Risks and clinical benefits of the device to be examined, with justification of the corresponding expected clinical outcomes in the clinical investigation plan.
3.4.   Description of the relevance of the clinical investigation in the context of the state of the art of clinical practice.
3.5.   Objectives and hypotheses of the clinical investigation.
3.6.   Design of the clinical investigation with evidence of its scientific robustness and validity.
3.6.1.   General information such as type of investigation with rationale for choosing it, for its endpoints and for its variables as set out in the clinical evaluation plan.
3.6.2.   Information on the investigational device, on any comparator and on any other device or medication to be used in the clinical investigation.
3.6.3.   Information on subjects, selection criteria, size of investigation population, representativeness of investigation population in relation to target population and, if applicable, information on vulnerable subjects involved such as children, pregnant women, immuno-compromised or, elderly subjects.
3.6.4.   Details of measures to be taken to minimise bias, such as randomisation, and management of potential confounding factors.
3.6.5.   Description of the clinical procedures and diagnostic methods relating to the clinical investigation and in particular highlighting any deviation from normal clinical practice.
3.6.6.   Monitoring plan.
3.7.   Statistical considerations, with justification, including a power calculation for the sample size, if applicable.
3.8.   Data management.
3.9.   Information about any amendments to the CIP.
3.10.   Policy regarding follow-up and management of any deviations from the CIP at the investigational site and clear prohibition of use of waivers from the CIP.
3.11.   Accountability regarding the device, in particular control of access to the device, follow-up in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning devices.
3.12.   Statement of compliance with the recognised ethical principles for medical research involving humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as with the applicable regulatory requirements.
3.13.   Description of the Informed consent process.
3.14.   Safety reporting, including definitions of adverse events and serious adverse events, device deficiencies, procedures and timelines for reporting.
3.15.   Criteria and procedures for follow-up of subjects following the end, temporary halt or early termination of an investigation, for follow-up of subjects who have withdrawn their consent and procedures for subjects lost to follow-up. Such procedures shall for implantable devices, cover as a minimum traceability.
3.16.   A description of the arrangements for taking care of the subjects after their participation in the clinical investigation has ended, where such additional care is necessary because of the subjects' participation in the clinical investigation and where it differs from that normally expected for the medical condition in question.
3.17.   Policy as regards the establishment of the clinical investigation report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 1 of Chapter I.
3.18.   List of the technical and functional features of the device, with specific mention of those covered by the investigation.
3.19.   Bibliography.
4.   Other information
4.1.   A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
4.2.   Where applicable according to national law, copy of the opinion or opinions of the ethics committee or committees concerned. Where according to national law the opinion or opinions of the ethics committee or committees is not required at the time of the submission of the application, a copy of the opinion or opinions shall be submitted as soon as available.
4.3.   Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 69 and the corresponding national law.
4.4.   Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document.
4.5.   Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular:
—
organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed;
—
a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects; and
—
a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects.
4.6.   Full details of the available technical documentation, for example detailed risk analysis/management documentation or specific test reports, shall, upon request, be submitted to the competent authority reviewing an application.
CHAPTER III
OTHER OBLIGATIONS OF THE SPONSOR
1.   The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter II of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the investigational device, that obligation may be fulfilled by that person on behalf of the sponsor.
2.   The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in a timely manner.
3.   The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical investigation with the device in question has ended, or, in the event that the device is subsequently placed on the market, at least 10 years after the last device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.
Each Member State shall require that this documentation is kept at the disposal of the competent authorities for the period referred to in the first subparagraph in case the sponsor, or its contact person or legal representative as referred to in Article 62(2) established within its territory, goes bankrupt or ceases its activity prior to the end of this period.
4.   The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.
5.   The Sponsor shall complete the follow-up of investigation subjects.
6.   The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or external inspection.
7.   The Sponsor shall prepare a clinical investigation report which includes at least the following:
—
Cover/introductory page or pages indicating the title of the investigation, the investigational device, the single identification number, the CIP number and the details with signatures of the coordinating investigators and the principal investigators from each investigational site.
—
Details of the author and date of the report.
—
A summary of the investigation covering the title, purpose of the investigation, description of the investigation, investigational design and methods used, the results of the investigation and conclusion of the investigation. The completion date of the investigation, and in particular details of early termination, temporary halts or suspensions of investigations.
—
Investigational device description, in particular clearly defined intended purpose.
—
A summary of the clinical investigation plan covering objectives, design, ethical aspects, monitoring and quality measures, selection criteria, target patient populations, sample size, treatment schedules, follow-up duration, concomitant treatments, statistical plan, including hypothesis, sample size calculation and analysis methods, as well as a justification.
—
Results of the clinical investigation covering, with rationale and justification, subject demographics, analysis of results related to chosen endpoints, details of subgroup analysis, as well as compliance with the CIP, and covering follow-up of missing data and of patients withdrawing from the clinical investigation, or lost to follow-up.
—
Summary of serious adverse events, adverse device effects, device deficiencies and any relevant corrective actions.
—
Discussion and overall conclusions covering safety and performance results, assessment of risks and clinical benefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions for specific patient populations, implications for the investigational device, limitations of the investigation.
ANNEX XVI
LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
1.
Contact lenses or other items intended to be introduced into or onto the eye.
2.
Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
3.
Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
4.
Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
5.
High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
6.
Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
ANNEX XVII
CORRELATION TABLE
Council Directive 90/385/EEC
Council Directive 93/42/EEC
This Regulation
Article 1(1)
Article 1(1)
Article 1(1)
Article 1(2)
Article 1(2)
Article 2
Article 1(3)
Article 1(3) first subparagraph
Article 1(9) first subparagraph
—
Article 1(3) second subparagraph
Article 1(9) second subparagraph
Article 1(4) and (4a)
Article 1(4) and (4a)
Article 1(8) first subparagraph
Article 1(5)
Article 1(7)
Article 1(11)
Article 1(6)
Article 1(5)
Article 1(6)
—
Article 1(6)
—
—
Article 1(8)
Article 1(13)
Article 2
Article 2
Article 5(1)
Article 3 first paragraph
Article 3 first paragraph
Article 5(2)
Article 3 second paragraph
Article 3 second paragraph
Article 1(12)
Article 4(1)
Article 4(1)
Article 24
Article 4(2)
Article 4(2)
Article 21(1) and (2)
Article 4(3)
Article 4(3)
Article 21(3)
Article 4(4)
Article 4(4)
Article 10(11)
Article 4(5)(a)
Article 4(5) first subparagraph
Article 20(6)
Article 4(5)(b)
Article 4(5) second subparagraph
—
Article 5(1)
Article 5(1)
Article 8(1)
Article 5(2)
Article 5(2)
Article 8(2)
Article 6(1)
Articles 5(3) and 6
—
Article 6(2)
Article 7(1)
Article 114
Article 7
Article 8
Articles 94 to 97
—
Article 9
Article 51
Article 8(1)
Article 10(1)
Articles 87(1) and 89 (2)
Article 8(2)
Article 10(2)
Article 87(10) and Article 87(11) first subparagraph
Article 8(3)
Article 10(3)
Article 89(7)
Article 8(4)
Article 10(4)
Article 91
Article 9(1)
Article 11(1)
Article 52(3)
—
Article 11(2)
Article 52(6)
—
Article 11(3)
Article 52(4) and (5)
—
Article 11(4)
—
—
Article 11(5)
Article 52(7)
Article 9(2)
Article 11 (6)
Article 52(8)
Article 9(3)
Article 11(8)
Article 11(3)
Article 9(4)
Article 11(12)
Article 52(12)
Article 9(5)
Article 11(7)
—
Article 9(6)
Article 11(9)
Article 53(1)
Article 9(7)
Article 11(10)
Article 53(4)
Article 9(8)
Article 11(11)
Article 56(2)
Article 9(9)
Article 11(13)
Article 59
Article 9(10)
Article 11(14)
Article 4(5) and Article 122 third paragraph
—
Article 12
Article 22
—
Article 12a
Article 17
Article 9a(1) first indent
Article 13(1)(c)
—
Article 9a(1) second indent
Article 13(1)(d)
Article 4(1)
—
Article 13(1)(a)
Article 51(3)(a) and Article 51(6)
—
Article 13(1)(b)
Article 51(3)(b) and Article 51(6)
Article 10
Article 15
Articles 62 to 82
Article 10a(1), second sentence of Article 10a(2) and Article 10a(3)
Article 14(1), second sentence of Article 14(2) and Article 14(3)
Articles 29(4), 30 and 31
Article 10a(2), first sentence
Article 14(2) first sentence
Article 11(1)
Article 10b
Article 14a
Articles 33 and 34
Article 10c
Article 14b
Article 98
Article 11(1)
Article 16(1)
Articles 42 and 43
Article 11(2)
Article 16(2)
Article 36
Article 11(3)
Article 16(3)
Article 46(4)
Article 11(4)
Article 16(4)
—
Article 11(5)
Article 16(5)
Article 56(5)
Article 11(6)
Article 16(6)
Article 56(4)
Article 11(7)
Article 16(7)
Articles 38(2) and 44(2)
Article 12
Article 17
Article 20
Article 13
Article 18
Articles 94 to 97
Article 14
Article 19
Article 99
Article 15
Article 20
Article 109
Article 15a
Article 20a
Article 102
Article 16
Article 22
—
Article 17
Article 23
—
—
Article 21
—

Summary:
Ensuring the safety and performance of medical devices
SUMMARY OF:
Regulation (EU) 2017/745 on medical devices
WHAT IS THE AIM OF THE REGULATION?
It updates the rules on placing, making available and putting into service 
medical devices
1
 
for human use
 and their accessories on the 
European Union
 (EU) market.
It also contains rules on how 
clinical investigations
2
 concerning such devices and accessories are carried out in the EU.
It aims to improve 
patient safety
 by introducing more stringent procedures for 
conformity assessment
 (to ensure that unsafe or non-compliant devices do not end up on the market) and 
post-market surveillance
.
Amending Regulation (EU) 
2020/561
 was adopted to allow EU 
Member States
 and their authorities and institutions to prioritise the fight against the 
COVID-19
 pandemic. It defers the application of certain rules of Regulation (EU) 2017/745 by 1 year, in order to ensure the smooth functioning of the EU’s 
internal market
, to maintain a high level of protection of 
public health
 and patient safety, to provide legal certainty and to avoid potential market disruption during the pandemic.
KEY POINTS
Scope
Besides medical devices, the regulation also covers certain groups of products which do not have an intended medical purpose. These include coloured contact lenses (i.e. lenses that do not correct vision) and liposuction equipment. A list of these products is included in Annex XVI to the regulation.
Classification
Medical devices are classified according to their intended purpose and their inherent risks (classes I, IIa, IIb and III as set out in Annex VIII to the regulation).
Notified bodies
The regulation tightens the rules concerning how the independent 
notified bodies
 – which assess the conformity of medium- and high-risk medical devices before they are placed on the market – are designated, organised and monitored.
These bodies have to meet the same high-quality standards throughout the EU and must have the required competences, resources and staff to successfully perform their conformity assessment tasks.
On-site inspections of manufacturers, of which some are unannounced, must be carried out.
Assessments of certain high-risk devices (e.g. implants) might also involve EU-level panels of independent experts (
expert panels
).
Clinical data
The regulation specifies what is required in the data collection of clinical investigations on medical devices. These requirements have been to a large extent aligned with those applicable for clinical trials on medicinal products. They include rules on informed consent and protecting vulnerable subjects (e.g. people under the age of 18, pregnant women or incapacitated people).
Clinical investigations conducted in more than one Member State will be subject to a 
single coordinated assessment
.
Obligations of manufacturers and other economic operators
Manufacturers have clearer and more stringent obligations to monitor the quality, performance and safety of devices.
They must ensure sufficient financial coverage with respect to their potential liability under Directive 
85/374/EEC
 on product liability (see 
summary
) and the related measures must be proportionate to the risk class, the type of device and the size of the enterprise.
Manufacturers have to establish 
quality management and post-market surveillance systems
 proportionate to the risk class and the type of device.
In the event of damages due to a defective device, a manufacturer’s authorised representative is jointly and severally liable.
Where 
hazardous substances
 which are carcinogenic, mutagenic or toxic to reproduction or which can interfere with endocrine systems are present in 
invasive medical devices
3
 beyond a 
certain threshold
, manufacturers must justify their presence to the notified body.
Specific obligations are also established for related economic operators: authorised representatives, importers, distributors and those dealing with systems and procedure packs.
Traceability
The regulation introduces a system for registering devices and manufacturers, importers and authorised representatives to ensure the traceability of devices throughout the supply chain by means of a 
unique device identifier
. This will ensure that measures can be taken rapidly if problems arise.
Single-use devices
These devices may only be 
reprocessed
 (cleaned, disinfected, tested, restored for technical and functional safety and sterilised) if permitted under national law and if they meet certain conditions laid down in this regulation. Any individual or legal person who reprocesses a single-use device to make it suitable for further use assumes the obligations of a manufacturer. In certain cases, Member States may allow for exceptions to the general rules where the single-use device is reprocessed and used within a health institution, provided that certain specific requirements laid down in the regulation are fulfilled.
Incident reporting
In addition to the obligation for manufacturers to report serious incidents and trends in non-serious incidents, the regulation introduces obligations for Member States to encourage and enable healthcare professionals, users and patients to report suspected incidents at the national level using standardised formats.
Market surveillance
The relevant EU authorities are responsible for ensuring that any unsafe or non-compliant device is not placed on the market, or is withdrawn from the market if found to be unsafe after being placed on the market.
Eudamed
A centralised system, the 
European database on medical devices
 (Eudamed), will be developed to provide Member States, economic operators, patients, healthcare professionals and the public with information on medical devices available in the EU.
Implant card
In the case of 
implantable devices
, manufacturers must provide patients with key information on an 
implant card
 delivered with the device. This includes:
the identification of the device, its name, serial number, lot number, the unique device identifier and the manufacturer’s details;
adverse effects on the device caused by instruments present at the time of investigations or treatment;
the expected lifetime of the device and any necessary follow-up.
Implementing acts
The full list of 
implementing acts
 to Regulation (EU) 2017/745 can be found 
here
.
Repeal of existing legislation – Directives 90/385/EEC and 93/42/EEC
The regulation, as amended by Regulation (EU) 2020/561, repeals Directives 
90/385/EEC
 and 
93/42/EEC
 from 
26 May 2021
, laying down specific transitional rules and some exceptions in Articles 120 and 122.
FROM WHEN DOES THE REGULATION APPLY?
It entered into force on 
25 May 2017
 and, further to amending Regulation (EU) 2020/561, has applied from 
26 May 2021
, 1 year later than originally intended. However, the dates of application for some of the regulation’s rules vary and are detailed in Articles 120, 122 and 123, as amended.
BACKGROUND
This regulation is one of two adopted by the EU to overhaul its laws on medical devices. The second regulation (Regulation (EU) 
2017/746
, see 
summary
) concerns 
in vitro
 diagnostic medical devices.
For further information, see: 
Medical devices
 (European Commission).
KEY TERMS
Medical device.
 A term covering a wide variety of products used, for instance, for: It does not achieve its principal intended action by pharmacological, immunological or metabolic means, but the latter may assist in its function. Examples range from bandages through hip replacements to pacemakers. The complete definition of the term medical device is laid down in Article 2(1) of Regulation (EU) 2017/745.
Clinical investigation.
 A systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
Invasive medical devices.
 A device which, wholly or partially, penetrates the body, either through an orifice or through the surface of the body.
MAIN DOCUMENT
Regulation (EU) 
2017/745
 of the European Parliament and of the Council of 
5 April 2017
 on medical devices, amending Directive 2001/83/EC, Regulation (EC) 
No 178/2002
 and Regulation (EC) 
No 1223/2009
 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 
5.5.2017
, 
pp. 1–175
).
Successive amendments to Regulation (EU) 2017/745 have been incorporated into the original text. This 
consolidated version
 is of documentary value only.
RELATED DOCUMENTS
Regulation (EU) 
2017/746
 of the European Parliament and of the Council of 
5 April 2017
 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 
5.5.2017
, 
pp. 176–332
).
See 
consolidated version
.
last update 
27.1.2022

--- DANISH ---

Document:
5.5.2017
DA
Den Europæiske Unions Tidende
L 117/1
EUROPA-PARLAMENTETS OG RÅDETS FORORDNING (EU) 2017/745
af 5. april 2017
om medicinsk udstyr, om ændring af direktiv 2001/83/EF, forordning (EF) nr. 178/2002 og forordning (EF) nr. 1223/2009 og om ophævelse af Rådets direktiv 90/385/EØF og 93/42/EØF
(EØS-relevant tekst)
EUROPA-PARLAMENTET OG RÅDET FOR DEN EUROPÆISKE UNION HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde, særlig artikel 114 og artikel 168, stk. 4, litra c),
under henvisning til forslag fra Europa-Kommissionen,
efter fremsendelse af udkast til lovgivningsmæssig retsakt til de nationale parlamenter,
under henvisning til udtalelse fra Det Europæiske Økonomiske og Sociale Udvalg 
(
1
)
,
efter høring af Regionsudvalget,
efter den almindelige lovgivningsprocedure 
(
2
)
, og
ud fra følgende betragtninger:
(1)
Rådets direktiv 90/385/EØF 
(
3
)
 og Rådets direktiv 93/42/EØF 
(
4
)
 udgør Unionens regelsæt for medicinsk udstyr bortset fra medicinsk udstyr til in vitro-diagnostik. Det er imidlertid nødvendigt med en grundlæggende revision af disse direktiver for at indføre et robust, gennemsigtigt, forudsigeligt og bæredygtigt regelsæt for medicinsk udstyr, som både sikrer et højt sikkerheds- og sundhedsniveau og støtter innovation.
(2)
Denne forordning har til formål at sikre et velfungerende indre marked for medicinsk udstyr med udgangspunkt i et højt sundhedsbeskyttelsesniveau for patienter og brugere og under hensyntagen til de små og mellemstore virksomheder, der er aktive i sektoren. Denne forordning fastsætter samtidig høje standarder for medicinsk udstyrs kvalitet og sikkerhed for at imødegå fælles sikkerhedsbekymringer for så vidt angår sådanne produkter. Disse to mål forfølges samtidigt og er uadskilleligt forbundne, og det ene er ikke sekundært i forhold til det andet. For så vidt angår artikel 114 i traktaten om Den Europæiske Unions funktionsmåde harmoniserer denne forordning bestemmelserne om omsætning og ibrugtagning af medicinsk udstyr og tilbehør dertil på EU-markedet, således at det kan omfattes af princippet om fri bevægelighed for varer. For så vidt angår artikel 168, stk. 4, litra c), i TEUF fastsætter denne forordning høje standarder for medicinsk udstyrs kvalitet og sikkerhed bl.a. ved at sikre, at oplysninger, der er genereret ved kliniske afprøvninger, er pålidelige og robuste, og at sikkerheden for de forsøgspersoner, der deltager i en klinisk afprøvning, er beskyttet.
(3)
Denne forordning søger ikke at harmonisere reglerne vedrørende den videre tilgængeliggørelse på markedet af medicinsk udstyr, efter at det allerede er ibrugtaget, såsom i forbindelse med salg af brugt udstyr.
(4)
Centrale elementer i den eksisterende reguleringstilgang, f.eks. overvågning af bemyndigede organer, overensstemmelsesvurderingsprocedurer, kliniske afprøvninger og klinisk evaluering, sikkerhedsovervågning og markedsovervågning, bør styrkes betydeligt, samtidig med at der for at forbedre sundheden og sikkerheden bør indføres bestemmelser, der sikrer gennemsigtighed og sporbarhed i forbindelse med medicinsk udstyr.
(5)
Der bør så vidt muligt tages hensyn til de retningslinjer, der på internationalt plan er fastlagt for medicinsk udstyr, navnlig inden for rammerne af Global Harmonization Task Force og dens opfølgende initiativ International Medical Devices Regulators Forum (IMDRF), for at fremme den internationale konvergens af bestemmelser, som bidrager til et højt globalt sikkerhedsbeskyttelsesniveau og til at lette handelen, navnlig bestemmelserne om unik udstyrsidentifikation, de generelle krav til sikkerhed og ydeevne, den tekniske dokumentation, klassificeringsreglerne, overensstemmelsesvurderingsprocedurerne og de kliniske afprøvninger.
(6)
Af historiske årsager blev aktivt, implantabelt medicinsk udstyr, der er omfattet af direktiv 90/385/EØF, og andet medicinsk udstyr, der er omfattet af direktiv 93/42/EØF, reguleret i to særskilte retsakter. Af forenklingshensyn bør begge direktiver, som er blevet ændret adskillige gange, afløses af én enkelt retsakt, der gælder for alt medicinsk udstyr bortset fra medicinsk udstyr til in vitro-diagnostik.
(7)
Denne forordnings anvendelsesområde bør være klart afgrænset fra anden EU-harmoniseringslovgivning vedrørende produkter, f.eks. medicinsk udstyr til in vitro-diagnostik, lægemidler, kosmetik og fødevarer. Derfor bør Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002 
(
5
)
 ændres for at udelukke medicinsk udstyr fra dens anvendelsesområde.
(8)
Det bør være medlemsstaternes ansvar fra sag til sag at afgøre, om et produkt falder ind under denne forordnings anvendelsesområde. For at sikre ensartede afgørelser om bestemmelse i den henseende i alle medlemsstater, navnlig med hensyn til grænsetilfælde, bør Kommissionen på eget initiativ eller efter behørigt begrundet anmodning fra en medlemsstat efter høring af Koordinationsgruppen for Medicinsk Udstyr (»MDCG«) fra sag til sag kunne afgøre, om et specifikt produkt eller en specifik kategori eller gruppe af produkter falder ind under denne forordnings anvendelsesområde. Når Kommissionen overvejer produkters reguleringsmæssige status i grænsetilfælde, der omfatter lægemidler, humane væv og celler, biocidholdige produkter eller fødevarer, bør den sikre, at Det Europæiske Lægemiddelagentur (EMA), Det Europæiske Kemikalieagentur og Den Europæiske Fødevaresikkerhedsautoritet høres i et passende omfang, hvis det er relevant.
(9)
Da det i visse tilfælde er svært at skelne mellem medicinsk udstyr og kosmetiske produkter, bør der i Europa-Parlamentets og Rådets forordning (EF) nr. 1223/2009 
(
6
)
 ligeledes indføres en mulighed for at træffe en EU-dækkende afgørelse vedrørende et produkts retlige status.
(10)
Produkter, der kombinerer et lægemiddel eller et lægemiddelstof og medicinsk udstyr, reguleres enten i henhold til denne forordning eller i henhold til Europa-Parlamentets og Rådets direktiv 2001/83/EF 
(
7
)
. Der bør i de to retsakter sikres et passende samspil i form af høringer i forbindelse med vurderinger, før udstyret bringes i omsætning, og af udveksling af oplysninger i forbindelse med sikkerhedsovervågningsaktiviteter, der involverer sådanne kombinationsprodukter. Der bør i forbindelse med markedsføringstilladelse for sådanne lægemidler, som integrerer en medicinsk udstyrsdel, foretages en passende vurdering af overensstemmelse med denne forordnings generelle krav til udstyrsdelens sikkerhed og ydeevne. Direktiv 2001/83/EF bør derfor ændres.
(11)
EU-lovgivningen, navnlig Europa-Parlamentets og Rådets forordning (EF) nr. 1394/2007 
(
8
)
 og Europa-Parlamentets og Rådets direktiv 2004/23/EF 
(
9
)
, er ufuldstændig, hvad angår visse produkter, der er fremstillet ved anvendelse af derivater af væv eller celler af human oprindelse, der er ikkelevedygtige eller gjort ikkelevedygtige. Sådanne produkter bør være omfattet af denne forordnings anvendelsesområde, forudsat at de er i overensstemmelse med definitionen af medicinsk udstyr eller er omfattet af denne forordning.
(12)
Visse grupper af produkter, som en fabrikant hævder kun har æstetisk eller andet ikkemedicinsk formål, men som svarer til medicinsk udstyr hvad angår funktion og risikoprofil, bør være omfattet af denne forordning. Med henblik på at sikre, at fabrikanten kan påvise, at de pågældende produkter er i overensstemmelse med de gældende krav, bør Kommissionen vedtage fælles specifikationer som minimum for anvendelsen af risikostyring og om nødvendigt klinisk evaluering vedrørende sikkerheden. Sådanne fælles specifikationer bør udvikles specifikt for en gruppe af produkter uden et medicinsk formål og bør ikke anvendes til overensstemmelsesvurdering af tilsvarende udstyr med et medicinsk formål. Udstyr med både et medicinsk og et ikkemedicinsk erklæret formål bør opfylde de krav, der gælder for både udstyr med og udstyr uden et medicinsk erklæret formål.
(13)
Som tilfældet er med produkter, der indeholder levedygtige væv eller celler af human eller animalsk oprindelse, som udtrykkeligt er udelukket fra direktiv 90/385/EØF og 93/42/EØF og dermed også fra denne forordning, bør det tydeliggøres, at produkter, som indeholder eller består af levedygtige biologiske materialer eller levedygtige organismer af anden oprindelse for at opnå eller støtte disse produkters erklærede formål, heller ikke er omfattet af denne forordning.
(14)
Kravene i Europa-Parlamentets og Rådets direktiv 2002/98/EF 
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 bør fortsat finde anvendelse.
(15)
Der hersker videnskabelig usikkerhed om de risici og fordele, der er forbundet med nanomaterialer, der anvendes til udstyr. For at sikre et højt sundhedsbeskyttelsesniveau, varers frie bevægelighed og fabrikanters retssikkerhed er der brug for en ensartet definition af nanomaterialer baseret på Kommissionens henstilling 2011/696/EU 
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 med den nødvendige fleksibilitet til at tilpasse nævnte definition til den videnskabelige og tekniske udvikling og efterfølgende reguleringsmæssige udvikling på EU-plan og på internationalt plan. Fabrikanter bør ved design og fremstilling af udstyr udvise særlig omhu, når de anvender nanopartikler, hvor der er en høj eller middelhøj risiko for indre eksponering. Sådant udstyr bør være underlagt de strengeste overensstemmelsesvurderingsprocedurer. Ved udarbejdelsen af gennemførelsesretsakter om praktisk og ensartet anvendelse af de pågældende krav i denne forordning bør der tages hensyn til relevante videnskabelige udtalelser fra de relevante videnskabelige komitéer.
(16)
De sikkerhedsaspekter, der er omhandlet i Europa-Parlamentets og Rådets direktiv 2014/30/EU 
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, udgør en integreret del af denne forordnings generelle krav til udstyrs sikkerhed og ydeevne. Derfor bør denne forordning betragtes som en lex specialis i forhold til det pågældende direktiv.
(17)
Denne forordning bør omfatte krav til design og fremstilling af udstyr, som udsender ioniserende stråling, uden at det berører anvendelsen af Rådets direktiv 2013/59/Euratom 
(
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, som forfølger andre mål.
(18)
Denne forordning bør omfatte krav til udstyrs design, sikkerhed og ydeevnekarakteristika, som skal udformes med henblik på at forebygge arbejdsskader, herunder beskytte mod stråling.
(19)
Det er nødvendigt at præcisere, at selvstændigt software anses for medicinsk udstyr, når det af fabrikanten specifikt er bestemt til at kunne anvendes til et eller flere af de medicinske formål, der er anført i definitionen af medicinsk udstyr, hvorimod software til generelle formål, selv når det benyttes i forbindelse med sundhedspleje, eller software, som er beregnet til livsstils- og velværeformål, ikke er medicinsk udstyr. Bestemmelsen af software som enten et udstyr eller et tilbehør er uafhængig af softwarens placering eller typen af sammenkobling mellem softwaret og udstyret.
(20)
For at forbedre retssikkerheden bør definitionerne i denne forordning vedrørende selve udstyret, tilgængeliggørelsen af udstyret, erhvervsdrivende, brugere og specifikke processer, overensstemmelsesvurderingen, kliniske afprøvninger og kliniske evalueringer, overvågning efter at udstyret er bragt i omsætning, sikkerhedsovervågning og markedsovervågning, standarder og andre tekniske specifikationer, bringes i overensstemmelse med veletableret praksis på området på EU-plan og på internationalt plan.
(21)
Det bør præciseres, at det er afgørende, at udstyr, der tilbydes personer i Unionen gennem tjenester i informationssamfundet som omhandlet i Europa-Parlamentets og Rådets direktiv (EU) 2015/1535 
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, og udstyr, der anvendes i forbindelse med en kommerciel aktivitet med henblik på at levere en diagnostisk eller terapeutisk tjeneste til personer i Unionen, opfylder kravene i denne forordning, når det pågældende produkt bringes i omsætning, eller tjenesten ydes i Unionen.
(22)
For at anerkende den vigtige rolle, som standardisering spiller på området for medicinsk udstyr, bør overholdelsen af harmoniserede standarder som defineret i Europa-Parlamentets og Rådets forordning (EU) nr. 1025/2012 
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 være et middel, som fabrikanterne kan bruge til at påvise overensstemmelse med denne forordnings generelle krav til sikkerhed og ydeevne og andre juridiske krav, såsom dem vedrørende kvalitets- og risikostyring.
(23)
Europa-Parlamentets og Rådets direktiv 98/79/EF 
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 giver Kommissionen mulighed for at vedtage fælles tekniske specifikationer for særlige kategorier af medicinsk udstyr til in vitro-diagnostik. På områder, hvor der ikke findes harmoniserede standarder, eller hvor disse er utilstrækkelige, bør Kommissionen have beføjelse til at fastsætte fælles specifikationer, der giver mulighed for at opfylde denne forordnings generelle krav til sikkerhed og ydeevne og krav til kliniske afprøvninger og klinisk evaluering og/eller klinisk opfølgning, efter at udstyret er bragt i omsætning.
(24)
Der bør udvikles fælles specifikationer efter høring af de relevante interessenter og under hensyntagen til de europæiske og internationale standarder.
(25)
Hvor det er relevant, bør bestemmelserne om udstyr bringes i overensstemmelse med de nye lovgivningsrammer for markedsføring af produkter, som består af Europa-Parlamentets og Rådets forordning (EF) nr. 765/2008 
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 og Europa-Parlamentets og Rådets afgørelse nr. 768/2008/EF 
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)
.
(26)
Bestemmelserne om EU-markedsovervågning og kontrol af produkter, der indføres på EU-markedet, som er fastsat i forordning (EF) nr. 765/2008, finder anvendelse på udstyr, der er omfattet af nærværende forordning, som ikke hindrer medlemsstaterne i at vælge, hvilke kompetente myndigheder der skal udføre disse opgaver.
(27)
Det bør tydeligt fastlægges, hvilke generelle forpligtelser der påhviler de forskellige erhvervsdrivende, herunder importører og distributører, med udgangspunkt i de nye lovgivningsmæssige rammer for markedsføring af produkter, uden at det berører de specifikke betingelser, der er fastsat i de forskellige dele af denne forordning, for at gøre kravene i denne forordning lettere at forstå og dermed forbedre de relevante aktørers overholdelse af reguleringen.
(28)
I denne forordning bør distributørers aktiviteter anses for at omfatte erhvervelse, opbevaring og levering af udstyr.
(29)
Flere af de forpligtelser, der påhviler fabrikanterne, såsom klinisk evaluering eller indberetning i forbindelse med sikkerhedsovervågning, og som kun blev fastsat i bilagene til direktiv 90/385/EØF og 93/42/EØF, bør indarbejdes i de dispositive bestemmelser i denne forordning for at lette dens anvendelse.
(30)
Sundhedsinstitutioner bør have mulighed for at fremstille, ændre og bruge udstyr internt og dermed imødekomme, i ikkeindustriel målestok, en patientmålgruppes specifikke behov, der ikke kan opfyldes på et passende ydeevneniveau af tilsvarende udstyr, der er tilgængeligt på markedet. I den forbindelse bør det for så vidt angår medicinsk udstyr, der alene fremstilles og bruges inden for sundhedsinstitutioner, herunder hospitaler såvel som institutioner såsom laboratorier og folkesundhedsinstitutter, der støtter sundhedssystemet og/eller imødekommer patientbehov, men som ikke anvendes til direkte behandling eller pleje af patienter, fastsættes, at visse bestemmelser i denne forordning ikke bør finde anvendelse, eftersom forordningens mål stadig vil blive opfyldt på en forholdsmæssigt afpasset måde. Det bør bemærkes, at begrebet »sundhedsinstitution« ikke omfatter organisationer, hvis primære formål er at forfølge sundhedsmæssige interesser eller sund livsstil, såsom motionscentre, kurbade, wellness- og fitnesscentre. Som følge heraf finder undtagelsen, der gælder for sundhedsinstitutioner, ikke anvendelse på sådanne organisationer.
(31)
I betragtning af at fysiske eller juridiske personer kan kræve erstatning for skade forårsaget af defekt udstyr i overensstemmelse med gældende EU-ret og national ret, bør fabrikanterne pålægges krav om, at de skal have indført foranstaltninger til at sikre tilstrækkelig finansiel dækning for så vidt angår deres mulige erstatningsansvar i henhold til Rådets direktiv 85/374/EØF 
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. Sådanne foranstaltninger bør stå i rimeligt forhold til risikoklassen, typen af udstyr og virksomhedens størrelse. I denne sammenhæng er det også hensigtsmæssigt at fastsætte regler om, hvordan en kompetent myndighed kan lette leveringen af oplysninger til personer, der har lidt skade som følge af defekt udstyr.
(32)
For at sikre, at udstyr, der fremstilles i produktionsserier, fortsat er i overensstemmelse med kravene i denne forordning, og at der i produktionsprocessen tages hensyn til erfaringer med anvendelsen af det udstyr, som de fremstiller, bør alle fabrikanter have et kvalitetsstyringssystem og et system til overvågning, efter at udstyret er bragt i omsætning, som bør stå i rimeligt forhold til risikoklassen og typen af det pågældende udstyr. For at mindske risici mest muligt eller forhindre hændelser vedrørende udstyr bør fabrikanterne desuden etablere et system til risikostyring og et system til indberetning af hændelser og sikkerhedsrelaterede korrigerende handlinger.
(33)
Risikostyringssystemet bør være nøje afstemt med og afspejlet i den kliniske evaluering af udstyret, herunder de kliniske risici, som der skal tages hensyn til som led i kliniske afprøvninger, klinisk evaluering og klinisk opfølgning, efter at udstyret er bragt i omsætning. Risikostyringsprocessen og processen for klinisk evaluering bør være indbyrdes afhængige og opdateres regelmæssigt.
(34)
Det bør sikres, at overvågning af og kontrol med fremstilling af udstyr, overvågning, efter at udstyret er bragt i omsætning, og sikkerhedsovervågningsaktiviteter forbundet med udstyret varetages af en person i fabrikantens organisation, der er ansvarlig for overholdelse af reguleringen, og som opfylder visse mindstekrav til kvalifikationer.
(35)
For fabrikanter, der ikke er etableret i Unionen, spiller den autoriserede repræsentant en central rolle med hensyn til at sikre, at udstyr, der fremstilles af disse fabrikanter, overholder kravene, og som fabrikanternes kontaktperson i Unionen. Som følge af denne centrale rolle bør den autoriserede repræsentant med henblik på håndhævelse gøres juridisk ansvarlig for defekt udstyr, i tilfælde af at en fabrikant, der er etableret uden for Unionen, ikke har opfyldt sine generelle forpligtelser. Den autoriserede repræsentants ansvar, der er fastsat i denne forordning, berører ikke bestemmelserne i direktiv 85/374/EØF, og den autoriserede repræsentant bør således hæfte solidarisk med importøren og fabrikanten. Den autoriserede repræsentants opgaver bør fastsættes i en skriftlig fuldmagt. I betragtning af de autoriserede repræsentanters rolle bør det klart defineres, hvilke mindstekrav de bør opfylde, herunder kravet om, at de skal råde over en person, som opfylder visse mindstekrav til kvalifikationer, som bør være de samme som dem, der gælder for en fabrikants person, der er ansvarlig for overholdelse af reguleringen.
(36)
For at sikre retssikkerheden i forbindelse med de forpligtelser, der påhviler de erhvervsdrivende, er det nødvendigt at præcisere, hvornår en distributør, importør eller anden person kan betragtes som fabrikant af udstyr.
(37)
Parallelhandel med produkter, der allerede er bragt i omsætning, er en lovlig form for handel på det indre marked i henhold til artikel 34 i TEUF med forbehold af de begrænsninger, der følger af behovet for at beskytte sundhed og sikkerhed og af behovet for at beskytte intellektuelle ejendomsrettigheder som omhandlet i artikel 36 i TEUF. Anvendelsen af princippet om parallelhandel giver imidlertid anledning til forskellige fortolkninger i medlemsstaterne. Derfor bør denne forordning præcisere betingelserne, navnlig kravene til ommærkning og ompakning, idet der tages hensyn til Domstolens retspraksis 
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 i andre relevante sektorer og eksisterende god praksis på området for medicinsk udstyr.
(38)
Oparbejdning og videre anvendelse af engangsudstyr bør kun finde sted, hvis det er tilladt ifølge national ret, og under overholdelse af kravene i denne forordning. Oparbejderne af engangsudstyr bør betragtes som fabrikanter af det oparbejdede udstyr og bør påtage sig de forpligtelser, der påhviler fabrikanter i henhold til denne forordning. Medlemsstaterne bør dog have mulighed for at beslutte, at de forpligtelser, der vedrører oparbejdning og genbrug af engangsudstyr, der finder sted i en sundhedsinstitution eller hos en ekstern oparbejder, der handler på institutionens vegne, kan afvige fra de forpligtelser for fabrikanter, der er beskrevet i denne forordning. I princippet bør en sådan afvigelse kun tillades, hvis den oparbejdning og det genbrug af engangsudstyr, der finder sted i en sundhedsinstitution eller hos en ekstern oparbejder, er i overensstemmelse med de fælles specifikationer, der er blevet vedtaget, eller i mangel af sådanne fælles specifikationer med relevante harmoniserede standarder og nationale forskrifter. Ved oparbejdning af sådant udstyr bør der med hensyn til sikkerhed og ydeevne sikres et niveau, der svarer til niveauet for tilsvarende nyt engangsudstyr.
(39)
Patienter, der får implanteret udstyr, bør gives klare og lettilgængelige væsentlige oplysninger, der gør det muligt at identificere det implanterede udstyr, og andre relevante oplysninger om udstyret, herunder eventuelle nødvendige advarsler om sundhedsrisici eller forholdsregler, der skal træffes, f.eks. angivelse af, om udstyret er foreneligt med visse former for diagnostisk udstyr eller med scannere, der anvendes til sikkerhedskontrol.
(40)
Udstyr bør som hovedregel være forsynet med CE-mærkning, som angiver, at det er i overensstemmelse med denne forordning, således at det frit kan omsættes inden for Unionen og ibrugtages i overensstemmelse med sit erklærede formål. Medlemsstaterne bør ikke skabe hindringer for omsætning eller ibrugtagning af udstyr, der opfylder kravene i denne forordning. Medlemsstaterne bør dog kunne beslutte, om de vil begrænse anvendelsen af en specifik type udstyr for så vidt angår aspekter, der ikke er omfattet af denne forordning.
(41)
Muligheden for at spore udstyr ved hjælp af et system for unik udstyrsidentifikation (UDI-system) baseret på internationale retningslinjer bør i væsentlig grad øge effektiviteten af udstyrs sikkerhedsrelaterede aktiviteter, efter at det er bragt i omsætning, som følge af forbedret indberetning af hændelser, målrettede sikkerhedsrelaterede korrigerende handlinger og bedre tilsyn fra de kompetente myndigheders side. Det bør også bidrage til at mindske lægefejl og til at bekæmpe forfalsket udstyr. Anvendelsen af UDI-systemet bør også forbedre sundhedsinstitutioners og andre erhvervsdrivendes politikker for indkøb og affaldsbortskaffelse og lagerstyring og om muligt være kompatibel med andre autentifikationssystemer, der allerede findes disse steder.
(42)
UDI-systemet bør finde anvendelse på alt udstyr, der bringes i omsætning, bortset fra udstyr efter mål, og være baseret på internationalt anerkendte principper, herunder definitioner, der er forenelige med dem, der anvendes af de vigtigste handelspartnere. Der bør i denne forordning fastsættes nærmere regler til sikring af, at UDI-systemet bliver funktionsdygtigt inden anvendelsen af denne forordning.
(43)
Det er af samfundshensyn nødvendigt med gennemsigtighed og passende adgang til information, som forelægges den tilsigtede bruger på en hensigtsmæssig måde, for at beskytte folkesundheden, for at styrke patienters og sundhedspersoners indflydelse og sætte dem i stand til at træffe informerede beslutninger og for at skabe et solidt grundlag for reguleringsmæssige beslutninger og opbygge tilliden til regelsættet.
(44)
Et nøgleaspekt af opfyldelsen af målene for denne forordning er etableringen af en europæisk database for medicinsk udstyr (Eudamed), der bør integrere forskellige elektroniske systemer til indsamling og behandling af oplysninger om udstyr på markedet og om de relevante erhvervsdrivende, visse aspekter af overensstemmelsesvurdering, bemyndigede organer, certifikater, kliniske afprøvninger, sikkerhedsovervågning og markedsovervågning. Formålet med databasen er at øge den samlede gennemsigtighed, herunder ved at give offentligheden og sundhedspersoner bedre adgang til oplysninger, undgå krav om gentagne indberetninger, fremme koordineringen mellem medlemsstaterne og strømline og lette informationsstrømmen mellem erhvervsdrivende, bemyndigede organer eller sponsorer og medlemsstaterne samt mellem medlemsstaterne indbyrdes og mellem disse og Kommissionen. I det indre marked kan dette kun sikres effektivt på EU-plan, og Kommissionen bør derfor videreudvikle og forvalte den europæiske database for medicinsk udstyr, som er oprettet ved Kommissionens afgørelse 2010/227/EU 
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.
(45)
For at lette anvendelsen af Eudamed bør der gratis stilles en internationalt anerkendt nomenklatur for medicinsk udstyr til rådighed for fabrikanterne og andre fysiske eller juridiske personer, der i henhold til denne forordning er forpligtet til at anvende denne nomenklatur. Denne nomenklatur bør også, når det er praktisk muligt, stilles gratis til rådighed for andre interessenter.
(46)
Eudameds elektroniske systemer vedrørende udstyr på markedet, relevante erhvervsdrivende og certifikater bør give offentligheden mulighed for at være velinformeret om udstyr på EU-markedet. Det elektroniske system for kliniske afprøvninger bør være et redskab til samarbejde mellem medlemsstaterne og til at give sponsorer mulighed for på frivillig basis at indsende én enkelt ansøgning for flere medlemsstater og til at indberette alvorlige uønskede hændelser, mangler ved udstyret og opdateringer heraf. Det elektroniske system til sikkerhedsovervågning bør give fabrikanterne mulighed for at indberette alvorlige hændelser og andre indberetningspligtige hændelser og støtte koordineringen af de kompetente myndigheders evaluering af sådanne hændelser. Det elektroniske system vedrørende markedsovervågning bør være et redskab til udveksling af oplysninger mellem kompetente myndigheder.
(47)
For så vidt angår oplysninger, der indsamles og behandles via de elektroniske systemer i Eudamed, finder Europa-Parlamentets og Rådets direktiv 95/46/EF 
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 anvendelse på den behandling af personoplysninger, der foretages i medlemsstaterne, under tilsyn af medlemsstaternes kompetente myndigheder, særlig de uafhængige offentlige myndigheder, som medlemsstaterne har udpeget. Europa-Parlamentets og Rådets forordning (EF) nr. 45/2001 
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 finder anvendelse på den behandling af personoplysninger, som Kommissionen foretager inden for rammerne af nærværende forordning, under tilsyn af Den Europæiske Tilsynsførende for Databeskyttelse. I overensstemmelse med forordning (EF) nr. 45/2001 bør Kommissionen udpeges som registeransvarlig for Eudamed og dets elektroniske systemer.
(48)
For implantabelt udstyr og for udstyr i klasse III bør fabrikanterne sammenfatte de vigtigste aspekter af udstyrets sikkerhed og ydeevne og resultatet af den kliniske evaluering i et dokument, som bør være offentligt tilgængeligt.
(49)
Sammenfatningen af sikkerhed og klinisk ydeevne for et udstyr bør navnlig omfatte udstyrets placering for så vidt angår diagnostiske eller terapeutiske muligheder under hensyntagen til den kliniske evaluering af udstyret i forhold til de diagnostiske eller terapeutiske alternativer og de særlige betingelser, som dette udstyr og dets alternativer kan tages i betragtning under.
(50)
Det er afgørende, at de bemyndigede organer fungerer hensigtsmæssigt for at sikre et højt beskyttelsesniveau for sundhed og sikkerhed, og at borgerne har tillid til systemet. Medlemsstaternes udpegelse og tilsyn med bemyndigede organer i overensstemmelse med detaljerede og strenge kriterier bør derfor være underlagt kontrol på EU-plan.
(51)
Bemyndigede organers vurderinger af fabrikanters tekniske dokumentation, navnlig dokumentationen om klinisk evaluering, bør evalueres kritisk af den nationale myndighed med ansvar for bemyndigede organer. Denne evaluering bør være et led i den risikobaserede tilgang til de bemyndigede organers kontrol- og tilsynsaktiviteter og bør baseres på stikprøver af den relevante dokumentation.
(52)
De bemyndigede organers position over for fabrikanterne bør styrkes, herunder med hensyn til deres ret og pligt til at foretage uanmeldte audit på stedet og foretage fysiske prøvninger eller laboratorieprøvninger af udstyr for at sikre fabrikanternes fortsatte overholdelse af kravene efter modtagelsen af den oprindelige certificering
(53)
For at øge gennemsigtigheden med hensyn til de nationale myndigheders kontrol med bemyndigede organer bør myndighederne med ansvar for de bemyndigede organer offentliggøre oplysninger om de nationale foranstaltninger, der gælder for deres vurdering af, udpegelse af og tilsyn med bemyndigede organer. I overensstemmelse med god administrativ praksis bør disse oplysninger opdateres af disse myndigheder, navnlig for at afspejle relevante, betydelige eller væsentlige ændringer af de pågældende procedurer.
(54)
Den medlemsstat, hvor et bemyndiget organ er etableret, bør være ansvarlig for håndhævelsen af kravene i denne forordning for så vidt angår det bemyndigede organ.
(55)
I lyset af navnlig medlemsstaternes ansvar for organisering og levering af sundhedstjenester og lægebehandling bør de kunne fastsætte yderligere krav til bemyndigede organer, der er udpeget til at foretage overensstemmelsesvurderingen af udstyr, og som er etableret på deres område, for så vidt angår spørgsmål, der ikke er reguleret i denne forordning. Den eventuelle fastsættelse af sådanne yderligere krav bør ikke berøre mere specifik horisontal EU-lovgivning om bemyndigede organer og ligebehandling af bemyndigede organer.
(56)
For så vidt angår implantabelt udstyr i klasse III og aktivt udstyr i klasse IIb, der er beregnet til at administrere og/eller fjerne lægemidler, bør de bemyndigede organer, undtagen i visse tilfælde, være forpligtet til at anmode ekspertpaneler om at foretage en grundig gennemgang af deres vurderingsrapport om den kliniske evaluering. De kompetente myndigheder bør underrettes om udstyr, der har fået tildelt et certifikat efter en overensstemmelsesvurderingsprocedure med inddragelse af et ekspertpanel. Høringen af ekspertpaneler i forbindelse med den kliniske evaluering bør føre til en harmoniseret evaluering af medicinsk højrisikoudstyr ved at udveksle ekspertise om kliniske aspekter og udvikle fælles specifikationer for kategorier af udstyr, der har været underkastet denne høringsproces.
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For udstyr i klasse III og for visse typer udstyr i klasse IIb bør en fabrikant forud for dennes kliniske evaluering og/eller afprøvning frivilligt kunne høre et ekspertpanel om den kliniske udviklingsstrategi og om forslag til kliniske afprøvninger.
(58)
Det er navnlig med henblik på overensstemmelsesvurderingsprocedurerne nødvendigt at opretholde inddelingen af udstyr i fire produktklasser i overensstemmelse med international praksis. Klassificeringsreglerne, der tager udgangspunkt i det menneskelige legemes sårbarhed, bør tage hensyn til de potentielle risici i forbindelse med udstyrets tekniske design og fremstilling. For at opretholde samme sikkerhedsniveau som fastsat i direktiv 90/385/EØF bør aktivt, implantabelt udstyr klassificeres i den højeste risikoklasse.
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Reglerne i den gamle ordning for invasivt udstyr tager ikke tilstrækkeligt hensyn til graden af invasivitet og den potentielle toksicitet for visse typer udstyr, der indføres i det menneskelige legeme. For at opnå en passende risikobaseret klassificering af udstyr, der består af stoffer eller en kombination af stoffer, der absorberes af eller fordeles lokalt i det menneskelige legeme, er det nødvendigt at indføre specifikke klassificeringsregler for sådant udstyr. Klassificeringsreglerne bør tage hensyn til det sted, hvor udstyret gør sin virkning i eller på det menneskelige legeme, eller hvor det indføres eller anvendes, og til om der forekommer en systemisk absorption af de stoffer, som udstyret består af, eller af disse stoffers metabolitter i det menneskelige legeme.
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Overensstemmelsesvurderingsproceduren for udstyr i klasse I bør som hovedregel gennemføres på fabrikanternes eneansvar, da risikoen i forbindelse med sådant udstyr er lille. For udstyr i klasse IIa, klasse IIb og klasse III bør det være obligatorisk at inddrage et bemyndiget organ i passende omfang.
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Overensstemmelsesvurderingsprocedurerne for udstyr bør yderligere styrkes og strømlines, mens kravene til de vurderinger, som de bemyndigede organer skal foretage, bør være klart defineret for at sikre lige vilkår.
(62)
Certifikater for frit salg bør indeholde oplysninger, der gør det muligt at anvende Eudamed med henblik på at indhente oplysninger om udstyret, navnlig med hensyn til om det findes på markedet, er tilbagekaldt fra markedet eller trukket tilbage, og om et eventuelt certifikat om dets overensstemmelse.
(63)
For at sikre et højt niveau med hensyn til sikkerhed og ydeevne bør påvisning af overholdelse af denne forordnings generelle krav til sikkerhed og ydeevne baseres på kliniske data, der for udstyr i klasse III og implantabelt udstyr som hovedregel bør stamme fra kliniske afprøvninger, der er blevet udført under ansvar af en sponsor. Det bør være muligt for såvel fabrikanten som en anden fysisk eller juridisk person at være den sponsor, der tager ansvar for den kliniske afprøvning.
(64)
Bestemmelserne om kliniske afprøvninger bør være i overensstemmelse med veletablerede internationale retningslinjer på dette område, såsom den internationale ISO-standard 14155:2011 om god klinisk praksis for klinisk afprøvning af medicinsk udstyr til brug på mennesker, for at resultaterne af kliniske afprøvninger, der foretages i Unionen, lettere kan anerkendes som dokumentation uden for Unionen, og for at resultaterne af kliniske afprøvninger, der foretages uden for Unionen i overensstemmelse med internationale retningslinjer, lettere kan anerkendes i Unionen. Bestemmelserne bør endvidere være i overensstemmelse med den seneste version af Verdenslægeorganisationens Helsingforserklæring om etiske principper for medicinsk forskning med mennesker.
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Det bør overlades til den medlemsstat, hvor en klinisk afprøvning skal foretages, at afgøre, hvilken relevant myndighed der skal inddrages i vurderingen af ansøgningen om at udføre en klinisk afprøvning, og at organisere inddragelsen af etiske komitéer inden for de frister for tilladelse til den kliniske afprøvning, der er fastsat i denne forordning. Disse afgørelser afhænger af den interne organisation i hver medlemsstat. Medlemsstaterne bør i den forbindelse sørge for inddragelse af lægmænd, navnlig patienter eller patientorganisationer. De bør også sikre, at den nødvendige ekspertise er til rådighed.
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Påføres en forsøgsperson under gennemførelsen af en kliniske afprøvning skade, og pådrager investigator eller sponsor sig som følge heraf et civil- eller strafferetligt ansvar, bør erstatningsbetingelserne i sådanne tilfælde, herunder spørgsmål om årsagssammenhæng og omfanget af skadeserstatningen og sanktionerne, fortsat være reguleret af national ret.
(67)
Der bør oprettes et elektronisk system på EU-plan for at sikre, at alle kliniske afprøvninger registreres og rapporteres i en offentligt tilgængelig database. For at beskytte retten til beskyttelse af personoplysninger, som anerkendes ved artikel 8 i Den Europæiske Unions charter om grundlæggende rettigheder (»chartret«), bør der ikke registreres personoplysninger om forsøgspersoner, der deltager i en klinisk afprøvning, i det elektroniske system. For at sikre synergi med området for kliniske forsøg med lægemidler bør det elektroniske system for kliniske afprøvninger være interoperabelt med den EU-database, der skal oprettes for kliniske forsøg med humanmedicinske lægemidler.
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Hvis en klinisk afprøvning skal gennemføres i mere end én medlemsstat, bør sponsoren have mulighed for at indsende en enkelt ansøgning for at mindske den administrative byrde. For at åbne mulighed for ressourcedeling og for at sikre en ensartet fremgangsmåde i forbindelse med vurdering af de sundheds- og sikkerhedsmæssige aspekter af udstyr bestemt til afprøvning og af det videnskabelige design af denne kliniske afprøvning, bør proceduren for vurdering af en sådan enkelt ansøgning koordineres mellem medlemsstaterne under ledelse af en koordinerende medlemsstat. En sådan koordineret vurdering bør ikke omfatte vurdering af rent nationale, lokale og etiske aspekter af en klinisk afprøvning, herunder informeret samtykke. I første omgang i en periode på syv år fra datoen for denne forordnings anvendelse bør medlemsstaterne på frivillig basis kunne deltage i den koordinerede vurdering. Efter denne periode bør alle medlemsstaterne være forpligtet til at deltage i den koordinerede vurdering. Kommissionen bør på baggrund af de opnåede erfaringer fra den frivillige koordinering mellem medlemsstaterne udarbejde en rapport om anvendelsen af de relevante bestemmelser om den koordinerede vurderingsprocedure. Hvis resultaterne i rapporten er negative, bør Kommissionen forelægge et forslag om at forlænge fristen for på frivillig basis at deltage i den koordinerede vurderingsprocedure.
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Sponsorer bør indberette visse uønskede hændelser og mangler ved udstyret, der indtræffer under kliniske afprøvninger, til de medlemsstater, hvori disse kliniske afprøvninger gennemføres. Medlemsstaterne bør have mulighed for at afbryde eller suspendere afprøvninger eller at tilbagekalde tilladelsen til de nævnte afprøvninger, hvis det anses for nødvendigt for at sikre en høj grad af beskyttelse af de forsøgspersoner, der deltager i en klinisk afprøvning. Denne information bør sendes til de øvrige medlemsstater.
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En klinisk afprøvnings sponsor bør inden for fristerne i denne forordning forelægge et sammendrag af resultaterne af den kliniske afprøvning, der er letforståeligt for den tilsigtede bruger, sammen med den kliniske afprøvningsrapport, hvis det er relevant. Hvis det af videnskabelige grunde ikke er muligt at forelægge sammendraget af resultaterne inden for de fastsatte frister, bør sponsoren begrunde dette og præcisere, hvornår resultaterne vil blive forelagt.
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Denne forordning bør omfatte kliniske afprøvninger, der har til formål at indsamle klinisk dokumentation med henblik på at påvise udstyrets overensstemmelse med de gældende krav, og bør også fastsætte de grundlæggende krav vedrørende etiske og videnskabelige vurderinger for andre typer af kliniske afprøvninger af medicinsk udstyr.
(72)
Der kræves særlige beskyttelsesforanstaltninger for forsøgspersoner uden handleevne, mindreårige samt gravide kvinder og ammende kvinder. Det bør dog overlades til medlemsstaterne at udpege en retligt udpeget repræsentant for forsøgspersoner uden handleevne og mindreårige.
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Principperne om reduktion, forfinelse og erstatning i forbindelse med dyreforsøg, der er fastsat i Europa-Parlamentets og Rådets direktiv 2010/63/EU 
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, bør overholdes. Navnlig bør unødvendige gentagelser af forsøg på og undersøgelser undgås.
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Fabrikanter bør spille en aktiv rolle i tiden efter, at udstyr er bragt i omsætning, ved systematisk og aktivt at indsamle oplysninger fra erfaringerne, efter at deres udstyr er bragt i omsætning, for at opdatere deres tekniske dokumentation og samarbejde med de nationale kompetente myndigheder med ansvar for sikkerhedsovervågnings- og markedsovervågningsaktiviteter. Med henblik herpå bør fabrikanterne indføre et omfattende system til overvågning, efter at udstyret er bragt i omsætning, der er etableret i henhold til deres kvalitetssikringssystem og baseret på en plan om overvågning, efter at udstyret er bragt i omsætning. Relevante data og oplysninger, der er indsamlet som led i overvågning, efter at udstyret er bragt i omsætning, og erfaringer fra eventuelle gennemførte forebyggende og/eller korrigerende handlinger bør anvendes til at opdatere alle relevante dele af den tekniske dokumentation, såsom dem, der vedrører risikovurdering og klinisk evaluering, og bør også tjene gennemsigtighedsformålet.
(75)
For bedre at beskytte forbrugernes sundhed og sikkerhed i forbindelse med udstyr på markedet bør det elektroniske system til sikkerhedsovervågning for udstyr gøres mere effektivt ved at oprette en central portal på EU-plan til at indberette alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger.
(76)
Medlemsstaterne bør træffe passende foranstaltninger for at gøre sundhedspersoner, brugere og patienter mere bevidste om betydningen af at indberette hændelser. Sundhedspersoner, brugere og patienter bør tilskyndes til og gives mulighed for at indberette formodede alvorlige hændelser på nationalt plan ved hjælp af harmoniserede formater. De nationale kompetente myndigheder bør underrette fabrikanterne om enhver mistanke om en alvorligt hændelser og bør, hvis en fabrikant bekræfter, at en sådan hændelse er indtruffet, sikre at passende opfølgning foretages for at mindske risikoen for gentagelser af sådanne hændelser.
(77)
Evalueringen af indberettede alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger bør gennemføres på nationalt plan, men der bør sikres koordinering, hvis lignende hændelser er indtruffet, eller hvis der skal gennemføres sikkerhedsrelaterede korrigerende handlinger i mere end én medlemsstat, med det formål at dele ressourcerne og sikre konsekvens med hensyn til den korrigerende handling.
(78)
I forbindelse med undersøgelsen af hændelser bør de kompetente myndigheder, hvis det er relevant, tage hensyn til oplysninger og synspunkter fra relevante interessenter, herunder patientorganisationer og organisationer, der repræsenterer sundhedspersoner, og sammenslutninger af fabrikanter.
(79)
Der bør sondres klart mellem indberetning af alvorlige uønskede hændelser og mangler ved udstyret i forbindelse med kliniske afprøvninger og indberetning af alvorlige hændelser, efter at udstyret er bragt i omsætning, for at undgå dobbelt indberetning.
(80)
Denne forordning bør indeholde bestemmelser om markedsovervågning for at styrke de nationale kompetente myndigheders rettigheder og forpligtelser, for at sikre en effektiv koordinering af deres markedsovervågningsaktiviteter og for at præcisere de gældende procedurer.
(81)
Enhver statistisk signifikant stigning i antallet eller alvoren af hændelser, der ikke er alvorlige, eller i forventede bivirkninger, som kan have væsentlig indvirkning på afvejningen af fordele og risici, og som kan medføre uacceptable risici, bør indberettes til de kompetente myndigheder, så de kan foretage en vurdering og træffe passende foranstaltninger.
(82)
Der bør nedsættes en ekspertgruppe, Koordinationsgruppen for Medicinsk Udstyr (MDCG), bestående af personer, der udpeges af medlemsstaterne på grundlag af deres rolle og ekspertise på området for medicinsk udstyr, herunder medicinsk udstyr til in vitro-diagnostik; gruppen bør varetage de opgaver, der pålægges den ved denne forordning og ved Europa-Parlamentets og Rådets forordning (EU) 2017/746 
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 rådgive Kommissionen og bistå Kommissionen og medlemsstaterne med at sikre en ensartet gennemførelse af denne forordning. MDCG bør kunne nedsætte undergrupper for at skaffe den nødvendige tilbundsgående tekniske ekspertise på området for medicinsk udstyr, herunder medicinsk udstyr til in vitro-diagnostik. Ved nedsættelsen af undergrupper bør der lægges passende vægt på muligheden for at inddrage eksisterende grupper på EU-plan på området for medicinsk udstyr.
(83)
Ekspertpaneler og ekspertlaboratorier bør udpeges af Kommissionen på grundlag af deres opdaterede kliniske, videnskabelige eller tekniske ekspertise med det formål at levere videnskabelig, teknisk og klinisk bistand til Kommissionen, MDCG, fabrikanter og bemyndigede organer i forbindelse med gennemførelsen af denne forordning. Ekspertpaneler bør desuden have til opgave at afgive en udtalelse om bemyndigede organers vurderingsrapporter om den kliniske evaluering for så vidt angår visse højrisikoudstyr.
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For at sikre et ensartet, højt beskyttelsesniveau for sundhed og sikkerhed i det indre marked, navnlig på områderne for kliniske afprøvninger og sikkerhedsovervågning, er det afgørende med en tættere koordinering mellem de nationale kompetente myndigheder ved hjælp af informationsudveksling og koordinerede vurderinger under ledelse af en koordinerende myndighed. Princippet om koordineret udveksling og vurdering bør også finde anvendelse på tværs af andre myndighedsaktiviteter, der er beskrevet i denne forordning, såsom udpegelse af bemyndigede organer, og bør fremmes inden for markedsovervågning med udstyr. Samarbejde, koordinering og kommunikation af aktiviteter bør også føre til mere effektiv udnyttelse af ressourcerne og ekspertisen på nationalt plan.
(85)
Kommissionen bør yde videnskabelig, teknisk og logistisk støtte til de koordinerende nationale myndigheder og sikre, at regelsættet for udstyr bliver effektivt og ensartet gennemført på EU-plan på basis af solid videnskabelig dokumentation.
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Unionen og, når det er relevant, medlemsstaterne bør aktivt deltage i internationalt reguleringssamarbejde om medicinsk udstyr for at lette udvekslingen af sikkerhedsrelevante oplysninger om medicinsk udstyr og for at støtte videreudviklingen af internationale reguleringsretningslinjer, der fremmer vedtagelsen i andre jurisdiktioner af bestemmelser, som fører til et beskyttelsesniveau for sundhed og sikkerhed, der svarer til det, der er fastsat ved denne forordning.
(87)
Medlemsstaterne bør træffe alle nødvendige foranstaltninger til at sikre, at bestemmelserne i denne forordning gennemføres, herunder ved at fastsætte sanktioner for overtrædelse heraf, som er effektive, står i rimeligt forhold til overtrædelsen og har afskrækkende virkning.
(88)
Denne forordning bør ikke påvirke medlemsstaternes ret til at opkræve gebyrer for aktiviteter på nationalt plan, men medlemsstaterne bør dog af hensyn til gennemsigtigheden underrette Kommissionen og de øvrige medlemsstater, inden de træffer afgørelse om sådanne gebyrers struktur og størrelse. For yderligere at sikre gennemsigtighed bør gebyrernes struktur og størrelse efter anmodning gøres offentligt tilgængelige.
(89)
Denne forordning overholder de grundlæggende rettigheder og de principper, som bl.a. chartret anerkender, navnlig respekt for den menneskelige værdighed, respekt for menneskets integritet, beskyttelse af personoplysninger, frihed for kunst og videnskab, frihed til at drive virksomhed og ejendomsretten. Denne forordning bør anvendes af medlemsstaterne i overensstemmelse med disse rettigheder og principper.
(90)
Beføjelsen til at vedtage delegerede retsakter i overensstemmelse med artikel 290 i TEUF bør delegeres til Kommissionen for at ændre visse ikkevæsentlige bestemmelser i denne forordning. Det er navnlig vigtigt, at Kommissionen gennemfører relevante høringer under sit forberedende arbejde, herunder på ekspertniveau, og at disse høringer gennemføres i overensstemmelse med principperne i den interinstitutionelle aftale af 13. april 2016 om bedre lovgivning 
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. For at sikre lige deltagelse i forberedelsen af delegerede retsakter modtager Europa-Parlamentet og Rådet navnlig alle dokumenter på samme tid som medlemsstaternes eksperter, og deres eksperter har systematisk adgang til møder i Kommissionens ekspertgrupper, der beskæftiger sig med forberedelse af delegerede retsakter.
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For at sikre ensartede betingelser for gennemførelsen af denne forordning bør Kommissionen tillægges gennemførelsesbeføjelser. Disse beføjelser bør udøves i overensstemmelse med Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011 
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.
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Rådgivningsproceduren bør anvendes ved gennemførelsesretsakter, der fastsætter formen og præsentationen af dataelementerne i fabrikantens sammenfatninger af sikkerhed og klinisk ydeevne, og som fastlægger modellen for certifikaterne for frit salg, da sådanne gennemførelsesretsakter er af proceduremæssig art og ikke har direkte indvirkning på sundhed og sikkerhed på EU-niveau.
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Kommissionen bør vedtage gennemførelsesretsakter, der straks finder anvendelse, når det i behørigt begrundede tilfælde vedrørende udvidelsen til Unionens område af en national undtagelse fra de gældende overensstemmelsesvurderingsprocedurer på grund af sagens hastende karakter er bydende nødvendigt.
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Kommissionen bør tillægges gennemførelsesbeføjelser, således at den kan udpege udstedende enheder, ekspertpaneler og ekspertlaboratorier.
(95)
For at give de erhvervsdrivende, navnlig SMV'er, de bemyndigede organer, medlemsstaterne og Kommissionen mulighed for at tilpasse sig til de ændringer, der indføres ved denne forordning, og sikre, at den anvendes korrekt, bør der fastsættes en tilstrækkelig lang overgangsperiode for denne tilpasning og for de organisatoriske foranstaltninger, der skal træffes. De visse dele af forordningen, der påvirker medlemsstaterne og Kommissionen direkte, bør dog gennemføres hurtigst muligt. Det er også særlig vigtigt, at der fra datoen for denne forordnings anvendelse er udpeget et tilstrækkeligt antal bemyndigede organer i overensstemmelse med de nye krav, således at man undgår mangel på medicinsk udstyr på markedet. Ikke desto mindre er det nødvendigt, at en eventuel udpegelse af et bemyndiget organ i overensstemmelse med kravene i denne forordning inden datoen for dens anvendelse ikke berører gyldigheden af udpegelsen af disse bemyndigede organer i henhold til direktiv 90/385/EØF og 93/42/EØF og deres kompetence til fortsat at udstede gyldige certifikater i henhold til disse to direktiver indtil datoen for denne forordnings anvendelse.
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For at sikre en gnidningsløs overgang til de nye regler om registrering af udstyr og af certifikater bør forpligtelsen til at indsende de relevante oplysninger til de elektroniske systemer, der i medfør af denne forordning er oprettet på EU-plan, forudsat at de tilsvarende IT-systemer udvikles i henhold til planen, først have fuldstændig virkning fra 18 måneder efter datoen for denne forordnings anvendelse. I denne overgangsperiode bør visse bestemmelser i direktiv 90/385/EØF og 93/42/EØF fortsat være gældende. For at undgå dobbeltregistreringer bør erhvervsdrivende og bemyndigede organer, som registreres i de relevante elektroniske systemer, der i medfør af denne forordning er oprettet på EU-plan, dog anses for at opfylde de registreringskrav, som medlemsstaterne vedtager i henhold til de pågældende bestemmelser.
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For at sikre en gnidningsløs indførelse af UDI-systemet bør tidspunktet for anvendelsen af forpligtelsen til at anbringe UDI-bæreren på udstyrets mærkning variere fra et til fem år efter datoen for denne forordnings anvendelse afhængig af klassen af det pågældende udstyr.
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Direktiv 90/385/EØF og 93/42/EØF bør ophæves for at sikre, at der kun gælder ét sæt regler for omsætning af medicinsk udstyr og relaterede aspekter, der er omfattet af denne forordning. Fabrikanters forpligtelser for så vidt angår tilrådighedsstillelse af dokumentation om udstyr, som de har bragt i omsætning, og fabrikanternes og medlemsstaternes forpligtelser for så vidt angår sikkerhedsovervågningsaktiviteter for udstyr, der er bragt i omsætning i henhold til nævnte direktiver, bør fortsat finde anvendelse. Mens det bør overlades medlemsstaterne at beslutte, hvordan sikkerhedsovervågningsaktiviteterne organiseres, er det ønskværdigt for medlemsstaterne at have mulighed for at indberette hændelser relateret til udstyr, der er bragt i omsætning i henhold til direktiverne, ved hjælp af de samme værktøjer som dem for indberetning vedrørende udstyr, som er bragt i omsætning i henhold til denne forordning. For at sikre en gnidningsløs overgang fra den gamle ordning til den nye ordning er det endvidere hensigtsmæssigt, at Kommissionens forordning (EU) nr. 207/2012 
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 og Kommissionens forordning (EU) nr. 722/2012 
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 fortsat bør gælde og finde anvendelse, medmindre og indtil de ophæves ved gennemførelsesretsakter, der vedtages af Kommissionen i henhold til nærværende forordning.
Afgørelse 2010/227/EU, der er vedtaget til gennemførelse af nævnte direktiver og direktiv 98/79/EF, bør også fortsat gælde og finde anvendelse indtil den dato, hvor Eudamed bliver fuldt funktionsdygtig. Omvendt er den fortsatte gyldighed ikke nødvendig for Kommissionens direktiv 2003/12/EF 
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 og 2005/50/EF 
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 og Kommissionens gennemførelsesforordning (EU) nr. 920/2013 
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.
(99)
Kravene i denne forordning bør gælde for alt udstyr, der bringes i omsætning eller ibrugtages fra datoen for denne forordnings anvendelse. For at sikre en gnidningsløs overgang bør det dog i en begrænset periode fra nævnte dato være muligt, at udstyr bringes i omsætning eller ibrugtages i medfør af et gyldigt certifikat, der er udstedt i henhold til direktiv 90/385/EØF og 93/42/EØF.
(100)
Den Europæiske Tilsynsførende for Databeskyttelse har afgivet udtalelse 
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 i henhold til artikel 28, stk. 2, i forordning (EF) nr. 45/2001.
(101)
Målene for denne forordning, nemlig at sikre et velfungerende indre marked for medicinsk udstyr og at sikre høje standarder for kvaliteten og sikkerheden af medicinsk udstyr, hvorved der sikres et højt beskyttelsesniveau for patienters, brugeres og andre personers sundhed og sikkerhed, kan ikke i tilstrækkelig grad opfyldes af medlemsstaterne, men kan på grund af omfanget og virkningerne heraf bedre nås på EU-plan; Unionen kan derfor vedtage foranstaltninger i overensstemmelse med nærhedsprincippet, jf. artikel 5 i traktaten om Den Europæiske Union. I overensstemmelse med proportionalitetsprincippet, jf. nævnte artikel, går denne forordning ikke videre, end hvad der er nødvendigt for at nå disse mål —
VEDTAGET DENNE FORORDNING:
KAPITEL I
ANVENDELSESOMRÅDE OG DEFINITIONER
Artikel 1
Genstand og anvendelsesområde
1.   Denne forordning fastlægger regler for at bringe medicinsk udstyr til human brug og tilbehør til sådant udstyr i omsætning, gøre det tilgængeligt på markedet eller ibrugtage det i Unionen. Denne forordning finder også anvendelse på kliniske afprøvninger vedrørende sådant medicinsk udstyr og tilbehør, som gennemføres i Unionen.
2.   Denne forordning finder også anvendelse fra datoen for anvendelse af fælles specifikationer vedtaget i henhold til artikel 9 på de grupper af produkter uden et medicinsk formål, der er opført på listen i bilag XVI, idet der tages hensyn til det aktuelle tekniske niveau og navnlig de eksisterende harmoniserede standarder for tilsvarende udstyr med et medicinsk formål, der bygger på lignende teknologi. De fælles specifikationer for hver af de grupper af produkter, der er opført på listen i bilag XVI, skal mindst omhandle anvendelse af risikostyring som fastsat i bilag I for den pågældende gruppe af produkter og om nødvendigt klinisk evaluering vedrørende sikkerheden.
De nødvendige fælles specifikationer vedtages senest den 26. maj 2020. De finder anvendelse fra seks måneder efter datoen for deres ikrafttræden eller fra den 26. maj 2020, alt efter hvad der falder senest.
Uanset artikel 122 forbliver medlemsstaternes foranstaltninger vedrørende spørgsmålet om, hvorvidt de produkter, der er omfattet af bilag XVI, kan kvalificeres som medicinsk udstyr i henhold til direktiv 93/42/EØF, gyldige indtil anvendelsesdatoen som omhandlet i første afsnit for de relevante fælles specifikationer for den pågældende gruppe af produkter.
Denne forordning finder også anvendelse på kliniske afprøvninger, der gennemføres i Unionen vedrørende produkter omhandlet i første afsnit.
3.   Udstyr med både et medicinsk erklæret formål og et ikkemedicinsk erklæret formål skal samlet opfylde de krav, der gælder for udstyr med et medicinsk formål, og dem, der gælder for udstyr uden et medicinsk formål.
4.   Med henblik på denne forordning benævnes medicinsk udstyr, tilbehør til medicinsk udstyr og produkter, der er opført på listen i bilag XVI, som forordningen finder anvendelse på i henhold til stk. 2, i det følgende »udstyr«.
5.   Hvis det kan begrundes under hensyn til ligheden mellem udstyr med et medicinsk formål, der er bragt i omsætning, og et produkt uden et medicinsk formål med hensyn til egenskaber og risici, tillægges Kommissionen beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for at ændre listen i bilag XVI ved at tilføje nye produktgrupper med henblik på at beskytte brugeres og andre personers sundhed og sikkerhed eller andre aspekter af folkesundheden.
6.   Denne forordning finder ikke anvendelse på:
a)
medicinsk udstyr til in vitro-diagnostik, som er omfattet af forordning (EU) 2017/746
b)
lægemidler som defineret i artikel 1, nr. 2), i direktiv 2001/83/EF. Ved vurderingen af, om et produkt er omfattet af direktiv 2001/83/EF eller af nærværende forordning, tages der navnlig hensyn til produktets hovedvirkningsmåde
c)
lægemidler til avanceret terapi, der er omfattet af forordning (EF) nr. 1394/2007
d)
humant blod, blodprodukter, plasma eller blodceller af human oprindelse eller udstyr, der, når det/de bringes i omsætning eller ibrugtages, inkorporerer sådanne blodprodukter, plasma eller celler, med undtagelse af udstyr som omhandlet i denne artikels stk. 8
e)
kosmetiske produkter, der er omfattet af forordning (EF) nr. 1223/2009
f)
transplantater, væv eller celler af animalsk oprindelse eller derivater heraf eller produkter, der indeholder eller består af transplantater, væv eller celler af animalsk oprindelse; denne forordning finder dog anvendelse på udstyr, der er fremstillet ved anvendelse af væv eller celler af animalsk oprindelse eller derivater heraf, som er ikkelevedygtige eller gjort ikkelevedygtige
g)
transplantater, væv eller celler af human oprindelse eller derivater heraf, der er omfattet af direktiv 2004/23/EF, eller produkter, der indeholder eller består af transplantater, væv eller celler af human oprindelse; denne forordning finder dog anvendelse på udstyr, der er fremstillet ved anvendelse af derivater af væv eller celler af human oprindelse, som er ikkelevedygtige eller gjort ikkelevedygtige
h)
produkter, bortset fra dem, der er omhandlet i litra d), f) og g), og som indeholder eller består af levedygtige biologiske materialer eller levedygtige organismer, herunder levende mikroorganismer, bakterier, svampe eller virus for at opnå eller støtte produktets erklærede formål
i)
fødevarer, der er omfattet af forordning (EF) nr. 178/2002.
7.   Ethvert udstyr, der, når det bringes i omsætning eller ibrugtages, som en integreret bestanddel indeholder medicinsk udstyr til in vitro-diagnostik som defineret i artikel 2, nr. 2), i forordning (EU) 2017/746, er omfattet af nærværende forordning. Kravene i forordning (EU) 2017/746 finder anvendelse på den del af udstyret, der omfatter medicinsk udstyr til in vitro-diagnostik.
8.   Ethvert udstyr, der, når det bringes i omsætning eller ibrugtages, som en integreret bestanddel indeholder et stof, der anvendt alene kan betragtes som et lægemiddel som defineret i artikel 1, nr. 2), i direktiv 2001/83/EF, herunder et lægemiddel fremstillet på basis af blod eller plasma fra mennesker som defineret i nævnte direktivs artikel 1, nr. 10), og der har en virkning ud over den, som udstyret har, skal vurderes og godkendes i overensstemmelse med denne forordning.
Hvis det pågældende stofs virkning er en hovedvirkning og ikke supplerer den virkning, som udstyret har, er det integrerede produkt dog omfattet af direktiv 2001/83/EF eller i påkommende tilfælde Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 
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. I så fald finder de relevante generelle krav til sikkerhed og ydeevne, jf. bilag I til denne forordning, anvendelse for så vidt angår udstyrsdelens sikkerhed og ydeevne.
9.   Ethvert udstyr, der er bestemt til administration af et lægemiddel som defineret i artikel 1, nr. 2), i direktiv 2001/83/EF, er omfattet af denne forordning, hvilket dog ikke berører bestemmelserne i nævnte direktiv og i forordning (EF) nr. 726/2004 for så vidt angår lægemidlet.
Hvis det udstyr, som er bestemt til administration af et lægemiddel, og lægemidlet bringes i omsætning på en sådan måde, at de udgør et enkelt integreret produkt, som udelukkende er beregnet til anvendelse i den givne kombination, og som ikke kan genanvendes, omfattes det pågældende enkelte integrerede produkt dog af direktiv 2001/83/EF eller i påkommende tilfælde forordning (EF) nr. 726/2004. I så fald finder de relevante generelle krav til sikkerhed og ydeevne, jf. bilag I til denne forordning, anvendelse for så vidt angår sikkerhed og ydeevne for det enkelte integrerede produkts udstyrsdel.
10.   Ethvert udstyr, der, når det bringes i omsætning eller ibrugtages, som en integreret bestanddel indeholder ikkelevedygtige væv eller celler af human oprindelse eller derivater heraf, der har en virkning ud over den, som udstyret har, skal vurderes og godkendes i overensstemmelse med denne forordning. I så fald finder bestemmelserne vedrørende donation, udtagning og testning, der er fastsat i direktiv 2004/23/EF, anvendelse.
Hvis virkningen af disse væv eller celler eller derivater heraf er en hovedvirkning og ikke supplerer den virkning, som udstyret har, og produktet ikke er omfattet af forordning (EF) nr. 1394/2007, er produktet omfattet af direktiv 2004/23/EF. I så fald finder de relevante generelle krav til sikkerhed og ydeevne, jf. bilag I til denne forordning, anvendelse for så vidt angår udstyrsdelens sikkerhed og ydeevne.
11.   Denne forordning er specifik EU-lovgivning som omhandlet i artikel 2, stk. 3, i direktiv 2014/30/EU.
12.   Udstyr, der også er en maskine i henhold til artikel 2, stk. 2, litra a), i Europa-Parlamentets og Rådets direktiv 2006/42/EF 
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, skal også, hvor der består en fare, som er relevant i henhold til nævnte direktiv, opfylde de væsentlige sikkerheds- og sundhedskrav i bilag I til nævnte direktiv, for så vidt disse krav er mere specifikke end de generelle krav til sikkerhed og ydeevne, der er fastsat i denne forordnings bilag I, kapitel II.
13.   Denne forordning berører ikke anvendelsen af direktiv 2013/59/Euratom.
14.   Denne forordning berører ikke en medlemsstats ret til at begrænse brugen af en specifik type udstyr i forbindelse med aspekter, der ikke er omfattet af denne forordning.
15.   Denne forordning berører ikke national ret om organiseringen, leveringen eller finansieringen af sundhedstjenester og lægebehandling, f.eks. kravet om, at visse former for udstyr kun må udleveres på recept, kravet om, at kun visse sundhedspersoner eller sundhedsinstitutioner må levere eller anvende visse former for udstyr, eller at deres anvendelse skal ledsages af specifik, faglig rådgivning.
16.   Intet i denne forordning begrænser pressefriheden eller ytringsfriheden i medierne, for så vidt som disse frihedsrettigheder er garanteret i Unionen og medlemsstaterne, navnlig i medfør af artikel 11 i Den Europæiske Unions charter om grundlæggende rettigheder.
Artikel 2
Definitioner
I denne forordning forstås ved:
1)   
»medicinsk udstyr«
: ethvert instrument, apparat, udstyr, software, implantat, reagens, materiale eller anden genstand, som ifølge fabrikanten er bestemt til anvendelse, alene eller i kombination, på mennesker med henblik på et eller flere af følgende særlige medicinske formål:
—
diagnosticering, forebyggelse, monitorering, forudsigelse, prognose, behandling eller lindring af sygdomme
—
diagnosticering, monitorering, behandling, afhjælpning af eller kompensation for skader eller handicap
—
afprøvning, udskiftning eller ændring af anatomien eller en fysiologisk eller patologisk proces eller tilstand
—
tilvejebringelse af oplysninger ved hjælp af in vitro-undersøgelse af prøvemateriale fra det menneskelige legeme, herunder organ-, blod- og vævsdonationer,
hvis forventede hovedvirkning i eller på det menneskelige legeme ikke fremkaldes ad farmakologisk, immunologisk eller metabolisk vej, men hvis virkning kan understøttes ad denne vej.
Følgende produkter anses også for at være medicinsk udstyr:
—
udstyr til svangerskabsforebyggelse eller -støtte
—
produkter, der specifikt er beregnet til rengøring, desinfektion eller sterilisering af udstyr som omhandlet i artikel 1, stk. 4, og af udstyr som omhandlet i dette nummers første afsnit
2)   
»tilbehør til medicinsk udstyr«
: enhver genstand, der, selv om den ikke i sig selv er medicinsk udstyr, ifølge fabrikanten er bestemt til at blive anvendt sammen med en eller flere slags bestemt medicinsk udstyr, for specifikt at muliggøre, at det medicinske udstyr kan anvendes i overensstemmelse med sit erklærede formål, eller for specifikt og direkte at hjælpe det medicinske udstyrs medicinske funktion i henhold til dets erklærede formål
3)   
»udstyr efter mål«
: ethvert udstyr, der er specialfremstillet efter recept fra enhver person, der i henhold til national ret er autoriseret i kraft af sine faglige kvalifikationer, med angivelse på vedkommendes ansvar af udstyrets særlige designegenskaber, og som er beregnet til udelukkende at blive brugt til en bestemt patient, alene med det formål at imødekomme vedkommendes individuelle forhold og behov.
Massefremstillet udstyr, som skal tilpasses for at opfylde en faglig brugers specifikke behov, og udstyr, som er massefremstillet ved hjælp af industrielle fremstillingsprocesser efter recept fra enhver autoriseret person, anses dog ikke for at være udstyr efter mål
4)   
»aktivt udstyr«
: ethvert udstyr, som for at kunne fungere er afhængigt af en anden form for energi end den, der udvikles af det menneskelige legeme til dette formål, eller tyngdekraften, og som virker ved at ændre densiteten af eller ved at omsætte denne energi. Udstyr, der er beregnet til uden nogen væsentlig ændring at overføre energi, stoffer eller andre elementer mellem aktivt udstyr og patienten, anses ikke for at være aktivt udstyr.
Software anses også for at være aktivt udstyr
5)   
»implantabelt udstyr«
: ethvert udstyr, herunder det, der helt eller delvis absorberes, som er bestemt til:
—
helt at skulle implanteres i det menneskelige legeme, eller
—
at skulle erstatte en epiteloverflade eller øjets overflade,
ved et klinisk indgreb og forblive på plads efter indgrebet.
Ethvert udstyr, der er bestemt til delvis at skulle implanteres i det menneskelige legeme ved et klinisk indgreb og forblive på plads efter indgrebet i mindst 30 dage, anses også for at være implantabelt udstyr
6)   
»invasivt udstyr«
: ethvert udstyr, som helt eller delvis trænger ind i legemet enten gennem en legemsåbning eller gennem legemets overflade
7)   
»generisk gruppe af udstyr«
: en gruppe af udstyr beregnet til samme eller lignende erklærede formål, eller som er baseret på beslægtet teknologi, hvilket muliggør en generisk klassifikation, der ikke afspejler individuelle egenskaber
8)   
»engangsudstyr«
: udstyr, der er beregnet til anvendelse på én enkelt person i forbindelse med en enkelt procedure
9)   
»forfalsket udstyr«
: ethvert udstyr med en urigtig beskrivelse af dets identitet og/eller dets oprindelse og/eller dets CE-mærkningscertifikater eller dokumenter vedrørende CE-mærkningsprocedurer. Denne definition omfatter ikke utilsigtet manglende overensstemmelse og berører ikke krænkelser af intellektuelle ejendomsrettigheder
10)   
»behandlingspakke«
: en kombination af produkter, der er samlet i en pakke og bragt i omsætning med henblik på at blive anvendt til et specifikt medicinsk formål
11)   
»system«
: en kombination af produkter, hvad enten de er samlet i en pakke eller ej, som er bestemt til at blive forbundet indbyrdes eller kombineret for at opfylde et specifikt medicinsk formål
12)   
»erklæret formål«
: den anvendelse, som et udstyr er bestemt til ifølge fabrikantens oplysninger på mærkningen, ifølge brugsanvisningen eller ifølge salgsfremmende materiale- eller salgsmateriale eller reklame- og salgserklæringer og som specificeret af fabrikanten i den kliniske evaluering
13)   
»mærkning«
: skriftlige, trykte eller grafiske oplysninger enten på selve udstyret eller på emballagen for hver enkelt enhed eller på emballagen for flere udstyr
14)   
»brugsanvisning«
: oplysninger, som fabrikanten stiller til rådighed for at informere om et udstyrs erklærede formål, om korrekt anvendelse af udstyret og om eventuelle forholdsregler
15)   
»unik udstyrsidentifikationskode« (»UDI«)
: en række numeriske eller alfanumeriske tegn, der udformes ved hjælp af internationalt anerkendte udstyrsidentifikations- og kodningsstandarder, og som muliggør entydig identifikation af specifikt udstyr på markedet
16)   
»ikkelevedygtig«
: uden stofskifte eller evne til formering
17)   
»derivat«
: et »ikkecellulært stof«, der er udvundet af væv eller celler af human eller animalsk oprindelse gennem en fremstillingsproces. Det endelige stof, der anvendes til fremstilling af udstyret i dette tilfælde, indeholder ikke celler eller væv
18)   
»nanomateriale«
: et naturligt, tilfældigt opstået eller fremstillet materiale, der indeholder partikler i ubundet tilstand eller som et aggregat eller et agglomerat, og hvor mindst 50 % af partiklerne i den antalsmæssige størrelsesfordeling i en eller flere eksterne dimensioner ligger i størrelsesintervallet 1-100 nm.
Fullerener, grafenflager og enkeltvæggede carbonnanorør med en eller flere eksterne dimensioner på under 1 nm anses også for at være nanomateriale
19)   
»partikel«
: med henblik på definitionen af nanomateriale i nr. 18), et meget lille stykke stof med veldefinerede fysiske grænser
20)   
»agglomerat«
: med henblik på definitionen af nanomateriale i nr. 18), en samling løst bundne partikler eller aggregater, hvor det resulterende eksterne overfladeområde svarer til summen af de enkelte komponenters overfladeområde
21)   
»aggregat«
: med henblik på definitionen af nanomateriale i nr. 18), en partikel, der består af tætbundne eller sammensmeltede partikler
22)   
»ydeevne«
: udstyrs evne til at opfylde det erklærede formål som angivet af fabrikanten
23)   
»risiko«
: kombination af sandsynligheden for skade og den pågældende skades alvor
24)   
»afvejning af fordele og risici«
: analyse af alle vurderinger af fordele og risici af mulig relevans for anvendelsen af udstyret til dets erklærede formål, når det anvendes i overensstemmelse med det af fabrikanten angivne erklærede formål
25)   
»kompatibilitet«
: et udstyrs evne, herunder software, når det bruges sammen med et eller flere udstyr i overensstemmelse med sit erklærede formål, til at:
a)
fungere uden at miste eller kompromittere evnen til at fungere efter formålet, og/eller
b)
integrere og/eller fungere uden behov for at ændre eller tilpasse en del af det kombinerede udstyr, og/eller
c)
blive anvendt sammen uden konflikt/interferens eller bivirkninger
26)   
»interoperabilitet«
: den evne, som to eller flere udstyr, herunder software, fra samme fabrikant eller forskellige fabrikanter har til at:
a)
udveksle oplysninger og anvende de oplysninger, der er blevet udvekslet, til korrekt at gennemføre en bestemt funktion uden at ændre indholdet af dataene, og/eller
b)
kommunikere med hinanden, og/eller
c)
samarbejde som tilsigtet
27)   
»gøre tilgængelig på markedet«
: enhver levering af udstyr, bortset fra udstyr bestemt til afprøvning, med henblik på distribution, forbrug eller anvendelse på EU-markedet som led i erhvervsvirksomhed mod eller uden vederlag
28)   
»bringe i omsætning«
: første tilgængeliggørelse af et udstyr, bortset fra udstyr bestemt til afprøvning, på EU-markedet
29)   
»ibrugtagning«
: det stadium, hvor et udstyr, bortset fra udstyr bestemt til afprøvning, stilles til rådighed for slutbrugeren og er klar til for første gang at blive anvendt i overensstemmelse med sit erklærede formål på EU-markedet
30)   
»fabrikant«
: en fysisk eller juridisk person, som fremstiller eller nyistandsætter udstyr, eller som får udstyr designet, fremstillet eller nyistandsat og markedsfører det pågældende udstyr i eget navn eller under eget varemærke
31)   
»nyistandsættelse«
: med henblik på definitionen af fabrikant, fuldstændig genopbygning af et udstyr, der allerede er bragt i omsætning eller ibrugtaget, eller fremstilling af et nyt udstyr af brugt udstyr, således at det bringes i overensstemmelse med denne forordning, kombineret med tildeling af en ny levetid til det nyistandsatte udstyr
32)   
»autoriseret repræsentant«
: enhver fysisk eller juridisk person, der er etableret i Unionen, og som har modtaget og accepteret en skriftlig fuldmagt fra en fabrikant etableret uden for Unionen til at handle på fabrikantens vegne i forbindelse med varetagelsen af specifikke opgaver vedrørende dennes forpligtelser i henhold til forordningen
33)   
»importør«
: enhver fysisk eller juridisk person, der er etableret i Unionen, og som bringer udstyr fra et tredjeland i omsætning på EU-markedet
34)   
»distributør«
: enhver fysisk eller juridisk person i forsyningskæden, bortset fra fabrikanten eller importøren, som gør udstyr tilgængeligt på markedet indtil ibrugtagningen
35)   
»erhvervsdrivende«
: en fabrikant, en autoriseret repræsentant, en importør, en distributør eller den person, der er omhandlet i artikel 22, stk. 1, og artikel 22, stk. 3
36)   
»sundhedsinstitution«
: en organisation, hvis hovedformål er pleje eller behandling af patienter eller fremme af folkesundheden
37)   
»bruger«
: enhver sundhedsperson eller lægmand, der bruger et udstyr
38)   
»lægmand«
: en person, som ikke har en formel uddannelse inden for et relevant sundhedsområde eller medicinsk fagområde
39)   
»oparbejdning«
: en proces, som brugt udstyr gennemgår, for at muliggøre sikker genbrug, herunder rengøring, desinfektion, sterilisering og procedurer i forbindelse hermed, samt testning og genoprettelse af den tekniske og funktionelle sikkerhed af det brugte udstyr
40)   
»overensstemmelsesvurdering«
: en proces til påvisning af, om denne forordnings krav vedrørende et udstyr er blevet opfyldt
41)   
»overensstemmelsesvurderingsorgan«
: et organ, der som tredjepart udfører overensstemmelsesvurderingsopgaver, herunder kalibrering, testning, certificering og inspektion
42)   
»bemyndiget organ«
: et overensstemmelsesvurderingsorgan, der er udpeget i overensstemmelse med denne forordning
43)   
»CE-overensstemmelsesmærkning« eller »CE-mærkning«
: mærkning, hvormed en fabrikant angiver, at et udstyr er i overensstemmelse med de gældende krav i denne forordning og anden gældende EU-harmoniseringslovgivning om anbringelse af denne mærkning
44)   
»klinisk evaluering«
: en systematisk og planlagt proces til løbende at generere, indsamle, analysere og vurdere kliniske data vedrørende udstyr for at verificere udstyrets sikkerhed og ydeevne, herunder kliniske fordele, når det anvendes som tiltænkt af fabrikanten
45)   
»klinisk afprøvning«
: en systematisk afprøvning, der involverer et eller flere mennesker, og som har til formål at vurdere udstyrs sikkerhed eller ydeevne
46)   
»udstyr bestemt til afprøvning«
: udstyr, der vurderes i en klinisk afprøvning
47)   
»klinisk afprøvningsplan«
: et dokument, der beskriver rationale, formål, design, metodologi, monitorering, statistiske overvejelser, tilrettelæggelse og gennemførelse af en klinisk afprøvning
48)   
»kliniske data«
: oplysninger vedrørende sikkerhed eller ydeevne, der stammer fra brugen af udstyr, og som indsamles ved:
—
klinisk(e) afprøvning(er) af det pågældende udstyr
—
klinisk(e) afprøvning(er) eller andre undersøgelser, der er offentliggjort i den videnskabelige litteratur, af udstyr, hvis ækvivalens med det pågældende udstyr kan godtgøres
—
rapporter offentliggjort i videnskabelig litteratur, som har været underkastet peer review, om anden klinisk erfaring med enten det pågældende udstyr eller udstyr, hvis ækvivalens med det pågældende udstyr kan godtgøres
—
klinisk relevante oplysninger fra overvågningen, efter at udstyret er bragt i omsætning, navnlig den kliniske opfølgning, efter at udstyret er bragt i omsætning
49)   
»sponsor«
: en person, et firma, en institution eller en organisation, der påtager sig ansvaret for igangsætningen, for ledelsen og organisering af finansieringen af den kliniske afprøvning
50)   
»forsøgsperson«
: en person, der deltager i en klinisk afprøvning
51)   
»klinisk dokumentation«
: de kliniske data og resultaterne af den kliniske evaluering vedrørende udstyr, der findes i tilstrækkelig mængde og er af tilstrækkelig kvalitet til, at det er muligt at foretage en kvalificeret vurdering af, om udstyret er sikkert og opnår den eller de tilsigtede kliniske fordele, når det anvendes som tiltænkt af fabrikanten
52)   
»klinisk ydeevne«
: udstyrs evne som følge af eventuelle direkte eller indirekte medicinske virkninger, der udspringer af dets tekniske eller funktionelle kendetegn, herunder diagnostiske kendetegn, til at opfylde sit erklærede formål som tiltænkt af fabrikanten
53)   
»kliniske fordele«
: udstyrs positive virkning på en persons helbred, der er udtrykt som et eller flere meningsfulde, målelige, patientrelevante kliniske resultater, herunder resultat(er) i forbindelse med diagnose eller en positiv virkning på patientbehandlingen eller folkesundheden
54)   
»investigator«
: en person, der er ansvarlig for gennemførelsen af en klinisk afprøvning på et klinisk afprøvningssted
55)   
»informeret samtykke«
: en forsøgspersons utvungne og frivillige tilkendegivelse af sin vilje til at deltage i en bestemt klinisk afprøvning efter at være blevet informeret om alle de aspekter af den kliniske afprøvning, som er relevante for forsøgspersonens beslutning om at deltage, eller når det drejer sig om mindreårige og forsøgspersoner, som er uden handleevne, tilladelse eller samtykke fra deres retligt udpegede repræsentant til at inddrage dem i den kliniske afprøvning
56)   
»etisk komité«
: et uafhængigt organ, som er nedsat i en medlemsstat i overensstemmelse med denne medlemsstats ret og bemyndiget til at afgive udtalelser med henblik på denne forordning under hensyntagen til lægmænds, navnlig patienters eller patientorganisationers, synspunkter
57)   
»uønsket hændelse«
: enhver utilsigtet medicinsk hændelse, utilsigtet sygdom eller skade eller ethvert utilsigtet klinisk tegn, herunder unormale laboratorieresultater, hos forsøgspersoner, brugere eller andre personer i forbindelse med en klinisk afprøvning, uanset om dette er relateret til udstyret bestemt til afprøvning
58)   
»alvorlig uønsket hændelse«
: enhver uønsket hændelse med et af følgende udfald:
a)
dødsfald
b)
alvorlig forringelse af forsøgspersonens helbred i form af:
i)
livstruende sygdom eller skade
ii)
varig forringelse af en legemsstruktur eller en legemsfunktion
iii)
hospitalsindlæggelse eller forlængelse af patientens hospitalsindlæggelse
iv)
medicinsk eller kirurgisk indgreb for at afværge livstruende sygdom eller skade eller varig forringelse af en legemsstruktur eller en legemsfunktion
v)
kronisk sygdom
c)
fosterskade, fosterdød eller et medfødt fysisk eller mentalt handicap eller fødselsskade
59)   
»mangel ved udstyret«
: enhver utilstrækkelighed i identiteten, kvaliteten, holdbarheden, pålideligheden, sikkerheden eller ydeevnen af udstyr bestemt til afprøvning, herunder funktionsfejl, brugerfejl eller unøjagtigheder i oplysninger fra fabrikanten.
60)   
»overvågning, efter at udstyret er bragt i omsætning«
: alle aktiviteter, som fabrikanter i samarbejde med andre erhvervsdrivende udfører for at etablere og opdatere en systematisk procedure for proaktiv indsamling og gennemgang af erfaringerne med det udstyr, de bringer i omsætning, gør tilgængeligt på markedet eller ibrugtager, for at identificere eventuelle behov for straks at foretage nødvendige, korrigerende eller forebyggende handlinger
61)   
»markedsovervågning«
: aktiviteter, der gennemføres, og foranstaltninger, der træffes af kompetente myndigheder for at kontrollere og sikre, at udstyr er i overensstemmelse med kravene i den relevante EU-harmoniseringslovgivning og ikke er til fare for sundhed og sikkerhed eller andre aspekter vedrørende beskyttelse af samfundsinteresser
62)   
»tilbagetrækning«
: enhver foranstaltning, der har til formål at opnå, at udstyr, der allerede er gjort tilgængeligt for slutbrugeren, returneres
63)   
»tilbagekaldelse«
: enhver foranstaltning, der har til formål at forhindre, at udstyr i forsyningskæden yderligere gøres tilgængeligt på markedet
64)   
»hændelse«
: enhver fejlfunktion eller enhver forringelse i egenskaber eller ydeevne af udstyr, som er gjort tilgængeligt på markedet, herunder brugsfejl som følge af ergonomiske egenskaber samt enhver unøjagtighed i fabrikantens oplysninger og enhver uønsket bivirkning
65)   
»alvorlig hændelse«
: enhver hændelse, som direkte eller indirekte førte, kunne have ført eller kunne føre til et af følgende udfald:
a)
en patients, brugers eller anden persons dødsfald
b)
midlertidig eller varig alvorlig forringelse af en patients, brugers eller anden persons sundhedstilstand
c)
en alvorlig trussel mod folkesundheden
66)   
»alvorlig trussel mod folkesundheden«
: en begivenhed, der vil kunne medføre en umiddelbar risiko for dødsfald, alvorlig forringelse af en persons sundhedstilstand eller alvorlig sygdom, der kan kræve omgående afhjælpende handlinger, og som vil kunne forårsage betydelig sygelighed eller dødelighed hos mennesker, eller som er usædvanlig eller uventet på det pågældende sted og tidspunkt
67)   
»korrigerende handling«
: enhver handling, der foretages for at fjerne årsagen til en potentiel eller faktisk afvigelse eller anden uønsket situation
68)   
»sikkerhedsrelateret korrigerende handling«
: korrigerende handling foretaget af en fabrikant af tekniske eller medicinske årsager for at forebygge eller mindske risikoen for en alvorlig hændelse vedrørende udstyr, der er gjort tilgængeligt på markedet
69)   
»sikkerhedsmeddelelse«
: en meddelelse udsendt af en fabrikant til brugere eller kunder i forbindelse med en sikkerhedsrelateret korrigerende handling
70)   
»harmoniseret standard«
: en europæisk standard som defineret i artikel 2, nr. 1), litra c), i forordning (EU) nr. 1025/2012
71)   
»fælles specifikationer«
: en række tekniske og/eller kliniske krav, der ikke er en standard, og som giver mulighed for at opfylde de retlige forpligtelser, som gælder for et udstyr, en proces eller et system.
Artikel 3
Ændring af visse definitioner
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for at tilpasse den definition af nanomaterialer, der er fastsat i artikel 2, nr. 18), og de relaterede definitioner i nr. 19), 20) og 21) på baggrund af den tekniske og videnskabelige udvikling og under hensyntagen til definitioner, der er aftalt på EU-plan og internationalt.
Artikel 4
Produkters reguleringsmæssige status
1.   Med forbehold af artikel 2, stk. 2), i direktiv 2001/83/EF fastlægger Kommissionen efter en behørigt begrundet anmodning fra en medlemsstat og efter høring af Koordinationsgruppen for Medicinsk Udstyr nedsat i henhold til artikel 103 i denne forordning (MDCG) ved hjælp af gennemførelsesretsakter, hvorvidt et specifikt produkt eller en specifik kategori eller gruppe af produkter falder ind under definitionerne af »medicinsk udstyr« eller »tilbehør til medicinsk udstyr«. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3, i denne forordning.
2.   Kommissionen kan også på eget initiativ efter høring af MDCG ved hjælp af gennemførelsesretsakter træffe afgørelse om spørgsmålene i denne artikels stk. 1. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
3.   Kommissionen sørger for, at medlemsstaterne udveksler ekspertise på områderne medicinsk udstyr, medicinsk udstyr til in vitro-diagnostik, lægemidler, humane væv og celler, kosmetik, biocider, fødevarer og eventuelt andre produkter for at fastlægge et produkts, en produktkategoris eller en produktgruppes reguleringsmæssige status.
4.   Når Kommissionen overvejer den mulige reguleringsmæssige status som udstyr for produkter, der omfatter lægemidler, humane væv og celler, biocider eller fødevarer, sikrer den, at Det Europæiske Lægemiddelagentur (EMA), Det Europæiske Kemikalieagentur (ECHA) og Den Europæiske Fødevaresikkerhedsautoritet (EFSA) høres i et passende omfang, hvis det er relevant.
KAPITEL II
TILGÆNGELIGGØRELSE PÅ MARKEDET OG IBRUGTAGNING AF UDSTYR, ERHVERVSDRIVENDES FORPLIGTELSER, OPARBEJDNING, CE-MÆRKNING OG FRI BEVÆGELIGHED
Artikel 5
Bringe i omsætning og ibrugtagning
1.   Udstyr må kun bringes i omsætning eller ibrugtages, hvis det er i overensstemmelse med denne forordning, og når det leveres forskriftsmæssigt og anbringes, vedligeholdes og anvendes korrekt i overensstemmelse med sit erklærede formål.
2.   Udstyr skal opfylde de generelle krav til sikkerhed og ydeevne, som er fastsat i bilag I, og som finder anvendelse på det, under hensyn til dets erklærede formål.
3.   Påvisning af overensstemmelse med de generelle krav til sikkerhed og ydeevne skal omfatte en klinisk evaluering i overensstemmelse med artikel 61.
4.   Udstyr, der fremstilles og anvendes i sundhedsinstitutioner, betragtes som ibrugtaget.
5.   Med undtagelse af de relevante generelle krav til sikkerhed og ydeevne i bilag I finder kravene i denne forordning ikke anvendelse på udstyr, der kun er fremstillet og anvendt i sundhedsinstitutioner, der er etableret i Unionen, såfremt alle følgende betingelser er opfyldt:
a)
udstyret er ikke overført til en anden retlig enhed
b)
fremstillingen og anvendelsen af udstyret er omfattet af passende kvalitetsstyringssystemer
c)
sundhedsinstitutionen begrunder i sin dokumentation, at patientmålgruppens specifikke behov ikke kan opfyldes eller ikke kan opfyldes på et passende ydeevneniveau af tilsvarende udstyr, der er tilgængeligt på markedet
d)
sundhedsinstitutionen fremsender efter anmodning oplysninger om anvendelsen af sådant udstyr til dens kompetente myndighed, der skal indeholde en begrundelse for dets fremstilling, ændring og anvendelse
e)
sundhedsinstitutionen udfærdiger en erklæring, som den offentliggør, og som indeholder:
i)
navn og adresse på den sundhedsinstitution, der har fremstillet udstyret
ii)
oplysninger, der er nødvendige for at identificere udstyret
iii)
en erklæring om, at udstyret opfylder de generelle krav til sikkerhed og ydeevne som fastsat i denne forordnings bilag I, og, hvis det er relevant, oplysninger om, hvilke krav der ikke er opfyldt fuldt ud med angivelse af begrundelse derfor
f)
sundhedsinstitutionen udarbejder dokumentation, der gør det muligt at forstå fremstillingsanlægget, fremstillingsprocessen, udstyrets design og data om udstyrets ydeevne, herunder det erklærede formål, og der er tilstrækkeligt detaljeret til, at den kompetente myndighed kan konstatere, om de generelle krav til sikkerhed og ydeevne som fastsat i denne forordnings bilag I er opfyldt
g)
sundhedsinstitutionen træffer alle nødvendige foranstaltninger til sikring af, at alt udstyr er fremstillet i overensstemmelse med dokumentationen, jf. litra f), og
h)
sundhedsinstitutionen gennemgår erfaringerne fra den kliniske brug af udstyret og foretager alle nødvendige korrigerende handlinger.
Medlemsstaterne kan kræve, at sådanne sundhedsinstitutioner forelægger den kompetente myndighed alle yderligere relevante oplysninger om sådant udstyr, som er blevet fremstillet og anvendt på deres område. Medlemsstaterne bevarer retten til at begrænse fremstillingen og anvendelsen af en specifik type af sådant udstyr og skal have adgang til at inspicere sundhedsinstitutionernes aktiviteter.
Dette stykke finder ikke anvendelse på udstyr, der fremstilles i industriel målestok.
6.   For at sikre en ensartet anvendelse af bilag I kan Kommissionen vedtage gennemførelsesretsakter, i det omfang det er nødvendigt for at løse spørgsmål vedrørende forskellige fortolkninger og den praktiske anvendelse. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 6
Fjernsalg
1.   Udstyr, der tilbydes gennem tjenester i informationssamfundet som defineret i artikel 1, stk. 1), litra b), i direktiv (EU) 2015/1535, til en fysisk eller juridisk person, der er etableret i Unionen, skal overholde denne forordnings bestemmelser.
2.   Uden at dette berører national ret vedrørende udøvelse af lægegerningen, skal udstyr, der ikke bringes i omsætning, men som anvendes som led i en kommerciel aktivitet, mod eller uden vederlag, med henblik på levering af diagnostiske eller terapeutiske tjenester, der ydes gennem tjenester i informationssamfundet, som defineret i artikel 1, stk. 1, litra b), i direktiv (EU) 2015/1535, eller ved hjælp af andre kommunikationsmidler, direkte eller gennem mellemmænd, til en fysisk eller juridisk person, der er etableret i Unionen, overholde denne forordnings bestemmelser.
3.   Efter anmodning fra en kompetent myndighed stiller en fysisk eller juridisk person, der tilbyder udstyr i overensstemmelse med stk. 1, eller som leverer en tjeneste i overensstemmelse med stk. 2, en kopi af EU-overensstemmelseserklæringen for det pågældende udstyr til rådighed.
4.   En medlemsstat kan ud fra hensyn til beskyttelse af folkesundheden kræve, at en udbyder af tjenester i informationssamfundet som defineret i artikel 1, stk. 1), litra b), i direktiv (EU) 2015/1535 indstiller sine aktiviteter.
Artikel 7
Anprisninger
I forbindelse med mærkning, brugsanvisning, tilgængeliggørelse, ibrugtagning af og reklame for udstyr er det forbudt at anvende tekst, navne, varemærker, billeder og figurer eller andre tegn, der kan vildlede brugeren eller patienten med hensyn til udstyrets erklærede formål, sikkerhed og ydeevne ved at:
a)
tilskrive udstyret funktioner og egenskaber, som det ikke har
b)
skabe et falsk indtryk af behandlingen eller diagnosticeringen, funktioner eller egenskaber, som udstyret ikke har
c)
undlade at oplyse brugeren eller patienten om en sandsynlig risiko forbundet med brugen af udstyret i overensstemmelse med dets erklærede formål
d)
foreslå en anden brug af udstyret end den, der blev anført som en del af det erklærede formål, som overensstemmelsesvurderingen blev gennemført med henblik på.
Artikel 8
Brug af harmoniserede standarder
1.   Udstyr, der er i overensstemmelse med de relevante harmoniserede standarder eller relevante dele af disse standarder, hvis referencer er offentliggjort i 
Den Europæiske Unions Tidende
, formodes at være i overensstemmelse med de krav i denne forordning, der er omfattet af disse standarder eller dele deraf.
Første afsnit finder også anvendelse på system- eller proceskrav, som skal være opfyldt i overensstemmelse med denne forordning af erhvervsdrivende eller sponsorer, herunder de krav, der vedrører kvalitetssikringssystemer, risikostyring, systemer til overvågning, efter at udstyret er bragt i omsætning, kliniske afprøvninger, klinisk evaluering eller klinisk opfølgning, efter at udstyret er bragt i omsætning (»PMCF«).
Ved henvisninger i denne forordning til harmoniserede standarder forstås harmoniserede standarder, hvortil henvisningerne er blevet offentliggjort i 
Den Europæiske Unions Tidende
.
2.   Henvisninger i denne forordning til de harmoniserede standarder omfatter også de monografier i Den Europæiske Farmakopé, der er vedtaget i overensstemmelse med konventionen om udarbejdelse af en europæisk farmakopé, navnlig om kirurgiske suturer og interaktion mellem lægemidler og materialer, som indgår i udstyr, der indeholder sådanne lægemidler, hvis referencer til disse monografier er offentliggjort i 
Den Europæiske Unions Tidende
.
Artikel 9
Fælles specifikationer
1.   Med forbehold af artikel 1, stk. 2, og artikel 17, stk. 5, og de i disse bestemmelser fastsatte frister og hvis der ikke findes harmoniserede standarder, eller hvis de relevante harmoniserede standarder er utilstrækkelige, eller hvis det er nødvendigt at afhjælpe folkesundhedsmæssige betænkeligheder, kan Kommissionen efter høring af MDCG ved gennemførelsesretsakter vedtage fælles specifikationer for så vidt angår de generelle krav til sikkerhed og ydeevne som fastsat i bilag I, den tekniske dokumentation som fastsat i bilag II og III, den kliniske evaluering og den kliniske opfølgning, efter at udstyret er bragt i omsætning, som fastsat i bilag XIV eller kravene vedrørende klinisk afprøvning som fastsat i bilag XV. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
2.   Udstyr, der er i overensstemmelse med de fælles specifikationer i stk. 1 anses for at opfylde de krav i denne forordning, der er omfattet af disse fælles specifikationer eller relevante dele deraf.
3.   Fabrikanterne skal overholde de fælles specifikationer i stk. 1, medmindre det kan begrundes behørigt, at de har valgt løsninger, der sikrer et niveau med hensyn til sikkerhed og ydeevne, der mindst svarer hertil.
4.   Uanset stk. 3 skal fabrikanter af produkter, der er opført på listen i bilag XVI, overholde de relevante fælles specifikationer for disse produkter.
Artikel 10
Fabrikanternes generelle forpligtelser
1.   Når fabrikanter bringer deres udstyr i omsætning eller tager det i brug, sikrer de, at det er designet og fremstillet i overensstemmelse med kravene i denne forordning.
2.   Fabrikanter skal etablere, dokumentere, implementere og vedligeholde et system til risikostyring som beskrevet i punkt 3 i bilag I.
3.   Fabrikanterne skal gennemføre en klinisk evaluering i overensstemmelse med kravene i artikel 61 og bilag XIV, herunder en PMCF.
4.   Fabrikanterne af andet udstyr end udstyr efter mål udarbejder og opdaterer teknisk dokumentation for det nævnte udstyr. Den tekniske dokumentation skal udformes således, at den gør det muligt at vurdere, om udstyret er i overensstemmelse med kravene i denne forordning. Den tekniske dokumentation skal omfatte de elementer, der er anført i bilag II og III.
Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for på baggrund af den tekniske udvikling at ændre bilag II og III.
5.   Fabrikanterne af udstyr efter mål udarbejder, opdaterer og stiller dokumentation i overensstemmelse med bilag XIII, punkt 2, til rådighed for de kompetente myndigheder.
6.   Hvis overensstemmelsen med de gældende krav er blevet dokumenteret efter den relevante overensstemmelsesvurderingsprocedure, udarbejder fabrikanter af udstyr, bortset fra udstyr efter mål eller udstyr bestemt til afprøvning, en EU-overensstemmelseserklæring i overensstemmelse med artikel 19 og anbringer CE-overensstemmelsesmærkningen i overensstemmelse med artikel 20.
7.   Fabrikanterne skal overholde de forpligtelser, der er forbundet med UDI-systemet, jf. artikel 27, og registreringsforpligtelserne, jf. artikel 29 og 31.
8.   Fabrikanterne stiller den tekniske dokumentation og EU-overensstemmelseserklæringen og, hvis det er relevant, en kopi af alle relevante certifikater, herunder eventuelle ændringer og tillæg, som er udstedt i overensstemmelse med artikel 56, til rådighed for de kompetente myndigheder i en periode på mindst 10 år, efter at det sidste udstyr, som er omfattet af EU-overensstemmelseserklæringen, er bragt i omsætning. For så vidt angår implantabelt udstyr skal perioden være på mindst 15 år, efter at det sidste udstyr er blevet bragt i omsætning.
Efter anmodning fra en kompetent myndighed forelægger fabrikanten som anført i anmodningen den fuldstændige tekniske dokumentation eller en sammenfatning heraf.
For at den autoriserede repræsentant kan varetage de opgaver, der er nævnt i artikel 11, stk. 3, sikrer en fabrikant med registreret forretningssted uden for Unionen, at den autoriserede repræsentant har permanent adgang til de nødvendige oplysninger.
9.   Fabrikanterne sikrer, at der er etableret procedurer til sikring af produktionsseriers fortsatte overensstemmelse med kravene i denne forordning. Der skal i fornødent omfang tages rettidigt hensyn til ændringer i udstyrets design eller egenskaber og til ændringer i de harmoniserede standarder eller de fælles specifikationer, som der er henvist til for at dokumentere udstyrets overensstemmelse med de gældende krav. Fabrikanter af andet udstyr end udstyr bestemt til afprøvning skal oprette, dokumentere, implementere, vedligeholde, opdatere og løbende forbedre et kvalitetsstyringssystem, der sikrer overensstemmelse med denne forordning på den mest effektive måde og på en måde, der står i rimeligt forhold til risikoklassen og typen af udstyr.
Kvalitetsstyringssystemet skal dække alle dele og elementer i en fabrikants organisation, der beskæftiger sig med kvaliteten af processer, procedurer og udstyr. Det styrer strukturen, ansvarsområderne, procedurerne, processerne og ledelsesressourcerne for at gennemføre de principper og foranstaltninger, der er nødvendige for at sikre overensstemmelse med bestemmelserne i denne forordning.
Kvalitetsstyringssystemet skal mindst omfatte følgende aspekter:
a)
en strategi for overholdelse af reguleringen, herunder overholdelse af procedurerne for overensstemmelsesvurdering og procedurerne for administration af ændringer af det udstyr, som er omfattet af systemet
b)
identifikation af de generelle krav til sikkerhed og ydeevne og udforskning af mulighederne for at imødekomme disse krav
c)
ledelsens ansvar
d)
ressourceforvaltning, herunder udvælgelse af og kontrol med leverandører og underentreprenører
e)
risikostyring som fastsat i punkt 3 i bilag I
f)
klinisk evaluering i overensstemmelse med artikel 61 og bilag XIV, herunder PMCF
g)
produktrealisering, herunder planlægning, design, udvikling, produktion og levering af tjenesteydelser
h)
verifikation af UDI-tildelinger efter artikel 27, stk. 3, til alt relevant udstyr og sikring af overensstemmelse og gyldighed af de oplysninger, der er forelagt i henhold til artikel 29
i)
etablering, implementering og opretholdelse af et system til overvågning, efter at udstyret er bragt i omsætning, i henhold til artikel 83
j)
varetagelse af kommunikation med kompetente myndigheder, bemyndigede organer, andre erhvervsdrivende, kunder og/eller andre interessenter
k)
processer for indberetning af alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger i forbindelse med sikkerhedsovervågning
l)
styring af korrigerende og forebyggende handlinger og verifikation af deres effektivitet
m)
processer for monitorering og måling af output, dataanalyse og produktforbedring.
10.   Fabrikanter af udstyr implementerer og opdaterer systemet til overvågning, efter at udstyret er bragt i omsætning, jf. artikel 83.
11.   Fabrikanterne sikrer, at udstyret ledsages af de oplysninger, der er omhandlet i bilag I, punkt 23, på et eller flere officielle EU-sprog som fastsat af den medlemsstat, hvor udstyret gøres tilgængeligt for brugeren eller patienten. Oplysningerne på mærkningen skal være umulige at slette, letlæselige og letforståelige for den tilsigtede bruger eller patienten.
12.   Hvis fabrikanterne finder eller har grund til at tro, at udstyr, som de har bragt i omsætning eller ibrugtaget, ikke er i overensstemmelse med denne forordning, foretager de straks de nødvendige korrigerende handlinger for at bringe det pågældende udstyr i overensstemmelse med kravene eller om nødvendigt tilbagekalde det eller trække det tilbage. De underretter distributørerne af det pågældende udstyr og, hvor det er relevant, den autoriserede repræsentant samt importører herom.
Hvis udstyret udgør en alvorlig risiko, skal fabrikanterne straks underrette de kompetente myndigheder i de medlemsstater, hvor de har gjort udstyret tilgængeligt, og i givet fald det bemyndigede organ, der har udstedt et certifikat for udstyret i overensstemmelse med artikel 56, om navnlig den manglende overensstemmelse og korrigerende handlinger.
13.   Fabrikanterne skal have et system til registrering og indberetning af hændelser og sikkerhedsrelaterede korrigerende handlinger som beskrevet i artikel 87 og 88.
14.   Efter anmodning fra en kompetent national myndighed forelægger fabrikanterne den al den information og dokumentation, der er nødvendig for at påvise produktets overensstemmelse med kravene, på et officielt EU-sprog, der er fastsat af den berørte medlemsstat. Den kompetente myndighed i den medlemsstat, hvor fabrikanten har sit registrerede forretningssted, kan kræve, at fabrikanterne stiller prøver af udstyret til rådighed uden vederlag eller, hvis det ikke er praktisk muligt, giver adgang til udstyret. Fabrikanterne skal, hvis en kompetent myndighed anmoder herom, samarbejde med denne om korrigerende handlinger, der er foretaget for at undgå eller, hvis det ikke er muligt, begrænse risici i forbindelse med udstyr, som er bragt i omsætning eller ibrugtaget.
Hvis fabrikanten ikke samarbejder, eller hvis den forelagte information og dokumentation er ufuldstændig eller ukorrekt, kan den kompetente myndighed med henblik på at sikre beskyttelsen af folkesundheden og patientsikkerheden træffe de nødvendige foranstaltninger for at forbyde eller begrænse tilgængeligheden af udstyr på sit nationale marked eller for at tilbagekalde udstyret fra markedet eller trække det tilbage, indtil fabrikanten samarbejder eller forelægger fuldstændige og korrekte oplysninger.
Hvis en kompetent myndighed finder eller har grund til at tro, at udstyr har forårsaget skade, skal den efter anmodning lette leveringen af de oplysninger og den dokumentation, der er omhandlet i første afsnit, til den potentielt skadede patient eller bruger og eventuelt patientens eller brugerens retsefterfølger, patientens eller brugerens sundhedsforsikringsselskab eller andre tredjeparter, der er berørt af den skade, som patienten eller brugeren er blevet påført, uden at dette berører databeskyttelsesreglerne og, medmindre væsentlige samfundsinteresser taler for at give adgang til oplysningerne, uden at dette berører beskyttelsen af intellektuelle ejendomsrettigheder.
Den kompetente myndighed behøver ikke at overholde den forpligtelse, der er fastlagt i tredje afsnit, hvis adgangen til de oplysninger og den dokumentation, der er omhandlet i første afsnit, sædvanligvis behandles i forbindelse med retssager.
15.   Hvis fabrikanterne får deres udstyr designet eller fremstillet af en anden juridisk eller fysisk person, skal oplysningerne om denne persons identitet indgå i de oplysninger, der skal fremlægges i overensstemmelse med artikel 30, stk. 1.
16.   Fysiske eller juridiske personer kan kræve erstatning for skade forårsaget af defekt udstyr i overensstemmelse med gældende EU-ret og national ret.
Fabrikanter skal på en måde, der står i rimeligt forhold til risikoklasse, type af udstyr og virksomhedens størrelse, have indført foranstaltninger for at sikre tilstrækkelig finansiel dækning for så vidt angår deres potentielle ansvar i henhold til direktiv 85/374/EØF, uden at dette berører strengere beskyttelsesforanstaltninger i henhold til national ret.
Artikel 11
Autoriseret repræsentant
1.   Hvis fabrikanten af udstyr ikke er etableret i en medlemsstat, kan udstyret kun bringes i omsætning i Unionen, hvis fabrikanten udpeger én autoriseret repræsentant.
2.   Udpegelsen udgør den autoriserede repræsentants fuldmagt, er kun gyldig, hvis den autoriserede repræsentant bekræfter dette skriftligt, og gælder som minimum for alt udstyr af samme generiske gruppe af udstyr.
3.   Den autoriserede repræsentant udfører de opgaver, der er fastsat i den fuldmagt, som den autoriserede repræsentant og fabrikanten er blevet enige om. Den autoriserede repræsentant forelægger på anmodning en kopi af fuldmagten for den kompetente myndighed.
Fuldmagten kræver, og fabrikanten tillader, at den autoriserede repræsentant udfører mindst følgende opgaver i relation til det udstyr, som er omfattet af den:
a)
verificerer, at EU-overensstemmelseserklæringen og den tekniske dokumentation er blevet udarbejdet, og, hvis det er relevant, at fabrikanten har gennemført en passende overensstemmelsesvurderingsprocedure
b)
stiller en kopi af den tekniske dokumentation og EU-overensstemmelseserklæringen og, hvis det er relevant, en kopi af det relevante certifikat, herunder eventuelle ændringer og tillæg, som er udstedt i overensstemmelse med artikel 56, til rådighed for de kompetente myndigheder i den periode, der er nævnt i artikel 10, stk. 8
c)
opfylder registreringsforpligtelserne i artikel 31 og verificerer, at fabrikanten har opfyldt registreringsforpligtelserne i artikel 27 og 29
d)
forelægger som svar på en kompetent myndigheds anmodning al den information og dokumentation, der er nødvendig for at påvise udstyrets overensstemmelse med kravene, for denne kompetente myndighed på et officielt EU-sprog, der er fastsat af den berørte medlemsstat
e)
fremsender eventuelle anmodninger fra en kompetent myndighed i den medlemsstat, hvor den autoriserede repræsentant har sit registrerede forretningssted om prøver af eller adgang til udstyr til fabrikanten, og verificerer, at den kompetente myndighed modtager prøverne eller får adgang til udstyret
f)
samarbejder med de kompetente myndigheder om forebyggende eller korrigerende handlinger, der foretages for at undgå eller, hvis det ikke er muligt, begrænse risici i forbindelse med udstyret
g)
informerer straks fabrikanten om klager og indberetninger fra sundhedspersoner, patienter og brugere om formodede hændelser i forbindelse med udstyr, for hvilket den autoriserede repræsentant er udpeget
h)
bringer fuldmagten til ophør, hvis fabrikanten handler i strid med sine forpligtelser i henhold til denne forordning.
4.   Den i denne artikels stk. 3 omhandlede fuldmagt må ikke uddelegere fabrikantens forpligtelser som fastsat i artikel 10, stk. 1, 2, 3, 4, 6, 7, 9, 10, 11 og 12.
5.   Hvis fabrikanten ikke er etableret i en medlemsstat og ikke har opfyldt de forpligtelser, der er fastsat i artikel 10, er den autoriserede repræsentant juridisk ansvarlig for defekt udstyr på samme grundlag som og hæfter solidarisk med fabrikanten, jf. dog denne artikels stk. 4.
6.   En autoriseret repræsentant, som bringer sin fuldmagt til ophør af den grund, der er omhandlet i stk. 3, litra h), underretter straks den kompetente myndighed i den medlemsstat, hvor den autoriserede repræsentant er etableret, og, hvis det er relevant, det bemyndigede organ, som har deltaget i overensstemmelsesvurderingen af udstyret, om fuldmagtens ophør og årsagerne hertil.
7.   Henvisninger i denne forordning til den kompetente myndighed i den medlemsstat, hvor fabrikanten har sit registrerede forretningssted, betragtes som henvisninger til den kompetente myndighed i den medlemsstat, hvor den autoriserede repræsentant, der er udpeget af fabrikanten, jf. stk. 1, har sit registrerede forretningssted.
Artikel 12
Udskiftning af den autoriserede repræsentant
De nærmere bestemmelser for udskiftning af den autoriserede repræsentant skal være klart fastlagt i en aftale mellem fabrikanten, så vidt muligt den afgående autoriserede repræsentant og den tiltrædende autoriserede repræsentant. Denne aftale skal mindst indeholde følgende:
a)
datoen for ophøret af den afgående autoriserede repræsentants fuldmagt og datoen for indledningen af den tiltrædende autoriserede repræsentants fuldmagt
b)
datoen, indtil hvilken den afgående autoriserede repræsentant må anføres i oplysningerne fra fabrikanten, herunder eventuelt salgsfremmende materiale
c)
overdragelse af dokumenter, herunder fortrolighedsaspekter og ejendomsrettigheder
d)
den afgående autoriserede repræsentants forpligtelse til efter fuldmagtens ophør at sende fabrikanten eller den tiltrædende autoriserede repræsentant eventuelle klager eller indberetninger fra sundhedspersoner, patienter eller brugere om formodede hændelser i forbindelse med udstyr, for hvilket vedkommende var udpeget som autoriseret repræsentant.
Artikel 13
Importørernes generelle forpligtelser
1.   Importørerne må kun bringe udstyr i omsætning på EU-markedet, som er i overensstemmelse med denne forordning.
2.   Med henblik på at bringe udstyr i omsætning verificerer importørerne, at:
a)
udstyret er CE-mærket, og der er udarbejdet en EU-overensstemmelseserklæring for udstyret
b)
en fabrikant er identificeret, og at vedkommende har udpeget en autoriseret repræsentant i overensstemmelse med artikel 11
c)
udstyret er mærket i overensstemmelse med denne forordning og ledsaget af den krævede brugsanvisning
d)
fabrikanten, hvis det er relevant, har tildelt udstyret en UDI i overensstemmelse med artikel 27.
Hvis en importør finder eller har grund til at tro, at et udstyr ikke er i overensstemmelse med kravene i denne forordning, må vedkommende ikke bringe udstyret i omsætning, før det er blevet bragt i overensstemmelse med de gældende krav, og skal underrette fabrikanten og dennes autoriserede repræsentant herom. Hvis importøren finder eller har grund til at tro, at udstyret udgør en alvorlig risiko eller er forfalsket, underretter vedkommende ligeledes den kompetente myndighed i den medlemsstat, hvor importøren er etableret.
3.   Importører skal på udstyret eller på dets emballage eller i et dokument, der ledsager udstyret, anføre deres navn, registrerede firmanavn eller registrerede varemærke, deres registrerede forretningssted og den adresse, hvor de kan kontaktes, således at de fysisk kan lokaliseres. De sikrer, at ingen supplerende mærkning skjuler oplysningerne i fabrikantens mærkning.
4.   Importørerne verificerer, at udstyret er registreret i det elektroniske system i overensstemmelse med artikel 29. Importørerne tilføjer deres oplysninger til registreringen i henhold til artikel 31.
5.   Importørerne sikrer, at opbevarings- og transportbetingelserne for udstyr, som de har ansvaret for, ikke bringer dets overensstemmelse med de væsentlige krav til sikkerhed og ydeevne fastsat i bilag I i fare, og overholder de betingelser, som fabrikanten har fastsat, såfremt de foreligger.
6.   Importørerne fører et register over klager, ikkeoverensstemmende udstyr og tilbagetrækninger og tilbagekaldelser og forelægger alle oplysninger, som fabrikanten, den autoriserede repræsentant og distributørerne anmoder om, for dem, så de kan undersøge klager.
7.   Importører, der finder eller har grund til at tro, at udstyr, som de har bragt i omsætning, ikke er i overensstemmelse med denne forordning, underretter omgående fabrikanten og dennes autoriserede repræsentant. Importørerne samarbejder med fabrikanten, dennes autoriserede repræsentant og de kompetente myndigheder for at sikre, at der foretages de nødvendige korrigerende handlinger for at bringe det pågældende udstyr i overensstemmelse, tilbagekalde det eller trække det tilbage. Hvis udstyret udgør en alvorlig risiko, underretter de også straks de kompetente myndigheder i de medlemsstater, hvor de har gjort udstyret tilgængeligt, og, hvis det er relevant, det bemyndigede organ, der har udstedt et certifikat i overensstemmelse med artikel 56 for det pågældende udstyr, og giver nærmere oplysninger om navnlig den manglende overensstemmelse og de korrigerende handlinger.
8.   Importører, der har modtaget klager eller indberetninger fra sundhedspersoner, patienter eller brugere om formodede hændelser i forbindelse med udstyr, som de har bragt i omsætning, fremsender straks disse oplysninger til fabrikanten og dennes autoriserede repræsentant.
9.   Importørerne opbevarer i den periode, der er nævnt i artikel 10, stk. 8, en kopi af EU-overensstemmelseserklæringen og, hvis det er relevant, en kopi af alle relevante certifikater, herunder eventuelle ændringer og tillæg, som er udstedt i overensstemmelse med artikel 56.
10.   Importørerne skal, hvis kompetente myndigheder anmoder herom samarbejde med disse om handlinger, der foretages for at undgå eller, hvis det ikke er muligt, begrænse risici i forbindelse med udstyr, som de har bragt i omsætning. Hvis en kompetent myndighed i den medlemsstat, hvor importøren har sit registrerede forretningssted, anmoder herom, stiller vedkommende prøver af udstyret til rådighed uden vederlag eller, hvis dette ikke er praktisk muligt, giver adgang til udstyret.
Artikel 14
Distributørernes generelle forpligtelser
1.   Når distributører gør udstyr tilgængeligt på markedet, handler de i forbindelse med deres aktiviteter med fornøden omhu med hensyn til de gældende krav.
2.   Distributørerne verificerer, før de gør udstyr tilgængeligt på markedet, at alle de følgende krav er opfyldt:
a)
udstyret er CE-mærket, og der er udarbejdet en EU-overensstemmelseserklæring for udstyret
b)
udstyret er ledsaget af de oplysninger, som fabrikanten skal fremlægge i overensstemmelse med artikel 10, stk. 11
c)
for importeret udstyr: Importøren har opfyldt kravene i artikel 13, stk. 3
d)
fabrikanten har, hvis det er relevant, tildelt udstyret en UDI.
Med henblik på at opfylde kravene i første afsnit, litra a), b) og d), kan distributøren anvende en prøveudtagningsmetode, der er repræsentativ for det udstyr, som den pågældende distributør leverer.
Hvis en distributør finder eller har grund til at tro, at et udstyr ikke er i overensstemmelse med kravene i denne forordning, må vedkommende ikke gøre udstyret tilgængeligt på markedet, før det er blevet bragt i overensstemmelse hermed, og skal underrette fabrikanten og i givet fald dennes autoriserede repræsentant og importøren herom. Hvis distributøren finder eller har grund til at tro, at udstyret udgør en alvorlig risiko eller er forfalsket, underetter vedkommende ligeledes den kompetente myndighed i den medlemsstat, hvor distributøren er etableret.
3.   Distributørerne sikrer, at opbevarings- og transportbetingelserne for det udstyr, som de har ansvaret for, opfylder de betingelser, som fabrikanten har fastsat.
4.   Distributører, der finder eller har grund til at tro, at udstyr, som de har gjort tilgængeligt på markedet, ikke er i overensstemmelse med denne forordning, underretter straks fabrikanten og eventuelt dennes autoriserede repræsentant og importøren. Distributørerne samarbejder med fabrikanten og i givet fald dennes autoriserede repræsentant og importøren samt med de kompetente myndigheder for at sikre, at der foretages de nødvendige korrigerende handlinger for at bringe det pågældende udstyr i overensstemmelse med kravene eller om nødvendigt at tilbagekalde det eller at trække det tilbage. Hvis distributøren mener eller har grund til at tro, at udstyret udgør en alvorlig risiko, skal vedkommende også straks underrette de kompetente myndigheder i de medlemsstater, hvor vedkommende har gjort udstyret tilgængeligt, og give nærmere oplysninger om navnlig den manglende overensstemmelse og korrigerende handlinger.
5.   Distributører, som har modtaget klager eller indberetninger fra sundhedspersoner, patienter eller brugere om formodede hændelser i forbindelse med udstyr, som de har gjort tilgængeligt, fremsender straks disse oplysninger til fabrikanten og i givet fald dennes autoriserede repræsentant og importøren. De fører et register over klager, ikkeoverensstemmende udstyr og tilbagetrækninger og tilbagekaldelser og holder fabrikanten og, hvis en sådan findes, den autoriserede repræsentant og importøren orienteret om en sådan monitorering og stiller alle oplysninger til rådighed for dem, når de anmoder herom.
6.   Distributørerne skal på anmodning af en kompetent myndighed forelægge denne al den information og dokumentation, som de har til rådighed, og som er nødvendig for at påvise udstyrets overensstemmelse med kravene.
Distributørerne anses for at have opfyldt forpligtelsen i første afsnit, når fabrikanten af eller i givet fald den autoriserede repræsentant for det pågældende udstyr forelægger de krævede oplysninger. Distributørerne skal på anmodning af de kompetente myndigheder samarbejde med disse om de foranstaltninger, de har truffet, for at undgå risici i forbindelse med udstyr, de har gjort tilgængeligt på markedet. Hvis en kompetent myndighed anmoder herom, stiller distributøren gratis stikprøver af udstyret til rådighed eller, hvis det ikke er praktisk muligt, giver adgang til udstyret.
Artikel 15
Person, der er ansvarlig for overholdelse af reguleringen
1.   Fabrikanterne skal i deres organisation have mindst én person, der er ansvarlig for overholdelse af reguleringen, og som har den fornødne ekspertise på området for medicinsk udstyr. Den fornødne ekspertise påvises ved en af følgende kvalifikationer:
a)
et eksamensbevis, certifikat eller andet kvalifikationsbevis for fuldført universitetsuddannelse eller en uddannelse, som den pågældende medlemsstat har anerkendt som svarende hertil, inden for jura, medicin, farmaci, ingeniørvidenskab eller en anden relevant videnskabelig disciplin og mindst et års erhvervserfaring med reguleringsmæssige spørgsmål eller kvalitetsstyringssystemer vedrørende medicinsk udstyr
b)
fire års erhvervserfaring med reguleringsmæssige spørgsmål eller kvalitetsstyringssystemer vedrørende medicinsk udstyr.
Med forbehold af nationale bestemmelser vedrørende faglige kvalifikationer kan fabrikanter af udstyr efter mål påvise den fornødne ekspertise, jf. første afsnit, ved at have mindst to års erhvervserfaring inden for et relevant fremstillingsområde.
2.   Mikrovirksomheder og små virksomheder i den i Kommissionens henstilling 2003/361/EF 
(
36
)
 anvendte betydning er ikke forpligtede til at have en person i deres organisation, der er ansvarlig for overholdelse af reguleringen, men skal til stadighed råde over en sådan person.
3.   Den person, der er ansvarlig for overholdelse af reguleringen, skal mindst være ansvarlig for at sikre, at:
a)
udstyrets overensstemmelse kontrolleres på passende vis i henhold til det kvalitetsstyringssystem, som udstyret fremstilles under, før et udstyr frigives
b)
den tekniske dokumentation og EU-overensstemmelseserklæringen er udarbejdet og opdateret
c)
overvågningsforpligtelserne, efter at udstyret er bragt i omsætning, er opfyldt i henhold til artikel 10, stk. 10
d)
indberetningsforpligtelserne i artikel 87-91 er opfyldt
e)
den erklæring, der er nævnt i bilag XV, kapitel II, punkt 4.1, er udstedt, for så vidt angår udstyr bestemt til afprøvning.
4.   Hvis flere personer i fællesskab er ansvarlige for overholdelse af reguleringen i overensstemmelse med stk. 1, 2 og 3, fastlægges deres respektive ansvarsområder skriftligt.
5.   Den person, der er ansvarlig for overholdelse af reguleringen, må ikke bringes i en ugunstig stilling i fabrikantens organisation i forbindelse med korrekt varetagelse af sine opgaver, uanset om vedkommende er ansat i organisationen eller ej.
6.   De autoriserede repræsentanter skal til stadighed råde over mindst én person, der er ansvarlig for overholdelse af reguleringen, og som har den fornødne ekspertise om de reguleringsmæssige krav til medicinsk udstyr i Unionen. Den fornødne ekspertise påvises ved en af følgende kvalifikationer:
a)
et eksamensbevis, certifikat eller andet kvalifikationsbevis for fuldført universitetsuddannelse eller en uddannelse, som den pågældende medlemsstat har anerkendt som svarende hertil, inden for jura, medicin, farmaci, ingeniørvidenskab eller en anden relevant videnskabelig disciplin og mindst et års erhvervserfaring med reguleringsmæssige spørgsmål eller kvalitetsstyringssystemer vedrørende medicinsk udstyr
b)
fire års erhvervserfaring med reguleringsmæssige spørgsmål eller kvalitetsstyringssystemer vedrørende medicinsk udstyr.
Artikel 16
Tilfælde, hvor fabrikanternes forpligtelser finder anvendelse på importører, distributører eller andre personer
1.   En distributør, importør eller anden fysisk eller juridisk person påtager sig de forpligtelser, som påhviler fabrikanterne, hvis vedkommende gør en af følgende:
a)
gør udstyr tilgængeligt på markedet i sit eget navn eller under sit registrerede firmanavn eller registrerede varemærke, undtagen i tilfælde, hvor en distributør eller importør indgår en aftale med en fabrikant, hvorved fabrikanten identificeres som sådan på mærkningen og er ansvarlig for at opfylde de krav, der pålægges fabrikanter i denne forordning
b)
ændrer det erklærede formål for udstyr, der allerede er bragt i omsætning eller ibrugtaget
c)
ændrer udstyr, der allerede er bragt i omsætning eller ibrugtaget, på en sådan måde, at overensstemmelsen med de gældende krav kan blive påvirket.
Første afsnit finder ikke anvendelse på en person, som uden at være fabrikant som defineret i artikel 2, nr. 30), til en bestemt patient samler eller tilpasser udstyr, der allerede er bragt i omsætning, uden at ændre dets erklærede formål.
2.   Med henblik på stk. 1, litra c), betragtes følgende ikke som en ændring af udstyr, der kan påvirke udstyrets opfyldelse af gældende krav:
a)
tilvejebringelse, herunder oversættelse, af fabrikantens oplysninger i overensstemmelse med bilag I, punkt 23, vedrørende udstyr, der allerede er bragt i omsætning, og af yderligere oplysninger, der er nødvendige for at markedsføre udstyret i den relevante medlemsstat
b)
ændringer af den ydre emballage til udstyr, der allerede er bragt i omsætning, herunder ændring af pakningsstørrelsen, hvis ompakning er nødvendig for at markedsføre udstyret i den relevante medlemsstat, og hvis det sker under sådanne betingelser, at udstyrets oprindelige tilstand ikke berøres. For udstyr, der markedsføres i steril tilstand, formodes det, at udstyrets oprindelige tilstand påvirkes negativt, hvis emballagen, der er nødvendig for at bevare den sterile tilstand, er åbnet, beskadiget eller på anden måde negativt påvirket af ompakningen.
3.   En distributør eller importør, som udfører de aktiviteter, der er nævnt i stk. 2, litra a) og b), skal på udstyret eller, hvis dette ikke er praktisk muligt, på dets emballage eller i et dokument, der ledsager udstyret, anføre den aktivitet, der er udført, sammen med vedkommendes navn, registrerede firmanavn eller registrerede varemærke, registrerede forretningssted og den adresse, hvor den pågældende kan kontaktes, således at denne fysisk kan lokaliseres.
Distributører eller importører sørger for, at de har et kvalitetsstyringssystem med procedurer, der sikrer, at oversættelsen af oplysningerne er korrekt og opdateret, og at de aktiviteter, der er nævnt i stk. 2, litra a) og b), foretages på en måde og under betingelser, som beskytter udstyrets oprindelige tilstand, og at det ompakkede udstyrs emballage ikke er defekt, af dårlig kvalitet eller sjusket. Kvalitetsstyringssystemet skal blandt andet omfatte procedurer, der sikrer, at distributøren eller importøren underrettes om korrigerende handlinger, som fabrikanten foretager i forhold til det pågældende udstyr for at reagere på sikkerhedsproblemer eller for at bringe udstyret i overensstemmelse med denne forordning.
4.   Senest 28 dage inden ommærket eller ompakket udstyr gøres tilgængeligt på markedet, underretter distributører eller importører, som udfører aktiviteter, jf. stk. 2, litra a) og b), fabrikanten og den kompetente myndighed i den medlemsstat, hvor de agter at gøre udstyret tilgængeligt, om intentionen om at gøre det ommærkede eller ompakkede udstyr tilgængeligt og giver efter anmodning fabrikanten og den kompetente myndighed en prøve eller model af det ommærkede eller ompakkede udstyr, herunder eventuelle oversatte mærkninger og brugsanvisninger. Inden for samme 28 dage forelægger distributøren eller importøren den kompetente myndighed et certifikat, der er udstedt af et bemyndiget organ udpeget til den type udstyr, som er omfattet af de aktiviteter, der er omhandlet i stk. 2, litra a) og b), og som certificerer, at distributørens eller importørens kvalitetsstyringssystem opfylder de krav, der er fastsat i stk. 3.
Artikel 17
Engangsudstyr og oparbejdning heraf
1.   Oparbejdning og videre anvendelse af engangsudstyr må kun finde sted, hvis det er tilladt ifølge national ret, og kun i overensstemmelse med denne artikel.
2.   Enhver fysisk eller juridisk person, som oparbejder engangsudstyr for at gøre det egnet til videre anvendelse i Unionen, anses for at være fabrikant af det oparbejdede udstyr og skal påtage sig de forpligtelser, som påhviler en fabrikant i henhold til denne forordning, herunder forpligtelserne vedrørende sporbarheden af det oparbejdede udstyr i overensstemmelse med denne forordnings kapitel III. Oparbejderen af udstyret betragtes som en producent med henblik på artikel 3, stk. 1, i direktiv 85/374/EØF.
3.   Uanset stk. 2 kan medlemsstater for så vidt angår engangsudstyr, der oparbejdes og anvendes i én enkelt sundhedsinstitution, beslutte ikke at anvende alle de regler vedrørende fabrikanternes forpligtelser, der er fastsat i denne forordning, forudsat at de sikrer, at:
a)
det oparbejdede udstyrs sikkerhed og ydeevne svarer til det oprindelige udstyrs, og at kravene i artikel 5, stk. 5, litra a), b), d), e), f), g) og h), er opfyldt
b)
oparbejdningen foretages i overensstemmelse med fælles specifikationer, der fastsætter krav vedrørende:
—
risikostyring, herunder analyse af konstruktion og materiale, egenskaber forbundet med udstyret (reverse engineering) og procedurer til påvisning af ændringer i det oprindelige udstyrs design og dets påtænkte anvendelse efter oparbejdning
—
validering af procedurer for hele processen, herunder trin for rengøring
—
produktets frigivelse og testning af ydeevne
—
kvalitetsstyringssystemet
—
indberetning af hændelser, der involverer oparbejdet udstyr, og
—
sporbarheden af det oparbejdede udstyr.
Medlemsstaterne tilskynder til og kan kræve, at sundhedsinstitutioner giver oplysninger til patienterne om brugen af oparbejdet udstyr i sundhedsinstitutionen og i givet fald andre relevante oplysninger om det oparbejdede udstyr, som patienterne behandles med.
Medlemsstaterne underretter Kommissionen og de øvrige medlemsstater om de nationale bestemmelser, der indføres i henhold til dette stykke, og begrundelsen for at indføre dem. Kommissionen stiller oplysningerne til rådighed for offentligheden.
4.   Medlemsstaterne kan vælge at anvende bestemmelserne i stk. 3, også for så vidt angår engangsudstyr, der er oparbejdet af en ekstern oparbejder, på anmodning af en sundhedsinstitution, forudsat at det oparbejdede udstyr i sin helhed leveres tilbage til denne sundhedsinstitution, og at den eksterne oparbejder opfylder kravene i stk. 3, litra a) og b).
5.   Kommissionen vedtager i overensstemmelse med artikel 9, stk. 1, senest den 26. maj 2020 de nødvendige fælles specifikationer, der er omhandlet i stk. 3, litra b). Disse fælles specifikationer skal stemme overens med den seneste videnskabelige dokumentation og omhandle anvendelsen af de generelle krav til sikkerhed og ydeevne, der er fastsat i denne forordning. Hvis disse fælles specifikationer ikke er vedtaget senest den 26. maj 2020, udføres oparbejdningen i overensstemmelse med alle relevante harmoniserede standarder og nationale bestemmelser, der sikrer opfyldelse af de krav, der er beskrevet i stk. 3, litra b). Overensstemmelse med fælles specifikationer eller i mangel af fælles specifikationer med alle de relevante harmoniserede standarder og nationale bestemmelser certificeres af et bemyndiget organ.
6.   Kun engangsudstyr, der er bragt i omsætning på markedet i overensstemmelse med denne forordning eller inden den 26. maj 2020 i overensstemmelse med direktiv 93/42/EØF, må oparbejdes.
7.   Engangsudstyr må kun oparbejdes, hvis oparbejdningen anses for sikker ifølge de seneste videnskabelige oplysninger.
8.   Navn og adresse på den juridiske eller fysiske person, der er omhandlet i stk. 2, og de andre relevante oplysninger omhandlet i bilag I, punkt 23, skal fremgå af det oparbejdede udstyrs mærkning og, hvis det er relevant, af dets brugsanvisning.
Navn og adresse på fabrikanten af det oprindelige engangsudstyr skal ikke længere fremgå af mærkningen, men nævnes i brugsanvisningen til det oparbejdede udstyr.
9.   En medlemsstat, der tillader oparbejdning af engangsudstyr, kan opretholde eller indføre nationale bestemmelser, der er strengere end dem, der er fastsat i denne forordning, og som på dens område begrænser eller forbyder følgende:
a)
oparbejdning af engangsudstyr og overførsel af engangsudstyr til en anden medlemsstat eller til et tredjeland med henblik på oparbejdning
b)
tilgængeliggørelse eller videre anvendelse af oparbejdet engangsudstyr.
Medlemsstaterne skal underrette Kommissionen og de øvrige medlemsstater om disse nationale bestemmelser. Kommissionen stiller sådanne oplysninger til rådighed for offentligheden.
10.   Kommissionen udarbejder senest den 27. maj 2024 en rapport om anvendelsen af denne artikel og forelægger den for Europa-Parlamentet og Rådet. På baggrund af denne rapport foreslår Kommissionen, hvis det er relevant, ændringer til denne forordning.
Artikel 18
Implantatkort og oplysninger, der skal gives til patienter med implanteret udstyr
1.   Fabrikanter af implantabelt udstyr udleverer følgende sammen med udstyret:
a)
oplysninger, der gør det muligt at identificere udstyret, herunder udstyrets navn, serienummer, lotnummer, UDI'en, udstyrsmodellen samt fabrikantens navn, adresse og websted
b)
advarsler, forholdsregler eller foranstaltninger, som patienten eller en sundhedsperson skal iagttage med hensyn til gensidig interferens med eksterne påvirkninger, lægeundersøgelser eller miljømæssige forhold, som med rimelighed kan forudses
c)
oplysninger om udstyrets forventede levetid og al nødvendig opfølgning
d)
andre oplysninger, der sikrer, at patienten kan anvende udstyret på sikker vis, herunder oplysningerne i bilag I, punkt 23.4, litra u).
De oplysninger, der er omhandlet i første afsnit, skal med henblik på at gøre dem tilgængelige for den konkrete patient, der har fået udstyr implanteret, gives på enhver måde, der giver hurtig adgang til disse oplysninger, og skal anføres på det eller de sprog, der er fastsat af den berørte medlemsstat. Oplysningerne skal formuleres således, at de let kan forstås af en lægmand, og skal opdateres, når det er hensigtsmæssigt. Opdateringer af oplysningerne skal gøres tilgængelige for patienten via det websted, der er nævnt i første afsnit, litra a).
Fabrikanten skal desuden give de oplysninger, der er omhandlet i første afsnit, litra a), på et implantatkort, der leveres sammen med udstyret.
2.   Medlemsstaterne skal pålægge sundhedsinstitutioner at stille de oplysninger, der er omhandlet i stk. 1, til rådighed på enhver måde, der giver hurtig adgang til oplysningerne, for patienter, der har fået udstyr implanteret, sammen med det implantatkort, der angiver deres identitet.
3.   Følgende implantater er undtaget fra forpligtelserne i denne artikel: suturer, hæfteklammer, tandfyldninger, tandbøjler, tandkroner, skruer, kiler, plader, tråd, nåle, clips og forbindelsesled. Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 med henblik på at ændre denne liste ved at tilføje andre typer af implantater til den eller ved at fjerne implantater fra den.
Artikel 19
EU-overensstemmelseserklæring
1.   Det skal af EU-overensstemmelseserklæringen fremgå, at kravene i denne forordning er opfyldt for så vidt angår det omfattede udstyr. Fabrikanten skal løbende opdatere EU-overensstemmelseserklæringen. EU-overensstemmelseserklæringen skal mindst indeholde de oplysninger, der er anført i bilag IV, og skal oversættes til det eller de officielle EU-sprog, der kræves af den eller de medlemsstater, hvor udstyret gøres tilgængeligt.
2.   Hvis udstyr for så vidt angår aspekter, der ikke er omfattet af denne forordning, er undergivet anden EU-lovgivning, som også kræver, at fabrikanten afgiver en EU-overensstemmelseserklæring om, at det er dokumenteret, at kravene i den pågældende lovgivning er opfyldt, udarbejdes der én enkelt EU-overensstemmelseserklæring for alle EU-retsakter, der finder anvendelse på udstyret. Erklæringen skal indeholde alle oplysninger, der er påkrævet for at identificere, hvilken EU-lovgivning erklæringen vedrører.
3.   Ved at udarbejde EU-overensstemmelseserklæringen står fabrikanten inde for, at udstyret opfylder kravene i denne forordning og i al anden EU-lovgivning, der gælder for udstyret.
4.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for at ændre mindstekravet til indholdet af EU-overensstemmelseserklæringen, jf. bilag IV, på baggrund af den tekniske udvikling.
Artikel 20
CE-overensstemmelsesmærkning
1.   Udstyr, der anses for at opfylde kravene i denne forordning, bortset fra udstyr efter mål og udstyr bestemt til afprøvning, skal være forsynet med CE-overensstemmelsesmærkning som gengivet i bilag V.
2.   CE-mærkningen er underkastet de generelle principper i artikel 30 i forordning (EF) nr. 765/2008.
3.   CE-mærkningen anbringes synligt, letlæseligt og således, at den ikke kan slettes, på selve udstyret eller på dets sterile pakning. Hvis en sådan anbringelse ikke er mulig eller hensigtsmæssig på grund af udstyrets art, anbringes CE-mærkningen på emballagen. CE-mærkningen skal også anbringes på en eventuel brugsanvisning og på en eventuel forhandlingsemballage.
4.   CE-mærkningen anbringes, før udstyret bringes i omsætning. Den kan følges af et piktogram eller en anden form for angivelse vedrørende risiko- eller brugskategori.
5.   Hvor det er relevant, skal CE-mærkningen følges af identifikationsnummeret for det bemyndigede organ, der er ansvarligt for overensstemmelsesvurderingsprocedurerne i artikel 52. Identifikationsnummeret skal også fremgå af salgsfremmende materiale, som nævner, at udstyret opfylder kravene til CE-mærkning.
6.   Hvis udstyret er omfattet af anden EU-lovgivning, som også indeholder bestemmelser om anbringelse af CE-mærkning, skal CE-mærkningen angive, at udstyret ligeledes opfylder kravene i denne anden lovgivning.
Artikel 21
Udstyr til særlige formål
1.   Medlemsstaterne må ikke skabe hindringer for:
a)
udstyr bestemt til afprøvning, der leveres til en investigator med henblik på klinisk afprøvning, hvis det opfylder betingelserne i artikel 62-80 og artikel 82, i gennemførelsesretsakterne vedtaget i henhold til artikel 81 og i bilag XV
b)
udstyr efter mål, som gøres tilgængeligt på markedet, hvis artikel 52, stk. 8, og bilag XIII er opfyldt.
Det udstyr, der er omhandlet i første afsnit, forsynes ikke med CE-mærkning, med undtagelse af det udstyr, der er omhandlet i artikel 74.
2.   Udstyr efter mål ledsages af den i bilag XIII, punkt 1, omhandlede erklæring, som skal gøres tilgængelig for den pågældende patient eller bruger, der er identificeret ved navn, et akronym eller en talkode.
Medlemsstaterne kan kræve, at fabrikanten af udstyr efter mål forelægger den kompetente myndighed en liste over sådant udstyr, der er gjort tilgængeligt på deres område.
3.   Medlemsstaterne må ikke modsætte sig, at der på messer og udstillinger, ved demonstrationer mv. præsenteres udstyr, som ikke er i overensstemmelse med denne forordning, når det ved synlig skiltning klart er anført, at det pågældende udstyr udelukkende er bestemt til præsentation eller demonstration og ikke kan gøres tilgængeligt, før det er bragt i overensstemmelse med denne forordning.
Artikel 22
System- og behandlingspakker
1.   Fysiske eller juridiske personer skal afgive en erklæring, hvis de kombinerer udstyr, der er forsynet med CE-mærkning, med følgende andet udstyr eller andre produkter på en måde, der er forenelig med udstyrets eller andre produkters erklærede formål, og inden for de anvendelsesgrænser, som fabrikanten har angivet, med henblik på at bringe dem i omsætning som system- eller behandlingspakker:
a)
andet udstyr, der er forsynet med CE-mærkning
b)
medicinsk udstyr til in vitro-diagnostik, som er forsynet med CE-mærkning i overensstemmelse med forordning (EU) 2017/746
c)
andre produkter, som er i overensstemmelse med den lovgivning, der kun gælder for disse produkter, hvis de anvendes inden for en medicinsk procedure, eller hvis det på anden måde er berettiget, at de indgår i system- eller behandlingspakken.
2.   I den erklæring, der afgives i henhold til stk. 1, skal den pågældende fysiske eller juridiske person erklære, at:
a)
vedkommende har verificeret udstyrets og i givet fald de andre produkters indbyrdes kompatibilitet i overensstemmelse med fabrikantens anvisninger og har udført sine aktiviteter i overensstemmelse med disse anvisninger
b)
vedkommende har pakket system- eller behandlingspakken og givet brugerne alle relevante oplysninger, herunder oplysninger fra fabrikanterne af det udstyr eller de andre produkter, som er blevet kombineret
c)
aktiviteten med at kombinere udstyr og, hvis det er relevant, andre produkter i system- eller behandlingspakker var underlagt passende interne monitorerings-, verifikations- og valideringsmetoder.
3.   Enhver fysisk eller juridisk person, som med henblik på omsætning steriliserer de i stk. 1 omhandlede system- eller behandlingspakker, skal efter eget valg anvende en af procedurerne i bilag IX eller proceduren i bilag XI, del A. Anvendelsen af disse procedurer og det bemyndigede organs inddragelse begrænses til de aspekter af proceduren, som vedrører steriliseringen, indtil den sterile emballage åbnes eller beskadiges. Den fysiske eller juridiske person udarbejder en erklæring om, at steriliseringen er blevet foretaget i overensstemmelse med fabrikantens anvisninger.
4.   Hvis system- eller behandlingspakken indeholder udstyr, der ikke er forsynet med CE-mærkning, eller hvis den valgte kombination af udstyr ikke er kompatibel med henblik på det oprindelige erklærede formål med udstyret, eller hvis steriliseringen ikke er blevet foretaget i overensstemmelse med fabrikantens anvisninger, behandles system- eller behandlingspakken som et selvstændigt udstyr og underkastes den relevante overensstemmelsesvurderingsprocedure i artikel 52. Den fysiske eller juridiske person påtager sig de forpligtelser, som påhviler fabrikanterne.
5.   De i denne artikels stk. 1 omhandlede system- eller behandlingspakker skal ikke selv være forsynet med ekstra CE-mærkning, men den i denne artikels stk. 1 og 3 omhandlede persons navn, registrerede firmanavn eller registrerede varemærke samt den adresse, hvor den pågældende kan kontaktes, således at personen fysisk kan lokaliseres, skal fremgå af system- eller behandlingspakkerne. System- eller behandlingspakker skal ledsages af de oplysninger, der er nævnt i bilag I, punkt 23. Den i denne artikels stk. 2 omhandlede erklæring stilles til rådighed for de kompetente myndigheder, efter at system- eller behandlingspakkerne er blevet kombineret, i den for det udstyr, der kombineres, gældende periode, jf. artikel 10, stk. 8. Hvis disse perioder er forskellige, gælder den længste periode.
Artikel 23
Dele og komponenter
1.   Enhver fysisk eller juridisk person, der gør en udstyrsdel tilgængelig på markedet, som er specifikt beregnet til at erstatte en identisk eller lignende integreret del eller komponent i udstyr, der er defekt eller slidt, for at opretholde eller genoprette udstyrets funktion uden at ændre dets ydeevne eller sikkerhedsegenskaber eller erklærede formål, sikrer, at udstyrsdelen ikke forringer udstyrets sikkerhed og ydeevne. Der skal stilles understøttende dokumentation til rådighed for de kompetente myndigheder i medlemsstaterne.
2.   En udstyrsdel, som er specielt beregnet til at erstatte en del eller en komponent, der indgår i udstyr, og som i væsentlig grad ændrer udstyrets ydeevne eller sikkerhedsegenskaber eller erklærede formål, betragtes som udstyr og skal opfylde kravene i denne forordning.
Artikel 24
Fri bevægelighed
Medmindre andet er fastsat i denne forordning, må medlemsstaterne ikke nægte, forbyde eller begrænse tilgængeliggørelse på markedet eller ibrugtagning på deres område af udstyr, som er i overensstemmelse med kravene i denne forordning.
KAPITEL III
IDENTIFIKATION OG SPORBARHED AF UDSTYR, REGISTRERING AF UDSTYR OG ERHVERVSDRIVENDE, SAMMENFATNING AF SIKKERHED OG KLINISK YDEEVNE, EUROPÆISK DATABASE FOR MEDICINSK UDSTYR
Artikel 25
Identifikation i forsyningskæden
1.   Distributører og importører skal samarbejde med fabrikanter eller autoriserede repræsentanter for at sikre et passende sporbarhedsniveau for udstyr.
2.   Erhvervsdrivende skal kunne identificere følgende over for den kompetente myndighed i den periode, der er omhandlet i artikel 10, stk. 8:
a)
enhver erhvervsdrivende, som de direkte har leveret udstyr til
b)
enhver erhvervsdrivende, som direkte har leveret udstyr til dem
c)
enhver sundhedsinstitution eller sundhedsperson, som de direkte har leveret udstyr til.
Artikel 26
Nomenklatur for medicinsk udstyr
For at lette anvendelsen af den europæiske database for medicinsk udstyr (Eudamed), jf. artikel 33, sikrer Kommissionen, at der gratis stilles en internationalt anerkendt nomenklatur for medicinsk udstyr til rådighed for fabrikanter og andre fysiske eller juridiske personer, der i henhold til denne forordning er forpligtet til at anvende denne nomenklatur. Kommissionen skal desuden bestræbe sig på at sikre, at nomenklaturen stilles gratis til rådighed for andre interessenter, når det er praktisk muligt.
Artikel 27
System for unik udstyrsidentifikation
1.   Systemet for unik udstyrsidentifikation (»UDI-systemet«) beskrevet i bilag VI, del C, skal gøre det muligt at identificere og lette sporingen af udstyr, bortset fra udstyr efter mål og udstyr bestemt til afprøvning, og skal bestå af følgende:
a)
fremstilling af en UDI, som omfatter følgende:
i)
en UDI-udstyrsidentifikationskode (»UDI-DI«), som er specifik for en fabrikant og et udstyr, og som giver adgang til de oplysninger, der er fastsat i bilag VI, del B
ii)
en UDI-produktionsidentifikationskode (»UDI-PI«), som identificerer fremstillingen af udstyrsenheden og, hvis det er relevant, det emballerede udstyr som anført i bilag VI, del C
b)
anbringelse af UDI'en på udstyrets mærkning eller på dets emballage
c)
erhvervsdrivendes, sundhedsinstitutionernes og sundhedspersonernes opbevaring af UDI'en i overensstemmelse med betingelserne fastlagt i henholdsvis denne artikels stk. 8 og 9
d)
etablering af et elektronisk system for unik udstyrsidentifikation (»UDI-database«) i overensstemmelse med artikel 28.
2.   Kommissionen udpeger ved hjælp af gennemførelsesretsakter en eller flere enheder, der skal drive et system for tildeling af UDI'er i henhold til denne forordning (»udstedende enhed«). Denne eller disse enheder skal opfylde alle nedenstående kriterier:
a)
enheden er en organisation med status som juridisk person
b)
systemet for tildeling af UDI'er er anvendeligt til at identificere udstyr under hele dets distribution og anvendelse i overensstemmelse med kravene i denne forordning
c)
systemet for tildeling af UDI'er er i overensstemmelse med de relevante internationale standarder
d)
enheden giver alle interesserede brugere adgang til sit system for tildeling af UDI'er i overensstemmelse med en række forud fastlagte og gennemsigtige vilkår og betingelser
e)
enheden forpligter sig til at gøre følgende:
i)
drive sit system for tildeling af UDI'er i mindst 10 år efter udpegelsen
ii)
efter anmodning stille oplysninger til rådighed for Kommissionen og medlemsstaterne vedrørende sit system for tildeling af UDI'er
iii)
fortsat opfylde kriterierne og vilkårene for udpegelsen.
Når Kommissionen udpeger udstedende enheder, bestræber den sig på at sikre, at UDI-bærerne som defineret i bilag VI, del C, er alment læsbare, uanset hvilket system der anvendes af den udstedende enhed, med henblik på at minimere de finansielle og administrative byrder for erhvervsdrivende og sundhedsinstitutioner.
3.   Før udstyr, bortset fra udstyr efter mål, bringes i omsætning, skal fabrikanten tildele udstyret og, hvis det er muligt, alle højere emballageniveauer en UDI, der er i oprettet overensstemmelse med de regler, som den udstedende enhed, der udpeges af Kommissionen i overensstemmelse med stk. 2, har.
Før udstyr, bortset fra end udstyr efter mål og udstyr bestemt til afprøvning, bringes i omsætning skal fabrikanten sikre, at de i bilag VI, del B, omhandlede oplysninger vedrørende det pågældende udstyr er korrekt indsendt og overført til den i artikel 28 omhandlede UDI-database.
4.   UDI-bærere anbringes på udstyrets mærkning og alle højere emballageniveauer. Højere emballageniveauer anses ikke for at omfatte fragtbeholdere.
5.   UDI'en anvendes til indberetning af alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger i overensstemmelse med artikel 87.
6.   Den grundlæggende UDI-DI som defineret i bilag VI, del C, skal fremgå af EU-overensstemmelseserklæringen, jf. artikel 19.
7.   Som en del af den tekniske dokumentation, jf. bilag II, skal fabrikanten føre en opdateret fortegnelse over alle UDI'er, som vedkommende har tildelt.
8.   De erhvervsdrivende skal, helst i elektronisk form, lagre og opbevare UDI'en for udstyr, som de har leveret, eller som de har fået leveret, hvis det pågældende udstyr tilhører:
—
implantabelt udstyr i klasse III
—
udstyr, kategorier eller grupper af udstyr, der fastlægges ved en foranstaltning, der er omhandlet i stk. 11, litra a).
9.   Sundhedsinstitutioner skal, helst i elektronisk form, lagre og opbevare UDI'en for udstyr, som de har leveret, eller som de har fået leveret, hvis det pågældende udstyr tilhører implantabelt udstyr i klasse III.
For andet udstyr end implantabelt udstyr i klasse III tilskynder medlemsstaterne til og kan de kræve, at sundhedsinstitutioner, helst i elektronisk form, lagrer og opbevarer UDI'en for udstyr, som de har fået leveret.
Medlemsstaterne tilskynder til og kan kræve, at sundhedspersoner, helst i elektronisk form, lagrer og opbevarer UDI'en for udstyr, som de har fået leveret.
10.   Kommissionen tillægges i overensstemmelse med artikel 115 beføjelse til at vedtage delegerede retsakter med henblik på at:
a)
ændre listen over de oplysninger, der er fastsat i bilag VI, del B, på baggrund af den tekniske udvikling, og
b)
ændre bilag VI i lyset af den internationale udvikling og den tekniske udvikling inden for unik udstyrsidentifikation.
11.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte nærmere bestemmelser og proceduremæssige aspekter for UDI-systemet med henblik på at sikre harmoniseret anvendelse heraf for så vidt angår følgende:
a)
fastlæggelse af det udstyr, de kategorier eller de grupper af udstyr, som forpligtelsen i stk. 8 skal finde anvendelse på
b)
specifikation af, hvilke oplysninger der skal fremgå af UDI-PI for specifikt udstyr eller grupper af udstyr.
De gennemførelsesretsakter, der er omhandlet i første afsnit, vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
12.   Ved vedtagelsen af de i stk. 11 nævnte foranstaltninger tager Kommissionen hensyn til alt det følgende:
a)
tavshedspligten og databeskyttelsen, jf. henholdsvis artikel 109 og 110
b)
den risikobaserede tilgang
c)
foranstaltningernes omkostningseffektivitet
d)
konvergensen af UDI-systemer, der er udviklet på internationalt plan
e)
behovet for at undgå dubletter i UDI-systemet
f)
behovene i medlemsstaternes sundhedssystemer og, hvor dette er muligt, kompatibilitet med andre systemer til identifikation af medicinsk udstyr, som anvendes af interessenterne.
Artikel 28
UDI-database
1.   Efter høring af MDCG opretter og forvalter Kommissionen en UDI-database til at validere, indsamle og behandle de oplysninger, der er nævnt i bilag VI, del B, og gøre dem tilgængelige for offentligheden.
2.   Ved design af UDI-databasen skal Kommissionen tage hensyn til de generelle principper, der er fastsat i bilag VI, del C, punkt 5. UDI-databasen skal navnlig designes således, at ingen UDI-PI'er og ingen kommercielt fortrolige produktoplysninger kan indgå i den.
3.   De centrale dataelementer, der skal indsendes til UDI-databasen, jf. bilag VI, del B, skal være gratis tilgængelige for offentligheden.
4.   Den tekniske design af UDI-databasen skal sikre maksimal adgang til de oplysninger, der er lagret i den, herunder flerbrugeradgang og automatisk up- og download af disse oplysninger. Kommissionen sørger for teknisk og administrativ støtte til fabrikanter og andre brugere af UDI-databasen.
Artikel 29
Registrering af udstyr
1.   Inden udstyr, bortset fra udstyr efter mål, bringes i omsætning, tildeler fabrikanten i overensstemmelse med reglerne fra den udstedende enhed, jf. artikel 27, stk. 2, udstyret en grundlæggende UDI-DI som defineret i bilag VI, del C, og indsender den til UDI-databasen sammen med de andre centrale dataelementer, jf. bilag VI, del B, vedrørende dette udstyr.
2.   Inden en system- eller behandlingspakke i henhold til artikel 22, stk. 1 og 3, der ikke er et udstyr efter mål, bringes i omsætning, tildeler den ansvarlige fysiske eller juridiske person i overensstemmelse med reglerne fra den udstedende enhed system- eller behandlingspakken en grundlæggende UDI-DI og indsender den til UDI-databasen sammen med de andre centrale dataelementer, jf. bilag VI, del B, vedrørende denne system- eller behandlingspakke.
3.   For så vidt angår udstyr, der er omfattet af overensstemmelsesvurdering som omhandlet i artikel 52, stk. 3, og stk. 4, andet og tredje afsnit, skal tildeling af en grundlæggende UDI-DI, jf. stk. 1 i denne artikel, foretages, inden fabrikanten ansøger et bemyndiget organ om en sådan vurdering.
For så vidt angår udstyr, der er omfattet af første afsnit, skal det bemyndigede organ medtage en henvisning til den grundlæggende UDI-DI på det certifikat, der udstedes i overensstemmelse med bilag XII, afdeling I, punkt 4, afsnit 4, litra a), og i Eudamed bekræfte, at de i bilag V, del A, punkt 2.2, omhandlede oplysninger er korrekte. Efter at det relevante certifikat er udstedt, og inden udstyret bringes i omsætning, skal fabrikanten indsende den grundlæggende UDI-DI til UDI-databasen sammen med de andre centrale dataelementer, jf. bilag VI, del B, vedrørende dette udstyr.
4.   Inden udstyr, bortset fra udstyr efter mål, bringes i omsætning, skal fabrikanten indføre eller, hvis de allerede foreligger, bekræfte de oplysninger, der er omhandlet i bilag VI, del A, punkt 2, med undtagelse af punkt 2.2 heri, i Eudamed og herefter løbende opdatere disse oplysninger.
Artikel 30
Elektronisk system for registrering af erhvervsdrivende
1.   Efter høring af MDCG opretter og forvalter Kommissionen et elektronisk system til at oprette det individuelle registreringsnummer, jf. artikel 31, stk. 2, og indsamle og behandle de oplysninger, der er nødvendige og rimelige for at identificere fabrikanten og i givet fald den autoriserede repræsentant og importøren. De nærmere detaljer om de oplysninger, som de erhvervsdrivende skal indsende til dette elektroniske system, er fastsat i bilag VI, del A, punkt 1.
2.   Medlemsstaterne kan opretholde eller indføre nationale bestemmelser om registrering af distributører af udstyr, der er gjort tilgængeligt på deres område.
3.   Senest to uger efter at udstyr, bortset fra udstyr efter mål, er bragt i omsætning, verificerer importørerne, at fabrikanten eller den autoriserede repræsentant har indsendt de oplysninger, der er omhandlet i stk. 1, til det elektroniske system.
Hvis det er relevant, underretter importøren den pågældende autoriserede repræsentant eller fabrikanten, hvis de i stk. 1 omhandlede oplysninger ikke er anført eller er ukorrekte. Importører tilføjer deres nærmere oplysninger til den eller de relevante registreringer.
Artikel 31
Registrering af fabrikanter, autoriserede repræsentanter og importører
1.   Inden udstyr, bortset fra udstyr efter mål, bringes i omsætning, skal fabrikanter, autoriserede repræsentanter og importører med henblik på registrering indsende de oplysninger, der er omhandlet i bilag VI, del A, punkt 1, til det elektroniske system, jf. artikel 30, forudsat at de ikke allerede er registreret i overensstemmelse med denne artikel. Hvis overensstemmelsesvurderingsproceduren kræver, at et bemyndiget organ inddrages i medfør af artikel 52, skal de oplysninger, der er nævnt i bilag VI, del A, punkt 1, indsendes til dette elektroniske system, inden der ansøges hos det bemyndigede organ.
2.   Efter at have verificeret de oplysninger, som er indført i henhold til stk. 1, indhenter den kompetente myndighed et individuelt registreringsnummer (»single registration number« — »SRN«) i det elektroniske system, jf. artikel 30, og udsteder det til fabrikanten, den autoriserede repræsentant eller importøren.
3.   Fabrikanten anvender SRN'et, når vedkommende ansøger et bemyndiget organ om overensstemmelsesvurdering og adgang til Eudamed med henblik på at opfylde sine forpligtelser i henhold til artikel 29.
4.   Senest en uge efter enhver ændring i forbindelse med de i nærværende artikels stk. 1 omhandlede oplysninger opdaterer den erhvervsdrivende dataene i det elektroniske system, jf. artikel 30.
5.   Senest et år efter indsendelsen af oplysningerne i overensstemmelse med stk. 1 og derefter hvert andet år skal den erhvervsdrivende bekræfte dataenes nøjagtighed. Hvis dette ikke er gjort inden for seks måneder efter disse frister, kan enhver medlemsstat træffe passende korrigerende foranstaltninger på sit område, indtil den pågældende erhvervsdrivende opfylder denne forpligtelse.
6.   Uden at dette berører den erhvervsdrivendes ansvar for dataene, skal den kompetente myndighed verificere de bekræftede oplysninger, jf. bilag VI, del A, punkt 1.
7.   De oplysninger, der i henhold til denne artikels stk. 1 er indført i det elektroniske system, jf. artikel 30, skal være offentligt tilgængelige.
8.   Den kompetente myndighed kan anvende oplysningerne til at opkræve et gebyr af fabrikanten, den autoriserede repræsentant eller importøren i henhold til artikel 111.
Artikel 32
Sammenfatning af sikkerhed og klinisk ydeevne
1.   For så vidt angår implantabelt udstyr og udstyr, der er klassificeret som klasse III, bortset fra udstyr efter mål og udstyr bestemt til afprøvning, udarbejder fabrikanten en sammenfatning af sikkerhed og klinisk ydeevne.
Sammenfatningen af sikkerhed og klinisk ydeevne skal være formuleret på en måde, der tydeligt forstås af den tilsigtede bruger og, hvis det er relevant, af patienten, og den skal gøres offentligt tilgængelig via Eudamed.
Udkastet til sammenfatning af sikkerhed og klinisk ydeevne skal indgå i den dokumentation, der skal forelægges det bemyndigede organ, der deltager i overensstemmelsesvurderingen i henhold til artikel 52, og det skal valideres af dette organ. Efter validering af sammenfatningen skal det bemyndigede organ uploade den til Eudamed. Fabrikanten skal på mærkningen eller brugsanvisningen angive, hvor sammenfatningen er tilgængelig.
2.   Sammenfatningen af sikkerhed og klinisk ydeevne skal indeholde mindst følgende aspekter:
a)
identifikation af udstyret og fabrikanten, herunder den grundlæggende UDI-DI og, hvis det allerede er udstedt, SRN'et
b)
udstyrets erklærede formål og eventuelle indikationer, kontraindikationer og målpopulationer
c)
en beskrivelse af udstyret, herunder en henvisning til den eller de tidligere generationer eller varianter, hvis sådanne findes, og en beskrivelse af forskellene samt, hvis det er relevant, en beskrivelse af eventuelt tilbehør, andet udstyr og produkter, som er bestemt til at skulle anvendes sammen med udstyret
d)
mulige diagnostiske eller terapeutiske alternativer
e)
henvisning til eventuelle harmoniserede standarder og fælles specifikationer, der er anvendt
f)
sammenfatningen af den kliniske evaluering, jf. bilag XIV, og relevante oplysninger om den kliniske opfølgning, efter at udstyret er bragt i omsætning
g)
foreslået profil og uddannelse for brugerne
h)
oplysninger om eventuelle tilbageværende risici og uønskede virkninger, advarsler og forholdsregler.
3.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte formen og præsentationen af de dataelementer, der skal medtages i sammenfatningen af sikkerhed og klinisk ydeevne. Disse gennemførelsesretsakter vedtages efter rådgivningsproceduren i artikel 114, stk. 2.
Artikel 33
Europæisk database for medicinsk udstyr
1.   Efter høring af MDCG opretter, opretholder og vedligeholder Kommissionen en europæisk database for medicinsk udstyr (»Eudamed«) med henblik på følgende:
a)
at give offentligheden mulighed for at være velinformeret om udstyr, der bringes i omsætning, relevante certifikater udstedt af bemyndigede organer og om relevante erhvervsdrivende
b)
at tillade unik identifikation af udstyr på det indre marked og lette sporbarheden af udstyr
c)
at give offentligheden mulighed for at være velinformeret om kliniske afprøvninger og at give sponsorer af kliniske afprøvninger mulighed for at opfylde forpligtelserne i artikel 62-80 og 82 og eventuelle retsakter vedtaget i henhold til artikel 81
d)
at give fabrikanter mulighed for at opfylde oplysningskravene i artikel 87-90 eller i eventuelle retsakter, der er vedtaget i henhold til artikel 91
e)
at give medlemsstaternes kompetente myndigheder og Kommissionen mulighed for at varetage deres opgaver i forbindelse med denne forordning på et velinformeret grundlag og at øge samarbejdet mellem dem.
2.   Eudamed skal omfatte følgende elektroniske systemer:
a)
det elektroniske system for registrering af udstyr, jf. artikel 29, stk. 4
b)
UDI-databasen, jf. artikel 28
c)
det elektroniske system for registrering af erhvervsdrivende, jf. artikel 30
d)
det elektroniske system for bemyndigede organer og certifikater, jf. artikel 57
e)
det elektroniske system for kliniske afprøvninger, jf. artikel 73
f)
det elektroniske system til sikkerhedsovervågning og overvågning, efter at udstyret er bragt i omsætning, jf. artikel 92
g)
det elektroniske system for markedsovervågning, jf. artikel 100.
3.   Ved design af Eudamed skal Kommissionen tage behørigt hensyn til forenelighed med nationale databaser og nationale webgrænseflader for at tillade import og eksport af data.
4.   Dataene skal indføres i Eudamed af medlemsstaterne, bemyndigede organer, erhvervsdrivende og sponsorer som fastlagt i bestemmelserne om de elektroniske systemer i stk. 2. Kommissionen sørger for teknisk og administrativ støtte til brugerne af Eudamed.
5.   Alle oplysninger, der indsamles og behandles af Eudamed, skal være tilgængelige for medlemsstaterne og Kommissionen. Oplysningerne skal være tilgængelige for bemyndigede organer, erhvervsdrivende, sponsorer og offentligheden i et omfang, der er angivet i de bestemmelser om elektroniske systemer, der er omhandlet i stk. 2.
Kommissionen sørger for, at de offentligt tilgængelige dele af Eudamed vises i et brugervenligt format, der er nemt at søge i.
6.   Eudamed skal kun indeholde personoplysninger i det omfang, det er nødvendigt, for at de elektroniske systemer, der er omhandlet i denne artikels stk. 2, kan indsamle og behandle oplysninger i overensstemmelse med denne forordning. Personoplysninger skal opbevares på en sådan måde, at det ikke er muligt at identificere registrerede i længere tidsrum end dem, der er nævnt i artikel 10, stk. 8.
7.   Kommissionen og medlemsstaterne sikrer, at registrerede på effektiv vis kan udøve deres ret til indsigt i, berigtigelse af og indsigelse mod deres personoplysninger i overensstemmelse med henholdsvis forordning (EF) nr. 45/2001 og direktiv 95/46/EF. De sikrer også, at registrerede på effektiv vis kan udøve retten til at få adgang til deres oplysninger og retten til at få ukorrekte eller ufuldstændige oplysninger berigtiget og slettet. Inden for deres respektive ansvarsområder sikrer Kommissionen og medlemsstaterne, at ukorrekte og ulovligt behandlede oplysninger slettes i overensstemmelse med den gældende lovgivning. Berigtigelser og sletninger skal foretages så hurtigt som muligt og senest 60 dage efter, at en registreret har anmodet herom.
8.   Kommissionen fastsætter ved hjælp af gennemførelsesretsakter de nærmere bestemmelser, der er nødvendige for oprettelse og vedligeholdelse af Eudamed. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3. Når Kommissionen vedtager disse gennemførelsesretsakter, sikrer den, at systemet så vidt muligt udvikles på en sådan måde, at det undgås, at samme oplysninger skal indføres to gange inden for samme modul eller i forskellige moduler i systemet.
9.   Med hensyn til Kommissionens ansvar i henhold til denne artikel og behandlingen af personoplysninger i forbindelse hermed betragtes Kommissionen som registeransvarlig for Eudamed og dets elektroniske systemer.
Artikel 34
Eudameds funktionsdygtighed
1.   Kommissionen udarbejder i samarbejde med MDCG funktionsspecifikationerne for Eudamed. Kommissionen udarbejder en plan for gennemførelsen af disse specifikationer senest den 26. maj 2018. Denne plan har til formål at sikre, at Eudamed er fuldt funktionsdygtig på en dato, der gør det muligt for Kommissionen at offentliggøre den meddelelse, som er omhandlet i denne artikels stk. 3, senest den 25. marts 2020, og at alle andre relevante frister, der er fastsat i artikel 123 i denne forordning og i artikel 113 i forordning (EU) 2017/746, er opfyldt.
2.   På grundlag af en uafhængig revisionsrapport underretter Kommissionen MDCG, når den har verificeret, at Eudamed har opnået fuld funktionsdygtighed, og at Eudamed opfylder de funktionsspecifikationer, der er udarbejdet i henhold til stk. 1.
3.   Kommissionen skal efter høring af MDCG, og når den har sikret sig, at de i stk. 2 nævnte betingelser er opfyldt, offentliggøre en meddelelse herom i 
Den Europæiske Unions Tidende
.
KAPITEL IV
BEMYNDIGEDE ORGANER
Artikel 35
Myndigheder med ansvar for bemyndigede organer
1.   Enhver medlemsstat, der har til hensigt at udpege et overensstemmelsesvurderingsorgan som bemyndiget organ, eller som har udpeget et bemyndiget organ til at udføre overensstemmelsesvurderingsaktiviteter i henhold til denne forordning, skal udpege en myndighed (»myndigheden med ansvar for bemyndigede organer«), der kan være sammensat af separate enheder i henhold til national ret, og som er ansvarlig for at indføre og gennemføre de nødvendige procedurer for vurdering, udpegelse og notifikation af overensstemmelsesvurderingsorganer og for tilsyn med bemyndigede organer, herunder disse organers underentreprenører og dattervirksomheder.
2.   Myndigheden med ansvar for bemyndigede organer skal være oprettet, organiseret og arbejde på en sådan måde, at der i dens arbejde sikres objektivitet og uvildighed, og at der undgås eventuelle interessekonflikter med overensstemmelsesvurderingsorganer.
3.   Myndigheden med ansvar for bemyndigede organer skal være organiseret på en sådan måde, at alle beslutninger om udpegelse eller notifikation træffes af personer, der ikke er identiske med dem, der foretog vurderingen.
4.   Myndigheden med ansvar for bemyndigede organer må ikke udføre aktiviteter, som udføres af bemyndigede organer på kommercielt eller konkurrencemæssigt grundlag.
5.   Myndigheden med ansvar for bemyndigede organer skal sikre de fortrolige aspekter af de indhentede oplysninger. Den skal dog udveksle oplysninger om bemyndigede organer med de øvrige medlemsstater, Kommissionen og, når det er påkrævet, med andre reguleringsmyndigheder.
6.   Myndigheden med ansvar for bemyndigede organer skal råde over et antal kompetente ansatte, der er permanent tilgængelige, for at den kan varetage sine opgaver behørigt.
Hvis myndigheden med ansvar for bemyndigede organer er en anden myndighed end den nationale kompetente myndighed for medicinsk udstyr, sikrer den, at den nationale myndighed med ansvar for medicinsk udstyr høres om relevante forhold.
7.   Medlemsstaterne offentliggør generelle oplysninger om deres foranstaltninger gældende for vurdering, udpegelse og notifikation af overensstemmelsesvurderingsorganer og for tilsyn med bemyndigede organer og om ændringer, som har betydelig indvirkning på sådanne opgaver.
8.   Myndigheden med ansvar for bemyndigede organer deltager i de peer review-aktiviteter, der er fastsat i artikel 48.
Artikel 36
Krav vedrørende bemyndigede organer
1.   Bemyndigede organer udfører de opgaver, som de er udpeget til i henhold til denne forordning. De skal opfylde de organisatoriske og generelle krav samt de kvalitetsstyrings-, ressource- og procedurekrav, der er nødvendige for at kunne udføre disse opgaver. Bemyndigede organer skal navnlig opfylde kravene i bilag VII.
For at kunne opfylde kravene i første afsnit skal bemyndigede organer til enhver tid råde over tilstrækkeligt administrativt, teknisk og videnskabeligt personale i overensstemmelse med bilag VII, punkt 3.1.1, og personale med relevant klinisk ekspertise i overensstemmelse med bilag VII, punkt 3.2.4, som det bemyndigede organ om muligt selv har ansat.
Det personale, der er nævnt i bilag VII, punkt 3.2.3 og 3.2.7, skal være ansat af selve det bemyndigede organ og må ikke være eksterne eksperter eller underentreprenører.
2.   Bemyndigede organer skal stille al relevant dokumentation til rådighed og på anmodning forelægge denne, herunder fabrikantens dokumentation, for myndigheden med ansvar for bemyndigede organer, så den kan udføre sine vurderings-, udpegelses-, notifikations-, tilsyns- og overvågningsaktiviteter og fremme vurderingen som anført i dette kapitel.
3.   For at sikre ensartet anvendelse af kravene i bilag VII kan Kommissionen vedtage gennemførelsesretsakter i det omfang, det er nødvendigt for at løse spørgsmål vedrørende forskellige fortolkninger og praktisk anvendelse. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 37
Dattervirksomheder og underentreprise
1.   Hvis et bemyndiget organ giver bestemte opgaver i forbindelse med overensstemmelsesvurderingen i underentreprise eller anvender en dattervirksomhed til bestemte opgaver i forbindelse med overensstemmelsesvurdering, skal det verificere, at underentreprenøren eller dattervirksomheden opfylder de gældende krav i bilag VII, og underrette myndigheden med ansvar for bemyndigede organer herom.
2.   De bemyndigede organer har det fulde ansvar for de opgaver, der på deres vegne udføres af underentreprenører eller dattervirksomheder.
3.   Bemyndigede organer offentliggør en liste over deres dattervirksomheder.
4.   Overensstemmelsesvurderingsaktiviteter må kun gives i underentreprise eller udføres af en dattervirksomhed, hvis den juridiske eller fysiske person, der anmodede om en overensstemmelsesvurdering, er blevet underrettet herom.
5.   De bemyndigede organer skal kunne stille alle de relevante dokumenter vedrørende verifikationen af underentreprenørens eller dattervirksomhedens kvalifikationer og det arbejde, som de har udført i henhold til denne forordning, til rådighed for myndigheden med ansvar for bemyndigede organer.
Artikel 38
Ansøgning om udpegelse fra overensstemmelsesvurderingsorganer
1.   Overensstemmelsesvurderingsorganer skal indgive ansøgning om udpegelse til myndigheden med ansvar for bemyndigede organer.
2.   Ansøgningen skal angive de overensstemmelsesvurderingsaktiviteter som defineret i denne forordning og de typer af udstyr, som organet ansøger om udpegelse for, og skal være ledsaget af dokumentation, der godtgør overholdelse af bilag VII.
For så vidt angår de organisatoriske og generelle krav og de kvalitetsstyringskrav, der er fastsat i bilag VII, punkt 1 og 2, kan et gyldigt akkrediteringscertifikat og den tilsvarende evalueringsrapport fra et nationalt akkrediteringsorgan i henhold til forordning (EF) nr. 765/2008 forelægges og skal tages i betragtning under den evaluering, der er beskrevet i artikel 39. Ansøgeren skal imidlertid på anmodning stille al den dokumentation, der er omhandlet i første afsnit, til rådighed for at godtgøre opfyldelse af disse krav.
3.   Det bemyndigede organ opdaterer den i stk. 2 omhandlede dokumentation, når der opstår relevante ændringer, så myndigheden med ansvar for bemyndigede organer har mulighed for at føre tilsyn med og verificere, at alle kravene i bilag VII fortsat opfyldes.
Artikel 39
Vurdering af ansøgningen
1.   Myndigheden med ansvar for bemyndigede organer kontrollerer inden for 30 dage, at den i artikel 38 omhandlede ansøgning er fuldstændig, og anmoder ansøgeren om at indsende eventuelle manglende oplysninger. Når ansøgningen er fuldstændig, sender denne myndighed den til Kommissionen.
Myndigheden med ansvar for bemyndigede organer gennemgår ansøgningen og den ledsagende dokumentation i henhold til sine egne procedurer og udarbejder en foreløbig vurderingsrapport.
2.   Myndigheden med ansvar for bemyndigede organer forelægger den foreløbige vurderingsrapport for Kommissionen, som straks videresender den til MDCG.
3.   Senest 14 dage efter forelæggelsen, jf. denne artikels stk. 2, udpeger Kommissionen sammen med MDCG et fælles vurderingshold, der består af tre eksperter, medmindre de særlige omstændigheder kræver et andet antal eksperter, som udvælges fra den i artikel 40, stk. 2, anførte liste. En af eksperterne skal være repræsentant for Kommissionen, der skal koordinere det fælles vurderingsholds aktiviteter. De to andre eksperter skal komme fra andre medlemsstater end den, hvor det ansøgende overensstemmelsesvurderingsorgan er etableret.
Det fælles vurderingshold skal bestå af eksperter, som er kompetente til at vurdere de overensstemmelsesvurderingsaktiviteter og de typer af udstyr, som ansøgningen vedrører, eller, navnlig hvis vurderingsproceduren iværksættes i henhold til artikel 47, stk. 3, for at sikre, at de specifikke betænkeligheder kan vurderes korrekt.
4.   Senest 90 dage efter udpegelsen af det fælles vurderingshold gennemgår det den dokumentation, der er forelagt sammen med ansøgningen i overensstemmelse med artikel 38. Det fælles vurderingshold kan give feedback til eller anmode om afklaring fra myndigheden med ansvar for bemyndigede organer vedrørende ansøgningen og den planlagte vurdering på stedet.
Myndigheden med ansvar for bemyndigede organer og det fælles vurderingshold planlægger og foretager sammen en vurdering på stedet af det ansøgende overensstemmelsesvurderingsorgan og, hvor det er relevant, af datterselskaber eller underentreprenører i eller uden for Unionen, som skal være omfattet af overensstemmelsesvurderingsprocessen.
Vurderingen på stedet af det ansøgende organ ledes af myndigheden med ansvar for bemyndigede organer.
5.   Resultater vedrørende et ansøgende overensstemmelsesvurderingsorgans manglende opfyldelse af kravene i bilag VII skal tages op i vurderingsprocessen og drøftes mellem myndigheden med ansvar for bemyndigede organer og det fælles vurderingshold med henblik på at nå til enighed og finde en løsning på eventuelle afvigende opfattelser med hensyn til vurdering af ansøgningen.
Ved afslutningen af vurderingen på stedet forelægger myndigheden med ansvar for bemyndigede organer en liste for det ansøgende overensstemmelsesvurderingsorgan med den manglende opfyldelse af kravene som følge af vurderingen og sammenfatter det fælles vurderingsholds vurdering.
Inden for en fastsat tidsramme skal det ansøgende overensstemmelsesvurderingsorgan forelægge en korrigerende og forebyggende handlingsplan for den nationale myndighed for at afhjælpe den manglende opfyldelse af kravene.
6.   Det fælles vurderingshold dokumenterer eventuelle udestående afvigende opfattelser for så vidt angår vurderingen senest 30 dage efter afslutningen af vurderingen på stedet og sender dem til myndigheden med ansvar for bemyndigede organer.
7.   Myndigheden med ansvar for bemyndigede organer vurderer efter modtagelse af en korrigerende og forebyggende handlingsplan fra det ansøgende organ, om den manglende opfyldelse af kravene, der blev identificeret under vurderingen, er blevet afhjulpet på passende vis. Denne plan skal angive hovedårsagen til den konstaterede manglende opfyldelse af kravene og skal omfatte en tidsramme for gennemførelse af handlingerne i den.
Myndigheden med ansvar for bemyndigede organer fremsender efter sin bekræftelse af den korrigerende og forebyggende handlingsplan planen og sin udtalelse herom til det fælles vurderingshold. Det fælles vurderingshold kan anmode myndigheden med ansvar for bemyndigede organer om yderligere afklaring og ændringer.
Myndigheden med ansvar for bemyndigede organer udarbejder sin endelige vurderingsrapport, som skal indeholde:
—
resultatet af vurderingen
—
en bekræftelse af, at de korrigerende og forebyggende handlinger er blevet behandlet og om nødvendigt gennemført på passende vis
—
eventuelle udestående afvigende opfattelser i forhold til det fælles vurderingshold og i givet fald
—
de anbefalede rammer for udpegelsen.
8.   Myndigheden med ansvar for bemyndigede organer forelægger sin endelige vurderingsrapport og i givet fald udkastet til udpegelse for Kommissionen, MDCG og det fælles vurderingshold.
9.   Det fælles vurderingshold afgiver en endelig udtalelse om vurderingsrapporten, som myndigheden med ansvar for bemyndigede organer har udarbejdet, og i givet fald udkastet til udpegelse til Kommissionen senest 21 dage efter modtagelsen af disse dokumenter, og Kommissionen fremsender straks denne endelige udtalelse til MDCG. Senest 42 dage efter modtagelsen af udtalelsen fra det fælles vurderingshold udsteder MDCG en anbefaling med hensyn til udkastet til udpegelse, som myndigheden med ansvar for bemyndigede organer skal tage behørigt hensyn til i sin afgørelse om udpegelse af det bemyndigede organ.
10.   Kommissionen kan ved gennemførelsesretsakter vedtage foranstaltninger, der fastsætter de nærmere bestemmelser for procedurerne og rapporterne vedrørende ansøgningen om udpegelse, jf. artikel 38, og vurderingen af ansøgningen, der er fastsat i denne artikel. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 40
Udnævnelse af eksperter til fælles vurdering af ansøgninger om notifikation
1.   Medlemsstaterne og Kommissionen udnævner eksperter, som er kvalificerede til at vurdere overensstemmelsesvurderingsorganer på området for medicinsk udstyr, til at deltage i de aktiviteter, der er omhandlet i artikel 39 og 48.
2.   Kommissionen fører en liste over de eksperter, som er udnævnt i medfør af denne artikels stk. 1, sammen med oplysninger om deres specifikke kompetence- og ekspertiseområde. Denne liste stilles til rådighed for medlemsstaternes kompetente myndigheder ved hjælp af det elektroniske system, der er omhandlet i artikel 57.
Artikel 41
Sprogkrav
Alle de dokumenter, der kræves i henhold til artikel 38 og 39, udarbejdes på et eller flere sprog, der fastsættes af den berørte medlemsstat.
Ved anvendelsen af stk. 1 skal medlemsstaterne overveje at acceptere og anvende et sprog, som er almindeligt forstået på det medicinske område, til hele eller en del af den pågældende dokumentation.
Kommissionen sørger for oversættelse af dokumentationen i henhold til artikel 38 og 39, eller dele heraf, til et officielt EU-sprog, for så vidt det er nødvendigt, for at denne dokumentation let kan forstås af det fælles vurderingshold, der er udpeget i henhold til artikel 39, stk. 3.
Artikel 42
Udpegelses- og notifikationsprocedure
1.   Medlemsstaterne må kun udpege overensstemmelsesvurderingsorganer, for hvilke vurderingen i henhold til artikel 39 er fuldført, og som opfylder kravene i bilag VII.
2.   Medlemsstaterne underretter Kommissionen og de øvrige medlemsstater om de overensstemmelsesvurderingsorganer, som de har udpeget, ved hjælp af det elektroniske notifikationsværktøj i databasen over bemyndigede organer (NANDO), der er udviklet og forvaltes af Kommissionen.
3.   Notifikationen skal ved hjælp af de koder, der er omhandlet i denne artikels stk. 13, klart præcisere rammerne for udpegelsen med angivelse af overensstemmelsesvurderingsaktiviteterne som defineret i denne forordning og de typer af udstyr, som det bemyndigede organ er bemyndiget til at vurdere og eventuelle betingelser i forbindelse med udpegelsen, jf. dog artikel 44.
4.   Notifikationen skal ledsages af den endelige vurderingsrapport fra myndigheden med ansvar for bemyndigede organer, den endelige udtalelse fra det fælles vurderingshold som omhandlet i artikel 39, stk. 9, og henstillingen fra MDCG. Hvis den bemyndigende medlemsstat ikke følger henstillingen fra MDCG, skal den forelægge en behørigt dokumenteret begrundelse herfor.
5.   Uden at dette berører artikel 44, skal den bemyndigende medlemsstat underrette Kommissionen og de øvrige medlemsstater om eventuelle betingelser i forbindelse med udpegelsen og forelægge dokumentation vedrørende de ordninger, der er indført til sikring af, at der regelmæssigt føres tilsyn med det bemyndigede organ, og at organet også fremover vil opfylde de krav, der er fastsat i bilag VII.
6.   Inden for 28 dage efter notifikationen som omhandlet i stk. 2 kan en medlemsstat eller Kommissionen gøre skriftlig indsigelse, hvori de redegør for deres argumenter, mod enten det bemyndigede organ, eller mod det tilsyn, som myndigheden med ansvar for bemyndigede organer fører med det bemyndigede organ. Hvis der ikke gøres indsigelse, offentliggør Kommissionen notifikationen i NANDO senest 42 dage efter at være blevet underrettet om den, jf. stk. 2.
7.   Hvis en medlemsstat eller Kommissionen gør indsigelse i henhold til stk. 6, skal Kommissionen forelægge sagen for MDCG senest 10 dage efter udløbet af den i stk. 6 omhandlede periode. Efter høring af de involverede parter afgiver MDCG udtalelse senest 40 dage, efter at sagen er blevet indbragt for den. Hvis MDCG er af den opfattelse, at notifikationen kan accepteres, offentliggør Kommissionen notifikationen i NANDO inden for 14 dage.
8.   Hvis MDCG efter at være blevet hørt i henhold til stk. 7 bekræfter den eksisterende indsigelse eller gør endnu en indsigelse, giver den bemyndigende medlemsstat et skriftligt svar på udtalelsen fra MDCG senest 40 dage efter modtagelsen. Svaret skal omhandle indsigelserne i udtalelsen og indeholde begrundelsen for den bemyndigende medlemsstats afgørelse om at udpege eller ikke at udpege overensstemmelsesvurderingsorganet.
9.   Hvis den bemyndigende medlemsstat beslutter at fastholde sin afgørelse om udpegelse af overensstemmelsesvurderingsorganet efter at have angivet begrundelsen herfor i henhold til stk. 8, offentliggør Kommissionen notifikationen i NANDO senest 14 dage efter at være blevet underrettet om den.
10.   Når Kommissionen offentliggør notifikationen i NANDO, tilføjer den også oplysningerne vedrørende notifikation af det bemyndigede organ i det elektroniske system, der er omhandlet i artikel 57, sammen med de dokumenter, der er nævnt i nærværende artikels stk. 4, og udtalelsen og svarene, der er omhandlet i nærværende artikels stk. 7 og 8.
11.   Udpegelsen træder i kraft dagen efter, at notifikationen er blevet offentliggjort i NANDO. Den offentliggjorte notifikation angiver omfanget af det bemyndigede organs lovlige overensstemmelsesvurderingsaktiviteter.
12.   Det pågældende overensstemmelsesvurderingsorgan kan først udføre et bemyndiget organs aktiviteter, efter at udpegelsen er trådt i kraft i overensstemmelse med stk. 11.
13.   Kommissionen udarbejder senest 26. november 2017 ved hjælp af gennemførelsesretsakter en liste over koder og tilsvarende typer af udstyr med henblik på at præcisere rammerne for udpegelsen af bemyndigede organer. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3. Kommissionen kan efter samråd med MDCG opdatere denne liste på grundlag af blandt andet oplysninger som følge af de koordineringsaktiviteter, der er beskrevet i artikel 48.
Artikel 43
Identifikationsnummer for og liste over bemyndigede organer
1.   Kommissionen tildeler et identifikationsnummer til hvert bemyndiget organ, som notifikationen træder i kraft for i overensstemmelse med artikel 42, stk. 11. Den tildeler kun ét identifikationsnummer, også selv om organet er bemyndiget i henhold til flere EU-retsakter. Hvis de med positivt udfald er blevet udpeget i henhold til denne forordning, bevarer organer, der er bemyndiget i henhold til direktiv 90/385/EØF og 93/42/EØF, det identifikationsnummer, som de har fået tildelt i henhold til disse direktiver.
2.   Kommissionen offentliggør i NANDO en liste over organer, der er bemyndiget i henhold til denne forordning, herunder de identifikationsnumre, som de er blevet tildelt, og de overensstemmelsesvurderingsaktiviteter, som er defineret i denne forordning og de typer af udstyr, til hvilke de er bemyndiget. Den offentliggør også listen i det elektroniske system, der er omhandlet i artikel 57. Kommissionen holder listen opdateret.
Artikel 44
Tilsyn med og vurdering af bemyndigede organer
1.   Bemyndigede organer skal straks og senest inden for 15 dage underrette myndigheden med ansvar for bemyndigede organer om relevante ændringer, der kan påvirke overensstemmelsen med de krav, som er fastsat i bilag VII, eller deres evne til at gennemføre overensstemmelsesvurderingsaktiviteterne vedrørende det udstyr, som de er blevet udpeget til.
2.   Myndighederne med ansvar for de bemyndigede organer fører tilsyn med de bemyndigede organer, der er etableret på deres område, og disses dattervirksomheder og underentreprenører for at sikre, at de til stadighed opfylder de krav og forpligtelser, der er fastsat i denne forordning. Bemyndigede organer forelægger efter anmodning fra deres myndighed med ansvar for bemyndigede organer alle de relevante oplysninger og dokumenter, der er nødvendige for, at myndigheden, Kommissionen og andre medlemsstater kan verificere overensstemmelse.
3.   Hvis Kommissionen eller en medlemsstats myndighed indgiver en anmodning til et bemyndiget organ, der er etableret på en anden medlemsstats område, vedrørende en overensstemmelsesvurdering, som dette bemyndigede organ har udført, sender den en kopi af anmodningen til den anden medlemsstats myndighed med ansvar for bemyndigede organer. Det pågældende bemyndigede organ skal straks og senest inden for 15 dage besvare anmodningen. Myndigheden med ansvar for bemyndigede organer skal sørge for, at der det bemyndigede organ følges op på forespørgsler fra myndighederne i en anden medlemsstat eller fra Kommissionen, medmindre der er en legitim grund til ikke at gøre det, i hvilket tilfælde sagen kan henvises til MDCG.
4.   Mindst en gang om året skal myndighederne med ansvar for bemyndigede organer på ny vurdere, om de bemyndigede organer, der er etableret på deres respektive område, og, hvis det er relevant, de dattervirksomheder og underentreprenører, der hører under disse bemyndigede organers ansvar, stadig opfylder kravene og deres forpligtelser, jf. bilag VII. Denne gennemgang skal omfatte en audit på stedet af hvert bemyndiget organ og om nødvendigt af dets dattervirksomheder og underentreprenører.
Den nationale myndighed med ansvar for bemyndigede organer skal udføre sine tilsyns- og vurderingsaktiviteter i henhold til en årlig plan for vurdering for at sikre, at den effektivt kan føre tilsyn med det bemyndigede organs fortsatte overholdelse af kravene i denne forordning. Denne plan skal indeholde en begrundet oversigt over, hvor hyppigt det bemyndigede organ og navnlig tilknyttede dattervirksomheder og underentreprenører skal vurderes. Myndigheden forelægger sin årlige plan for tilsyn med eller vurdering af hvert bemyndiget organ, som den er ansvarlig for, for MDCG og for Kommissionen.
5.   Det tilsyn med bemyndigede organer, som udføres af myndigheden med ansvar for bemyndigede organer, skal omfatte en observeret audit af det bemyndigede organs personale, herunder om nødvendigt dattervirksomheders og underentreprenørers personale, når dette personel er i gang med at gennemføre vurderinger af kvalitetsstyringssystemet på en fabrikants anlæg.
6.   Tilsyn med af bemyndigede organer, som udføres af myndigheden med ansvar for bemyndigede organer, skal tage hensyn til data fra markedsovervågning, sikkerhedsovervågning og overvågning, efter at udstyret er bragt i omsætning, som kan være med til at styre deres aktiviteter.
Myndigheden med ansvar for bemyndigede organer skal sørge for en systematisk opfølgning af klager og anden information, herunder fra andre medlemsstater, som kan tyde på, at et bemyndiget organ ikke har overholdt sine forpligtelser eller har fraveget fælles eller bedste praksis.
7.   Myndigheden med ansvar for bemyndigede organer kan i tillæg til det regelmæssige tilsyn eller vurderinger på stedet foretage gennemgange med kort varsel, uden varsel eller af en bestemt årsag, hvis det er nødvendigt for at afhjælpe et bestemt problem eller verificere overensstemmelse.
8.   Myndigheden med ansvar for bemyndigede organer skal evaluere de bemyndigede organers vurderinger af fabrikanternes tekniske dokumentation, navnlig dokumentationen vedrørende klinisk evaluering som nærmere beskrevet i artikel 45.
9.   Myndigheden med ansvar for bemyndigede organer dokumenterer og registrerer alle konklusioner vedrørende det bemyndigede organs manglende overholdelse af kravene i bilag VII og fører tilsyn med den rettidige gennemførelse af korrigerende og forebyggende handlinger.
10.   Tre år efter notifikationen af et bemyndiget organ, og derefter hvert fjerde år, skal en fuldstændig fornyet vurdering af, om det bemyndigede organ fortsat opfylder kravene i bilag VII, foretages af myndigheden med ansvar for bemyndigede organer i den medlemsstat, hvori organet er etableret, og af et fælles vurderingshold, der er udpeget med henblik på proceduren i artikel 38 og 39.
11.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for at ændre stk. 10 med henblik på at ændre den hyppighed, hvormed de fuldstændige fornyede vurderinger, der er omhandlet i dette stykke, skal foretages.
12.   Medlemsstaterne aflægger mindst en gang om året rapport til Kommissionen og MDCG om deres tilsynsaktiviteter og vurderingsaktiviteter på stedet vedrørende bemyndigede organer og eventuelt dattervirksomheder og underentreprenører. Rapporten beskriver udførligt resultatet af disse aktiviteter, herunder aktiviteterne i henhold til stk. 7, og behandles fortroligt af MDCG og Kommissionen, men skal dog indeholde en sammenfatning, som gøres offentligt tilgængelig.
Sammenfatningen af rapporten indlæses i det elektroniske system, der er omhandlet i artikel 57.
Artikel 45
Gennemgang af det bemyndigede organs vurdering af den tekniske dokumentation og dokumentation vedrørende kliniske evalueringer
1.   Myndigheden med ansvar for bemyndigede organer skal som led i sit løbende tilsyn med bemyndigede organer evaluere et passende antal af det bemyndigede organs vurderinger af fabrikanternes tekniske dokumentation, navnlig den i bilag II, punkt 6.1, litra d) og c), omhandlede dokumentation vedrørende klinisk evaluering for at verificere konklusionerne fra det bemyndigede organ på grundlag af de oplysninger, som fabrikanten har forelagt. Den evaluering, som myndigheden med ansvar for bemyndigede organer foretager, skal udføres både eksternt og på stedet.
2.   De stikprøver, der skal evalueres i henhold til stk. 1, skal være planlagte og repræsentative for de typer af og risici ved udstyr, der certificeres af det bemyndigede organ, navnlig højrisikoudstyr, og være behørigt begrundet og dokumenteret i en stikprøveplan, som myndigheden med ansvar for bemyndigede organer stiller til rådighed for MDCG efter anmodning.
3.   Myndigheden med ansvar for bemyndigede organer vurderer, om det bemyndigede organs evaluering er udført korrekt, og kontrollerer de anvendte procedurer, den tilhørende dokumentation og konklusionerne fra det bemyndigede organ. Sådan kontrol omfatter fabrikantens tekniske dokumentation og dokumentation vedrørende kliniske evalueringer, som det bemyndigede organ har baseret sin vurdering på. Sådanne evalueringer skal udføres ved brug af fælles specifikationer.
4.   Disse evalueringer skal også indgå som led i den fornyede vurdering af bemyndigede organer i overensstemmelse med artikel 44, stk. 10, og de fælles vurderingsaktiviteter i artikel 47, stk. 3. Disse evalueringer skal udføres ved at benytte passende ekspertise.
5.   MDCG kan på grundlag af rapporterne om evalueringer og vurderinger udført af myndigheden med ansvar for bemyndigede organer eller de fælles vurderingshold, input fra aktiviteterne vedrørende markedsovervågning, sikkerhedsovervågning og overvågning, efter at udstyret er bragt i omsætning, som beskrevet i kapitel VII, den løbende monitorering af den tekniske udvikling, eller identificeringen af betænkeligheder og nye spørgsmål vedrørende udstyrs sikkerhed og ydeevne henstille til, at den stikprøve, der foretages i henhold til denne artikel, dækker en større eller mindre del af den tekniske dokumentation og dokumentationen vedrørende klinisk evaluering, som et bemyndiget organ har vurderet.
6.   Kommissionen kan ved gennemførelsesretsakter vedtage foranstaltninger, der fastsætter de nærmere ordninger og tilhørende dokumenter for samt koordinering af evaluering af vurderingerne af dokumentationen for de tekniske og kliniske vurderinger, jf. denne artikel. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 46
Ændringer af udpegelser og notifikationer
1.   Myndigheden med ansvar for bemyndigede organer skal underrette Kommissionen og de øvrige medlemsstater om enhver relevant ændring af udpegelsen af et bemyndiget organ.
Procedurerne i artikel 39 og artikel 42 finder anvendelse på udvidelser af rammerne for udpegelsen.
Med hensyn til andre ændringer af udpegelsen end udvidelser af rammerne for den, finder procedurerne i de følgende stykker anvendelse.
2.   Kommissionen skal straks offentliggøre den ændrede notifikation i NANDO. Kommissionen indfører straks oplysninger om ændringer af det bemyndigede organs udpegelse i det elektroniske system, der er omhandlet i artikel 57.
3.   Hvis et bemyndiget organ beslutter at indstille sine overensstemmelsesvurderingsaktiviteter, underretter det myndigheden med ansvar for bemyndigede organer og de pågældende fabrikanter hurtigst muligt og i tilfælde af planlagt indstilling ét år, inden dets aktiviteter indstilles. Certifikaterne kan forblive gyldige i en midlertidig periode på ni måneder, efter at det bemyndigede organs aktiviteter er indstillet, forudsat at et andet bemyndiget organ skriftligt har bekræftet, at det vil påtage sig ansvaret for det udstyr, der er omfattet af disse certifikater. Det nye bemyndigede organ foretager en fuld vurdering af det berørte udstyr inden udgangen af denne periode, før det udsteder nye certifikater for dette udstyr. Hvis det bemyndigede organ har indstillet sine aktiviteter, skal myndigheden med ansvar for bemyndigede organer tilbagekalde udpegelsen.
4.   Hvis en myndighed med ansvar for bemyndigede organer har konstateret, at et bemyndiget organ ikke længere opfylder kravene i bilag VII, eller at det ikke opfylder sine forpligtelser eller ikke har gennemført de nødvendige korrigerende foranstaltninger, skal myndigheden suspendere, begrænse eller helt eller delvis tilbagekalde udpegelsen, afhængigt af i hvor alvorlig grad det bemyndigede organ ikke opfylder disse krav eller forpligtelser. En suspension må ikke vare længere end et år og kan forlænges én gang med yderligere et år.
Myndigheden med ansvar for bemyndigede organer skal straks underrette Kommissionen og de øvrige medlemsstater om enhver suspension, begrænsning eller tilbagekaldelse af en udpegelse.
5.   Hvis et bemyndiget organs udpegelse er blevet suspenderet, begrænset eller helt eller delvist tilbagekaldt, underretter dette organ de pågældende fabrikanter inden for senest 10 dage.
6.   Hvis en udpegelse begrænses, suspenderes eller tilbagekaldes, skal myndigheden med ansvar for bemyndigede organer tage hensigtsmæssige skridt til at sikre, at det pågældende bemyndigede organs dokumenter opbevares, og stille dem til rådighed for myndigheder i andre medlemsstater med ansvar for bemyndigede organer og for myndigheder med ansvar for markedsovervågning på disses anmodning.
7.   Hvis en udpegelse begrænses, suspenderes eller tilbagekaldes, skal myndigheden med ansvar for bemyndigede organer:
a)
vurdere indvirkningen på certifikater, der er udstedt af det bemyndigede organ
b)
forelægge en rapport om sine resultater til Kommissionen og de øvrige medlemsstater senest tre måneder efter, at den har givet meddelelse om ændringerne af udpegelsen
c)
pålægge det bemyndigede organ at suspendere eller tilbagekalde alle certifikater, der uretmæssigt er blevet udstedt, inden for en rimelig tidsfrist, der fastsættes af myndigheden, for at sikre beskyttelsen af udstyr på markedet
d)
i det elektroniske system, der er omhandlet i artikel 57, indføre oplysninger vedrørende certifikater, som den har krævet suspenderet eller tilbagekaldt
e)
underrette den kompetente myndighed for medicinsk udstyr i den medlemsstat, hvor fabrikanten har sit registrerede forretningssted, gennem det elektroniske system, der er omhandlet i artikel 57, om de certifikater, som den har krævet suspenderet eller tilbagekaldt. Den kompetente myndighed træffer de fornødne foranstaltninger, hvis det er nødvendigt for at undgå en potentiel risiko for patienters, brugeres eller andre personers sundhed eller sikkerhed.
8.   Med undtagelse af uretmæssigt udstedte certifikater og tilfælde, hvor en udpegelse er blevet suspenderet eller begrænset, vedbliver certifikaterne med at være gyldige i følgende tilfælde:
a)
myndigheden med ansvar for bemyndigede organer har senest én måned efter suspensionen eller begrænsningen bekræftet, at der ikke er noget sikkerhedsproblem vedrørende certifikater, der er berørt af suspensionen eller begrænsningen og myndigheden med ansvar for bemyndigede organer har angivet en frist og forventede foranstaltninger til at afhjælpe suspensionen eller begrænsningen, eller
b)
myndigheden med ansvar for bemyndigede organer har bekræftet, at ingen certifikater af relevans for suspensionen vil blive udstedt, ændret eller genudstedt under suspensionen eller begrænsningen, og anfører, hvorvidt det bemyndigede organ har kapacitet til at fortsætte med at føre tilsyn med og fortsat være ansvarligt for eksisterende udstedte certifikater i suspensions- eller begrænsningsperioden. Hvis myndigheden med ansvar for bemyndigede organer afgør, at det bemyndigede organ ikke har kapacitet til at støtte eksisterende udstedte certifikater, skal fabrikanten senest tre måneder efter suspensionen eller begrænsningen skriftligt bekræfte over for den kompetente myndighed for medicinsk udstyr i den medlemsstat, hvor fabrikanten af det udstyr, der er omfattet af certifikatet, har sit registrerede forretningssted, at et andet kvalificeret bemyndiget organ midlertidigt varetager det bemyndigede organs funktioner med hensyn til at føre tilsyn med og fortsat være ansvarligt for certifikaterne i suspensions- eller begrænsningsperioden.
9.   Med undtagelse af uretmæssigt udstedte certifikater og tilfælde, hvor en udpegelse er blevet tilbagekaldt, vedbliver certifikaterne med at være gyldige i ni måneder i følgende tilfælde:
a)
hvis den kompetente myndighed for medicinsk udstyr i den medlemsstat, hvor fabrikanten af det udstyr, der er omfattet af certifikaterne, har sit registrerede forretningssted, har bekræftet, at der ikke er noget sikkerhedsproblem forbundet med det pågældende udstyr, og
b)
et andet bemyndiget organ skriftligt har bekræftet, at det straks varetager ansvaret for dette udstyr og vil have færdiggjort vurderingen af det inden 12 måneder efter tilbagekaldelse af udpegelsen.
Under de omstændigheder, der er omhandlet i første afsnit, kan den kompetente myndighed for medicinsk udstyr i den medlemsstat, hvor fabrikanten af det udstyr, der er omfattet af certifikatet, har sit registrerede forretningssted, forlænge certifikaternes foreløbige gyldighed i yderligere perioder på tre måneder, dog i alt højst 12 måneder.
Den myndighed eller det bemyndigede organ, der har påtaget sig funktionerne for det bemyndigede organ, der er berørt af ændringen af udpegelsen, underretter straks Kommissionen, medlemsstaterne og de øvrige bemyndigede organer herom.
Artikel 47
Anfægtelse af bemyndigede organers kompetence
1.   Kommissionen undersøger sammen med MDCG alle sager, hvor den er blevet gjort opmærksom på betænkeligheder vedrørende et bemyndiget organs, eller en eller flere af dets dattervirksomheders eller underentreprenørers, fortsatte opfyldelse af kravene i bilag VII eller de forpligtelser, der påhviler dem. Den skal sikre, at den relevante myndighed med ansvar for bemyndigede organer underrettes og får mulighed for at undersøge disse betænkeligheder.
2.   Den bemyndigende medlemsstat forelægger efter anmodning Kommissionen alle oplysninger om udpegelsen af det pågældende bemyndigede organ.
3.   Kommissionen kan sammen med MDCG, hvis det er relevant, indlede den vurderingsprocedure, der er beskrevet i artikel 39, stk. 3 og 4, når der er rimelig grund til bekymring for, om et bemyndiget organ eller et bemyndiget organs dattervirksomhed eller underentreprenør til stadighed opfylder kravene i bilag VII, og når undersøgelsen foretaget af myndigheden med ansvar for de bemyndigede organer ikke vurderes at have imødekommet denne bekymring fuldt ud eller efter anmodning fra myndigheden med ansvar for bemyndigede organer. Indrapporteringen og resultatet af denne vurderingsprocedure skal følge principperne i artikel 39. Alternativt kan Kommissionen, afhængigt af hvor alvorligt spørgsmålet er, sammen med MDCG anmode om, at myndigheden med ansvar for bemyndigede organer giver op til to eksperter fra den liste, der er oprettet i henhold til artikel 40, tilladelse til at deltage i en vurdering på stedet som led i de planlagte tilsyns- og vurderingsaktiviteter i overensstemmelse med artikel 44 og som angivet i den årlige vurderingsplan, der er beskrevet i artikel 44, stk. 4.
4.   Hvis Kommissionen konstaterer, at et bemyndiget organ ikke længere opfylder kravene vedrørende dets udpegelse, skal den underrette den bemyndigende medlemsstat herom og anmode den om at træffe de nødvendige korrigerende foranstaltninger, herunder om nødvendigt suspension, begrænsning eller tilbagekaldelse af udpegelsen.
Hvis medlemsstaten ikke træffer de nødvendige korrigerende foranstaltninger, kan Kommissionen ved hjælp af gennemførelsesretsakter suspendere, begrænse eller tilbagekalde udpegelsen. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3. Den underretter den pågældende medlemsstat om sin afgørelse og opdaterer NANDO og det elektroniske system, der er omhandlet i artikel 57.
5.   Kommissionen sikrer, at alle fortrolige oplysninger, som den indhenter som led i sine undersøgelser, behandles i overensstemmelse hermed.
Artikel 48
Peer review og udveksling af erfaringer mellem myndigheder med ansvar for bemyndigede organer
1.   Kommissionen sørger for at organisere udveksling af erfaringer og koordinering af administrativ praksis mellem myndighederne med ansvar for bemyndigede organer. En sådan udveksling skal omfatte elementer som bl.a.:
a)
udarbejdelse af dokumenter om bedste praksis vedrørende aktiviteterne i myndighederne med ansvar for bemyndigede organer
b)
udarbejdelse af dokumenter med vejledning for bemyndigede organer med hensyn til gennemførelsen af denne forordning
c)
eksperternes uddannelse og kvalifikationer, jf. artikel 40
d)
monitorering af tendenser vedrørende ændringer af udpegelser og notifikationer af bemyndigede organer og tendenser med hensyn til tilbagekaldelser af certifikater og overførsler heraf mellem bemyndigede organer
e)
monitorering af anvendelsen og anvendeligheden af koder, der beskriver rammerne, jf. artikel 42, stk. 13
f)
udvikling af en mekanisme til peer review mellem myndigheder og Kommissionen
g)
metoder til kommunikation til offentligheden om myndighedernes og Kommissionens tilsyns- og overvågningsaktiviteter vedrørende bemyndigede organer.
2.   Myndighederne med ansvar for bemyndigede organer deltager i et peer review hvert tredje år ved hjælp af den mekanisme, der er udviklet i henhold til denne artikels stk. 1. Sådanne peer reviews skal normalt gennemføres parallelt med de vurderinger på stedet, der er beskrevet i artikel 39. Alternativt kan en myndighed vælge, at sådanne peer reviews skal finde sted som en del af dens tilsynsaktiviteter, jf. artikel 44.
3.   Kommissionen deltager i tilrettelæggelsen og yder støtte til implementeringen af peer review-mekanismen.
4.   Kommissionen skal udarbejde en årlig sammenfattende rapport for peer review-aktiviteterne, der gøres offentligt tilgængelig.
5.   Kommissionen kan ved hjælp af gennemførelsesretsakter vedtage foranstaltninger, der fastsætter de nærmere bestemmelser og tilhørende dokumenter i forbindelse med peer review-mekanismen og uddannelse og kvalifikationer, jf. denne artikels stk. 1. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 49
Koordinering af bemyndigede organer
Kommissionen sikrer, at der etableres passende koordinering og samarbejde mellem de bemyndigede organer, og at denne koordinering og dette samarbejde fungerer i form af en koordineringsgruppe af bemyndigede organer for medicinsk udstyr, herunder medicinsk udstyr til in vitro-diagnostik. Denne gruppe mødes regelmæssigt og mindst en gang om året.
De organer, der er bemyndiget i henhold til denne forordning, deltager i denne gruppes arbejde.
Kommissionen kan fastsætte nærmere bestemmelser for arbejdet i koordineringsgruppen af bemyndigede organer.
Artikel 50
Liste over standardgebyrer
De bemyndigede organer opstiller lister over deres standardgebyrer for de overensstemmelsesvurderingsaktiviteter, som de udfører, og gør disse lister offentligt tilgængelige.
KAPITEL V
KLASSIFICERING OG OVERENSSTEMMELSESVURDERING
AFDELING 1
Klassificering
Artikel 51
Klassificering af udstyr
1.   Udstyr inddeles i klasse I, IIa, IIb og III under hensyn til udstyrets erklærede formål og de dermed forbundne risici. Klassificeringen foretages i overensstemmelse med bilag VIII.
2.   Enhver tvist mellem fabrikanten og det berørte bemyndigede organ som følge af anvendelsen af bilag VIII forelægges den kompetente myndighed i den medlemsstat, hvor fabrikanten har sit registrerede forretningssted. Hvis fabrikanten ikke har noget registreret forretningssted i Unionen og endnu ikke har udpeget en autoriseret repræsentant, forelægges sagen den kompetente myndighed i den medlemsstat, hvor den autoriserede repræsentant, jf. bilag IX, punkt 2.2, andet afsnit, litra b), har sit registrerede forretningssted. Hvis det bemyndigede organ er etableret i en anden medlemsstat end fabrikantens, træffer den kompetente myndighed sin afgørelse efter høring af den kompetente myndighed i den medlemsstat, der har udpeget det bemyndigede organ.
Den kompetente myndighed i den medlemsstat, hvori fabrikanten har sit registrerede forretningssted, underretter MDCG og Kommissionen om sin afgørelse. Afgørelsen stilles til rådighed efter anmodning.
3.   Efter anmodning fra en medlemsstat træffer Kommissionen efter høring af MDCG afgørelse om følgende ved hjælp af gennemførelsesretsakter:
a)
anvendelsen af bilag VIII på et givet udstyr eller en kategori eller gruppe af udstyr med henblik på at fastslå klassificeringen af det pågældende udstyr
b)
at udstyr eller en kategori eller en gruppe af udstyr skal omklassificeres af hensyn til folkesundheden på grundlag af ny videnskabelig dokumentation eller på grundlag af eventuelle oplysninger, der bliver tilgængelige i forbindelse med sikkerhedsovervågnings- og markedsovervågningsaktiviteter, som en undtagelse fra bilag VIII.
4.   Kommissionen kan også på eget initiativ og efter høring af MDCG ved hjælp af gennemførelsesretsakter træffe afgørelse om spørgsmålene i stk. 3, litra a) og b).
5.   For at sikre en ensartet anvendelse af bilag VIII og under hensyntagen til de relevante videnskabelige udtalelser fra de relevante videnskabelige komitéer kan Kommissionen vedtage gennemførelsesretsakter, i det omfang det er nødvendigt for at løse spørgsmål vedrørende forskellige fortolkninger og den praktiske anvendelse.
6.   Gennemførelsesretsakterne, jf. denne artikels stk. 3, 4 og 5, vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
AFDELING 2
Overensstemmelsesvurdering
Artikel 52
Overensstemmelsesvurderingsprocedurer
1.   Inden udstyr bringes i omsætning, foretager fabrikanten en overensstemmelsesvurdering af udstyret i overensstemmelse med de gældende overensstemmelsesvurderingsprocedurer i bilag IX-XI.
2.   Inden ibrugtagning af udstyr, som ikke bringes i omsætning, foretager fabrikanten en vurdering af udstyrets overensstemmelse med kravene i overensstemmelse med de gældende overensstemmelsesvurderingsprocedurer i bilag IX-XI.
3.   Fabrikanter af udstyr i klasse III, bortset fra udstyr efter mål og udstyr bestemt til afprøvning, skal følge en overensstemmelsesvurdering som omhandlet i bilag IX. Alternativt kan fabrikanten vælge at anvende en overensstemmelsesvurdering som omhandlet i bilag X, kombineret med en overensstemmelsesvurdering som omhandlet i bilag XI.
4.   Fabrikanter af udstyr i klasse IIb, bortset fra udstyr efter mål og udstyr bestemt til afprøvning, skal følge en overensstemmelsesvurderingsprocedure som omhandlet i kapitel I og III i bilag IX, og herunder en vurdering af den tekniske dokumentation som omhandlet i punkt 4 i nævnte bilag af mindst et repræsentativt udstyr pr. generisk gruppe af udstyr.
For implantabelt udstyr i klasse IIb, bortset fra suturer, hæfteklammer, tandfyldninger, tandbøjler, tandkroner, skruer, kiler, plader, tråd, nåle, klemmer og forbindelsesled, skal hvert udstyr dog underkastes en vurdering af den tekniske dokumentation som omhandlet i bilag IX, punkt 4.
Alternativt kan fabrikanten vælge at anvende en overensstemmelsesvurdering baseret på typeafprøvning som omhandlet i bilag X, kombineret med en overensstemmelsesvurdering baseret på produktoverensstemmelsesverifikation som omhandlet i bilag XI.
5.   Hvis det kan begrundes med brug af veletablerede teknologier, der ligner dem, der anvendes i undtaget udstyret på listen i denne artikels stk. 4, andet afsnit, og som anvendes i implantabelt udstyr i klasse IIb, eller hvis det kan begrundes med henblik på at beskytte patienters, brugeres eller andre personers sundhed og sikkerhed eller andre aspekter af folkesundheden, tillægges Kommissionen beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for at ændre den pågældende liste ved at tilføje andre typer af implantabelt udstyr i klasse IIb på listen eller fjerne udstyr derfra.
6.   Fabrikanter af udstyr i klasse IIa, bortset fra udstyr efter mål og udstyr bestemt til afprøvning, skal følge en overensstemmelsesvurderingsprocedure som omhandlet i bilag IX, kapitel I og III, herunder en vurdering af den tekniske dokumentation som omhandlet i nævnte bilags punkt 4 for mindst ét repræsentativt udstyr for hver udstyrskategori.
Alternativt kan fabrikanten vælge at udarbejde den tekniske dokumentation, der er fastsat i bilag II og III, kombineret med en overensstemmelsesvurdering som omhandlet i bilag XI, punkt 10 eller 18. Vurderingen af den tekniske dokumentation skal udføres for mindst ét repræsentativt udstyr for hver udstyrskategori.
7.   Fabrikanter af udstyr i klasse I, bortset fra udstyr efter mål og udstyr bestemt til afprøvning, skal erklære, at deres produkter er i overensstemmelse med de relevante krav ved at udstede EU-overensstemmelseserklæringen, jf. artikel 19, når de har udarbejdet den tekniske dokumentation, der er omhandlet i bilag II og III. Hvis udstyret markedsføres i steril tilstand, har en målefunktion eller er genanvendelige kirurgiske instrumenter, skal fabrikanten anvende procedurerne i bilag IX, kapitel I og III, eller i bilag XI, del A. Det bemyndigede organs inddragelse i disse procedurer skal dog begrænses:
a)
for så vidt angår udstyr, som bringes i omsætning i steril tilstand, til de aspekter, som vedrører opnåelse, sikring og fastholdelse af den sterile tilstand
b)
for så vidt angår udstyr, som har en målefunktion, til de aspekter, som vedrører udstyrets overensstemmelse med metrologiske krav
c)
for så vidt angår genanvendelige kirurgiske instrumenter til de aspekter, der vedrører genbrug af udstyret, navnlig rengøring, desinfektion, sterilisering, vedligeholdelse og funktionstest og den tilhørende brugsanvisning.
8.   Fabrikanter af udstyr efter mål følger den procedure, der er fastsat i bilag XIII, og udarbejder den i nævnte bilag, punkt 1, omhandlede erklæring, inden sådant udstyr bringes i omsætning.
I tillæg til den procedure, der finder anvendelse i henhold til første afsnit, skal fabrikanter af implantabelt udstyr efter mål i klasse III også følge overensstemmelsesvurderingsproceduren som omhandlet i bilag IX, kapitel I. Alternativt kan fabrikanten vælge at anvende en overensstemmelsesvurdering som omhandlet i bilag XI, del A.
9.   Ud over de procedurer, der skal følges i henhold til denne artikels stk. 3, 4, 6, eller 7, skal proceduren i bilag IX, punkt 5.2, eller i bilag X, punkt 6, alt efter hvad der er relevant, ligeledes følges for udstyr omhandlet i artikel 1, stk. 8, første afsnit.
10.   Ud over de procedurer, der skal følges i henhold til denne artikels stk. 3, 4, 6, eller 7, skal proceduren i bilag IX, punkt 5.3, eller i bilag X, punkt 6, alt efter hvad der er relevant, ligeledes følges for udstyr, som i overensstemmelse med artikel 1, stk. 6, litra f) eller g), og med artikel 1, stk. 10, første afsnit, er omfattet af denne forordning.
11.   Ud over de procedurer, der skal følges i henhold til stk. 3, 4, 6, eller 7, skal proceduren i bilag IX, punkt 5.4, eller i bilag X, punkt 6, alt efter hvad der er relevant, ligeledes følges for udstyr, der består af stoffer eller af en kombination af stoffer, der er bestemt til at blive indgivet i det menneskelige legeme via en legemsåbning eller påført huden, og som absorberes af eller fordeles lokalt i det menneskelige legeme.
12.   Den medlemsstat, hvor det bemyndigede organ er etableret, kan kræve, at alle eller bestemte dokumenter, herunder den tekniske dokumentation, audit, vurdering og inspektionsrapporter vedrørende de procedurer, der er omhandlet i stk. 1-7 og 9-11, gøres tilgængelige på et eller flere officielle EU-sprog som fastsat af denne medlemsstat. Hvis der ikke findes et sådant krav, skal disse dokumenter foreligge på ethvert officielt EU-sprog, som det bemyndigede organ kan acceptere.
13.   Udstyr bestemt til afprøvning skal omfattes af kravene i artikel 62-81.
14.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte nærmere bestemmelser og proceduremæssige aspekter for at sikre en harmoniseret anvendelse af de bemyndigede organers overensstemmelsesvurderingsprocedurer med hensyn til følgende aspekter:
a)
hyppigheden af og prøveudtagningsgrundlaget for vurderingen af den tekniske dokumentation, på et repræsentativt grundlag, som omhandlet i bilag IX, punkt 2.3, tredje afsnit, og punkt 3.5, for udstyr i klasse IIa og IIb, og i bilag XI, punkt 10.2, for udstyr i klasse IIa
b)
mindstehyppigheden af uanmeldte audit på stedet og stikprøvekontrol, som de bemyndigede organer skal gennemføre i overensstemmelse med bilag IX, punkt 3.4, under hensyntagen til risikoklasse og type af udstyr
c)
de fysiske prøvninger, laboratorieprøvninger eller andre prøvninger, som de bemyndigede organer skal foretage i forbindelse med stikprøvekontrol, vurdering af den tekniske dokumentation og typeafprøvning i overensstemmelse med bilag IX, punkt 3.4 og 4.3, bilag X, punkt 3, og bilag XI, punkt 15.
De gennemførelsesretsakter, der er omhandlet i første afsnit, vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 53
Inddragelse af bemyndigede organer i overensstemmelsesvurderingsprocedurer
1.   Hvis overensstemmelsesvurderingsproceduren kræver et bemyndiget organs inddragelse, kan fabrikanten indsende en ansøgning til et bemyndiget organ efter eget valg, forudsat at det valgte bemyndigede organ er udpeget til overensstemmelsesvurderingsaktiviteter vedrørende de pågældende typer af udstyr. Fabrikanten kan ikke indsende en ansøgning parallelt med et andet bemyndiget organ for samme overensstemmelsesvurderingsprocedure.
2.   Det pågældende bemyndigede organ skal ved hjælp af det elektroniske system, der er omhandlet i artikel 57, orientere de andre bemyndigede organer om enhver fabrikant, der trækker sin ansøgning tilbage før det bemyndigede organs afgørelse vedrørende overensstemmelsesvurderingen.
3.   Når der indsendes en ansøgning til et bemyndiget organ i henhold til stk. 1, skal fabrikanter erklære, om de har trukket en ansøgning til et andet bemyndiget organ tilbage inden dette bemyndigede organs afgørelse, og give oplysninger om eventuelle tidligere ansøgninger vedrørende samme overensstemmelsesvurdering, som et andet bemyndiget organ har givet afslag på.
4.   Det bemyndigede organ kan kræve alle de oplysninger eller data fra fabrikanten, der er nødvendige for en korrekt gennemførelse af den valgte overensstemmelsesvurderingsprocedure.
5.   Bemyndigede organer og deres personale skal udføre overensstemmelsesvurderingsaktiviteterne med den størst mulige faglige integritet og den nødvendige tekniske og videnskabelige kompetence på det specifikke område og må ikke påvirkes af nogen form for pression og incitament, navnlig af økonomisk art, som kan have indflydelse på deres afgørelser eller resultaterne af deres overensstemmelsesvurderingsaktiviteter, særlig hvad angår personer eller grupper af personer, som har en interesse i resultaterne af disse aktiviteter.
Artikel 54
Procedure for høring i forbindelse med klinisk evaluering for så vidt angår visse former for udstyr i klasse III og klasse IIb
1.   I tillæg til de procedurer, der finder anvendelse i henhold til artikel 52, skal et bemyndiget organ også følge proceduren for høring i forbindelse med klinisk evaluering som omhandlet i bilag IX, punkt 5.1, eller som omhandlet i bilag X, punkt 6, alt efter tilfældet, når det udfører en overensstemmelsesvurdering af følgende udstyr:
a)
implantabelt udstyr i klasse III, og
b)
aktivt udstyr i klasse IIb, der er beregnet til at administrere og/eller fjerne et lægemiddel, som omhandlet i bilag VIII, punkt 6.4 (regel 12).
2.   Den procedure, der er omhandlet i stk. 1, er ikke påkrævet for det udstyr, der er omhandlet deri:
a)
i tilfælde af fornyelse af et certifikat, der udstedt i henhold til denne forordning
b)
hvis udstyret er designet ved at ændre udstyr, der allerede er markedsført af den samme fabrikant med samme erklærede formål, såfremt fabrikanten til det bemyndigede organs tilfredshed har påvist, at ændringerne ikke forringer forholdet mellem fordele og risici for udstyret, eller
c)
hvis principperne for den kliniske evaluering af udstyrskategorien er blevet behandlet i en fælles specifikation, jf. artikel 9, og hvis det bemyndigede organ bekræfter, at fabrikantens kliniske evaluering af dette udstyr er i overensstemmelse med de relevante fælles specifikationer for klinisk evaluering af denne udstyrstype.
3.   Det bemyndigede organ underetter de kompetente myndigheder, myndigheden med ansvar for bemyndigede organer og Kommissionen via det system, der er omhandlet i artikel 57, om, hvorvidt den procedure, der er omhandlet i denne artikels stk. 1, skal følges eller ej. Underretningen skal være ledsaget af vurderingsrapporten om den kliniske evaluering.
4.   Kommissionen udarbejder en årlig oversigt over udstyr, der er omfattet af proceduren i bilag IX, punkt 5.1, og omhandlet i bilag X, punkt 6. Den årlige oversigt skal omfatte underretningerne i overensstemmelse med denne artikels stk. 3 og bilag IX, punkt 5.1, litra e), og en opgørelse over de tilfælde, hvor det bemyndigede organ ikke har fulgt ekspertpanelets anbefalinger. Kommissionen forelægger denne oversigt for Europa-Parlamentet, Rådet og MDCG.
5.   Kommissionen udarbejder senest den 27. maj 2025 en rapport om anvendelsen af denne artikel og forelægger den for Europa-Parlamentet og Rådet. Rapporten skal tage hensyn til de årlige oversigter og eventuelle relevante henstillinger fra MDCG. På baggrund af denne rapport foreslår Kommissionen, hvis det er relevant, ændringer til denne forordning.
Artikel 55
Mekanisme til kontrol af overensstemmelsesvurderinger af visse former for udstyr i klasse III og klasse IIb
1.   Et bemyndiget organ underetter de kompetente myndigheder om certifikater, som det har udstedt for udstyr, som har været genstand for overensstemmelsesvurderingen i henhold til artikel 54, stk. 1. En sådan underretning skal ske via det elektroniske system, der er omhandlet i artikel 57, og indeholde sammenfatningen af sikkerhed og klinisk ydeevne i henhold til artikel 32, evalueringsrapporten fra det bemyndigede organ, de brugsanvisninger, der er omhandlet i bilag I, punkt 23.4, og, hvis det er relevant, den videnskabelige udtalelse fra de ekspertpaneler, der alt efter tilfældet er omhandlet i bilag IX, punkt 5.1, eller bilag X, punkt 6. I tilfælde af divergerende synspunkter mellem det bemyndigede organ og ekspertpanelerne skal en fuld begrundelse også indeholdes.
2.   En kompetent myndighed og, hvis det er relevant, Kommissionen kan i tilfælde af rimelig tvivl anvende yderligere procedurer i overensstemmelse med artikel 44, 45, 46, 47 eller 94 og, hvis det skønnes nødvendigt, træffe passende foranstaltninger i henhold til artikel 95 og 97.
3.   MDCG og eventuelt Kommissionen kan i tilfælde af rimelig tvivl anmode om videnskabelig rådgivning fra ekspertpanelerne for så vidt angår ethvert udstyrs sikkerhed og ydeevne.
Artikel 56
Overensstemmelsescertifikat
1.   De certifikater, der udstedes af de bemyndigede organer i overensstemmelse med bilag IX, X og XI, udfærdiges på et officielt EU-sprog fastsat af den medlemsstat, hvor det bemyndigede organ er etableret, eller på et officielt EU-sprog, som det bemyndigede organ kan acceptere. Certifikaterne skal mindst indeholde de oplysninger, der er fastsat i bilag XII.
2.   Certifikaterne er gyldige i den periode, der er angivet deri, dog højst i fem år. På fabrikantens anmodning kan certifikatets gyldighedsperiode forlænges med yderligere perioder på hver højst fem år på grundlag af en fornyet vurdering i overensstemmelse med de gældende overensstemmelsesvurderingsprocedurer. Et eventuelt tillæg til et certifikat er gyldigt lige så længe som det certifikat, det supplerer.
3.   Bemyndigede organer kan begrænse udstyrets erklærede formål til visse grupper af patienter eller kræve, at fabrikanterne foretager specifikke PMCF-undersøgelser i henhold til bilag XIV, del B.
4.   Hvis et bemyndiget organ fastslår, at fabrikanten ikke længere opfylder kravene i denne forordning, suspenderer eller tilbagekalder organet det udstedte certifikat eller begrænser det under iagttagelse af proportionalitetsprincippet, medmindre fabrikanten gennem passende korrigerende handlinger og inden for en passende frist fastsat af det bemyndigede organ sikrer, at kravene opfyldes. Det bemyndigede organ skal begrunde sin beslutning.
5.   I det elektroniske system, der er omhandlet i artikel 57, indfører det bemyndigede organ alle oplysninger om udstedte certifikater, herunder ændringer og tillæg hertil, og om certifikater, der er suspenderet, på ny er blevet gyldige, tilbagekaldt, afvist eller begrænset. Sådanne oplysninger skal være offentligt tilgængelige.
6.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for at ændre mindstekravet til indholdet af de certifikater, der er fastlagt i bilag XII, på baggrund af den tekniske udvikling.
Artikel 57
Elektronisk system for bemyndigede organer og overensstemmelsescertifikater
1.   Kommissionen opretter og forvalter efter høring af MDCG et elektronisk system til indsamling og behandling af følgende oplysninger:
a)
listen over dattervirksomheder, jf. artikel 37, stk. 3
b)
listen over eksperter, jf. artikel 40, stk. 2
c)
oplysninger om notifikationen, jf. artikel 42, stk. 10, og de ændrede notifikationer, jf. artikel 46, stk. 2
d)
listen over bemyndigede organer, jf. artikel 43, stk. 2
e)
resuméet af rapporten, jf. artikel 44, stk. 12
f)
underretninger om overensstemmelsesvurderinger og certifikater, jf. artikel 54, stk. 3, og artikel 55, stk. 1
g)
tilbagetrækning af eller afslag på ansøgninger om certifikater, jf. artikel 53, stk. 2, og bilag VII, punk 4.3
h)
oplysningerne vedrørende certifikater, jf. artikel 56, stk. 5
i)
sammenfatningen af sikkerhed og klinisk ydeevne, jf. artikel 32.
2.   De oplysninger, der indsamles og behandles af det elektroniske system, skal være tilgængelige for de kompetente myndigheder i medlemsstaterne, for Kommissionen, for de bemyndigede organer, når det er relevant, og for offentligheden, når det er fastsat andre steder i denne forordning eller i forordning (EU) 2017/746.
Artikel 58
Frivillig udskiftning af bemyndiget organ
1.   Hvis en fabrikant ophæver kontrakten med et bemyndiget organ og indgår aftale med et andet bemyndiget organ om en overensstemmelsesvurdering af samme udstyr, skal de nærmere bestemmelser for udskiftningen af bemyndiget organ være klart fastlagt i en aftale mellem fabrikanten, det tiltrædende bemyndigede organ og så vidt muligt det afgående bemyndigede organ. Denne aftale skal mindst dække følgende:
a)
den dato, fra hvilken certifikater udstedt af det afgående bemyndigede organ ikke længere er gyldige
b)
den dato, indtil hvilken det afgående bemyndigede organs identifikationsnummer må anføres i fabrikantens oplysninger, herunder eventuelt salgsfremmende materiale
c)
overdragelse af dokumenter, herunder fortrolighedsaspekter og ejendomsrettigheder
d)
den dato, hvorefter de overensstemmelsesvurderingsopgaver, som er pålagt det afgående bemyndigede organ, pålægges det tiltrædende bemyndigede organ
e)
det sidste serienummer eller lotnummer, som det afgående bemyndigede organ er ansvarligt for.
2.   Det afgående bemyndigede organ tilbagekalder certifikater, som det har udstedt for det pågældende udstyr, på den dato, hvor de bliver ugyldige.
Artikel 59
Undtagelse fra overensstemmelsesvurderingsprocedurerne
1.   Uanset artikel 52 kan en kompetent myndighed efter en behørigt begrundet anmodning give tilladelse til, at et specifikt udstyr, for hvilket de i nævnte artikel omhandlede procedurer ikke er blevet fulgt, kan bringes i omsætning eller ibrugtages på den pågældende medlemsstats område, hvis folkesundhedshensyn eller patienters sikkerhed eller sundhed taler herfor.
2.   Medlemsstaten underretter Kommissionen og de øvrige medlemsstater om alle beslutninger om at tillade, at udstyr bringes i omsætning eller ibrugtages i overensstemmelse med stk. 1, hvis en sådan tilladelse ikke kun gælder anvendelse til én enkelt patient.
3.   På grundlag af en underretning, jf. denne artikels stk. 2, kan Kommissionen i undtagelsestilfælde vedrørende folkesundheden eller patienters sikkerhed eller sundhed ved hjælp af gennemførelsesretsakter udvide gyldigheden af en tilladelse, der er udstedt af en medlemsstat i overensstemmelse med denne artikels stk. 1, til Unionens område i en begrænset periode og fastsætte de betingelser, hvorpå udstyret kan bringes i omsætning eller ibrugtages. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
I behørigt begrundede særligt hastende tilfælde vedrørende menneskers sikkerhed og sundhed vedtager Kommissionen efter proceduren i artikel 114, stk. 4, gennemførelsesretsakter, der finder anvendelse straks.
Artikel 60
Certifikater for frit salg
1.   Med henblik på eksport og efter anmodning fra en fabrikant eller en autoriseret repræsentant udsteder den medlemsstat, hvor fabrikanten eller den autoriserede repræsentant har sit registrerede forretningssted, et certifikat for frit salg, der certificerer, at fabrikanten eller den autoriserede repræsentant har sit registrerede forretningssted på dens område, og at det pågældende udstyr, der er forsynet med CE-mærkning i overensstemmelse med denne forordning, kan markedsføres lovligt i Unionen. Certifikatet for frit salg angiver den grundlæggende UDI-DI for udstyret som indsendt til UDI-databasen, jf. artikel 29. Hvis et bemyndiget organ har udstedt et certifikat i henhold til artikel 56, skal certifikatet for frit salg angive det unikke nummer, der identificerer det certifikat, der er udstedt af det bemyndigede organ, jf. bilag XII, kapitel II, punkt 3.
2.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte en model for certifikater for frit salg under hensyntagen til international praksis med hensyn til anvendelse af certifikater for frit salg. Disse gennemførelsesretsakter vedtages efter rådgivningsproceduren i artikel 114, stk. 2.
KAPITEL VI
KLINISK EVALUERING OG KLINISKE AFPRØVNINGER
Artikel 61
Klinisk evaluering
1.   Verifikationen af, at udstyr under de normale påtænkte anvendelsesforhold er i overensstemmelse med relevante generelle krav til sikkerhed og ydeevne som fastsat i bilag I, og vurderingen af uønskede bivirkninger og om forholdet mellem fordele og risici er acceptabelt, jf. bilag I, punkt 1 og 8, baseres på kliniske data med tilstrækkelig klinisk dokumentation, herunder, hvis det er relevant, data som omhandlet i bilag III.
Fabrikanten specificerer og begrunder omfanget af den kliniske dokumentation, der er nødvendig for at påvise overensstemmelse med de relevante generelle krav til sikkerhed og ydeevne. Det nævnte omfang af klinisk dokumentation skal være passende i betragtning af udstyrets egenskaber og erklærede formål.
Med henblik herpå planlægger, udfører og dokumenterer fabrikanterne en klinisk evaluering i overensstemmelse med denne artikel og bilag XIV, del A.
2.   For alt udstyr i klasse III og udstyr i klasse IIb, jf. artikel 54, stk. 1, litra b), kan fabrikanten, forud for den kliniske evaluering og/eller afprøvning, høre et ekspertpanel som omhandlet i artikel 106 for at gennemgå fabrikantens tilsigtede kliniske udviklingsstrategi og forslag til klinisk afprøvning. Fabrikanten skal tage behørigt hensyn til de synspunkter, som ekspertpanelet har udtrykt. Sådanne hensyn skal dokumenteres i den kliniske evalueringsrapport, jf. nærværende artikels stk. 12.
Fabrikanten må ikke påberåbe sig ret til de synspunkter, som ekspertpanelet har udtrykt for så vidt angår en eventuel fremtidig overensstemmelsesvurderingsprocedure.
3.   En klinisk evaluering skal følge en defineret og metodologisk forsvarlig fremgangsmåde baseret på:
a)
en kritisk evaluering af relevant, foreliggende videnskabelig litteratur, som beskriver udstyrets sikkerhed, ydeevne, designegenskaber og erklærede formål, hvor følgende betingelser er opfyldt:
—
det er påvist, at udstyret, der underkastes klinisk evaluering med henblik på dets erklærede formål, er ækvivalent med det udstyr, som dataene omhandler, i overensstemmelse med bilag XIV, punkt 3, og
—
dataene på passende vis godtgør, at udstyret er i overensstemmelse med de relevante generelle krav til sikkerhed og ydeevne
b)
en kritisk evaluering af resultaterne af alle tilgængelige kliniske afprøvninger under behørig hensyntagen til, hvorvidt undersøgelserne blev udført i henhold til artikel 62-80, eventuelle retsakter vedtaget i medfør af artikel 81, og bilag XV, og
c)
en overvejelse af de foreliggende alternative behandlingsmuligheder for dette formål, hvis det er relevant.
4.   For implantabelt udstyr og udstyr i klasse III skal der udføres kliniske afprøvninger, medmindre:
—
udstyret er designet ved at ændre udstyr, der allerede er markedsført af den samme fabrikant
—
fabrikanten har påvist og det bemyndigede organ har godkendt, at det ændrede udstyr er ækvivalent med det markedsførte udstyr, jf. bilag XIV, punkt 3, og
—
den kliniske evaluering af det markedsførte udstyr er tilstrækkelig til at påvise det ændrede udstyrs overensstemmelse med de relevante krav til sikkerhed og ydeevne.
I så fald skal det bemyndigede organ kontrollere, at PMCF-planen er hensigtsmæssig og omfatter undersøgelser, efter at udstyret er bragt i omsætning, med henblik på at påvise udstyrets sikkerhed og ydeevne.
Det er desuden ikke nødvendigt at udføre kliniske afprøvninger i de tilfælde, der er omhandlet i stk. 6.
5.   En fabrikant af udstyr, der påvist er ækvivalent med allerede markedsført udstyr, som denne ikke har fremstillet, kan også anvende stk. 4 med henblik på ikke at udføre en klinisk afprøvning, forudsat at de følgende betingelser er opfyldt i tillæg til kravene i nævnte stykke:
—
de to fabrikanter har en aftale, der udtrykkeligt tillader, at fabrikanten af det andet udstyr har fuld adgang til den tekniske på løbende basis, og
—
den originale kliniske er blevet udført i overensstemmelse med kravene i denne forordning,
og fabrikanten af det andet udstyr giver det bemyndigede organ klar dokumentation herfor.
6.   Kravet om at udføre kliniske afprøvninger i henhold til stk. 4 finder ikke anvendelse på implantabelt udstyr og udstyr i klasse III:
a)
der på lovlig vis er bragt i omsætning eller ibrugtaget i overensstemmelse med direktiv 90/385/EØF eller direktiv 93/42/EØF, og for hvilke den kliniske evaluering:
—
er baseret på tilstrækkelige kliniske data, og
—
er i overensstemmelse med den relevante produktspecifikke fælles specifikation for klinisk evaluering af denne udstyrstype, hvis en sådan fælles specifikation foreligger, eller
b)
der er suturer, hæfteklammer, tandfyldninger, tandbøjler, tandkroner, skruer, kiler, plader, tråd, nåle, klemmer og forbindelsesled, for hvilke den kliniske evaluering er baseret på tilstrækkelige kliniske data og er i overensstemmelse med den relevante produktspecifikke fælles specifikation, hvis en sådan fælles specifikation foreligger.
7.   I tilfælde, hvor stk. 4 ikke anvendes i henhold til stk. 6, skal fabrikanten begrunde det i den kliniske evalueringsrapport og det bemyndigede organ i vurderingsrapporten om den kliniske evaluering.
8.   Hvis det kan begrundes med brug af veletablerede teknologier, der ligner dem, der anvendes i de undtagne udstyr på listen i denne artikels stk. 6, litra b), som anvendes i andet udstyr, eller hvis det kan begrundes med henblik på at beskytte patienters, brugeres eller andre personers sundhed og sikkerhed eller andre aspekter af folkesundheden, tillægges Kommissionen beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for at ændre den i artikel 52, stk. 4, andet afsnit, og nærværende artikels stk. 6, litra b), omhandlede liste over undtagne udstyr ved at tilføje andre typer af implantabelt udstyr eller udstyr i klasse III til listen eller fjerne udstyr derfra.
9.   For så vidt angår de produkter uden et medicinsk formål, der er opført på listen i bilag XVI, forstås kravet om at påvise en klinisk fordel i overensstemmelse med dette kapitel og bilag XIV og XV som et krav om at påvise udstyrets ydeevne. Kliniske evalueringer af disse produkter baseres på relevante data vedrørende sikkerhed, herunder data fra overvågningen, efter at udstyret er bragt i omsætning, PMFC, og, hvis det er relevant, specifikke kliniske afprøvninger. Der skal udføres kliniske afprøvninger af disse produkter, medmindre anvendelse af eksisterende kliniske data fra tilsvarende medicinsk udstyr er behørigt begrundet.
10.   Hvis påvisning af overensstemmelse med generelle krav til sikkerhed og ydeevne baseret på kliniske data ikke skønnes hensigtsmæssig, skal der gives en fyldestgørende begrundelse for alle undtagelser på grundlag af resultaterne af fabrikantens risikostyring og under hensyntagen til de særlige egenskaber ved interaktionen mellem udstyr og legeme, den forventede kliniske ydeevne og fabrikantens angivelser, jf. dog stk. 4. I så fald skal fabrikanten give en behørig begrundelse i den tekniske dokumentation, der er omhandlet i bilag II, hvorfor vedkommende anser en påvisning af overensstemmelse med de generelle krav til sikkerhed og ydeevne på basis af resultaterne af ikkekliniske forsøgsmetoder, herunder ydeevneevaluering, bench test og præklinisk evaluering, for at være tilstrækkelig.
11.   Den kliniske evaluering og den tilhørende dokumentation skal opdateres i hele det pågældende udstyrs livscyklus med kliniske data fra gennemførelsen af fabrikantens PMCF-plan i overensstemmelse med bilag XIV, del B, og planen for overvågning, efter at udstyret er bragt i omsætning, jf. artikel 84.
PMCF-evalueringsrapporten og, hvis angivet, sammenfatningen om sikkerhed og klinisk ydeevne som omhandlet i artikel 32, opdateres for så vidt angår udstyr i klasse III og implantabelt udstyr med disse data mindst én gang om året.
12.   Den kliniske evaluering, resultaterne heraf og den kliniske dokumentation, der udledes heraf, skal dokumenteres i en klinisk evalueringsrapport, jf. bilag XIV, punkt 4, der bortset fra for udstyr efter mål skal indgå i det pågældende udstyrs tekniske dokumentation, jf. bilag II.
13.   Hvis det er nødvendigt for at sikre en ensartet anvendelse af bilag XIV, kan Kommissionen under hensyntagen til den tekniske og videnskabelige udvikling vedtage gennemførelsesretsakter, i det omfang det er nødvendigt for at løse spørgsmål vedrørende forskellige fortolkninger og den praktiske anvendelse. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 62
Generelle krav vedrørende kliniske afprøvninger, der gennemføres for at påvise udstyrets overensstemmelse med de gældende krav
1.   Kliniske afprøvninger skal designes, tillades, gennemføres, registreres og rapporteres i overensstemmelse med bestemmelserne i denne artikel og i artikel 63-80, retsakter vedtaget i medfør af artikel 81, og bilag XV, når de udføres som en del af den kliniske evaluering med henblik på overensstemmelsesvurdering med et eller flere af følgende formål:
a)
at fastslå og verificere, at et udstyr ved forskriftsmæssig brug er designet, fremstillet og emballeret på en sådan måde, at det er egnet til at opfylde et eller flere af de specifikke formål, der er omhandlet i artikel 2, nr. 1), og opnå den af fabrikanten anførte ydeevne
b)
at fastslå og verificere de af fabrikanten anførte kliniske fordele ved udstyret
c)
at fastslå og verificere udstyrets kliniske sikkerhed og at fastslå eventuelle uønskede bivirkninger ved forskriftsmæssig brug af udstyret og vurdere, om det udgør en acceptabel risiko set i forhold til de fordele, der kan opnås med udstyret.
2.   Hvis sponsor af en klinisk afprøvning ikke er etableret i Unionen, sikrer denne sponsor, at der er udpeget en fysisk eller juridisk person i Unionen som dennes retlige repræsentant. Den retlige repræsentant er ansvarlig for at sikre, at sponsors forpligtelser i henhold til denne forordning opfyldes, og er adressat for al kommunikation med sponsor i henhold til denne forordning. Al kommunikation med denne retlige repræsentant anses for kommunikation med sponsor.
Medlemsstaterne kan vælge ikke at anvende første afsnit på kliniske afprøvninger, der udelukkende skal gennemføres på deres område eller på deres område og et tredjelands område, forudsat at de sikrer, at sponsor udpeger mindst en kontaktperson på deres område for den pågældende kliniske afprøvning, som skal være adressat for al kommunikation med sponsor i henhold til denne forordning.
3.   Kliniske afprøvninger skal designes og gennemføres på en sådan måde, at de forsøgspersoner, der deltager i en klinisk afprøvning, er beskyttet med hensyn til deres rettigheder, sikkerhed, værdighed og velfærd, som skal komme før alle andre interesser, og at kliniske data, der genereres, er videnskabeligt underbyggede, pålidelige og robuste.
Kliniske afprøvninger skal underkastes en videnskabelig og etisk gennemgang. Den etiske gennemgang foretages af en etisk komité i overensstemmelse med national ret. Medlemsstaterne sikrer, at procedurerne for den etiske komités gennemgang er forenelige med de procedurer, der er fastsat i denne forordning for vurdering af ansøgningen om tilladelse til en klinisk afprøvning. Mindst én lægmand skal deltage i den etiske gennemgang.
4.   En klinisk afprøvning, som omhandlet i stk. 1, må kun gennemføres, hvis alle de følgende betingelser er opfyldt:
a)
den kliniske afprøvning er omfattet af en tilladelse fra den eller de medlemsstater, hvor den kliniske afprøvning skal foretages, i overensstemmelse med denne forordning, medmindre andet er anført
b)
en etisk komité, der er nedsat i henhold til national ret, har ikke afgivet en negativ udtalelse i forbindelse med den kliniske afprøvning, der gælder for hele den pågældende medlemsstat i henhold til dens nationale ret
c)
sponsor eller dennes retlige repræsentant eller kontaktperson i henhold til stk. 2 er etableret i Unionen
d)
sårbare populationer og forsøgspersoner beskyttes på passende vis i overensstemmelse med artikel 64-68
e)
de forventede fordele for forsøgspersonerne eller for folkesundheden kan berettige de forudseelige risici og ulemper, og overholdelse af denne betingelse overvåges konstant
f)
forsøgspersonen eller, hvis forsøgspersonen ikke kan give et informeret samtykke, dennes retligt udpegede repræsentant har givet informeret samtykke i overensstemmelse med artikel 63
g)
forsøgspersonen eller, hvis denne ikke kan give et informeret samtykke, dennes retligt udpegede repræsentant har modtaget kontaktoplysninger for en enhed, hvor der kan indhentes yderligere information, såfremt dette er nødvendigt
h)
forsøgspersonens ret til fysisk og mental integritet samt retten til privatlivets fred respekteres, og oplysninger vedrørende forsøgspersonen beskyttes efter bestemmelserne i direktiv 95/46/EF
i)
den kliniske afprøvning er designet således, at det involverer færrest mulige smerter og gener, mindst mulig frygt og færrest mulige andre forudseelige risici for forsøgspersonerne, og såvel risikotærsklen som belastningsgraden skal fastsættes specifikt i den kliniske afprøvningsplan og til stadighed kontrolleres
j)
ansvaret for den medicinske behandling, der gives forsøgspersonerne, påhviler en behørigt kvalificeret læge eller, hvor det er relevant, en behørigt kvalificeret tandlæge eller enhver anden, der i henhold til national ret har beføjelse til yde den relevante patientpleje under kliniske afprøvningsbetingelser
k)
der er ikke udøvet nogen utilbørlig påvirkning på forsøgspersonen, herunder af økonomisk art, eller, hvor det er relevant, på dennes retligt udpegede repræsentanter for så vidt angår deltagelse i den kliniske afprøvning
l)
det pågældende udstyr bestemt til afprøvning er i overensstemmelse med de gældende generelle krav til sikkerhed og ydeevne i bilag I, undtagen for så vidt angår de aspekter, der er omfattet af den kliniske afprøvning, og at der med hensyn til disse aspekter er truffet alle nødvendige forholdsregler for at beskytte forsøgspersonernes sundhed og sikkerhed. Dette omfatter, hvor det er relevant, testning af den tekniske og biologiske sikkerhed og præklinisk evaluering samt bestemmelser inden for områderne arbejdssikkerhed og forebyggelse af ulykker under hensyntagen til det aktuelle tekniske niveau
m)
kravene i bilag XV er opfyldt.
5.   Enhver forsøgsperson eller, hvis denne ikke kan give et informeret samtykke, dennes retligt udpegede repræsentant kan når som helst, uden at det er til skade for vedkommende og uden at skulle give en begrundelse herfor, udgå af den kliniske afprøvning ved at trække sit informerede samtykke tilbage. Tilbagetrækningen af det informerede samtykke berører hverken de aktiviteter, der allerede er gennemført, eller anvendelsen af de data, som er indhentet på grundlag af det informerede samtykke, før det blev trukket tilbage, jf. dog direktiv 95/46/EF.
6.   Investigator skal være en person, der udøver et erhverv, som i den berørte medlemsstat kvalificerer den pågældende til at være investigator, fordi vedkommende har den nødvendige videnskabelige viden og erfaring i patientpleje. Andet personale, der er involveret i gennemførelse af en klinisk afprøvning, skal være tilstrækkeligt kvalificeret med hensyn til uddannelse eller erfaring til at varetage sine opgaver inden for det relevante medicinske område og inden for kliniske forskningsmetoder.
7.   De faciliteter, hvor den kliniske afprøvning gennemføres, skal være egnede til den kliniske afprøvning og skal svare til faciliteterne, hvor udstyret er bestemt til at skulle anvendes.
Artikel 63
Informeret samtykke
1.   Informeret samtykke skal være skriftligt, dateret og underskrevet af den person, der gennemfører den i stk. 2, litra c), omhandlede samtale, og af forsøgspersonen eller, hvis forsøgspersonen ikke kan give et informeret samtykke, dennes retligt udpegede repræsentant efter at være blevet behørigt informeret i overensstemmelse med stk. 2. Hvis forsøgspersonen ikke er stand til at skrive, kan samtykke afgives og registreres ved hjælp af passende alternative midler i nærværelse af mindst ét upartisk vidne. I sådanne tilfælde underskriver og daterer vidnet det dokument, ved hvilket der er givet informeret samtykke. Forsøgspersonen eller, hvis forsøgspersonen ikke kan give et informeret samtykke, dennes retligt udpegede repræsentant får udleveret en kopi af det dokument eller den optagelse, alt efter tilfældet, som der er givet informeret samtykke ved. Det informerede samtykke skal være dokumenteret. Forsøgspersonen eller dennes retligt udpegede repræsentant skal have en passende frist til at overveje sin beslutning om at deltage i den kliniske afprøvning.
2.   Information, som udleveres til forsøgspersonen eller, hvis forsøgspersonen ikke kan give et informeret samtykke, dennes retligt udpegede repræsentant med henblik på at opnå informeret samtykke, skal:
a)
gøre det muligt for forsøgspersonen eller dennes retligt udpegede juridiske repræsentant at forstå:
i)
den kliniske afprøvnings art, formål, fordele, implikationer, risici og ulemper
ii)
forsøgspersonens rettigheder og garantier for så vidt angår dennes beskyttelse, navnlig retten til at nægte at deltage i den kliniske afprøvning samt retten til når som helst at udgå af den kliniske afprøvning, uden at det er til skade for vedkommende og uden at skulle give en begrundelse herfor
iii)
betingelserne for, hvorledes den kliniske afprøvning skal gennemføres, herunder den forventede varighed af forsøgspersonens deltagelse i den kliniske afprøvning, og
iv)
mulige behandlingsalternativer, herunder opfølgningsforanstaltninger, såfremt forsøgspersonens deltagelse i den kliniske afprøvning indstilles
b)
være fyldestgørende, koncis, klar, relevant og forståelig for forsøgspersonen eller dennes retligt udpegede repræsentant
c)
gives under en forudgående samtale med et medlem af afprøvningsholdet, der er behørigt kvalificeret i henhold til national ret
d)
indeholde information om den gældende skadeserstatningsordning, jf. artikel 69, og
e)
indeholde det EU-dækkende unikke individuelle identifikationsnummer for den kliniske afprøvning som omhandlet i artikel 70, stk. 1, og information om tilgængeligheden af resultaterne af den kliniske afprøvning i overensstemmelse med denne artikels stk. 6.
3.   Den i stk. 2 omhandlede information skal udarbejdes skriftligt og være tilgængelig for forsøgspersonen eller, hvis denne ikke kan give informeret samtykke, dennes retligt udpegede repræsentant.
4.   Under den i stk. 2, litra c), nævnte samtale rettes der særlig opmærksomhed mod informationsbehovet hos særlige patientpopulationer og de enkelte forsøgspersoner samt mod de metoder, der anvendes til at give informationen.
5.   Under den i stk. 2, litra c), nævnte samtale verificeres det, at forsøgspersonen har forstået informationen.
6.   Forsøgspersonen skal informeres om, at en klinisk afprøvningsrapport og et resumé, som er forståeligt for den tilsigtede bruger, gøres tilgængelige i henhold til artikel 77, stk. 5, i det elektroniske system for kliniske afprøvninger som omhandlet i artikel 73, uanset udfaldet af den kliniske afprøvning, og skal så vidt muligt informeres, så snart de er blevet tilgængelige.
7.   Denne forordning berører ikke national ret, der kræver, at en mindreårig, som er i stand til at danne sig en mening og vurdere den information, vedkommende får, selv skal indvillige i at deltage i en klinisk afprøvning oven i det informerede samtykke, der gives af den retligt udpegede repræsentant.
Artikel 64
Kliniske afprøvninger på forsøgspersoner uden handleevne
1.   For så vidt angår forsøgspersoner uden handleevne, der ikke har givet eller ikke har nægtet at give et informeret samtykke, inden de blev ude af stand til at give samtykke, må den kliniske afprøvning kun gennemføres, hvis alle de følgende betingelser, ud over betingelserne i artikel 62, stk. 4, er opfyldt:
a)
der er indhentet et informeret samtykke fra deres retligt udpegede repræsentant
b)
forsøgspersoner uden handleevne har modtaget den i artikel 63, stk. 2, omhandlede information på en måde, som er afpasset efter deres evne til at forstå den
c)
investigator respekterer et udtrykkeligt ønske fra en forsøgsperson, der er i stand til at danne sig en mening og til at vurdere den i artikel 63, stk. 2, omhandlede information, om ikke at deltage i eller om når som helst at udgå af den kliniske afprøvning
d)
der gives ingen tilskyndelse eller økonomisk begunstigelse til forsøgspersonerne eller deres retligt udpegede repræsentanter, bortset fra en kompensation for udgifter og tab af indkomst, der er direkte forbundet med deltagelsen i den kliniske afprøvning
e)
den kliniske afprøvning er afgørende i forbindelse med forsøgspersoner uden handleevne, og data af sammenlignelig validitet kan ikke indhentes ved kliniske afprøvninger på personer, der er i stand til at give et informeret samtykke, eller ved andre forskningsmetoder
f)
den kliniske afprøvning direkte vedrører en sygdomstilstand, som forsøgspersonen befinder sig i
g)
der er videnskabeligt belæg for at antage, at deltagelse i den kliniske afprøvning vil give en direkte fordel for forsøgspersonen uden handleevne, der opvejer de risici og byrder, der er forbundet med det.
2.   Forsøgspersonen skal så vidt muligt deltage i proceduren for informeret samtykke.
Artikel 65
Kliniske afprøvninger på mindreårige
En klinisk afprøvning på mindreårige må kun gennemføres, hvis alle de følgende betingelser, ud over betingelserne i artikel 62, stk. 4, er opfyldt:
a)
der er indhentet et informeret samtykke fra deres retligt udpegede repræsentant
b)
de mindreårige har fra investigator eller medlemmer af afprøvningsholdet, der er uddannet i eller har erfaring med at arbejde med børn, modtaget den information, der er omhandlet i artikel 63, stk. 2, på en måde, som er tilpasset deres alder og mentale modenhed
c)
investigator respekterer et udtrykkeligt ønske fra en mindreårig, der er i stand til at danne sig en mening og til at vurdere den i artikel 63, stk. 2, omhandlede information, om ikke at deltage i eller om når som helst at udgå af den kliniske afprøvning
d)
der gives ingen tilskyndelse eller økonomisk begunstigelse til forsøgspersonen eller dennes retligt udpegede juridiske repræsentant, bortset fra en kompensation for udgifter og tab af indkomst, der er direkte forbundet med deltagelsen i den kliniske afprøvning
e)
den kliniske afprøvning har til formål at undersøge behandlinger af en sygdomstilstand, som kun forekommer hos mindreårige, eller den kliniske afprøvning er afgørende i forbindelse med mindreårige for at validere data indhentet ved kliniske afprøvninger på personer, der er i stand til at give informeret samtykke, eller ved andre forskningsmetoder
f)
den kliniske afprøvning skal enten direkte vedrøre en sygdomstilstand, som den pågældende mindreårige befinder sig i, eller være af en sådan art, at den kun kan udføres på mindreårige
g)
der er videnskabeligt belæg for at antage, at deltagelse i den kliniske afprøvning vil give en direkte fordel for den mindreårige forsøgsperson, som opvejer de risici og byrder, der er forbundet med den
h)
den mindreårige deltager i proceduren for informeret samtykke på en måde, der er tilpasset vedkommendes alder og mentale modenhed
i)
bliver den mindreårige i løbet af den kliniske afprøvning retlig kompetent til at give informeret samtykke i henhold til national ret, skal dennes udtrykkelige informerede samtykke indhentes, før denne forsøgsperson kan fortsætte sin deltagelse i den kliniske afprøvning.
Artikel 66
Kliniske afprøvninger på gravide eller ammende kvinder
En klinisk afprøvning på gravide eller ammende kvinder må kun gennemføres, hvis alle de følgende betingelser, ud over betingelserne i artikel 62, stk. 4, er opfyldt:
a)
den kliniske afprøvning har potentiale til at give den berørte gravide eller ammende kvinde eller hendes embryo, foster eller barn efter fødslen en direkte fordel, som opvejer de risici og byrder, der er forbundet med den
b)
ved forskning, der gennemføres på ammende kvinder, udvises der særlig omhu for at undgå enhver negativ indvirkning på barnets sundhed
c)
der gives ingen tilskyndelse eller økonomisk begunstigelse til forsøgspersonen, bortset fra en kompensation for udgifter og tab af indkomst, der er direkte forbundet med deltagelsen i den kliniske afprøvning.
Artikel 67
Supplerende nationale foranstaltninger
Medlemsstaterne kan opretholde supplerende foranstaltninger vedrørende personer, der gennemfører tvungen militærtjeneste, frihedsberøvede personer, personer, der som følge af retsafgørelser ikke kan deltage i kliniske afprøvninger, eller personer, der bor på plejeinstitutioner.
Artikel 68
Kliniske afprøvninger i akutte situationer
1.   Uanset artikel 62, stk. 4, litra f), artikel 64, stk. 1, litra a) og b), og artikel 65, litra a) og b), kan der indhentes informeret samtykke til at deltage i en klinisk afprøvning og information om den kliniske afprøvning kan gives, efter at beslutningen om at inkludere forsøgspersonen i den kliniske afprøvning træffes, forudsat at denne beslutning træffes på tidspunktet for den første intervention på en forsøgsperson i overensstemmelse med den kliniske afprøvningsplan for den kliniske afprøvning, forudsat at alle de følgende betingelser er opfyldt:
a)
på grund af situationens hastende karakter som følge af en pludselig livstruende eller anden pludselig alvorlig sygdomstilstand kan forsøgspersonen ikke forinden give informeret samtykke eller modtage forudgående information om den kliniske afprøvning
b)
der er videnskabeligt belæg for at antage, at forsøgspersonens deltagelse i den kliniske afprøvning har potentiale til at give forsøgspersonen en direkte klinisk relevant fordel, som kan føre til en målbar sundhedsmæssig bedring, der kan lette forsøgspersonens lidelser og/eller forbedre dennes sundhed eller føre til en diagnosticering af forsøgspersonens lidelse
c)
det er ikke muligt inden for det terapeutiske vindue at give al forudgående information til og indhente forudgående informeret samtykke fra dennes retligt udpegede repræsentant
d)
investigator certificerer, at vedkommende ikke er bekendt med, at forsøgspersonen tidligere har fremført indvendinger mod at deltage i den kliniske afprøvning
e)
den kliniske afprøvning vedrører direkte forsøgspersonens sygdomstilstand, som gør det umuligt inden for det terapeutiske vindue at indhente forudgående informeret samtykke fra forsøgspersonen eller fra dennes retligt udpegede repræsentant og give forudgående information, og den kliniske afprøvning er af en sådan art, at det udelukkende kan udføres i akutte situationer
f)
den kliniske afprøvning medfører en minimal risiko og en minimal byrde for forsøgspersonen i forhold til standardbehandlingen af forsøgspersonens tilstand.
2.   Efter en intervention i henhold til stk. 1 i denne artikel skal der i overensstemmelse med artikel 63 indhentes informeret samtykke, for at forsøgspersonen fortsat kan deltage i den kliniske afprøvning, og informationen om den kliniske afprøvning gives i overensstemmelse med følgende bestemmelser:
a)
for så vidt angår forsøgspersoner uden handleevne og mindreårige, skal investigator uden unødig forsinkelse indhente det informerede samtykke fra deres retligt udpegede repræsentanter, og den i artikel 63, stk. 2, nævnte information skal hurtigst muligt gives til forsøgspersonen og til dennes retligt udpegede repræsentant
b)
for så vidt angår andre forsøgspersoner skal det informerede samtykke af investigator indhentes uden unødig forsinkelse fra forsøgspersonen eller dennes retligt udpegede repræsentant, alt efter hvad der kan ske hurtigst, og den i artikel 63, stk. 2, nævnte information skal alt efter tilfældet så hurtigt som muligt gives til forsøgspersonen eller dennes retligt udpegede repræsentant.
Er der indhentet informeret samtykke fra den retligt udpegede repræsentant, skal der med henblik på litra b) indhentes informeret samtykke fra forsøgspersonen til fortsat at deltage i den kliniske afprøvning, så snart vedkommende er i stand til at give informeret samtykke.
3.   Når forsøgspersonen eller eventuelt dennes retligt udpegede repræsentant ikke giver samtykke, informeres de om, at de kan modsætte sig, at de data, der er indhentet ved den kliniske afprøvning, anvendes.
Artikel 69
Skadeserstatning
1.   Medlemsstaterne sikrer, at der findes erstatningsordninger for skader påført en forsøgsperson som følge af deltagelse i en klinisk afprøvning, der gennemføres på deres område, i form af forsikring, en garanti eller en tilsvarende ordning, der med hensyn til sit formål kan sidestilles hermed, og som er passende i forhold til risikoens art og omfang.
2.   Sponsor og investigator anvender den i stk. 1 nævnte ordning i den form, der er hensigtsmæssig for den medlemsstat, hvori den kliniske afprøvning gennemføres.
Artikel 70
Ansøgning om kliniske afprøvninger
1.   Sponsor af en klinisk afprøvning indsender en ansøgning til den medlemsstat, hvor den kliniske afprøvning skal gennemføres (med henblik på denne artikel benævnt »den berørte medlemsstat«), ledsaget af den dokumentation, der er omhandlet i bilag XV, kapitel II.
Ansøgningen skal indsendes ved hjælp af det elektroniske system, der er omhandlet i artikel 73, og som genererer et EU-dækkende unikt individuelt identifikationsnummer for den kliniske afprøvning, der skal anvendes i al relevant kommunikation i forbindelse med denne kliniske afprøvning. Senest 10 dage efter modtagelsen af ansøgningen underretter den berørte medlemsstat sponsor om, hvorvidt den kliniske afprøvning falder ind under denne forordnings anvendelsesområde, og hvorvidt dokumentationen i ansøgningen er fuldstændig i overensstemmelse med bilag XV, kapitel II.
2.   Senest en uge efter enhver ændring i forbindelse med den dokumentation, der er omhandlet i bilag XV, kapitel II, opdaterer sponsor de relevante data i det elektroniske system, der er omhandlet i artikel 73, og ændringen af dokumentationen skal klart kunne identificeres. Den berørte medlemsstat underrettes om opdateringen ved hjælp af det elektroniske system.
3.   Hvis den berørte medlemsstat finder, at den kliniske afprøvning, som der er ansøgt om, ikke falder ind under denne forordnings anvendelsesområde, eller at dossieret i forbindelse med ansøgningen ikke er fuldstændigt, underretter den sponsor herom og fastsætter en frist på højst 10 dage for sponsor til at fremsætte bemærkninger eller til at fuldstændiggøre ansøgningen ved hjælp af det elektroniske system omhandlet i artikel 73. Den berørte medlemsstat kan om nødvendigt forlænge denne frist med højst 20 dage.
Hvis sponsor ikke har fremsat bemærkninger eller fuldstændiggjort ansøgningen inden for den frist, der er nævnt i første afsnit, anses ansøgningen for at være bortfaldet. Hvis sponsor anser ansøgningen for at falde ind under denne forordnings anvendelsesområde og/eller være fuldstændig, men den berørte medlemsstat ikke er enig, anses ansøgningen for at være afslået. Den berørte medlemsstat sikrer, at et sådant afslag kan påklages.
Den berørte medlemsstat underretter senest fem dage efter modtagelsen af bemærkningerne eller de yderligere oplysninger, der er anmodet om, sponsor om, hvorvidt den kliniske afprøvning anses for at falde ind under denne forordnings anvendelsesområde, og hvorvidt ansøgningen er fuldstændig.
4.   Den berørte medlemsstat kan også forlænge hver periode, jf. stk. 1 og 3, med yderligere fem dage.
5.   Med henblik på dette kapitel er ansøgningens valideringsdato den dato, hvor sponsor underrettes i overensstemmelse med stk. 1 eller 3. Hvis sponsor ikke underrettes, er valideringsdatoen den sidste dag i de frister, der er nævnt i henholdsvis stk. 1, 3 og 4.
6.   I den periode, hvor ansøgningen bliver vurderet, kan medlemsstaten anmode om supplerende oplysninger fra sponsor. Udløbet af perioden fastsat i stk. 7, litra b), suspenderes fra datoen for den første anmodning indtil det tidspunkt, hvor de supplerende oplysninger modtages.
7.   Sponsor kan påbegynde den kliniske afprøvning i følgende tilfælde:
a)
for udstyr i klasse I bestemt til afprøvning eller for ikkeinvasivt udstyr i klasse IIa og IIb, medmindre andet er anført i national ret, umiddelbart efter ansøgningens valideringsdato, jf. stk. 5, og forudsat at den kompetente etiske komité i den berørte medlemsstat ikke har afgivet en negativ udtalelse vedrørende den kliniske afprøvning, der gælder for hele den pågældende medlemsstat i henhold til national ret
b)
for andet udstyr bestemt til afprøvning end det i litra a) omhandlede, så snart den berørte medlemsstat har underrettet sponsor om sin tilladelse, og forudsat at den kompetente etiske komité i den berørte medlemsstat ikke har afgivet en negativ udtalelse vedrørende den kliniske afprøvning, der gælder for hele den pågældende medlemsstat i henhold til national ret. Medlemsstaten underretter sponsor om tilladelsen senest 45 dage efter den valideringsdato, der er omhandlet i stk. 5. Medlemsstaten kan forlænge denne periode med yderligere 20 dage med henblik på at konsultere eksperter.
8.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for på baggrund af den tekniske udvikling og den internationale reguleringsmæssige udvikling at ændre kravene, jf. bilag XV, kapitel II.
9.   For at sikre en ensartet anvendelse af kravene i bilag XV, kapitel II, kan Kommissionen vedtage gennemførelsesretsakter, i det omfang det er nødvendigt for at løse spørgsmål vedrørende forskellige fortolkninger og den praktiske anvendelse. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 71
Medlemsstaternes vurdering
1.   Medlemsstaterne sikrer, at de personer, der validerer og vurderer ansøgningen eller træffer afgørelse herom, ikke har interessekonflikter, er uafhængige af sponsor, de involverede investigatorer og af de fysiske eller juridiske personer, som finansierer den kliniske afprøvning, og at de ikke udsættes for anden uretmæssig påvirkning.
2.   Medlemsstaterne sikrer, at vurderingen foretages i fællesskab af et passende antal personer, der tilsammen har den nødvendige erfaring og de nødvendige kvalifikationer.
3.   Medlemsstaterne vurderer, om den kliniske afprøvning er designet på en sådan måde, at eventuelle resterende risici for forsøgspersoner eller tredjemand, efter risikominimering, er berettigede, når de holdes op mod de kliniske fordele, der forventes. De undersøger, under hensyntagen til gældende fælles specifikationer eller harmoniserede standarder, navnlig:
a)
påvisningen af, at udstyr bestemt til afprøvning overholder de gældende generelle krav til sikkerhed og ydeevne, undtagen for så vidt angår de aspekter, der er omfattet af den kliniske afprøvning, og at der med hensyn til disse aspekter er truffet alle nødvendige forholdsregler for at beskytte forsøgspersonernes sundhed og sikkerhed. Dette omfatter, hvor det er relevant, garanti for testning af den tekniske og biologiske sikkerhed og præklinisk evaluering
b)
om de risikominimeringsløsninger, der anvendes af sponsor, er beskrevet i harmoniserede standarder og, i tilfælde af at sponsoren ikke anvender harmoniserede standarder, om risikominimeringsløsningerne sikrer et beskyttelsesniveau, der svarer til det beskyttelsesniveau, som de harmoniserede standarder giver
c)
om de planlagte foranstaltninger for sikker installation, ibrugtagning og vedligeholdelse af udstyr bestemt til afprøvning er tilstrækkelige
d)
pålideligheden og robustheden af de data, der genereres i den kliniske afprøvning, under hensyntagen til statistiske metoder, afprøvningens design og metodologiske aspekter, herunder prøvestørrelse, komparator og endepunkter
e)
om kravene i bilag XV er opfyldt
f)
for så vidt angår udstyr til steril brug, dokumentation for validering af fabrikantens steriliseringsprocedurer eller oplysninger om genanvendelses- og steriliseringsprocedurer, der skal udføres af afprøvningsstedet
g)
påvisningen af sikkerheden, kvaliteten og anvendeligheden for alle komponenter af animalsk eller human oprindelse eller for stoffer, der kan betragtes som lægemidler i henhold til direktiv 2001/83/EF.
4.   Medlemsstaterne afslår at give tilladelse til den kliniske afprøvning, hvis:
a)
ansøgningsdossieret, som er indsendt i henhold til artikel 70, stk. 1, fortsat er ufuldstændigt
b)
udstyret eller de forelagte dokumenter, især afprøvningsplanen og investigators brochure, ikke svarer til den videnskabelige viden, og navnlig hvis den kliniske afprøvning ikke er egnet til at dokumentere udstyrets sikkerhed, ydeevneegenskaber eller fordele for forsøgspersoner eller patienter
c)
kravene i artikel 62 ikke er opfyldt, eller
d)
vurderinger i henhold til stk. 3 er negative.
Medlemsstaterne sikrer, at et afslag i henhold til første afsnit kan påklages.
Artikel 72
Gennemførelse af en klinisk afprøvning
1.   Sponsor og investigator sikrer, at den kliniske afprøvning gennemføres i overensstemmelse med den godkendte kliniske afprøvningsplan.
2.   Med henblik på at verificere, at forsøgspersoners rettigheder, sikkerhed og velbefindende beskyttes, at de indberettede data er pålidelige og robuste, samt at gennemførelsen af den kliniske afprøvning er i overensstemmelse med denne forordnings krav, sikrer sponsor passende monitorering af gennemførelsen af en klinisk afprøvning. Omfanget og arten af monitoreringen fastlægges af sponsor på grundlag af en vurdering, der tager højde for alle den kliniske afprøvnings egenskaber, herunder følgende:
a)
den kliniske afprøvnings formål og metodologi, og
b)
graden af interventionens afvigelse fra normal klinisk praksis.
3.   Alle oplysninger om den kliniske afprøvning registreres, behandles, håndteres og opbevares af sponsor eller investigator alt efter omstændighederne på en måde, der muliggør korrekt indberetning, fortolkning og verifikation, samtidig med at fortroligheden af optegnelser og forsøgspersonernes personoplysninger beskyttes i overensstemmelse med gældende ret om beskyttelse af personoplysninger.
4.   Der iværksættes de fornødne tekniske og organisatoriske foranstaltninger til at beskytte de informationer og personoplysninger, der behandles, mod uautoriseret eller ulovlig adgang, videregivelse, udbredelse, ændring eller tilintetgørelse eller mod hændeligt tab, navnlig når behandlingen indebærer overførsel via et netværk.
5.   Medlemsstaterne inspicerer afprøvningsstedet/afprøvningsstederne i en passende grad for at sikre, at de kliniske afprøvninger gennemføres i henhold til kravene i denne forordning og den godkendte afprøvningsplan.
6.   Sponsor indfører en procedure for akutte situationer, der muliggør øjeblikkelig identificering og om nødvendigt øjeblikkelig tilbagetrækning af det udstyr, der anvendes i afprøvningen.
Artikel 73
Elektronisk system for kliniske afprøvninger
1.   Kommissionen skal i samarbejde med medlemsstaterne oprette, forvalte og vedligeholde et elektronisk system
a)
til oprettelse af individuelle identifikationsnumre for kliniske afprøvninger, jf. artikel 70, stk. 1
b)
til brug som indgang for indsendelse af alle ansøgninger eller underretninger om kliniske afprøvninger som omhandlet i artikel 70, 74, 75 og 78 samt for alle andre indsendelser af data eller behandling af data i denne sammenhæng
c)
til udveksling af oplysninger vedrørende kliniske afprøvninger i overensstemmelse med nærværende forordning mellem medlemsstaterne og mellem disse og Kommissionen, herunder udveksling af oplysninger som omhandlet i artikel 70 og 76
d)
til oplysninger, som sponsor skal give i overensstemmelse med artikel 77, herunder den kliniske afprøvningsrapport og dens resumé som krævet i stk. 5 i nævnte artikel
e)
til indberetning af de alvorlige uønskede hændelser og de mangler ved udstyret og opdateringerne heraf, der er omhandlet i artikel 80.
2.   Ved oprettelsen af det i denne artikels stk. 1 omhandlede elektroniske system sikrer Kommissionen, at det er kompatibelt med EU-databasen for kliniske forsøg med humanmedicinske lægemidler, der er oprettet i henhold til artikel 81 i Europa-Parlamentets og Rådets forordning (EU) nr. 536/2014 
(
37
)
, for så vidt angår kliniske afprøvninger af udstyr kombineret med kliniske forsøg i medfør af nævnte forordning.
3.   De oplysninger, der er omhandlet i stk. 1, litra c), skal kun være tilgængelige for medlemsstaterne og Kommissionen. De oplysninger, der er omhandlet i de andre litraer i nævnte stykke, skal være offentligt tilgængelige, medmindre alle eller dele af disse oplysninger skal behandles fortroligt af følgende årsager:
a)
beskyttelse af personoplysninger i henhold til forordning (EF) nr. 45/2001
b)
beskyttelse af kommercielt fortrolige oplysninger, navnlig i investigatorbrochuren, især ved at der tages hensyn til status for overensstemmelsesvurderingen af udstyret, medmindre væsentlige samfundsinteresser taler for at give adgang til dem
c)
effektivt tilsyn med gennemførelsen af den kliniske afprøvning fra den eller de berørte medlemsstaters side.
4.   Ingen personoplysninger vedrørende forsøgspersoner må være offentligt tilgængelige.
5.   Brugergrænsefladen i det elektroniske system, der er omhandlet i stk. 1, skal være tilgængelig på alle Unionens officielle sprog.
Artikel 74
Kliniske afprøvninger vedrørende udstyr, der er forsynet med CE-mærkning
1.   Hvis der skal gennemføres en klinisk afprøvning i henhold til udstyrets erklærede formål for yderligere at vurdere udstyr, der allerede er forsynet med CE-mærkning i overensstemmelse med artikel 20, stk. 1, (»PMCF-afprøvning«), og hvis afprøvningen indebærer, at forsøgspersoner udsættes for yderligere procedurer end dem, der udføres ved den normale anvendelse af udstyret, og disse yderligere procedurer er invasive eller belastende, underretter sponsor de berørte medlemsstater mindst 30 dage inden afprøvningens påbegyndelse ved hjælp af det elektroniske system, der er omhandlet i artikel 73. Sponsor vedlægger den dokumentation, der er omhandlet i bilag XV, kapitel II, som en del af underretningen. Artikel 62, stk. 4, litra b)-k) og m), artikel 75, 76 og 77, artikel 80, stk. 5, og de relevante bestemmelser i bilag XV finder anvendelse på PMCF-afprøvninger.
2.   Hvis der skal gennemføres en klinisk afprøvning ved anvendelse, der ligger uden for udstyrets erklærede formål, for at vurdere udstyr, der allerede er forsynet med CE-mærkning i overensstemmelse med artikel 20, stk. 1, finder artikel 62-81 anvendelse.
Artikel 75
Væsentlige ændringer af kliniske afprøvninger
1.   Hvis en sponsor har til hensigt at indføre ændringer i en klinisk afprøvning, der kan have en væsentlig indflydelse på forsøgspersonernes sikkerhed, sundhed eller rettigheder eller på robustheden eller pålideligheden af de kliniske data, der er genereret i forbindelse med afprøvningen, underretter sponsor ved hjælp af det elektroniske system, der er omhandlet i artikel 73, inden for en uge den eller de medlemsstater, hvor den kliniske afprøvning gennemføres eller skal gennemføres, om begrundelsen for disse ændringer og deres art. Sponsor skal vedlægge en opdateret version af den relevante dokumentation, jf. bilag XV, kapitel II, som en del af underretningen. Ændringer af den relevante dokumentation skal klart kunne identificeres.
2.   Medlemsstaterne vurderer alle væsentlige ændringer af den kliniske afprøvning i overensstemmelse med proceduren i artikel 71.
3.   Sponsor må tidligst gennemføre de ændringer, der er omhandlet i stk. 1, 38 dage efter den underretning, der er omhandlet i nævnte stykke, medmindre:
a)
den medlemsstat, hvor den kliniske afprøvning gennemføres eller skal gennemføres, har givet sponsor afslag af de grunde, der er omhandlet i artikel 71, stk. 4, eller ud fra hensynet til folkesundheden, forsøgspersonernes og brugernes sikkerhed eller sundhed eller den offentlige orden, eller
b)
en etisk komité i den pågældende medlemsstat har afgivet en negativ udtalelse vedrørende den væsentlige ændring af den kliniske afprøvning, som i henhold til national ret gælder for hele den pågældende medlemsstat.
4.   Den eller de berørte medlemsstater kan forlænge perioden, jf. stk. 3, med yderligere syv dage med henblik på at konsultere eksperter.
Artikel 76
Korrigerende handlinger, der træffes af medlemsstaterne, og udveksling af oplysninger mellem medlemsstaterne
1.   Har den medlemsstat, hvor den kliniske afprøvning gennemføres eller skal gennemføres, grunde til at mene, at kravene i denne forordning ikke er opfyldt, kan den som minimum træffe enhver af følgende foranstaltninger på sit område:
a)
tilbagekalde tilladelsen til den kliniske afprøvning
b)
suspendere eller afbryde den kliniske afprøvning
c)
kræve, at sponsor ændrer et hvilket som helst aspekt af den kliniske afprøvning.
2.   Inden den berørte medlemsstat træffer en af de i stk. 1 nævnte foranstaltninger, anmoder den sponsor eller investigator eller begge om en udtalelse, bortset fra tilfælde, hvor det er påkrævet, at der foretages øjeblikkelige handlinger. Denne udtalelse skal afgives inden for syv dage.
3.   Hvis en medlemsstat har truffet en foranstaltning, jf. denne artikels stk. 1, eller har givet afslag på en klinisk afprøvning eller af sponsoren er blevet underrettet om, at en klinisk afprøvning af sikkerhedsgrunde er blevet afbrudt, underretter den pågældende medlemsstat alle medlemsstater og Kommissionen om den pågældende beslutning og begrundelsen herfor ved hjælp af det elektroniske system, som er omhandlet i artikel 73.
4.   Hvis sponsor trækker en ansøgning tilbage, inden en medlemsstat har truffet sin beslutning, skal oplysningerne herom stilles til rådighed for alle medlemsstater og Kommissionen via det elektroniske system, der er omhandlet i artikel 73.
Artikel 77
Oplysninger, som sponsor skal give ved afslutningen af en klinisk afprøvning eller ved en midlertidig standsning eller afbrydelse
1.   Hvis sponsor midlertidigt har standset en klinisk afprøvning eller har afbrudt en klinisk afprøvning, informerer sponsor inden for 15 dage den medlemsstat, hvor den pågældende kliniske afprøvning er blevet midlertidigt standset eller afbrudt, via det elektroniske system, der er omhandlet i artikel 73, om den midlertidige standsning eller afbrydelsen og giver en begrundelse. Hvis sponsor af sikkerhedsgrunde midlertidigt har standset eller afbrudt den kliniske afprøvning, informerer sponsor inden for 24 timer alle de medlemsstater, hvor den pågældende kliniske afprøvning gennemføres.
2.   Afslutningen af en klinisk afprøvning anses for at falde sammen med den sidste forsøgspersons sidste besøg, medmindre der i den kliniske afprøvningsplan er fastsat et andet tidspunkt for afslutningen.
3.   Sponsor underretter hver medlemsstat, hvor den kliniske afprøvning blev gennemført, om afslutningen af den kliniske afprøvning i den pågældende medlemsstat. Denne underretning foretages senest 15 dage efter afslutningen af den kliniske afprøvning i den pågældende medlemsstat.
4.   Hvis en afprøvning gennemføres i mere end én medlemsstat, underretter sponsor alle de medlemsstater, hvor den kliniske afprøvning blev gennemført, om afslutningen af den kliniske afprøvning i alle medlemsstater. Denne underretning foretages senest 15 dage efter den pågældende afslutning af den kliniske afprøvning.
5.   Uanset resultatet af den kliniske afprøvning forelægger sponsor senest et år efter afslutningen af den kliniske afprøvning eller senest tre måneder efter afbrydelsen eller den midlertidige standsning for de medlemsstater, hvor der blev gennemført en klinisk afprøvning, en klinisk afprøvningsrapport, jf. bilag XV, kapitel I, punkt 2.8, og kapitel III, punkt 7.
Den kliniske afprøvningsrapport ledsages af et resumé, der er let forståeligt for den tilsigtede bruger. Sponsor forelægger både rapporten og resuméet ved hjælp af det elektroniske system, der er omhandlet i artikel 73.
Hvis det af videnskabelige grunde ikke er muligt at forelægge den kliniske afprøvningsrapport inden for et år efter afslutningen af afprøvningen, skal den forelægges, så snart den foreligger. I så fald angives det i den kliniske afprøvningsplan, jf. bilag XV, kapitel II, punkt 3, hvornår resultaterne af den kliniske afprøvning vil foreligge, sammen med en begrundelse.
6.   Kommissionen udsteder retningslinjer vedrørende indholdet og strukturen af resuméet af den kliniske afprøvningsrapport.
Kommissionen kan endvidere udarbejde retningslinjer for format og deling af rådata i de tilfælde, hvor sponsor beslutter at dele rådata på frivillig basis. Disse retningslinjer kan tage udgangspunkt i og, hvis det er muligt, tilpasse de eksisterende retningslinjer for deling af rådata i forbindelse med kliniske afprøvninger.
7.   Resuméet og den kliniske afprøvningsrapport, jf. denne artikels stk. 5, skal gøres offentligt tilgængelige via det elektroniske system, jf. artikel 73, senest når udstyret er blevet registreret i henhold til artikel 29, og inden det bringes i omsætning. I tilfælde af afbrydelse eller midlertidig standsning skal resuméet og rapporten gøres offentligt tilgængelige umiddelbart efter forelæggelsen.
Hvis udstyret ikke er registreret i henhold til artikel 29 inden for et år efter indførelsen af resuméet og rapporten i det elektroniske system i henhold til denne artikels stk. 5, gøres de offentligt tilgængelige på dette tidspunkt.
Artikel 78
Koordineret vurderingsprocedure for kliniske afprøvninger
1.   Ved hjælp af det elektroniske system, som er omhandlet i artikel 73, kan sponsor for en klinisk afprøvning, der skal gennemføres i mere end én medlemsstat, med henblik på artikel 70 indsende en enkelt ansøgning, som efter modtagelsen sendes elektronisk til alle de medlemsstater, hvor den kliniske afprøvning skal gennemføres.
2.   I den enkelte ansøgning som omhandlet i stk. 1 foreslår sponsor, at en af de medlemsstater, hvor den kliniske afprøvning skal gennemføres, fungerer som koordinerende medlemsstat. De medlemsstater, hvor den kliniske afprøvning skal gennemføres, skal senest seks dage efter indsendelsen af ansøgningen nå til enighed om, hvem af dem der påtager sig rollen som koordinerende medlemsstat. Hvis de ikke når til enighed om en koordinerende medlemsstat, påtager den koordinerende medlemsstat, som sponsor har foreslået, sig denne rolle.
3.   Under den i stk. 2 omhandlede koordinerende medlemsstats ledelse koordinerer de berørte medlemsstater deres vurdering af ansøgningen, navnlig af den dokumentation, der er omhandlet i bilag XV, kapitel II.
Fuldstændigheden af den dokumentation, der er omhandlet i bilag XV, kapitel II, punkt 1.13, 3.1.3, 4.2, 4.3 og 4.4, skal dog vurderes særskilt af hver enkelt berørt medlemsstat i henhold til artikel 70, stk. 1-5.
4.   Med hensyn til dokumentation, bortset fra den, der er omhandlet i stk. 3, andet afsnit, skal den koordinerende medlemsstat:
a)
senest seks dage efter modtagelsen af ansøgningen underrette sponsor om, at den er koordinerende medlemsstat (»underretningsdatoen«)
b)
med henblik på validering af ansøgningen tage hensyn til eventuelle overvejelser, som en berørt medlemsstat har forelagt senest syv dage efter underretningsdatoen
c)
senest 10 dage efter underretningsdatoen vurdere, om den kliniske afprøvning er omfattet af denne forordning, og om ansøgningen er fuldstændig, samt underrette sponsor herom. Artikel 70, stk. 1 og 3-5, finder anvendelse på den koordinerende medlemsstat i forbindelse med den pågældende vurdering
d)
fastslå resultaterne af sin vurdering i et udkast til vurderingsrapport, der senest 26 dage efter valideringsdatoen skal fremsendes til de berørte medlemsstater. Senest 38 dage efter valideringsdatoen fremsender de øvrige berørte medlemsstater deres kommentarer og forslag til udkastet til vurderingsrapporten og den tilgrundliggende ansøgning til den koordinerende medlemsstat, som tager behørigt hensyn til disse kommentarer og forslag i færdiggørelsen af den endelige vurderingsrapport, der senest 45 dage efter valideringsdatoen fremsendes til sponsor og de øvrige berørte medlemsstater.
Alle de berørte medlemsstater tager den endelige vurderingsrapport i betragtning, når der træffes beslutning om sponsors ansøgning i overensstemmelse med artikel 70, stk. 7.
5.   For så vidt angår vurderingen af den dokumentation, der er omhandlet i stk. 3, andet afsnit, kan hver berørt medlemsstat en enkelt gang anmode om supplerende oplysninger fra sponsor. Sponsor forelægger de supplerende oplysninger, der er anmodet om, inden for den frist, der er fastsat af den berørte medlemsstat, og som ikke må overstige 12 dage fra modtagelsen af anmodningen. Udløbet af den sidste frist i henhold til stk. 4, litra d), suspenderes fra datoen for anmodningen indtil det tidspunkt, hvor de supplerende oplysninger modtages.
6.   For udstyr i klasse IIb og III kan den koordinerende medlemsstat også forlænge perioderne, jf. stk. 4, med yderligere 50 dage med henblik på at konsultere eksperter.
7.   Kommissionen kan ved hjælp af gennemførelsesretsakter yderligere specificere procedurer og tidsplaner for koordinerede vurderinger, som skal tages i betragtning af de berørte medlemsstater, når der træffes beslutning om sponsors ansøgning. Sådanne gennemførelsesretsakter kan også fastsætte procedurer og tidsplaner for koordineret vurdering i tilfælde af væsentlige ændringer i henhold til denne artikels stk. 12 i tilfælde af indberetning af uønskede hændelser i henhold til artikel 80, stk. 4, og i tilfælde af kliniske afprøvninger af kombinationsprodukter af medicinsk udstyr og lægemidler, hvor sidstnævnte er under sideløbende koordineret vurdering i forbindelse med et klinisk forsøg i henhold til forordning (EU) nr. 536/2014. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
8.   Er den koordinerende medlemsstats konklusion vedrørende området for koordineret vurdering, at gennemførelsen af den kliniske afprøvning kan accepteres eller accepteres under overholdelse af særlige betingelser, anses den pågældende konklusion for at være alle de berørte medlemsstaters konklusion.
Uanset første afsnit må en berørt medlemsstat kun erklære sig uenig i den koordinerende medlemsstats konklusion vedrørende området for koordineret vurdering af følgende grunde:
a)
når den finder, at deltagelse i den kliniske afprøvning ville føre til, at en forsøgsperson ville modtage en behandling, der er ringere end den behandling, der modtages i normal klinisk praksis i den berørte medlemsstat
b)
overtrædelse af national ret, eller
c)
overvejelser vedrørende forsøgspersoners sikkerhed eller dataenes pålidelighed og robusthed, som er fremført i henhold til stk. 4, litra b).
Erklærer en af de berørte medlemsstater sig uenig i konklusionen på grundlag af dette stykkes andet afsnit, underretter den via det elektroniske system, der er omhandlet i artikel 73, Kommissionen, alle de andre berørte medlemsstater og sponsor herom og giver en detaljeret begrundelse.
9.   Er den koordinerende medlemsstats konklusion vedrørende området for koordineret vurdering, at den kliniske afprøvning ikke kan accepteres, anses den pågældende konklusion for at være alle de berørte medlemsstaters konklusion.
10.   En berørt medlemsstat afslår at give tilladelse til en klinisk afprøvning, hvis den ikke er enig i den koordinerende medlemsstats konklusion for så vidt angår nogen af de i stk. 8, andet afsnit, anførte grunde, eller hvis den af behørigt begrundede årsager finder, at aspekterne omfattet af bilag XV, kapitel II, punkt 1.13, 3.1.3, 4.2, 4.3 og 4.4, ikke er overholdt, eller hvis en etisk komité har afgivet negativ udtalelse vedrørende den pågældende kliniske afprøvning, som i henhold til national ret gælder for hele den pågældende medlemsstat. Den berørte medlemsstat sikrer, at et sådant afslag kan påklages.
11.   Hver berørt medlemsstat underretter via det elektroniske system, der er omhandlet i artikel 73, sponsor om, hvorvidt den kliniske afprøvning er tilladt, om den er tilladt på visse betingelser, eller om der er givet afslag. Underretningen sker ved hjælp af en enkelt afgørelse senest fem dage efter den koordinerende medlemsstats fremsendelse i henhold til stk. 4, litra d), af den endelige vurderingsrapport. Hvis en tilladelse til en klinisk afprøvning er underlagt betingelser, må det kun være sådanne betingelser, som ifølge deres natur ikke kan opfyldes på tidspunktet for denne tilladelse.
12.   De berørte medlemsstater underrettes om alle væsentlige ændringer, der er nævnt i artikel 75, ved hjælp af det elektroniske system, som er omhandlet i artikel 73. Enhver vurdering af, om der er begrundelse for uenighed, jf. nærværende artikels stk. 8, andet afsnit, skal foretages under ledelse af den koordinerende medlemsstat, bortset fra væsentlige ændringer vedrørende bilag XV, kapitel II, punkt 1.13, 3.1.3, 4.2, 4.3 og 4.4, som vurderes særskilt af hver berørt medlemsstat.
13.   Kommissionen yder administrativ støtte til den koordinerende medlemsstat i forbindelse med udførelsen af dens opgaver i henhold til dette kapitel.
14.   Den procedure, der er fastsat i denne artikel, skal indtil den 27. maj 2027 kun anvendes i de medlemsstater, hvori den kliniske afprøvning skal gennemføres, og som har accepteret procedurens anvendelse. Efter den 27. maj 2027 skal alle medlemsstater anvende den nævnte procedure.
Artikel 79
Gennemgang af den koordinerede vurderingsprocedure
Senest den 27. maj 2026 forelægger Kommissionen en rapport for Europa-Parlamentet og Rådet om erfaringerne med anvendelsen af artikel 78 og foreslår om nødvendigt en gennemgang af artikel 78, stk. 14, og artikel 123, stk. 3, litra h).
Artikel 80
Registrering og indberetning af uønskede hændelser i forbindelse med kliniske afprøvninger
1.   Sponsor foretager en fuldstændig registrering af alle følgende punkter:
a)
enhver uønsket hændelse af den type, der i den kliniske afprøvningsplan er identificeret som kritisk for evalueringen af resultaterne af den pågældende kliniske afprøvning
b)
enhver alvorlig uønsket hændelse
c)
enhver mangel ved udstyret, som kunne have ført til en alvorlig uønsket hændelse, hvis der ikke var blevet truffet passende foranstaltninger, hvis der ikke var blevet grebet ind, eller hvis omstændighederne havde været mindre gunstige
d)
alle nye oplysninger i forbindelse med en hændelse, der er omhandlet i litra a)-c).
2.   Sponsor indberetter straks alle følgende punkter til alle de medlemsstater, hvor den kliniske afprøvning gennemføres, ved hjælp af det elektroniske system, der er omhandlet i artikel 73:
a)
enhver alvorlig uønsket hændelse, som har en kausal sammenhæng med det udstyr, der afprøves, komparatoren eller afprøvningsproceduren, eller hvor en sådan kausal sammenhæng med rimelighed er mulig
b)
enhver mangel ved udstyret, som kunne have ført til en alvorlig uønsket hændelse, hvis der ikke var blevet truffet passende foranstaltninger, hvis der ikke var blevet grebet ind, eller hvis omstændighederne havde været mindre gunstige
c)
alle nye oplysninger i forbindelse med en hændelse, der er omhandlet i litra a) og b).
Indberetningsfristen skal tage hensyn til hændelsens alvor. Hvis det er nødvendigt for at sikre rettidig indberetning, kan sponsor forelægge en første ufuldstændig indberetning fulgt op af en fuldstændig indberetning.
På anmodning fra enhver medlemsstat, hvor den kliniske afprøvning gennemføres, forelægger sponsor alle de oplysninger, der er omhandlet i stk. 1.
3.   Sponsor indberetter ligeledes enhver hændelse, der er omhandlet i denne artikels stk. 2, og som finder sted i tredjelande, hvor der gennemføres en klinisk afprøvning i henhold til en klinisk afprøvningsplan, der er den samme som den, der gælder for en klinisk afprøvning, der er omfattet af denne forordning, til de medlemsstater, hvor den kliniske afprøvning gennemføres, ved hjælp af det elektroniske system, der er omhandlet i artikel 73.
4.   For så vidt angår en klinisk afprøvning, i forbindelse med hvilken sponsor har indsendt én enkelt ansøgning, jf. artikel 78, indberetter sponsor enhver hændelse, der er omhandlet i nærværende artikels stk. 2, ved hjælp af det elektroniske system, der er omhandlet i artikel 73. Efter modtagelsen sendes denne indberetning elektronisk til alle de medlemsstater, hvor den kliniske afprøvning gennemføres.
Under ledelse af den koordinerende medlemsstat, jf. artikel 78, stk. 2, koordinerer medlemsstaterne deres vurdering af alvorlige uønskede hændelser og mangler ved udstyret for at afgøre, om en klinisk afprøvning skal ændres, suspenderes eller afbrydes eller om tilladelsen til den kliniske afprøvning skal tilbagekaldes.
Dette stykke berører ikke de øvrige medlemsstaters ret til at foretage deres egen evaluering og til at vedtage foranstaltninger i overensstemmelse med denne forordning for at sikre beskyttelsen af folkesundheden og patientsikkerheden. Den koordinerende medlemsstat og Kommissionen skal holdes underrettet om resultatet af en sådan evaluering og vedtagelsen af sådanne foranstaltninger.
5.   For så vidt angår PMCF-afprøvninger, jf. artikel 74, stk. 1, finder bestemmelserne om sikkerhedsovervågning i artikel 87-90 og i de retsakter, der er vedtaget i henhold til artikel 91, anvendelse i stedet for denne artikel.
6.   Uanset stk. 5 finder denne artikel anvendelse, når der er fastlagt en kausal sammenhæng mellem den alvorlige uønskede hændelse og den foregående afprøvningsprocedure.
Artikel 81
Gennemførelsesretsakter
Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte de nærmere bestemmelser og proceduremæssige aspekter, der er nødvendige for at gennemføre dette kapitel, med hensyn til følgende:
a)
harmoniserede elektroniske formularer til ansøgningen om kliniske afprøvninger og vurderingen heraf, jf. artikel 70 og 78, idet der tages hensyn til specifikke kategorier eller grupper af udstyr
b)
det elektroniske systems funktion, jf. artikel 73
c)
harmoniserede elektroniske formularer til indberetning af PMCF-afprøvninger, jf. artikel 74, stk. 1, og væsentlige ændringer, jf. artikel 75
d)
udveksling af oplysninger mellem medlemsstaterne, jf. artikel 76
e)
harmoniserede elektroniske formularer til indberetning af alvorlige uønskede hændelser og mangler ved udstyret, jf. artikel 80
f)
fristerne for indberetning af alvorlige uønskede hændelser og mangler ved udstyret under hensyn til alvoren af den hændelse, der skal indberettes, jf. artikel 80
g)
ensartet anvendelse af kravene til klinisk dokumentation eller data, der er nødvendige for at påvise overensstemmelse med de væsentlige krav til sikkerhed og ydeevne fastsat i bilag I.
De gennemførelsesretsakter, der er omhandlet i stk. 1, vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 82
Krav vedrørende andre kliniske afprøvninger
1.   Kliniske afprøvninger, der ikke gennemføres i henhold til nogen af formålene i artikel 62, stk. 1, skal overholde bestemmelserne i artikel 62, stk. 2 og 3, artikel 62, stk. 4, litra b), c), d), f), h) og l), og artikel 62, stk. 6.
2.   For at beskytte forsøgspersonernes rettigheder, sikkerhed, værdighed og velfærd og den videnskabelige og etiske integritet af de kliniske afprøvninger, der ikke gennemføres med henblik på nogen af formålene i artikel 62, stk. 1, skal hver medlemsstat definere eventuelle yderligere krav om sådanne afprøvninger, hvis det er relevant for den enkelte berørte medlemsstat.
KAPITEL VII
OVERVÅGNING, EFTER AT UDSTYRET ER BRAGT I OMSÆTNING, SIKKERHEDSOVERVÅGNING OG MARKEDSOVERVÅGNING
AFDELING 1
Overvågning, efter at udstyret er bragt i omsætning
Artikel 83
Fabrikantens system til overvågning, efter at udstyret er bragt i omsætning
1.   Fabrikanterne skal for hvert udstyr planlægge, etablere, dokumentere, implementere, vedligeholde og opdatere et system til overvågning, efter at udstyret er bragt i omsætning, på en måde, der skal stå i rimeligt forhold til udstyrets risikoklasse og være passende for denne type udstyr. Dette system skal udgøre en integreret del af fabrikantens kvalitetsstyringssystem i overensstemmelse med artikel 10, stk. 9.
2.   Systemet til overvågning, efter at udstyret er bragt i omsætning, skal være egnet til aktivt og systematisk at indsamle, registrere og analysere relevante data om et udstyrs kvalitet, ydeevne og sikkerhed i hele dets levetid, til at drage de nødvendige konklusioner og til at fastlægge, gennemføre og monitorere forebyggende og korrigerende handlinger.
3.   Data, der indsamles af fabrikantens system til overvågning, efter at udstyret er bragt i omsætning, skal navnlig anvendes til
a)
at opdatere afvejningen af fordele og risici og forbedre risikostyringen, jf. bilag I, kapitel I
b)
at opdatere design- og fremstillingsoplysningerne, brugsanvisningen og mærkningen
c)
at opdatere den kliniske evaluering
d)
at opdatere sammenfatningen af sikkerhed og klinisk ydeevne, jf. artikel 32
e)
at identificere behov for en forebyggende, korrigerende eller sikkerhedsrelateret korrigerende handling
f)
at identificere muligheder for at forbedre udstyrets brugbarhed, ydeevne og sikkerhed
g)
når det er relevant, at bidrage til overvågning af andet udstyr, efter at det er bragt i omsætning, og
h)
at påvise og indberette tendenser i overensstemmelse med artikel 88.
Den tekniske dokumentation opdateres i overensstemmelse hermed.
4.   Hvis der under overvågningen, efter at udstyret er bragt i omsætning, identificeres et behov for en forebyggende eller korrigerende handling eller begge, gennemfører fabrikanten passende foranstaltninger og orienterer de berørte kompetente myndigheder og i givet fald det bemyndigede organ. Hvis en alvorlig hændelse identificeres, eller der foretages en sikkerhedsrelateret korrigerende handling, indberettes det i overensstemmelse med artikel 87.
Artikel 84
Plan for overvågning, efter at udstyret er bragt i omsætning
Systemet til overvågning, efter at udstyret er bragt i omsætning, der er omhandlet i artikel 83, skal baseres på en plan for overvågning, efter at udstyret er bragt i omsætning, som der er fastlagt krav for i bilag III, punkt 1.1. For udstyr, bortset fra udstyr efter mål, skal planen for overvågning, efter at udstyret er bragt i omsætning, være en del af den tekniske dokumentation, jf. bilag II.
Artikel 85
Rapport om overvågning, efter at udstyret er bragt i omsætning
Fabrikanter af udstyr i klasse I udarbejder en rapport om overvågning, efter at udstyret er bragt i omsætning, som sammendrager resultater og konklusioner af analyserne af de data fra overvågningen, efter at udstyret er bragt i omsætning, der er indsamlet som resultat af den plan for overvågning, efter at udstyret er bragt i omsætning, der er omhandlet i artikel 84, sammen med et rationale for og en beskrivelse af eventuelle forebyggende og korrigerende handlinger. Rapporten opdateres efter behov og stilles til rådighed for den kompetente myndighed efter anmodning.
Artikel 86
Periodisk opdateret sikkerhedsindberetning
1.   Fabrikanter af udstyr i klasse IIa, klasse IIb og klasse III udarbejder en periodisk opdateret sikkerhedsindberetning for hvert udstyr og, hvis dette er relevant, for hver kategori eller gruppe af udstyr, som sammendrager resultater og konklusioner af analyserne af de data fra overvågningen, efter at udstyret er bragt i omsætning, der er indsamlet som resultat af den plan for overvågning, efter at udstyret er bragt i omsætning, der er omhandlet i artikel 84, sammen med et rationale for og en beskrivelse af eventuelle forebyggende og korrigerende handlinger. I hele det pågældende udstyrs levetid skal denne periodiske opdaterede sikkerhedsindberetning angive:
a)
de konklusioner, der skal anvendes ved afvejningen af fordele og risici
b)
PMCF'ens vigtigste resultater, og
c)
udstyrets salgsmængde og et skøn over størrelsen af og andre karakteristika for den population, der anvender udstyret, og, hvis det er praktisk muligt, udstyrets anvendelseshyppighed.
Fabrikanter af udstyr i klasse IIb og klasse III skal opdatere den periodiske opdaterede sikkerhedsindberetning mindst én gang årligt. Denne periodiske opdaterede sikkerhedsindberetning skal, bortset fra udstyr efter mål, være en del af den tekniske dokumentation, jf. bilag II og III.
Fabrikanter af udstyr i klasse IIa skal opdatere den periodiske opdaterede sikkerhedsindberetning, når det er nødvendigt, og mindst hvert andet år. Denne periodiske opdaterede sikkerhedsindberetning skal, bortset fra udstyr efter mål, være en del af den tekniske dokumentation, jf. bilag II og III.
For udstyr efter mål skal den periodiske opdaterede sikkerhedsindberetning være en del af dokumentationen i bilag XIII, punkt 2.
2.   For udstyr i klasse III eller implantabelt udstyr fremlægger fabrikanter periodiske opdaterede sikkerhedsindberetninger via det elektroniske system, der er omhandlet i artikel 92, for det bemyndigede organ, der deltager i overensstemmelsesvurdering i overensstemmelse med artikel 52. Det bemyndigede organ gennemgår indberetningen og tilføjer sin evaluering til det elektroniske system med en detaljeret beskrivelse af eventuelle foranstaltninger, der er truffet. Disse periodiske opdaterede sikkerhedsindberetninger og evalueringen fra det bemyndigede organ gøres tilgængelige for de kompetente myndigheder via det elektroniske system.
3.   For andet udstyr end det, der er omhandlet i stk. 2, stiller fabrikanterne periodiske opdaterede sikkerhedsindberetninger til rådighed for det bemyndigede organ, der deltager i overensstemmelsesvurderingen, og, efter anmodning, for de kompetente myndigheder.
AFDELING 2
Sikkerhedsovervågning
Artikel 87
Indberetning af alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger
1.   Fabrikanter af udstyr, der er gjort tilgængeligt på EU-markedet, bortset fra udstyr bestemt til afprøvning, skal til de relevante kompetente myndigheder, jf. artikel 92, stk. 5 og 7, indberette følgende:
a)
enhver alvorlig hændelse vedrørende udstyr, der er gjort tilgængeligt på EU-markedet, bortset fra forventede bivirkninger, som er klart dokumenterede i produktinformationen og kvantificeret i den tekniske dokumentation og er genstand for indberetning af tendenser i henhold til artikel 88
b)
enhver sikkerhedsrelateret korrigerende handling vedrørende udstyr, der er gjort tilgængeligt på EU-markedet, herunder sikkerhedsrelaterede korrigerende handlinger, der foretages i et tredjeland i forbindelse med udstyr, der også lovligt er gjort tilgængeligt på EU-markedet, hvis årsagen til den sikkerhedsrelaterede korrigerende handling ikke kun er begrænset til udstyr, der er gjort tilgængeligt i tredjelandet.
De i første afsnit omhandlede indberetninger skal indsendes via det i artikel 92 omhandlede elektroniske system.
2.   Generelt skal der i fristen for indberetning, jf. stk. 1, tages hensyn til den alvorlige hændelses alvor.
3.   Fabrikanterne skal indberette enhver alvorlig hændelse, jf. stk. 1, litra a), umiddelbart efter, at de har etableret den kausale sammenhæng mellem den pågældende hændelse og deres udstyr, eller at en sådan kausal sammenhæng med rimelighed er mulig, og højst 15 dage efter, at de har fået kendskab til hændelsen.
4.   Uanset stk. 3 skal indberetningen, jf. stk. 1, i tilfælde af en alvorlig trussel mod folkesundheden finde sted straks og højst to dage efter, at fabrikanten har fået kendskab til denne trussel.
5.   Uanset stk. 3 skal indberetningen i tilfælde af død eller en uventet alvorlig forringelse af en persons sundhedstilstand finde sted, straks efter at fabrikanten har etableret, eller så snart han får mistanke om en kausal sammenhæng mellem udstyret og den alvorlige hændelse, dog senest 10 dage efter den dato, hvor fabrikanten bliver bekendt med den alvorlige hændelse.
6.   Hvis det er nødvendigt for at sikre rettidig indberetning, kan fabrikanten forelægge en første ufuldstændig indberetning fulgt op af en fuldstændig indberetning.
7.   Hvis fabrikanten efter at være blevet bekendt med en hændelse, der potentielt skal indberettes, er usikker på, om hændelsen skal indberettes, skal denne alligevel forelægge en rapport inden for den frist, der kræves i henhold til stk. 2-5.
8.   Fabrikanten skal, med undtagelse af nødstilfælde, hvor han straks skal foretage den sikkerhedsrelaterede korrigerende handling, uden unødigt ophold indberette den sikkerhedsrelaterede korrigerende handling, der er omhandlet i stk. 1, litra b), inden den sikkerhedsrelaterede korrigerende handling foretages.
9.   For så vidt angår alvorlige hændelser, der forekommer med samme udstyr eller type af udstyr, og hvis årsag er identificeret, eller for hvilke der er foretaget en sikkerhedsrelateret korrigerende handling, eller hvis hændelserne er almindelige og veldokumenterede, kan fabrikanten forelægge periodiske sammenfattende indberetninger i stedet for individuelle indberetninger af alvorlige hændelser, på betingelse af at den koordinerende kompetente myndighed, der er omhandlet i artikel 89, stk. 9, i samråd med de kompetente myndigheder, der er omhandlet i artikel 92, stk. 8, litra a), er blevet enig med fabrikanten om form, indhold og hyppighed af den periodiske sammenfattende indberetning. Hvis artikel 92, stk. 8, litra a) og b), omhandler en enkelt kompetent myndighed, kan fabrikanten forelægge periodiske sammenfattende indberetninger efter aftale med denne kompetente myndighed.
10.   Medlemsstaterne træffer passende foranstaltninger såsom gennemførelse af målrettede oplysningskampagner for at tilskynde sundhedspersoner, brugere og patienter til og give dem mulighed for at indberette formodede alvorlige hændelser, jf. stk. 1, litra a), til de kompetente myndigheder.
De kompetente myndigheder registrerer de indberetninger, som de modtager fra sundhedspersoner, brugere og patienter, centralt på nationalt niveau.
11.   Hvis en kompetent myndighed i en medlemsstat modtager sådanne indberetninger om formodede alvorlige hændelser, jf. stk. 1, litra a), fra sundhedspersoner, brugere og patienter, skal den træffe de nødvendige foranstaltninger til at sikre, at fabrikanten af det pågældende udstyr straks underrettes om den formodede alvorlige hændelse.
Hvis fabrikanten af det pågældende udstyr mener, at hændelsen er en alvorlig hændelse, skal denne forelægge den kompetente myndighed i den medlemsstat, hvor den alvorlige hændelse fandt sted, en indberetning om den alvorlige hændelse i henhold til stk. 1-5 i denne artikel og foretage passende opfølgning i overensstemmelse med artikel 89.
Hvis fabrikanten af det pågældende udstyr mener, at hændelsen ikke er en alvorlig hændelse eller er en forventet uønsket bivirkning, der vil være omfattet af indberetning af tendenser i henhold til artikel 88, skal denne forelægge en begrundelse. Hvis den kompetente myndighed ikke er enig i konklusionen i begrundelsen, kan den anmode fabrikanten om at forelægge en indberetning i overensstemmelse med stk. 1-5 i denne artikel og anmode fabrikanten om at sikre, at der foretages en passende opfølgning i overensstemmelse med artikel 89.
Artikel 88
Indberetning af tendenser
1.   Fabrikanter skal via det elektroniske system, der er omhandlet i artikel 92, indberette enhver statistisk signifikant stigning i hyppigheden eller alvoren af hændelser, der ikke er alvorlige hændelser, eller som er forventede uønskede bivirkninger, som kan have væsentlig indvirkning på analysen af forholdet mellem fordele og risici, jf. bilag I, punkt 1 og 5, og som har medført eller kan medføre risici for patienters, brugeres eller andre personers sundhed og sikkerhed, der er uacceptable, sammenlignet med de forventede fordele. Den signifikante stigning fastsættes i forhold til den forventede hyppighed eller alvor af sådanne hændelser i forbindelse med det pågældende udstyr eller den pågældende kategori eller gruppe af udstyr i løbet af en bestemt periode som fastsat i den tekniske dokumentation og produktinformationen.
Fabrikanten skal i planen for overvågning, efter at udstyret er bragt i omsætning, jf. artikel 84, angive, hvordan de hændelser, der er omhandlet i første afsnit, skal behandles, og hvilke metoder der skal anvendes til at kortlægge statistisk signifikante stigninger i hyppigheden eller alvoren af sådanne hændelser, samt observationsperioden.
2.   De kompetente myndigheder kan gennemføre deres egne vurderinger af de i stk. 1 omhandlede indberetninger af tendenser og anmode fabrikanten om at vedtage passende foranstaltninger i overensstemmelse med denne forordning med henblik på at sikre beskyttelsen af folkesundheden og patientsikkerheden. Hver kompetent myndighed skal orientere Kommissionen, de øvrige kompetente myndigheder og det bemyndigede organ, der har udstedt certifikatet, om resultaterne af denne vurdering og om vedtagelsen af sådanne foranstaltninger.
Artikel 89
Analyse af alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger
1.   Efter indberetning af en alvorlig hændelse i henhold til artikel 87, stk. 1, skal fabrikanten straks foretage de nødvendige undersøgelser vedrørende den alvorlige hændelse og det berørte udstyr. Dette omfatter en risikovurdering af hændelsen og sikkerhedsrelaterede korrigerende handlinger under hensyntagen til kriterier, der er omhandlet i nærværende artikels stk. 3, hvis det er hensigtsmæssigt.
Fabrikanten samarbejder med de kompetente myndigheder og, hvis det er relevant, med det berørte bemyndigede organ under de undersøgelser, der er omhandlet i første afsnit, og må ikke foretage nogen undersøgelse, der medfører ændringer af udstyret eller af en prøve af den berørte batch på en sådan måde, at det kan påvirke en efterfølgende evaluering af årsagerne til hændelsen, uden først at orientere de kompetente myndigheder om en sådan handling.
2.   Medlemsstaterne tager de nødvendige skridt til sikring af, at alle oplysninger om en alvorlig hændelse, der er indtruffet på deres område, eller en sikkerhedsrelateret korrigerende handling, der er foretaget eller skal foretages på deres område, og som kommer til deres kendskab i overensstemmelse med artikel 87, evalueres centralt på nationalt plan af deres kompetente myndighed, om muligt sammen med fabrikanten og, når dette er relevant, det berørte bemyndigede organ.
3.   I forbindelse med den evaluering, der er omhandlet i stk. 2, evaluerer den kompetente myndighed de risici, der opstår som følge af den indberettede alvorlige hændelse, og evaluerer eventuelle sikkerhedsrelaterede korrigerende handlinger i forbindelse hermed under hensyntagen til beskyttelse af folkesundheden og kriterier såsom kausal sammenhæng, sporbarhed, sandsynlighed for problemets gentagelse, udstyrets anvendelseshyppighed, sandsynlighed for forekomst af direkte eller indirekte skader, disse skaders omfang, de kliniske fordele ved udstyret, tilsigtede og potentielle brugere og den berørte population. Den kompetente myndighed evaluerer også egnetheden af den sikkerhedsrelaterede korrigerende handling, som fabrikanten påtænker at foretage eller har foretaget, og behovet for og typen af andre korrigerende handlinger, navnlig under hensyntagen til princippet om indbygget sikkerhed, jf. bilag I.
Efter anmodning fra den kompetente nationale myndighed forelægger fabrikanter alle de dokumenter, der er nødvendige for risikovurderingen.
4.   Den kompetente myndighed fører tilsyn med fabrikantens undersøgelse af en alvorlig hændelse. Når det er nødvendigt, kan en kompetent myndighed gribe ind i en fabrikants undersøgelse eller iværksætte en uafhængig undersøgelse.
5.   Fabrikanten forelægger den kompetente myndighed en endelig rapport, der indeholder dens resultater af undersøgelsen, ved hjælp af det elektroniske system, der er omhandlet i artikel 92. Rapporten skal indeholde konklusioner og, når det er relevant, angive de korrigerende handlinger, der skal foretages.
6.   For så vidt angår udstyr omhandlet i artikel 1, stk. 8, første afsnit, og hvis den alvorlige hændelse eller den sikkerhedsrelaterede korrigerende handling kan vedrøre et stof, der anvendt alene betragtes som et lægemiddel, underretter den evaluerende kompetente myndighed eller den koordinerende kompetente myndighed, jf. stk. 9 i denne artikel, den nævnte nationale kompetente myndighed eller EMA, alt efter hvem som har udstedt den videnskabelige udtalelse om det pågældende stof, jf. artikel 52, stk. 9, om den alvorlige hændelse eller den sikkerhedsrelaterede korrigerende handling.
For så vidt angår udstyr omfattet af denne forordning i overensstemmelse med artikel 1, stk. 6, litra g), og hvis den alvorlige hændelse eller den sikkerhedsrelaterede korrigerende handling kan være knyttet til derivater af væv eller celler af human oprindelse, som anvendes til fremstilling af udstyret, og for så vidt angår udstyr, der i henhold til artikel 1, stk. 10, er omfattet af denne forordning, underretter den kompetente myndighed eller den koordinerende kompetente myndighed, jf. stk. 9 i denne artikel, den kompetente myndighed for humane væv og celler, der blev hørt af det bemyndigede organ i overensstemmelse med artikel 52, stk. 10.
7.   Efter at have foretaget evalueringen i overensstemmelse med denne artikels stk. 3 underretter den evaluerende kompetente myndighed via det elektroniske system, jf. artikel 92, straks de øvrige kompetente myndigheder om de korrigerende handlinger, som fabrikanten har foretaget eller påtænker at foretage, eller som det kræves, at fabrikanten foretager for at minimere risikoen for gentagelse af den alvorlige hændelse, herunder oplysninger om de tilgrundliggende hændelser og resultaterne af dens vurdering.
8.   Fabrikanten sikrer, at oplysninger om den sikkerhedsrelaterede korrigerende handling, der er foretaget, straks meddeles brugerne af det pågældende udstyr ved hjælp af en sikkerhedsmeddelelse. Sikkerhedsmeddelelsen skal udarbejdes på det eller de officielle EU-sprog, som er fastsat af den medlemsstat, hvor den sikkerhedsrelaterede korrigerende handling foretages. Medmindre der er tale om hastetilfælde, skal indholdet af udkastet til sikkerhedsmeddelelsen forelægges den evaluerende kompetente myndighed eller i de i stk. 9 omhandlede tilfælde den koordinerende kompetente myndighed for at give den mulighed for at fremsætte bemærkninger. Indholdet af sikkerhedsmeddelelsen skal være ens i alle medlemsstater, medmindre situationen i den enkelte medlemsstat berettiger, at den er forskellig.
Sikkerhedsmeddelelsen skal gøre det muligt at foretage en korrekt identifikation af det anvendte udstyr, navnlig ved at medtage de relevante UDI'er, og en korrekt identifikation, navnlig ved at medtage SRN'et, hvis det allerede er udstedt, af den fabrikant, der har foretaget den sikkerhedsrelaterede korrigerende handling. Sikkerhedsmeddelelsen skal på en klar måde uden at nedtone risikoniveauet redegøre for grundene til den sikkerhedsrelaterede korrigerende handling, idet der henvises til udstyrets fejlfunktion og dermed forbundne risici for patienter, brugere eller andre personer, og klart angive alle de foranstaltninger, som brugerne skal træffe.
Fabrikanten indfører sikkerhedsmeddelelsen i det elektroniske system, jf. artikel 92, hvorigennem denne information skal gøres tilgængelig for offentligheden.
9.   De kompetente myndigheder deltager aktivt i en procedure til at koordinere deres vurderinger, jf. stk. 3, i følgende tilfælde:
a)
hvis der er problemer med hensyn til en særlig alvorlig hændelse eller en særlig gruppe af alvorlige hændelser vedrørende samme udstyr eller samme type udstyr fra samme fabrikant i mere end én medlemsstat
b)
hvis hensigtsmæssigheden af en sikkerhedsrelateret korrigerende handling, der foreslås af en fabrikant i mere end én medlemsstat, kan drages i tvivl.
Denne koordinerede procedure omfatter følgende:
—
udpegelse af en koordinerende kompetent myndighed i hvert enkelt tilfælde, når det er påkrævet
—
fastlæggelse af den koordinerede vurderingsproces, herunder den koordinerende kompetente myndigheds opgaver og ansvar og inddragelse af andre kompetente myndigheder.
Medmindre andet er aftalt mellem de kompetente myndigheder, skal den koordinerende kompetente myndighed være den kompetente myndighed i den medlemsstat, hvor fabrikanten har sit registrerede forretningssted.
Den koordinerende kompetente myndighed underretter gennem det elektroniske system, der er omhandlet i artikel 92, fabrikanten, de øvrige kompetente myndigheder og Kommissionen om, at den har påtaget sig funktionen som koordinerende myndighed.
10.   Udpegelsen af en koordinerende kompetent myndighed må ikke berøre de øvrige kompetente myndigheders ret til at foretage deres egen vurdering og til at vedtage foranstaltninger i overensstemmelse med denne forordning for at sikre beskyttelsen af folkesundheden og patientsikkerheden. Den koordinerende kompetente myndighed og Kommissionen skal holdes underrettet om resultatet af en sådan vurdering og vedtagelsen af sådanne foranstaltninger.
11.   Kommissionen yder administrativ støtte til den koordinerende kompetente myndighed i forbindelse med udførelsen af dens opgaver i henhold til dette kapitel.
Artikel 90
Analyse af sikkerhedsovervågningsdata
Kommissionen indfører sammen med medlemsstaterne systemer og processer til aktiv monitorering af de data, der findes i det elektroniske system, jf. artikel 92, for at identificere tendenser, mønstre eller signaler i disse data, der kan afdække nye risici eller sikkerhedsbekymringer.
Hvis en hidtil ukendt risiko identificeres eller frekvensen af en forventet risiko i væsentlig grad og negativ retning ændrer afvejningen af fordele og risici, underretter den kompetente myndighed eller eventuelt den koordinerende kompetente myndighed fabrikanten eller i givet fald den autoriserede repræsentant, som så foretager de nødvendige korrigerende handlinger.
Artikel 91
Gennemførelsesretsakter
Kommissionen kan ved hjælp af gennemførelsesretsakter og efter høring af MDCG vedtage de nærmere bestemmelser og proceduremæssige aspekter, der er nødvendige for at gennemføre artikel 85-90 og 92 med hensyn til følgende:
a)
typologien over alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger i forbindelse med specifikt udstyr eller kategorier eller grupper af udstyr
b)
indberetning af alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger og sikkerhedsmeddelelser samt forelæggelse af periodiske sammenfattende indberetninger, indberetninger om overvågning, efter at udstyret er bragt i omsætning, periodiske opdaterede sikkerhedsindberetninger og indberetninger af tendenser foretaget af fabrikanter, jf. henholdsvis artikel 85, 86, 87, 88 og 89
c)
standardiserede strukturerede formularer til elektronisk og ikkeelektronisk indberetning, herunder et minimumsdatasæt til sundhedspersoners, brugeres og patienters indberetning af formodede alvorlige hændelser
d)
frister for indberetning af sikkerhedsrelaterede korrigerende handlinger og for fabrikanters foretagelse af periodiske sammenfattende indberetninger og indberetninger af tendenser, idet der tages hensyn til alvoren af den hændelse, der skal indberettes, jf. artikel 87
e)
harmoniserede formularer til udveksling af oplysninger mellem de kompetente myndigheder, jf. artikel 89
f)
procedurer for udpegelse af en koordinerende kompetent myndighed samt den koordinerede evalueringsproces, herunder den koordinerende kompetente myndigheds opgaver og ansvar og inddragelse af andre kompetente myndigheder i denne proces.
De gennemførelsesretsakter, der er omhandlet i stk. 1, vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 92
Elektronisk system til sikkerhedsovervågning og overvågning, efter at udstyret er bragt i omsætning
1.   Kommissionen opretter og forvalter i samarbejde med medlemsstaterne et elektronisk system til indsamling og behandling af følgende oplysninger:
a)
fabrikanters indberetninger af alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger, jf. artikel 87, stk. 1, og artikel 89, stk. 5
b)
fabrikanternes periodiske sammenfattende indberetninger, jf. artikel 87, stk. 9
c)
fabrikanternes indberetninger af tendenser, jf. artikel 88
d)
periodiske opdaterede sikkerhedsindberetninger, jf. artikel 86
e)
fabrikanternes sikkerhedsmeddelelser, jf. artikel 89, stk. 8
f)
de oplysninger, som udveksles mellem medlemsstaternes kompetente myndigheder og mellem disse og Kommissionen, jf. artikel 89, stk. 7 og 9.
Dette elektroniske system skal indeholde relevante link til UDI-databasen.
2.   De oplysninger, der er omhandlet i nærværende artikels stk. 1, gøres tilgængelige gennem det elektroniske system for medlemsstaternes kompetente myndigheder og Kommissionen. De bemyndigede organer skal også have adgang til disse oplysninger, for så vidt som de vedrører udstyr, som de har udstedt et certifikat for i overensstemmelse med artikel 53.
3.   Kommissionen sikrer, at sundhedspersoner og offentligheden har en passende grad af adgang til det elektroniske system omhandlet i stk. 1.
4.   På grundlag af aftaler mellem Kommissionen og de kompetente myndigheder i tredjelande eller internationale organisationer kan Kommissionen give disse kompetente myndigheder eller internationale organisationer adgang til det elektroniske system omhandlet i stk. 1 på relevant niveau. Disse aftaler skal være baseret på gensidighed og indeholde bestemmelser om tavshedspligt og databeskyttelse svarende til dem, der gælder i Unionen.
5.   Indberetninger af alvorlige hændelser, jf. artikel 87, stk. 1, litra a), overføres efter modtagelsen automatisk via det elektroniske system, der er omhandlet i nærværende artikels stk. 1, til den kompetente myndighed i den medlemsstat, hvor den pågældende hændelse indtraf.
6.   Indberetninger af tendenser, jf. artikel 88, stk. 1, overføres efter modtagelsen automatisk via det elektroniske system, der er omhandlet i nærværende artikels stk. 1, til de kompetente myndigheder i den medlemsstat, hvor de pågældende hændelser indtraf.
7.   Indberetninger af sikkerhedsrelaterede korrigerende handlinger, jf. artikel 87, stk. 1, litra b), overføres efter modtagelsen automatisk via det elektroniske system, der er omhandlet i nærværende artikels stk. 1, til de kompetente myndigheder i følgende medlemsstater:
a)
de medlemsstater, hvori den sikkerhedsrelaterede korrigerende handling foretages eller skal foretages
b)
den medlemsstat, hvor fabrikanten har sit registrerede forretningssted.
8.   De periodiske sammenfattende indberetninger, jf. artikel 87, stk. 9, overføres efter modtagelsen automatisk via det elektroniske system, der er omhandlet i nærværende artikels stk. 1, til den kompetente myndighed i:
a)
den eller de medlemsstater, som deltager i koordineringsproceduren i overensstemmelse med artikel 89, stk. 9, og som har tilsluttet sig den periodiske sammenfattende indberetning
b)
den medlemsstat, hvor fabrikanten har sit registrerede forretningssted.
9.   De oplysninger, der er omhandlet i denne artikels stk. 5-8, skal efter modtagelsen overføres automatisk ved hjælp af det elektroniske system, der er omhandlet i denne artikels stk. 1, til det bemyndigede organ, der udstedte certifikatet for det pågældende udstyr i overensstemmelse med artikel 56.
AFDELING 3
Markedsovervågning
Artikel 93
Markedsovervågningsaktiviteter
1.   De kompetente myndigheder gennemfører passende kontrol af udstyrs overensstemmelsesegenskaber og ydeevne, herunder om nødvendigt en gennemgang af dokumentation og fysisk kontrol eller laboratoriekontrol af passende stikprøver. De kompetente myndigheder tager navnlig hensyn til etablerede principper for risikovurdering og risikostyring og til sikkerhedsovervågningsdata samt klager.
2.   De kompetente myndigheder udarbejder årlige overvågningsaktivitetsplaner og tildeler et tilstrækkeligt antal materielle og kompetente menneskelige ressourcer med henblik på at udføre disse aktiviteter, idet der tages hensyn til det europæiske markedsovervågningsprogram, der er udviklet af MDCG i henhold til artikel 105, og lokale forhold.
3.   Med henblik på at opfylde forpligtelserne i stk. 1
a)
kan de kompetente myndigheder bl.a. forlange, at de erhvervsdrivende fremlægger den dokumentation og de oplysninger, som er nødvendige for, at myndighederne kan udføre deres opgaver, og, hvis det er berettiget, stiller de nødvendige stikprøver af udstyr til rådighed eller giver adgang til udstyr uden vederlag, og
b)
skal de kompetente myndigheder foretage både anmeldte og, hvis det er nødvendigt, uanmeldte inspektioner af lokaler, der tilhører erhvervsdrivende, samt lokaler, der tilhører leverandører og/eller underleverandører, og, hvis det er nødvendigt, af anlæg, der tilhører erhvervsmæssige brugere.
4.   De kompetente myndigheder udarbejder et årligt sammendrag af resultaterne af deres overvågningsaktiviteter og gør det tilgængeligt for de øvrige kompetente myndigheder ved hjælp af det elektroniske system, der er omhandlet i artikel 100.
5.   De kompetente myndigheder kan konfiskere, destruere eller på anden vis ubrugeliggøre udstyr, der udgør en uacceptabel risiko, eller forfalsket udstyr, hvis de anser det for nødvendigt af hensyn til beskyttelsen af folkesundheden.
6.   Efter hver inspektion, der foretages med henblik på stk. 1, udarbejder den kompetente myndighed en rapport om resultaterne af inspektionen, der vedrører opfyldelse af de gældende retlige og tekniske krav i henhold til denne forordning. Rapporten skal angive eventuelle påkrævede korrigerende handlinger.
7.   Den kompetente myndighed, der har foretaget inspektionen, informerer den erhvervsdrivende, der har været genstand for inspektion, om indholdet af den rapport, som er omhandlet i nærværende artikels stk. 6. Inden den endelige rapport vedtages, giver den kompetente myndighed denne erhvervsdrivende mulighed for at fremsætte bemærkninger. Denne endelige inspektionsrapport indføres i det elektroniske system, der er omhandlet i artikel 100.
8.   Medlemsstaterne gennemgår og evaluerer deres markedsovervågningsaktiviteter. Denne form for gennemgang og evaluering foretages mindst hvert fjerde år, og resultaterne heraf meddeles de øvrige medlemsstater og Kommissionen. Hver medlemsstat skal gøre et sammendrag af resultaterne tilgængeligt for offentligheden ved hjælp af det elektroniske system, der er omhandlet i artikel 100.
9.   Medlemsstaternes kompetente myndigheder koordinerer deres markedsovervågningsaktiviteter, samarbejder med hinanden og udveksler resultaterne af disse aktiviteter med hinanden og med Kommissionen for at sikre et harmoniseret og højt niveau for markedsovervågning i samtlige medlemsstater.
Hvis det er relevant, indgår medlemsstaternes kompetente myndigheder aftaler om arbejdsdeling, fælles markedsovervågningsaktiviteter og specialisering.
10.   Hvis mere end én myndighed i en medlemsstat er ansvarlig for markedsovervågning og kontrol ved de ydre grænser, samarbejder disse myndigheder med hinanden og udveksler oplysninger, der er relevante for deres rolle og funktioner.
11.   Når det er relevant, samarbejder medlemsstaternes kompetente myndigheder med de kompetente myndigheder i tredjelande med henblik på udveksling af oplysninger og teknisk bistand og med henblik på at fremme aktiviteter i forbindelse med markedsovervågning.
Artikel 94
Evaluering af udstyr, der mistænkes for at udgøre en uacceptabel risiko eller anden manglende overensstemmelse med kravene
Hvis en medlemsstats kompetente myndigheder på grundlag af data, der er opnået ved hjælp af sikkerhedsovervågnings- eller markedsovervågningsaktiviteter, eller anden information har grund til at antage, at udstyr
a)
kan udgøre en uacceptabel risiko for patienters, brugeres eller andre personers sundhed eller sikkerhed eller for andre aspekter af beskyttelsen af folkesundheden, eller
b)
på anden vis ikke er i overensstemmelse med de krav, der er fastsat i denne forordning,
foretager de en evaluering af det pågældende udstyr, der omfatter alle de krav, der er fastsat i denne forordning, og som vedrører den risiko, der er forbundet med udstyret, eller enhver anden manglende overensstemmelse med kravene for udstyret.
De relevante erhvervsdrivende skal samarbejde med de kompetente myndigheder.
Artikel 95
Procedure for behandling af udstyr, der udgør en uacceptabel risiko for sundhed og sikkerhed
1.   Hvis de kompetente myndigheder efter at have foretaget en evaluering i henhold til artikel 94 konstaterer, at udstyret udgør en uacceptabel risiko for patienters, brugeres eller andre personers sundhed eller sikkerhed eller for andre aspekter af beskyttelsen af folkesundheden, skal de straks pålægge fabrikanten af det pågældende udstyr, dennes autoriserede repræsentant og alle øvrige relevante erhvervsdrivende at foretage alle nødvendige og behørigt begrundede korrigerende handlinger, for at bringe udstyret i overensstemmelse med de krav i denne forordning, der vedrører den risiko, som udstyret udgør, og på en måde, som står i passende forhold til risikoens art, at begrænse tilgængeliggørelsen af udstyret på markedet, underkaste tilgængeliggørelsen særlige krav, tilbagekalde udstyret fra markedet eller trække det tilbage inden for en rimelig frist, der er klart defineret og meddelt til den relevante erhvervsdrivende.
2.   De kompetente myndigheder underretter straks Kommissionen, de øvrige medlemsstater og, hvis der er udstedt et certifikat i overensstemmelse med artikel 56 for det pågældende udstyr, det bemyndigede organ, der udstedte dette certifikat, om resultaterne af evalueringen og om de foranstaltninger, som de har pålagt de erhvervsdrivende at træffe, ved hjælp af det elektroniske system, jf. artikel 100.
3.   De erhvervsdrivende, jf. stk. 1, skal straks sikre, at der foretages alle fornødne korrigerende handlinger i hele Unionen med hensyn til alt berørt udstyr, som de har gjort tilgængeligt på markedet.
4.   Hvis den i stk. 1 omhandlede erhvervsdrivende ikke foretager de fornødne korrigerende handlinger inden for den frist, der er omhandlet i stk. 1, skal de kompetente myndigheder træffe alle nødvendige foranstaltninger for at forbyde eller begrænse tilgængeliggørelsen af udstyret på deres nationale marked eller for at tilbagekalde udstyret fra markedet eller trække det tilbage.
De kompetente myndigheder underretter straks Kommissionen, de øvrige medlemsstater og det bemyndigede organ, jf. denne artikels stk. 2, om disse foranstaltninger ved hjælp af det elektroniske system, der er omhandlet i artikel 100.
5.   Den i stk. 4 omhandlede underretning skal indeholde alle tilgængelige oplysninger, navnlig hvad angår de nødvendige data til identifikation og sporing af udstyr, der ikke er i overensstemmelse med kravene, udstyrets oprindelse, arten af den påståede manglende overensstemmelse med kravene og af den pågældende risiko, arten og varigheden af de trufne nationale foranstaltninger samt de synspunkter, som den relevante erhvervsdrivende har fremsat.
6.   De øvrige medlemsstater ud over den medlemsstat, der har indledt proceduren, underretter straks Kommissionen og de øvrige medlemsstater ved hjælp af det elektroniske system, der er omhandlet i artikel 100, om eventuelle yderligere og relevante oplysninger, som de råder over, om det pågældende udstyrs manglende overensstemmelse med kravene og om eventuelle foranstaltninger, som de har vedtaget i forbindelse med det pågældende udstyr.
Hvis de ikke er indforstået med den meddelte nationale foranstaltning, underretter de straks Kommissionen og de øvrige medlemsstater om deres indsigelser ved hjælp af det elektroniske system, jf. artikel 100.
7.   Hvis en medlemsstat eller Kommissionen ikke inden for to måneder efter modtagelsen af den i stk. 4 omhandlede underretning har gjort indsigelse mod eventuelle foranstaltninger truffet af en medlemsstat, anses disse foranstaltninger for at være berettigede.
I så fald sikrer samtlige medlemsstater, at der straks træffes hertil svarende fornødne restriktive foranstaltninger eller forbudsforanstaltninger med hensyn til det pågældende udstyr, herunder tilbagekaldelse, tilbagetrækning eller begrænsning af udstyrets tilgængelighed på deres nationale marked.
Artikel 96
Procedure for evaluering af nationale foranstaltninger på EU-plan
1.   Hvis en medlemsstat inden for to måneder efter modtagelsen af den i artikel 95, stk. 4, omhandlede underretning har gjort indsigelse mod en foranstaltning truffet af en anden medlemsstat, eller hvis Kommissionen finder, at foranstaltningen er i strid med EU-retten, evaluerer Kommissionen efter høring af de pågældende kompetente myndigheder og, hvis det er nødvendigt, de berørte erhvervsdrivende denne nationale foranstaltning. På grundlag af resultaterne af denne evaluering kan Kommissionen ved hjælp af en gennemførelsesretsakt træffe afgørelse om, hvorvidt den nationale foranstaltning er berettiget. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
2.   Hvis Kommissionen anser den nationale foranstaltning for at være berettiget, jf. denne artikels stk. 1, finder artikel 95, stk. 7, andet afsnit, anvendelse. Hvis Kommissionen anser den nationale foranstaltning for at være uberettiget, skal den berørte medlemsstat trække foranstaltningen tilbage.
Hvis Kommissionen ikke har truffet en afgørelse i henhold til denne artikels stk. 1 senest otte måneder efter modtagelsen af den underretning, der er omhandlet i artikel 95, stk. 4, anses den nationale foranstaltning for at være berettiget.
3.   Hvis en medlemsstat eller Kommissionen mener, at den risiko for sundheden og sikkerheden, der stammer fra et udstyr, ikke kan begrænses på tilfredsstillende vis ved hjælp af de foranstaltninger, der træffes af den eller de berørte medlemsstater, kan Kommissionen på anmodning af en medlemsstat eller på eget initiativ ved hjælp af gennemførelsesretsakter træffe de nødvendige og behørigt begrundede foranstaltninger for at sikre beskyttelsen af sundheden og sikkerheden, herunder foranstaltninger, der begrænser eller forbyder omsætning og ibrugtagning af det pågældende udstyr. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 97
Anden manglende overensstemmelse med kravene
1.   Hvis en medlemsstats kompetente myndigheder efter at have foretaget en evaluering i henhold til artikel 94 konstaterer, at et udstyr ikke er i overensstemmelse med kravene i denne forordning, men ikke udgør en uacceptabel risiko for patienters, brugeres eller andre personers sundhed eller sikkerhed eller for andre aspekter af beskyttelsen af folkesundheden, skal de pålægge den pågældende erhvervsdrivende at bringe den manglende overensstemmelse til ophør inden for en rimelig tidsfrist, der er klart defineret og meddelt til den erhvervsdrivende, og som står i et passende forhold til den manglende overensstemmelse.
2.   Hvis den erhvervsdrivende ikke bringer den manglende overensstemmelse til ophør inden den i denne artikels stk. 1 omhandlede frist, træffer den berørte medlemsstat straks alle nødvendige foranstaltninger for at begrænse eller forbyde, at produktet gøres tilgængeligt på markedet, eller sikre, at det trækkes tilbage eller tilbagekaldes fra markedet. Medlemsstaten underretter straks Kommissionen og de øvrige medlemsstater om disse foranstaltninger ved hjælp af det elektroniske system, jf. artikel 100.
3.   For at sikre ensartet anvendelse af denne artikel kan Kommissionen ved hjælp af gennemførelsesretsakter angive passende foranstaltninger, som de kompetente myndigheder skal træffe for at imødegå bestemte former for manglende overensstemmelse. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 98
Forebyggende sundhedsmæssige foranstaltninger
1.   Finder en medlemsstat efter at have foretaget en evaluering, som tyder på en potentiel risiko i forbindelse med et udstyr eller en specifik kategori eller gruppe af udstyr, at tilgængeliggørelse på markedet eller ibrugtagning af et udstyr eller en specifik kategori eller gruppe af udstyr for at beskytte patienters, brugeres og andre personers sundhed og sikkerhed eller andre aspekter af folkesundheden bør forbydes, begrænses eller underkastes særlige krav, eller at dette udstyr eller denne kategori eller gruppe af udstyr bør tilbagekaldes fra markedet eller trækkes tilbage, kan den træffe alle nødvendige og begrundede foranstaltninger.
2.   Den i stk. 1 omhandlede medlemsstat underretter straks Kommissionen og de øvrige medlemsstater herom og begrunder samtidig sin beslutning ved hjælp af det elektroniske system, jf. artikel 100.
3.   Kommissionen vurderer i samråd med MDCG og om nødvendigt de berørte erhvervsdrivende de nationale foranstaltninger, der er truffet. Kommissionen kan ved hjælp af gennemførelsesretsakter træffe afgørelse om, hvorvidt de nationale foranstaltninger er berettigede eller ej. Hvis Kommissionen ikke har truffet nogen afgørelse senest seks måneder efter underretningen, anses de nationale foranstaltninger for at være berettigede. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
4.   Hvis den i denne artikels stk. 3 omhandlede vurdering viser, at tilgængeliggørelse på markedet eller ibrugtagning af et udstyr eller en specifik kategori eller gruppe af udstyr bør forbydes, begrænses eller underkastes særlige krav, eller at dette udstyr eller denne kategori eller gruppe af udstyr bør tilbagekaldes fra markedet eller trækkes tilbage i alle medlemsstaterne for at beskytte patienters, brugeres og andre personers sundhed og sikkerhed eller andre aspekter af folkesundheden, kan Kommissionen vedtage gennemførelsesretsakter for at træffe de nødvendige og behørigt begrundede foranstaltninger. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 99
God administrativ praksis
1.   Enhver foranstaltning, der træffes af medlemsstaternes kompetente myndigheder i henhold til artikel 95-98, skal indeholde en nøjagtig beskrivelse af de forhold, som ligger til grund herfor. Hvis en sådan foranstaltning er rettet til en specifik erhvervsdrivende, meddeler den kompetente myndighed straks den berørte erhvervsdrivende denne foranstaltning og underretter samtidig den erhvervsdrivende om klagemulighederne i henhold til gældende ret eller administrativ praksis i den berørte medlemsstat, og inden for hvilken frist klager skal være fremsat. Hvis foranstaltningen er generel, skal den offentliggøres på passende vis.
2.   Medmindre et umiddelbart tiltag er nødvendigt på grund af en uacceptabel risiko for menneskers sundhed eller sikkerhed, skal den berørte erhvervsdrivende have lejlighed til at fremsætte bemærkninger til den kompetente myndighed inden for en rimelig frist, der er klart defineret, inden der træffes en foranstaltning.
Hvis der træffes foranstaltninger, uden at den erhvervsdrivende har haft mulighed for at fremsætte bemærkninger, jf. første afsnit, skal denne have mulighed for at fremsætte bemærkninger så hurtigt som muligt, og de trufne foranstaltninger revurderes derefter omgående.
3.   Alle vedtagne foranstaltninger trækkes omgående tilbage eller ændres, såfremt den erhvervsdrivende påviser, at vedkommende har foretaget effektive korrigerende handlinger, og at udstyret er i overensstemmelse med kravene i denne forordning.
4.   Hvis en foranstaltning, der vedtages i henhold til artikel 95-98, vedrører udstyr, for hvilket et bemyndiget organ har deltaget i overensstemmelsesvurderingen, underretter de kompetente myndigheder ved hjælp af det elektroniske system, der er omhandlet i artikel 100, det relevante bemyndigede organ og myndigheden med ansvar for det bemyndigede organ om den trufne foranstaltning.
Artikel 100
Elektronisk system for markedsovervågning
1.   Kommissionen opretter og forvalter i samarbejde med medlemsstaterne et elektronisk system til indsamling og behandling af følgende oplysninger:
a)
sammendrag af resultaterne af overvågningsaktiviteterne, jf. artikel 93, stk. 4
b)
den endelige inspektionsrapport, jf. artikel 93, stk. 7
c)
oplysninger om udstyr, som udgør en uacceptabel risiko for sundheden og sikkerheden, jf. artikel 95, stk. 2, 4 og 6
d)
oplysninger om produkters manglende overensstemmelse, jf. artikel 97, stk. 2
e)
oplysninger om forebyggende sundhedsmæssige foranstaltninger, jf. artikel 98, stk. 2
f)
sammendrag af resultaterne af evalueringerne og vurderingerne af medlemsstaternes markedsovervågningsaktiviteter, jf. artikel 93, stk. 8.
2.   De oplysninger, der er nævnt i denne artikels stk. 1, sendes straks via det elektroniske system til alle berørte kompetente myndigheder og i givet fald til det bemyndigede organ, der har udstedt et certifikat i henhold til artikel 56 for det pågældende udstyr, og skal være tilgængelige for medlemsstaterne og Kommissionen.
3.   Oplysninger, der udveksles mellem medlemsstaterne, må ikke offentliggøres, hvis det kan skade markedsovervågningsaktiviteter og samarbejdet mellem medlemsstaterne.
KAPITEL VIII
SAMARBEJDE MELLEM MEDLEMSSTATERNE, KOORDINATIONSGRUPPEN FOR MEDICINSK UDSTYR, EKSPERTLABORATORIER, EKSPERTPANELER OG REGISTRE OVER UDSTYR
Artikel 101
Kompetente myndigheder
Medlemsstaterne udpeger den eller de kompetente myndigheder, der er ansvarlige for gennemførelsen af denne forordning. De giver deres myndigheder de beføjelser, ressourcer, udstyr og viden, der er nødvendige for, at de kan udføre deres opgaver i henhold til denne forordning. Medlemsstaterne giver meddelelse om de kompetente myndigheders navne og kontaktoplysninger til Kommissionen, som offentliggør en liste over kompetente myndigheder.
Artikel 102
Samarbejde
1.   Medlemsstaternes kompetente myndigheder samarbejder med hinanden og med Kommissionen. Kommissionen sørger for tilrettelæggelse af den udveksling af oplysninger, der er nødvendig for, at denne forordning kan anvendes på en ensartet måde.
2.   Medlemsstaterne deltager med støtte fra Kommissionen, når det er hensigtsmæssigt, i initiativer på internationalt plan med henblik på at sikre samarbejde mellem reguleringsmyndigheder på området for medicinsk udstyr.
Artikel 103
Koordinationsgruppen for Medicinsk Udstyr
1.   Der nedsættes herved en koordinationsgruppe for medicinsk udstyr (MDCG).
2.   Hver medlemsstat udpeger for en treårig periode, der kan forlænges, et medlem og en suppleant med ekspertise på området medicinsk udstyr og et medlem og en suppleant med ekspertise på området medicinsk udstyr til in vitro-diagnostik, til MDCG. En medlemsstat kan vælge kun at udpege ét medlem og én suppleant, som hver især har ekspertise på begge områder.
Medlemmerne af MDCG udvælges på grundlag af deres kompetence og erfaringer på området for medicinsk udstyr og medicinsk udstyr til in vitro-diagnostik. De repræsenterer medlemsstaternes kompetente myndigheder. Kommissionen offentliggør medlemmernes navne og tilhørsforhold.
Suppleanterne repræsenterer og stemmer på vegne af medlemmerne i disses fravær.
3.   MDCG mødes med regelmæssige mellemrum samt efter behov på anmodning af Kommissionen eller en medlemsstat. Møderne skal have deltagelse enten af medlemmer, der er udpeget på baggrund af deres rolle og ekspertise på området medicinsk udstyr, eller af medlemmer, der er udpeget på baggrund af deres ekspertise på området medicinsk udstyr til in vitro-diagnostik, eller af medlemmer, der er udpeget på baggrund af deres ekspertise på begge områder, eller deres suppleanter, alt efter hvad der er relevant.
4.   MDCG skal gøre sit yderste for at nå til enighed. Hvis enighed ikke kan opnås, træffer MDCG beslutning med et flertal af sine medlemmers stemmer. Medlemmer med divergerende holdninger kan anmode om, at deres holdninger og begrundelserne herfor anføres i MDCG's holdning.
5.   En repræsentant for Kommissionen varetager MDCG's formandskab. Formanden deltager ikke i afstemningerne i MDCG.
6.   MDCG kan med udgangspunkt i den enkelte sag invitere eksperter og andre tredjeparter til at deltage i møderne eller komme med skriftlige bidrag.
7.   MDCG kan nedsætte stående eller midlertidige undergrupper. Hvis det er relevant, inviteres organisationer, der repræsenterer medikoindustrien, sundhedspersoner, laboratorier, patienter og forbrugere på EU-plan til at deltage i sådanne undergrupper som observatører.
8.   MDCG fastsætter selv sin forretningsorden, der navnlig skal fastlægge procedurer for følgende:
—
vedtagelse af udtalelser eller henstillinger eller andre holdninger, herunder i hastetilfælde
—
delegering af opgaver til rapporterende og medrapporterende medlemmer
—
gennemførelse af artikel 107 om interessekonflikter
—
undergruppernes funktionsmåde.
9.   MDCG har de opgaver, der er fastsat i artikel 105 denne forordning og artikel 99 i forordning (EU) 2017/746.
Artikel 104
Støtte fra Kommissionen
Kommissionen støtter de nationale kompetente myndigheders samarbejde. Den sørger navnlig for tilrettelæggelsen af udvekslinger af erfaringer mellem de kompetente myndigheder og yder teknisk, videnskabelig og logistisk støtte til MDCG og dens undergrupper. Den tilrettelægger møderne i MDCG og dens undergrupper, deltager i disse møder og sikrer en passende opfølgning.
Artikel 105
MDCG's opgaver
I henhold til denne forordning har MDCG til opgave at:
a)
bidrage til vurderingen af ansøgende overensstemmelsesvurderingsorganer og bemyndigede organer i henhold til bestemmelserne i kapitel IV
b)
rådgive Kommissionen på dennes anmodning om forhold vedrørende koordineringsgruppen af bemyndigede organer, der er nedsat i henhold til artikel 49
c)
bidrage til udvikling af retningslinjer, der skal sikre en effektiv og harmoniseret gennemførelse af denne forordning, navnlig hvad angår udpegelse af og tilsyn med bemyndigede organer, anvendelse af de generelle krav til sikkerhed og ydeevne, fabrikanternes gennemførelse af kliniske evalueringer og kliniske afprøvninger, bemyndigede organers vurdering og sikkerhedsovervågningsaktiviteter
d)
bidrage til den løbende monitorering af den tekniske udvikling og vurdering af, om de generelle krav til sikkerhed og ydeevne i denne forordning og forordning (EU) 2017/746 er tilstrækkelige til at sikre udstyrs sikkerhed og ydeevne, og dermed bidrage til at identificere, hvorvidt der er behov for at ændre denne forordnings bilag I
e)
bidrage til udviklingen af standarder for udstyr, fælles specifikationer og videnskabelige retningslinjer, herunder produktspecifikke retningslinjer, for klinisk afprøvning af visse former for udstyr, især implantabelt udstyr og udstyr i klasse III
f)
bistå medlemsstaternes kompetente myndigheder i deres koordineringsaktiviteter, navnlig på områderne for klassificering og fastlæggelse af den reguleringsmæssige status for udstyr, kliniske afprøvninger, sikkerhedsovervågning og markedsovervågning, herunder udvikling og opretholdelse af en ramme for et europæisk markedsovervågningsprogram med et mål om at opnå effektivitet og harmonisering af markedsovervågning i Unionen i overensstemmelse med artikel 93
g)
rådgive Kommissionen, enten på eget initiativ eller på Kommissionens anmodning, i vurderingen af ethvert spørgsmål vedrørende gennemførelsen af denne forordning
h)
bidrage til harmoniseret administrativ praksis med hensyn til udstyr i medlemsstaterne.
Artikel 106
Levering af videnskabelige, tekniske og kliniske udtalelser og rådgivning
1.   Kommissionen skal ved hjælp af gennemførelsesretsakter og i samråd med MDCG sørge for, at der udpeges ekspertpaneler til vurderingen af den kliniske evaluering på relevante medicinske områder som omhandlet i denne artikels stk. 9, og at de fremlægger synspunkter i overensstemmelse med artikel 48, stk. 6, i forordning (EU) 2017/746 om ydeevneevaluering af visse former for medicinsk udstyr til in vitro-diagnostik og, når det er nødvendigt, til kategorier eller grupper af udstyr eller til specifikke farer, der er forbundet med kategorier eller grupper af udstyr, under overholdelse af principperne om højeste videnskabelige kompetence, uvildighed, uafhængighed og gennemsigtighed De samme principper finder anvendelse, når Kommissionen beslutter at udpege ekspertlaboratorier i overensstemmelse med nærværende artikels stk. 7.
2.   Ekspertpaneler og ekspertlaboratorier kan udpeges på områder, hvor Kommissionen i samråd med MDCG har identificeret et behov for levering af konsekvent videnskabelig, teknisk og/eller klinisk rådgivning eller laboratorieekspertise i forbindelse med gennemførelsen af denne forordning. Ekspertpaneler og ekspertlaboratorier kan udpeges på et stående eller midlertidigt grundlag.
3.   Ekspertpaneler består af rådgivere, som Kommissionen har udpeget på grundlag af opdateret klinisk, videnskabelig eller teknisk ekspertise på området og med en geografisk fordeling, der afspejler forskelligartetheden i videnskabelige og kliniske tilgange i Unionen. Kommissionen fastsætter antallet af medlemmer i hvert panel i overensstemmelse med, hvad der er behov for.
Ekspertpanelernes medlemmer udfører deres opgaver under iagttagelse af uvildighed og objektivitet. De må hverken anmode om eller tage imod instrukser fra bemyndigede organer eller fabrikanter. Hvert medlem udfærdiger en interesseerklæring, der gøres offentligt tilgængelig.
Kommissionen skal etablere systemer og procedurer til aktivt at håndtere og forebygge potentielle interessekonflikter.
4.   Ekspertpaneler skal tage højde for relevante oplysninger fra interessenter, herunder patientorganisationer og sundhedspersoner, når de udarbejder deres videnskabelige udtalelser.
5.   Kommissionen kan efter samråd med MDCG udpege rådgivere til ekspertpaneler efter offentliggørelse i 
Den Europæiske Unions Tidende
 og på Kommissionens websted efter en indkaldelse af interessetilkendegivelser. Afhængig af opgavens art og behovet for specifik ekspertise kan rådgivere udpeges til ekspertpanelerne for en periode på højst tre år, og deres mandat kan forlænges.
6.   Kommissionen kan efter samråd med MDCG optage rådgivere på en central liste over tilgængelige eksperter, der, selv om de ikke formelt er udpeget til et panel, er til rådighed med henblik på at rådgive og støtte arbejdet i ekspertpanelet efter behov. Denne liste offentliggøres på Kommissionens websted.
7.   Kommissionen kan ved hjælp af gennemførelsesretsakter og efter samråd med MDCG udpege ekspertlaboratorier på grundlag af deres ekspertise i:
—
fysisk-kemisk karakterisering, eller
—
mikrobiologisk, bioforligelighedsmæssig, mekanisk, elektrisk, elektronisk eller ikkeklinisk biologisk og toksikologisk testning af specifikt udstyr og specifikke kategorier eller grupper af udstyr.
Kommissionen udpeger kun ekspertlaboratorier, for hvilke en medlemsstat eller Det Fælles Forskningscenter har indgivet en ansøgning om udpegelse.
8.   Ekspertlaboratorier skal opfylde følgende kriterier:
a)
have passende og tilstrækkeligt kvalificeret personale med den nødvendige viden og erfaring inden for det udstyr, de er udpeget for
b)
besidde det nødvendige udstyr til udførelsen af de opgaver, de pålægges
c)
have den nødvendige viden om internationale standarder og bedste praksis
d)
have en passende administrativ organisation og struktur
e)
sikre, at deres medarbejdere behandler alle oplysninger og data, som de modtager som led i udførelsen af deres opgaver, fortroligt.
9.   Ekspertpaneler udpeget til klinisk evaluering på relevante medicinske områder udfører de opgaver, der er fastsat i artikel 54, stk. 1, artikel 61, stk. 2, og bilag IX, punkt 5.1, eller bilag X, punkt 6, alt efter hvad der er relevant.
10.   Ekspertpaneler og ekspertlaboratorier kan, afhængigt af hvad der er behov for, have til opgave at:
a)
levere videnskabelig, teknisk og klinisk bistand til Kommissionen og MDCG i forbindelse med gennemførelsen af denne forordning
b)
bidrage til udviklingen og opretholdelsen af passende vejledning og fælles specifikationer til:
—
klinisk afprøvning
—
klinisk evaluering og PMCF
—
undersøgelser af ydeevne
—
ydeevneevaluering og opfølgning af ydeevne, efter at udstyret er bragt i omsætning
—
fysisk-kemisk karakterisering, og
—
mikrobiologisk, bioforligelighedsmæssig, mekanisk, elektrisk, elektronisk eller ikkeklinisk toksikologisk testning
af specifikt udstyr eller en kategori eller gruppe af udstyr eller med henblik på specifikke farer, der er forbundet med en kategori eller gruppe af udstyr
c)
udvikle og gennemgå retningslinjerne for klinisk evaluering og retningslinjerne for ydeevneevaluering for en tidssvarerende gennemførelse af overensstemmelsesvurdering med hensyn til klinisk evaluering, ydeevneevaluering, fysisk-kemisk karakterisering og mikrobiologisk, bioforligelighedsmæssig, mekanisk, elektrisk, elektronisk eller ikkeklinisk toksikologisk testning
d)
bidrage til udviklingen af standarder på internationalt plan og sikre, at sådanne standarder afspejler det aktuelle teknologiske niveau
e)
afgive udtalelser i forbindelse med fabrikanternes høringer i overensstemmelse med artikel 61, stk. 2, og de bemyndigede organers og medlemsstaternes høringer i overensstemmelse med nærværende artikels stk. 11-13
f)
bidrage til identificering af betænkeligheder og nye spørgsmål om medicinsk udstyrs sikkerhed og ydeevne
g)
fremlægge synspunkter i overensstemmelse med artikel 48, stk. 4, i forordning (EU) 2017/746 om ydeevneevaluering af visse former for medicinsk udstyr til in vitro-diagnostik.
11.   Kommissionen letter medlemsstaternes og bemyndigede organers og fabrikanters adgang til rådgivning fra ekspertpaneler og ekspertlaboratorier vedrørende bl.a. kriterierne for et passende datasæt til vurdering af udstyrs overensstemmelse, navnlig for så vidt angår de kliniske data, som er påkrævede til klinisk evaluering, for så vidt angår fysisk-kemisk karakterisering og for så vidt angår mikrobiologisk, bioforligelighedsmæssig, mekanisk, elektrisk, elektronisk og ikkeklinisk toksikologisk testning.
12.   Når medlemmerne af ekspertpanelerne vedtager deres videnskabelige udtalelse i overensstemmelse med stk. 9, skal de gøre deres yderste for at nå til enighed. Hvis der ikke kan opnås konsensus, træffer ekspertpanelerne deres beslutning med et flertal af medlemmernes stemmer, og den videnskabelige udtalelse skal omtale de divergerende holdninger og begrundelserne herfor.
Kommissionen offentliggør den videnskabelige udtalelse og rådgivning i overensstemmelse med denne artikels stk. 9 og 11 og sikrer hensynet til fortrolighedsaspekter som omhandlet i artikel 109. Retningslinjerne for klinisk evaluering, jf. stk. 10, litra c), offentliggøres efter høring af MDCG.
13.   Kommissionen kan pålægge fabrikanter og bemyndigede organer at betale gebyrer for den rådgivning, som ekspertpaneler og ekspertlaboratorier leverer. Gebyrernes struktur og størrelse samt omfanget og strukturen af udgifter, der kan kræves godtgjort, vedtages af Kommissionen ved hjælp af gennemførelsesretsakter, idet der tages hensyn til målene om passende gennemførelse af denne forordning, beskyttelse af sundhed og sikkerhed, støtte til innovation og omkostningseffektivitet og nødvendigheden af at opnå aktiv deltagelse i ekspertpanelerne. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
14.   De gebyrer, der skal betales til Kommissionen i henhold til proceduren i denne artikels stk. 13, skal fastsættes på en gennemsigtig måde og på grundlag af omkostningerne for de tjenesteydelser, der leveres. De gebyrer, der skal betales, skal nedsættes i tilfælde af en procedure for høring i forbindelse med klinisk evaluering, der er indledt i overensstemmelse med bilag IX, punkt 5.1, litra c), og som omfatter en fabrikant, der er en mikrovirksomhed, en lille eller mellemstor virksomhed som defineret i henstilling 2003/361/EF.
15.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 115 for at ændre de opgaver for ekspertpanelerne og ekspertlaboratorierne, der er omhandlet i nærværende artikels stk. 10.
Artikel 107
Interessekonflikter
1.   Medlemmerne af MDCG, dens undergrupper, medlemmer af ekspertpaneler og ekspertlaboratorier må ikke have økonomiske eller andre interesser i medikoindustrien, som kan påvirke deres upartiskhed. De forpligter sig til at handle uafhængigt og i offentlighedens interesse. De skal afgive en erklæring, hvori de anfører, om de har direkte eller indirekte interesser i medikoindustrien, og opdatere den pågældende erklæring, når der indtræder en relevant ændring. Denne erklæring om interesser offentliggøres på Kommissionens websted. Denne artikel finder ikke anvendelse på de repræsentanter for interesseorganisationer, der deltager i MDCG's undergrupper.
2.   Eksperter og andre tredjeparter, der fra sag til sag bliver indbudt af MDCG, skal afgive en erklæring om eventuelle interesser, de måtte have i den pågældende sag.
Artikel 108
Registre og databaser for udstyr
Kommissionen og medlemsstaterne træffer alle passende foranstaltninger for at tilskynde til oprettelse af registre og databaser for specifikke typer af udstyr og fastsættelse af fælles principper med henblik på indsamling af sammenlignelige oplysninger. Sådanne registre og databaser skal bidrage til den uafhængige evaluering af udstyrets sikkerhed og ydeevne på lang sigt eller til sporbarheden af implantabelt udstyr eller til alle sådanne egenskaber.
KAPITEL IX
TAVSHEDSPLIGT, DATABESKYTTELSE, FINANSIERING OG SANKTIONER
Artikel 109
Tavshedspligt
1.   Medmindre andet er fastsat i denne forordning og med forbehold af medlemsstaternes gældende nationale bestemmelser og praksis med hensyn til tavshedspligt, skal alle parter, der er involveret i anvendelsen af denne forordning, behandle de oplysninger og data, som de modtager i forbindelse med udførelsen af deres opgaver, fortroligt med henblik på at beskytte:
a)
personoplysninger i overensstemmelse med artikel 110
b)
en fysisk eller juridisk persons kommercielt fortrolige oplysninger og forretningshemmeligheder, herunder intellektuelle ejendomsrettigheder, medmindre videregivelse er i offentlighedens interesse
c)
den effektive gennemførelse af denne forordning, navnlig for så vidt angår inspektioner, undersøgelser eller audit.
2.   Med forbehold af stk. 1 må oplysninger, der udveksles på fortrolig basis mellem kompetente myndigheder og mellem kompetente myndigheder og Kommissionen, ikke videregives uden forudgående samtykke fra den myndighed, der har afgivet oplysningerne.
3.   Stk. 1 og 2 berører ikke Kommissionens, medlemsstaternes og bemyndigede organers rettigheder og forpligtelser med hensyn til udveksling af oplysninger og udsendelse af advarsler eller de berørte parters forpligtelse til at afgive oplysninger inden for strafferetten.
4.   Kommissionen og medlemsstaterne kan udveksle fortrolige oplysninger med reguleringsmyndigheder i tredjelande, med hvilke de har indgået bilaterale eller multilaterale aftaler om fortrolighed.
Artikel 110
Databeskyttelse
1.   Medlemsstaterne anvender direktiv 95/46/EF på behandlingen af personoplysninger i medlemsstaterne i medfør af denne forordning.
2.   Forordning (EF) nr. 45/2001 finder anvendelse på Kommissionens behandling af personoplysninger i henhold til denne forordning.
Artikel 111
Opkrævning af gebyrer
1.   Denne forordning berører ikke medlemsstaternes mulighed for at opkræve gebyrer for de aktiviteter, der er fastsat i denne forordning, på betingelse af at gebyret fastsættes på en gennemsigtig måde og på grundlag af principperne om omkostningsdækning.
2.   Medlemsstaterne underretter Kommissionen og de øvrige medlemsstater senest tre måneder før, gebyrernes struktur og størrelse skal fastsættes. Gebyrernes struktur og størrelse skal efter anmodning gøres offentligt tilgængelige.
Artikel 112
Finansiering af aktiviteter forbundet med udpegelse af og tilsyn med bemyndigede organer
De udgifter, der er forbundet med fælles vurderingsaktiviteter, dækkes af Kommissionen. Kommissionen fastsætter ved hjælp af gennemførelsesretsakter omfanget og strukturen af udgifter, der kan kræves godtgjort, og andre nødvendige gennemførelsesbestemmelser. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 114, stk. 3.
Artikel 113
Sanktioner
Medlemsstaterne fastsætter regler om sanktioner, der skal anvendes i tilfælde af overtrædelser af bestemmelserne i denne forordning, og træffer alle nødvendige foranstaltninger for at sikre, at de anvendes. Sanktionerne skal være effektive, stå i et rimeligt forhold til overtrædelsen og have afskrækkende virkning. Medlemsstaterne giver senest den 25. februar 2020 Kommissionen meddelelse om disse regler og foranstaltninger og underretter den straks om senere ændringer, der berører dem.
KAPITEL X
AFSLUTTENDE BESTEMMELSER
Artikel 114
Udvalgsprocedure
1.   Kommissionen bistås af et udvalg for medicinsk udstyr. Dette udvalg er et udvalg som omhandlet i forordning (EU) nr. 182/2011.
2.   Når der henvises til dette stykke, finder artikel 4 i forordning (EU) nr. 182/2011 anvendelse.
3.   Når der henvises til dette stykke, finder artikel 5 i forordning (EU) nr. 182/2011 anvendelse.
Afgiver udvalget ikke nogen udtalelse, vedtager Kommissionen ikke udkastet til gennemførelsesretsakt, og artikel 5, stk. 4, tredje afsnit, i forordning (EU) nr. 182/2011 finder anvendelse.
4.   Når der henvises til dette stykke, finder artikel 8 i forordning (EU) nr. 182/2011 sammenholdt med dennes artikel 4 eller 5, alt efter hvad der er relevant, anvendelse.
Artikel 115
Udøvelse af de delegerede beføjelser
1.   Beføjelsen til at vedtage delegerede retsakter tillægges Kommissionen på de i denne artikel fastlagte betingelser.
2.   Beføjelsen til at vedtage delegerede retsakter, jf. artikel 1, stk. 5, artikel 3, artikel 10, stk. 4, artikel 18, stk. 3, artikel 19, stk. 4, artikel 27, stk. 10, artikel 44, stk. 11, artikel 52, stk. 5, artikel 56, stk. 6, artikel 61, stk. 8, artikel 70, stk. 8, og artikel 106, stk. 15, tillægges Kommissionen for en periode på fem år fra den 25. maj 2017. Kommissionen udarbejder en rapport vedrørende delegationen af beføjelser senest ni måneder inden udløbet af femårsperioden. Delegationen af beføjelser forlænges stiltiende for perioder af samme varighed, medmindre Europa-Parlamentet eller Rådet modsætter sig en sådan forlængelse senest tre måneder inden udløbet af hver periode.
3.   Den i artikel 1, stk. 5, artikel 3, artikel 10, stk. 4, artikel 18, stk. 3, artikel 19, stk. 4, artikel 27, stk. 10, artikel 44, stk. 11, artikel 52, stk. 5, artikel 56, stk. 6, artikel 61, stk. 8, artikel 70, stk. 8, og artikel 106, stk. 15, omhandlede delegation af beføjelser kan til enhver tid tilbagekaldes af Europa-Parlamentet eller Rådet. En afgørelse om tilbagekaldelse bringer delegationen af de beføjelser, der er angivet i den pågældende afgørelse, til ophør. Den får virkning dagen efter offentliggørelsen af afgørelsen i 
Den Europæiske Unions Tidende
 eller på et senere tidspunkt, der angives i afgørelsen. Den berører ikke gyldigheden af delegerede retsakter, der allerede er i kraft.
4.   Inden vedtagelsen af en delegeret retsakt hører Kommissionen eksperter, som er udpeget af hver enkelt medlemsstat, i overensstemmelse med principperne i den interinstitutionelle aftale af 13. april 2016 om bedre lovgivning.
5.   Så snart Kommissionen vedtager en delegeret retsakt, giver den samtidigt Europa-Parlamentet og Rådet meddelelse herom.
6.   En delegeret retsakt vedtaget i henhold til artikel 1, stk. 5, artikel 3, artikel 10, stk. 4, artikel 18, stk. 3, artikel 19, stk. 4, artikel 27, stk. 10, artikel 44, stk. 11, artikel 52, stk. 5, artikel 56, stk. 6, artikel 61, stk. 8, artikel 70, stk. 8, og artikel 106, stk. 15, træder kun i kraft, hvis hverken Europa-Parlamentet eller Rådet har gjort indsigelse inden for en frist på tre måneder fra meddelelsen af den pågældende retsakt til Europa-Parlamentet og Rådet, eller hvis Europa-Parlamentet og Rådet inden udløbet af denne frist begge har underrettet Kommissionen om, at de ikke agter at gøre indsigelse. Fristen forlænges med tre måneder på Europa-Parlamentets eller Rådets initiativ.
Artikel 116
Særskilte delegerede retsakter for forskellige delegerede beføjelser
Kommissionen vedtager en særskilt delegeret retsakt for hver beføjelse, der er delegeret til den i henhold til denne forordning.
Artikel 117
Ændring af direktiv 2001/83/EF
I bilag I til direktiv 2001/83/EF affattes punkt 3.2, nr. 12), således:
»12)
Hvis et produkt i overensstemmelse med artikel 1, stk. 8, andet afsnit, eller artikel 1, stk. 9, andet afsnit, i Europa-Parlamentets og Rådets forordning (EU) 2017/745.
 (
*1
)
, er omfattet af dette direktiv, skal dossieret i forbindelse med ansøgninger om markedsføringstilladelse, hvis et sådant foreligger, indeholde resultaterne af vurderingen af udstyrsdelens overensstemmelse med de relevante generelle krav til sikkerhed og ydeevne fastsat i bilag I til nævnte forordning, som er indeholdt i fabrikantens EU-overensstemmelseserklæring, eller det relevante certifikat udstedt af et bemyndiget organ, der giver fabrikanten lov til at anbringe CE-mærkningen på det medicinske udstyr.
Hvis dossieret ikke indeholder resultaterne af den i første afsnit omhandlede overensstemmelsesvurdering, og hvis det i forbindelse med overensstemmelsesvurderingen af udstyret, hvis anvendt alene, kræves, at der inddrages et bemyndiget organ i overensstemmelse med forordning (EU) 2017/745, kræver myndigheden, at ansøgeren fremlægger en udtalelse om udstyrsdelens overensstemmelse med de relevante generelle krav til sikkerhed og ydeevne fastsat i bilag I til nævnte forordning, som afgives af et bemyndiget organ, der er udpeget i overensstemmelse med forordningen for den pågældende type af udstyr.
Artikel 118
Ændring af forordning (EF) nr. 178/2002
I artikel 2, stk. 3, i forordning (EF) nr. 178/2002 tilføjes følgende litra:
»i)
medicinsk udstyr som defineret i Europa-Parlamentets og Rådets forordning (EU) 2017/745
 (
*2
)
.
Artikel 119
Ændring af forordning (EF) nr. 1223/2009
I artikel 2 i forordning (EF) nr. 1223/2009 tilføjes følgende stykke:
»4.   Kommissionen kan på anmodning af en medlemsstat eller på eget initiativ træffe de foranstaltninger, der er nødvendige for at fastlægge, om et bestemt produkt eller en bestemt gruppe af produkter er omfattet af definitionen af et »kosmetisk produkt«. Disse foranstaltninger vedtages efter forskriftsproceduren i artikel 32, stk. 2.«
Artikel 120
Overgangsbestemmelser
1.   Fra den 26. maj 2020 er enhver offentliggørelse af en notifikation vedrørende et bemyndiget organ i overensstemmelse med direktiv 90/385/EØF og 93/42/EØF ugyldig.
2.   Certifikater, der er udstedt af bemyndigede organer i overensstemmelse med direktiv 90/385/EØF og 93/42/EØF inden den 25. maj 2017, vedbliver med at være gyldige indtil udløbet af den periode, der er anført på certifikatet, bortset fra certifikater, der er udstedt i overensstemmelse med bilag 4 til direktiv 90/385/EØF eller bilag IV til direktiv 93/42/EØF, der bliver ugyldige senest den 27. maj 2022.
Certifikater, der er udstedt af bemyndigede organer i henhold til direktiv 90/385/EØF og 93/42/EØF fra den 25. maj 2017, vedbliver med at være gyldige indtil udløbet af den periode, der er anført på certifikatet, dog højst i fem år efter udstedelsen. De bliver dog ugyldige senest den 27. maj 2024.
3.   Uanset denne forordnings artikel 5 kan udstyr med et certifikat, der blev udstedt i overensstemmelse med direktiv 90/385/EØF eller 93/42/EØF, og som er gyldigt i medfør af nærværende artikels stk. 2, kun bringes i omsætning eller ibrugtages, hvis det fra denne forordnings anvendelsesdato fortsat er i overensstemmelse med et af nævnte direktiver, og forudsat at der ikke er nogen væsentlige ændringer i designet eller det erklærede formål. Denne forordnings krav vedrørende overvågning, efter at udstyret er bragt i omsætning, markedsovervågning, sikkerhedsovervågning, registrering af erhvervsdrivende og af udstyr finder dog anvendelse i stedet for de tilsvarende krav i nævnte direktiver.
Med forbehold af kapitel IV og denne artikels stk. 1 er det bemyndigede organ, som udstedte det i første afsnit omhandlede certifikat, fortsat ansvarlig for passende overvågning for så vidt angår alle de gældende krav for det udstyr, som det har certificeret.
4.   Udstyr, der lovligt er bragt i omsætning i henhold til direktiv 90/385/EØF og 93/42/EØF før den 26. maj 2020, og udstyr, der er bragt i omsætning fra den 26. maj 2020, i kraft af et certifikat som omhandlet i denne artikels stk. 2, kan fortsat gøres tilgængeligt på markedet eller ibrugtages indtil den 27. maj 2025.
5.   Uanset direktiv 90/385/EØF og 93/42/EØF kan udstyr, der opfylder kravene i denne forordning, bringes i omsætning før den 26. maj 2020.
6.   Uanset direktiv 90/385/EØF og 93/42/EØF kan overensstemmelsesvurderingsorganer, som er i overensstemmelse med denne forordning, udpeges og notificeres før den 26. maj 2020. Bemyndigede organer, der er udpeget og notificeret i overensstemmelse med denne forordning, kan anvende de overensstemmelsesvurderingsprocedurer, der er fastsat i denne forordning, og udstede certifikater i henhold til denne forordning, før den 26. maj 2020.
7.   For så vidt angår udstyr, der er underlagt den høringsprocedure, der er fastsat i artikel 54, finder nærværende artikels stk. 5 anvendelse, forudsat at de nødvendige udpegelser til MDCG og ekspertpanelerne er foretaget.
8.   Uanset artikel 10a og artikel 10b, stk. 1, litra a), i direktiv 90/385/EØF og artikel 14, stk. 1 og 2, og artikel 14a, stk. 1, litra a) og b), i direktiv 93/42/EØF anses fabrikanter, de autoriserede repræsentanter, importører og bemyndigede organer, der i perioden, som begynder på den seneste af de datoer, der er omhandlet i artikel 123, stk. 3, litra d), og slutter 18 måneder senere, opfylder bestemmelserne i artikel 29, stk. 4, og artikel 56, stk. 5, i denne forordning, for at opfylde de love og bestemmelser, som medlemsstaterne har vedtaget i overensstemmelse med henholdsvis artikel 10a i direktiv 90/385/EØF og artikel 14, stk. 1 og 2, i direktiv 93/42/EØF og med henholdsvis artikel 10b, stk. 1, litra a), i direktiv 90/385/EØF og artikel 14a, stk. 1, litra a) og b), i direktiv 93/42/EØF, jf. afgørelse 2010/227/EU.
9.   Tilladelser, der gives af medlemsstaternes kompetente myndigheder i overensstemmelse med artikel 9, stk. 9, i direktiv 90/385/EØF og artikel 11, stk. 13, i direktiv 93/42/EØF, fortsætter med at være gyldige som angivet i tilladelsen.
10.   Udstyr, der er omfattet af denne forordning i overensstemmelse med artikel 1, stk. 6, litra f) og g), og som er bragt lovligt i omsætning eller ibrugtaget i overensstemmelse med de gældende regler i medlemsstaterne før den 26. maj 2020, må fortsat bringes i omsætning og ibrugtages i de pågældende medlemsstater.
11.   Kliniske afprøvninger, som er påbegyndt i overensstemmelse med artikel 10 i direktiv 90/385/EØF eller artikel 15 i direktiv 93/42/EØF før den 26. maj 2020, kan fortsættes. Fra og med den 26. maj 2020 skal indberetning af alvorlige uønskede hændelser og mangler ved udstyr dog foretages i overensstemmelse med denne forordning.
12.   Indtil Kommissionen i medfør af artikel 27, stk. 2, har udpeget de udstedende enheder, anses GS1 HIBCC og ICCBBA som udpegede udstedende enheder.
Artikel 121
Evaluering
Senest den 27. maj 2027 vurderer Kommissionen anvendelsen af denne forordning og udarbejder en evalueringsrapport om fremskridt med hensyn til at nå dens mål, herunder en vurdering af de nødvendige ressourcer for at gennemføre denne forordning. Der skal især fokuseres på sporingen af medicinsk udstyr, jf. artikel 27, gennem de erhvervsdrivendes, sundhedsinstitutionernes og sundhedspersonernes opbevaring af UDI'en.
Artikel 122
Ophævelse
Uden at dette berører denne forordnings artikel 120, stk. 3 og 4, og uden at det berører medlemsstaternes og fabrikanternes forpligtelser for så vidt angår sikkerhedsovervågning og fabrikanternes forpligtelser for så vidt angår tilrådighedsstillelse af dokumentation, jf. direktiv 90/385/EØF og 93/42/EØF, ophæves nævnte direktiver med virkning fra den 26. maj 2020 med undtagelse af
—
artikel 8 og 10, artikel 10b, stk. 1, litra b) og c), artikel 10b, stk. 2, og artikel 10b, stk. 3, i direktiv 90/385/EØF og forpligtelserne vedrørende sikkerhedsovervågning og kliniske afprøvninger i de tilhørende bilag, som ophæves med virkning fra den seneste af de datoer, der er omhandlet i denne forordnings artikel 123, stk. 3, litra d)
—
artikel 10a og artikel 10b, stk. 1, litra a), i direktiv 90/385/EØF og forpligtelserne vedrørende registrering af udstyr og erhvervsdrivende og certifikatmeddelelser i de tilhørende bilag, som ophæves med virkning fra 18 måneder efter den seneste af de datoer, der er omhandlet i denne forordnings artikel 123, stk. 3, litra d)
—
artikel 10, artikel 14a, stk. 1, litra c) og d), artikel 14a, stk. 2, artikel 14a, stk. 3, og artikel 15 i direktiv 93/42/EØF og forpligtelserne vedrørende sikkerhedsovervågning og kliniske afprøvninger i de tilhørende bilag, som ophæves med virkning fra den seneste af de datoer, der er omhandlet i denne forordnings artikel 123, stk. 3, litra d), og
—
artikel 14, stk. 1 og 2, og artikel 14a, stk. 1, litra a) og b), i direktiv 93/42/EØF og forpligtelserne vedrørende registrering af udstyr og erhvervsdrivende og certifikatmeddelelser i de tilhørende bilag, som ophæves med virkning fra 18 måneder efter den seneste af de datoer, der er omhandlet i denne forordnings artikel 123, stk. 3, litra d).
For så vidt angår udstyr omhandlet i artikel 120, stk. 3 og 4, finder de i stk. 1 omhandlede direktiver fortsat anvendelse indtil den 27. maj 2025 i det omfang, det er nødvendigt med henblik på anvendelsen af de nævnte stykker.
Uanset stk. 1 forbliver forordning (EU) nr. 207/2012 og (EU) nr. 722/2012 i kraft og finder fortsat anvendelse, medmindre og indtil de ophæves ved gennemførelsesretsakter, der vedtages af Kommissionen i henhold til nærværende forordning.
Henvisninger til de ophævede direktiver gælder som henvisninger til nærværende forordning og læses efter sammenligningstabellen i nærværende forordnings bilag XVII.
Artikel 123
Ikrafttræden og anvendelsesdato
1.   Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i 
Den Europæiske Unions Tidende
.
2.   Den anvendes fra den 26. maj 2020.
3.   Uanset stk. 2:
a)
anvendes artikel 35-50 fra den 26. november 2017. De forpligtelser, der påhviler de bemyndigede organer i medfør af artikel 35-50, finder imidlertid kun anvendelse på de organer, som indgiver en ansøgning om udpegelse i overensstemmelse med artikel 38 fra den nævnte dato og indtil den 26. maj 2020
b)
Artikel 101 og 103 finder anvendelse fra den 26. november 2017
c)
Artikel 102 finder anvendelse fra den 26. maj 2018
d)
Uden at det berører forpligtelserne for Kommissionen i henhold til artikel 34, anvendes de forpligtelser og krav, som vedrører Eudamed, fra den dato, der svarer til seks måneder efter datoen for offentliggørelsen af den meddelelse, der er omhandlet i artikel 34, stk. 3, hvis Eudamed som følge af omstændigheder, der ikke med rimelighed kunne have været forudset ved udarbejdelsen af den plan, der er omhandlet i artikel 34, stk. 1, ikke er fuldt funktionsdygtig den 26. maj 2020. De i forrige punktum omhandlede bestemmelser er:
—
artikel 29
—
artikel 31
—
artikel 32
—
artikel 33, stk. 4
—
artikel 40, stk. 2, andet punktum
—
artikel 42, stk. 10
—
artikel 43, stk. 2
—
artikel 44, stk. 12, andet afsnit
—
artikel 46, stk. 7, litra d) og e)
—
artikel 53, stk. 2
—
artikel 54, stk. 3
—
artikel 55, stk. 1
—
artikel 70-77
—
artikel 78, stk. 1-13
—
artikel 79-82
—
artikel 86, stk. 2
—
artikel 87 og 88
—
artikel 89, stk. 5 og 7, og stk. 8, tredje afsnit
—
artikel 90
—
artikel 93, stk. 4, 7 og 8
—
artikel 95, stk. 2 og 4
—
artikel 97, stk. 2, sidste punktum
—
artikel 99, stk. 4, og
—
artikel 120, stk. 3, første afsnit, andet punktum.
Indtil Eudamed er fuldt funktionsdygtig finder de tilsvarende bestemmelser i direktiv 90/385/EØF og 93/42/EØF fortsat anvendelse med henblik på at opfylde de krav, der er fastsat i de i dette litras første afsnit nævnte bestemmelser vedrørende udveksling af oplysninger, herunder navnlig oplysninger om indberetning i forbindelse med sikkerhedsovervågning, kliniske afprøvninger, registrering af udstyr og erhvervsdrivende samt certifikatmeddelelser.
e)
artikel 29, stk. 4, og artikel 56, stk. 5, anvendes fra 18 måneder efter den seneste af de datoer, der er omhandlet i litra d)
f)
for implantabelt udstyr og for udstyr i klasse III anvendes artikel 27, stk. 4, fra den 26. maj 2021. For udstyr i klasse IIa og IIb anvendes artikel 27, stk. 4, fra den 26. maj 2023. For udstyr i klasse I anvendes artikel 27, stk. 4, fra den 26. maj 2025.
g)
for genanvendeligt udstyr, der skal være forsynet med en UDI-bærer på selve udstyret, anvendes artikel 27, stk. 4, to år efter den dato, der er omhandlet i nærværende stykkes litra f), for den respektive udstyrsklasse i nævnte litra.
h)
den procedure, der er fastsat i artikel 78, finder anvendelse fra den 26. maj 2027, jf. dog artikel 78, stk. 14
i)
artikel 120, stk. 12, finder anvendelse fra den 26. maj 2019.
Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver medlemsstat.
Udfærdiget i Strasbourg, 5. april 2017.
På Europa-Parlamentets vegne
A. TAJANI
Formand
På Rådets vegne
I. BORG
Formand
(
1
)
  Udtalelse af 14.2.2013 (
EUT C 133 af 9.5.2013, s. 52
).
(
2
)
  Europa-Parlamentets holdning af 2.4.2014 (endnu ikke offentliggjort i EUT) og Rådets førstebehandlingsholdning af 7.3.2017 (endnu ikke offentliggjort i EUT).
(
3
)
  Rådets direktiv 90/385/EØF af 20. juni 1990 om indbyrdes tilnærmelse af medlemsstaternes lovgivning om aktivt, implantabelt medicinsk udstyr (
EFT L 189 af 20.7.1990, s. 17
).
(
4
)
  Rådets direktiv 93/42/EØF af 14. juni 1993 om medicinsk udstyr (
EFT L 169 af 12.7.1993, s. 1
).
(
5
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002 af 28. januar 2002 om generelle principper og krav i fødevarelovgivningen, om oprettelse af Den Europæiske Fødevaresikkerhedsautoritet og om procedurer vedrørende fødevaresikkerhed (
EFT L 31 af 1.2.2002, s. 1
).
(
6
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 1223/2009 af 30. november 2009 om kosmetiske produkter (
EUT L 342 af 22.12.2009, s. 59
).
(
7
)
  Europa-Parlamentets og Rådets direktiv 2001/83/EF af 6. november 2001 om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler (
EFT L 311 af 28.11.2001, s. 67
).
(
8
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 1394/2007 af 13. november 2007 om lægemidler til avanceret terapi og om ændring af direktiv 2001/83/EF og forordning (EF) nr. 726/2004 (
EUT L 324 af 10.12.2007, s. 121
).
(
9
)
  Europa-Parlamentets og Rådets direktiv 2004/23/EF af 31. marts 2004 om fastsættelse af standarder for kvaliteten og sikkerheden ved donation, udtagning, testning, behandling, præservering, opbevaring og distribution af humane væv og celler (
EUT L 102 af 7.4.2004, s. 48
).
(
10
)
  Europa-Parlamentets og Rådets direktiv 2002/98/EF af 27. januar 2003 om fastsættelse af standarder for kvaliteten og sikkerheden ved tapning, testning, behandling, opbevaring og distribution af humant blod og blodkomponenter (
EUT L 33 af 8.2.2003, s. 30
).
(
11
)
  Kommissionens henstilling 2011/696/EU af 18. oktober 2011 om definitionen af nanomaterialer (
EUT L 275 af 20.10.2011, s. 38
).
(
12
)
  Europa-Parlamentets og Rådets direktiv 2014/30/EU af 26. februar 2014 om harmonisering af medlemsstaternes lovgivning om elektromagnetisk kompatibilitet (
EUT L 96 af 29.3.2014, s. 79
).
(
13
)
  Rådets direktiv 2013/59/Euratom af 5. december 2013 om fastlæggelse af grundlæggende sikkerhedsnormer til beskyttelse mod de farer, som er forbundet med udsættelse for ioniserende stråling, og om ophævelse af direktiv 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom og 2003/122/Euratom (
EUT L 13 af 17.1.2014, s. 1
).
(
14
)
  Europa-Parlamentets og Rådets direktiv (EU) 2015/1535 af 9. september 2015 om en informationsprocedure med hensyn til tekniske forskrifter samt forskrifter for informationssamfundets tjenester (
EUT L 241 af 17.9.2015, s. 1
).
(
15
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 1025/2012 af 25. oktober 2012 om europæisk standardisering, om ændring af Rådets direktiv 89/686/EØF og 93/15/EØF og Europa-Parlamentets og Rådets direktiv 94/9/EF, 94/25/EF, 95/16/EF, 97/23/EF, 98/34/EF, 2004/22/EF, 2007/23/EF, 2009/23/EF og 2009/105/EF og om ophævelse af Rådets beslutning 87/95/EØF og Europa-Parlamentets og Rådets afgørelse nr. 1673/2006/EF (
EUT L 316 af 14.11.2012, s. 12
).
(
16
)
  Europa-Parlamentets og Rådets direktiv 98/79/EF af 27. oktober 1998 om medicinsk udstyr til in vitro-diagnostik (
EFT L 331 af 7.12.1998, s. 1
).
(
17
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 765/2008 af 9. juli 2008 om kravene til akkreditering og markedsovervågning i forbindelse med markedsføring af produkter og om ophævelse af Rådets forordning (EØF) nr. 339/93 (
EUT L 218 af 13.8.2008, s. 30
).
(
18
)
  Europa-Parlamentets og Rådets afgørelse nr. 768/2008/EF af 9. juli 2008 om fælles rammer for markedsføring af produkter og om ophævelse af Rådets afgørelse 93/465/EØF (
EUT L 218 af 13.8.2008, s. 82
).
(
19
)
  Rådets direktiv 85/374/EØF af 25. juli 1985 om tilnærmelse af medlemsstaternes administrativt eller ved lov fastsatte bestemmelser om produktansvar (
EFT L 210 af 7.8.1985, s. 29
).
(
20
)
  Dom af 28.7.2011, Orifarm og Paranova, forenede sager C-400/09 og C-207/10, ECLI:EU:C:2011:519.
(
21
)
  Kommissionens afgørelse 2010/227/EU af 19. april 2010 om den europæiske database for medicinsk udstyr (
EUT L 102 af 23.4.2010, s. 45
).
(
22
)
  Europa-Parlamentet og Rådets direktiv 95/46/EF af 24. oktober 1995 om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger og om fri udveksling af sådanne oplysninger (
EFT L 281 af 23.11.1995, s. 31
).
(
23
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 45/2001 af 18. december 2000 om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger i fællesskabsinstitutionerne og -organerne og om fri udveksling af sådanne oplysninger (
EFT L 8 af 12.1.2001, s. 1
).
(
24
)
  Europa-Parlamentets og Rådets direktiv 2010/63/EU af 22. september 2010 om beskyttelse af dyr, der anvendes til videnskabelige formål (
EUT L 276 af 20.10.2010, s. 33
).
(
25
)
  Europa-Parlamentets og Rådets forordning (EU) 2017/746 af 5. april 2017 om medicinsk udstyr til in vitro-diagnostik og om ophævelse af direktiv 98/79/EF og Kommissionens afgørelse 2010/227/EU (se side 176 i denne EUT).
(
26
)
  
            
EUT L 123 af 12.5.2016, s. 1
.
(
27
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011 af 16. februar 2011 om de generelle regler og principper for, hvordan medlemsstaterne skal kontrollere Kommissionens udøvelse af gennemførelsesbeføjelser (
EUT L 55 af 28.2.2011, s. 13
).
(
28
)
  Kommissionens forordning (EU) nr. 207/2012 af 9. marts 2012 om elektroniske brugsanvisninger til medicinsk udstyr (
EUT L 72 af 10.3.2012, s. 28
).
(
29
)
  Kommissionens forordning (EU) nr. 722/2012 af 8. august 2012 om særlige krav for så vidt angår kravene i Rådets direktiv 90/385/EØF og 93/42/EØF med hensyn til aktivt, implantabelt medicinsk udstyr og medicinsk udstyr, der er fremstillet af animalsk væv (
EUT L 212 af 9.8.2012, s. 3
).
(
30
)
  Kommissionens direktiv 2003/12/EF af 3. februar 2003 om omklassificering af brystimplantater i overensstemmelse med direktiv 93/42/EØF om medicinsk udstyr (
EUT L 28 af 4.2.2003, s. 43
).
(
31
)
  Kommissionens direktiv 2005/50/EF af 11. august 2005 om omklassificering af hofte-, knæ- og skulderledsproteser i overensstemmelse med Rådets direktiv 93/42/EØF om medicinsk udstyr (
EUT L 210 af 12.8.2005, s. 41
).
(
32
)
  Kommissionens gennemførelsesforordning (EU) nr. 920/2013 af 24. september 2013 om udpegelse og overvågning af bemyndigede organer i henhold til Rådets direktiv 90/385/EØF om aktivt, implantabelt medicinsk udstyr og Rådets direktiv 93/42/EØF om medicinsk udstyr (
EUT L 253 af 25.9.2013, s. 8
).
(
33
)
  
            
EUT C 358 af 7.12.2013, s. 10
.
(
34
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 af 31. marts 2004 om fastlæggelse af fællesskabsprocedurer for godkendelse og overvågning af human- og veterinærmedicinske lægemidler og om oprettelse af et europæisk lægemiddelagentur (
EUT L 136 af 30.4.2004, s. 1
).
(
35
)
  Europa-Parlamentets og Rådets direktiv 2006/42/EF af 17. maj 2006 om maskiner og om ændring af direktiv 95/16/EF (
EUT L 157 af 9.6.2006, s. 24
).
(
36
)
  Kommissionens henstilling 2003/361/EF af 6. maj 2003 om definitionen af mikrovirksomheder, små og mellemstore virksomheder (
EUT L 124 af 20.5.2003, s. 36
).
(
37
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 536/2014 af 16. april 2014 om kliniske forsøg med humanmedicinske lægemidler og om ophævelse af direktiv 2001/20/EF (
EUT L 158 af 27.5.2014, s. 1
).
BILAG
I
Generelle krav til sikkerhed og ydeevne
II
Teknisk dokumentation
III
Teknisk dokumentation om overvågning, efter at udstyret er bragt i omsætning
IV
EU-overensstemmelseserklæring
V
CE-overensstemmelsesmærkning
VI
Oplysninger, der skal indsendes ved registrering af udstyr og erhvervsdrivende, jf. artikel 29, stk. 4, og artikel 31, centrale dataelementer, der sammen med UDI-DI skal indsendes til UDI-databasen, jf. artikel 28 og 29, og UDI-systemet
VII
Krav, som skal være opfyldt af de bemyndigede organer
VIII
Klassificeringsregler
IX
Overensstemmelsesvurdering baseret på et kvalitetsstyringssystem og på en vurdering af den tekniske dokumentation
X
Overensstemmelsesvurdering på grundlag af typeafprøvning
XI
Overensstemmelsesvurdering på grundlag af produktoverensstemmelsesverifikation
XII
Certifikater, der udstedes af bemyndigede organer
XIII
Procedure for udstyr efter mål
XIV
Klinisk evaluering og klinisk opfølgning, efter at udstyret er bragt i omsætning
XV
Kliniske afprøvninger
XVI
Liste over grupper af produkter uden et medicinsk formål som omhandlet i artikel 1, stk. 2
XVII
Sammenligningstabel
BILAG I
GENERELLE KRAV TIL SIKKERHED OG YDEEVNE
KAPITEL I
GENERELLE KRAV
1.   Udstyret skal have den af fabrikanten anførte ydeevne og skal designes og fremstilles på en sådan måde, at det under normale anvendelsesbetingelser er egnet til dets erklærede formål. Det skal være sikkert og effektivt og må ikke forværre patientens kliniske tilstand eller bringe vedkommendes sikkerhed i fare og heller ikke være til fare for brugerens eller eventuelt andre personers sikkerhed og sundhed, idet det forudsættes, at eventuelle risici ved brugen er acceptable i forhold til de fordele, som udstyret frembyder for patienten, og er forenelige med et højt sikkerheds- og sundhedsbeskyttelsesniveau, under hensyntagen til det almindeligt anerkendte tekniske niveau.
2.   Ved kravet i dette bilag om at begrænse risici så meget som muligt forstås begrænsning af risici så meget som muligt, uden at det forringer forholdet mellem fordele og risici.
3.   Fabrikanter skal etablere, implementere, dokumentere og opretholde et risikostyringssystem.
Ved risikostyring forstås en kontinuerlig iterativ proces i hele udstyrets livscyklus, som kræver regelmæssig systematisk opdatering. Når fabrikanter gennemfører risikostyring, skal de:
a)
udarbejde og dokumentere en risikostyringsplan for hvert enkelt udstyr
b)
identificere og analysere de kendte og forudsigelige farer, der er forbundet med hvert enkelt udstyr
c)
vurdere og evaluere de risici, der er forbundet med og som opstår ved den tilsigtede brug og ved forkert brug, som med rimelighed kan forudses
d)
fjerne eller kontrollere de i litra c) nævnte risici i overensstemmelse med kravene i punkt 4
e)
evaluere den betydning, som oplysninger fra fremstillingsfasen, navnlig fra systemet til overvågning, efter at udstyret er bragt i omsætning, har for farer og hyppigheden heraf, for vurderinger af de dermed forbundne risici, samt for den samlede risiko, forholdet mellem fordele og risici og accepten af risici, og
f)
på grundlag af evalueringen af betydningen af de i litra e) nævnte oplysninger om nødvendigt ændre kontrolforanstaltninger i overensstemmelse med kravene i punkt 4.
4.   De risikokontrolforanstaltninger, som fabrikanter vælger med henblik på design og fremstilling af udstyr, skal følge sikkerhedsprincipper under hensyntagen til det almindeligt anerkendte tekniske niveau. For at begrænse risiciene skal fabrikanter styre dem, således at den risiko, der stadig er forbundet med de enkelte farer, samt den samlede tilbageværende risiko, bedømmes til at være acceptabel. For at nå frem til de bedst egnede løsninger skal fabrikanter i følgende rækkefølge:
a)
fjerne eller begrænse risici så meget som muligt ved hjælp af sikker design og fremstilling
b)
i givet fald træffe de nødvendige beskyttelsesforholdsregler, herunder om nødvendigt alarmsignaler, for så vidt angår farer, som ikke kan fjernes, og
c)
stille sikkerhedsrelaterede oplysninger (advarsler/forholdsregler/kontraindikationer) til rådighed og, hvis det er relevant, tilbyde brugerne uddannelse.
Fabrikanter skal oplyse brugerne om eventuelle tilbageværende risici.
5.   Med henblik på at fjerne eller begrænse risici i forbindelse med brugerfejl skal fabrikanten:
a)
i videst muligt omfang begrænse risici i forbindelse med udstyrets ergonomiske karakteristika og de omgivelser, hvori det skal anvendes (design med henblik på patientsikkerhed), og
b)
tage hensyn til de tilsigtede brugeres teknologiske viden, erfaring, uddannelse og, hvor det er hensigtsmæssigt, de omgivelser, hvori udstyret skal anvendes, samt de lægelige og fysiske omstændigheder (design med henblik på lægfolk, fagfolk, handicappede eller andre brugere).
6.   Et udstyrs karakteristika og ydeevne må i den af fabrikanten angivne levetid ikke forringes så meget, at patientens, brugerens eller eventuelt andre personers sundhed eller sikkerhed trues, når udstyret udsættes for de påvirkninger, som kan opstå under normale anvendelsesforhold, og hvis udstyret har været korrekt vedligeholdt i overensstemmelse med fabrikantens anvisninger.
7.   Udstyr skal designes, fremstilles og emballeres på en sådan måde, at dets karakteristika og ydeevne ved den tilsigtede brug ikke forringes under transport og opbevaring, f.eks. som følge af temperatur- og fugtighedssvingninger, under hensyntagen til de anvisninger og oplysninger, som fabrikanten har givet.
8.   Alle kendte og forudsigelige risici og eventuelle uønskede bivirkninger skal minimeres og være acceptable, når de sammenlignes med de vurderede fordele for patienten og/eller brugeren, der følger af den ydeevne udstyret har under normale anvendelsesvilkår.
9.   For det i bilag XVI omhandlede udstyr skal de generelle sikkerhedskrav i punkt 1 og 8 forstås således, at udstyret, når det anvendes under de fastsatte forhold og med formålet for øje, slet ikke udgør nogen risiko eller udgør en risiko, der ikke er højere end den maksimalt acceptable risiko i forbindelse med produktets anvendelse, som er forenelig med et højt sikkerheds- og sundhedsbeskyttelsesniveau for mennesker.
KAPITEL II
KRAV TIL DESIGN OG FREMSTILLING
10.   Kemiske, fysiske og biologiske egenskaber
10.1.   Udstyr skal designes og fremstilles på en sådan måde, at de karakteristika og krav til ydeevne, der er omhandlet i kapitel I, opnås. Der skal navnlig lægges vægt på følgende:
a)
valget af materialer og stoffer, navnlig med hensyn til toksicitet og, hvor det er relevant, brændbarhed
b)
den indbyrdes kompatibilitet mellem de anvendte materialer og stoffer og biologiske væv, celler samt legemsvæsker, idet der tages hensyn til udstyrets erklærede formål og, hvor det er relevant, absorptionen, fordelingen, metaboliseringen og udskillelsen
c)
den indbyrdes kompatibilitet mellem de forskellige dele af udstyr, der består af mere end én implantabel del
d)
processernes virkning på materialeegenskaberne
e)
hvor det er hensigtsmæssigt, resultaterne af biofysisk forskning eller modelleringsforskning, hvis validitet er demonstreret på forhånd
f)
de anvendte materialers mekaniske egenskaber, der i givet fald afspejler forhold som styrke, duktilitet, brudstyrke, slidstyrke og træthedsstyrke
g)
overfladeegenskaberne, og
h)
bekræftelsen på af, at udstyret opfylder alle definerede kemiske og/eller fysiske specifikationer.
10.2.   Udstyr skal designes, fremstilles og emballeres på en sådan måde, at den risiko, som kontaminerende stoffer og reststoffer udgør for patienter, under hensyntagen til udstyrets erklærede formål, og for det personale, der deltager i transporten, opbevaringen og anvendelsen af udstyret, mindskes mest muligt. Der skal især tages hensyn til væv udsat for disse kontaminerende stoffer og reststoffer samt til udsættelsens varighed og hyppighed.
10.3.   Udstyr skal designes og fremstilles på en sådan måde, at det uden fare kan anvendes sammen med materialer og stoffer, herunder luftarter, som de kommer i kontakt med ved dets tilsigtede brug. Hvis udstyret er beregnet til at administrere lægemidler, skal det designes og fremstilles på en sådan måde, at det er kompatibelt med de pågældende lægemidler i henhold til de bestemmelser og restriktioner, der gælder for disse lægemidler, og at både lægemidlernes og udstyrets ydeevne bevares i overensstemmelse med deres respektive indikationer og tilsigtede brug.
10.4.   Stoffer
10.4.1.   Design og fremstilling af udstyr
Udstyr skal designes og fremstilles på en sådan måde, at de risici, som skyldes stoffer eller partikler, herunder slidaffald, nedbrydningsprodukter og restprodukter, der frigøres af udstyret, begrænses så meget som muligt.
Udstyr eller de dele heraf eller de materialer, der anvendes heri, som
—
er invasive og kommer i direkte kontakt med det menneskelige legeme
—
(gen)administrerer lægemidler, legemsvæsker eller andre stoffer, herunder luftarter, til/fra legemet, eller
—
transporterer eller opbevarer sådanne lægemidler, legemsvæsker eller stoffer, herunder luftarter, der skal (gen)administreres til legemet,
må kun indeholde følgende stoffer i en koncentration på over 0,1 % vægtprocent, hvis det er berettiget i henhold til punkt 10.4.2:
a)
stoffer i kategori 1A eller 1B, som er kræftfremkaldende, mutagene eller reproduktionstoksiske (»CMR«) i overensstemmelse med i bilag VI, del 3, til Europa-Parlamentets og Rådets forordning (EF) nr. 1272/2008 
(
1
)
, eller
b)
stoffer med hormonforstyrrende egenskaber, for hvilke der foreligger videnskabelig dokumentation for mulige alvorlige konsekvenser for menneskers sundhed, og som fastlægges enten i overensstemmelse med den procedure, der er omhandlet i artikel 59 i Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 
(
2
)
, eller, når en delegeret retsakt er vedtaget af Kommissionen i henhold til artikel 5, stk. 3, første afsnit, i Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 
(
3
)
, i overensstemmelse med de kriterier, der er relevante for menneskers sundhed blandt kriterierne fastsat deri.
10.4.2.   Begrundelse vedrørende tilstedeværelse af CMR-stoffer og/eller hormonforstyrrende stoffer
Begrundelsen for tilstedeværelse af sådanne stoffer baseres på:
a)
en analyse af og et skøn over patientens eller brugerens mulige eksponering for stoffet
b)
en analyse af mulige alternative stoffer, materialer eller design, herunder, når de foreligger, oplysninger om uafhængig forskning, undersøgelser, der har været underkastet peer review, videnskabelige udtalelser fra relevante videnskabelige komitéer og en analyse af sådanne alternativers tilgængelighed
c)
argumentation for, hvorfor stoffer og/eller materielle erstatninger, hvis de foreligger, eller ændringer af designet, hvis de er gennemførlige, er utilstrækkelige i forbindelse med opretholdelse af produktets funktioner, ydeevne og forhold mellem fordele og risici, idet der bl.a. tages hensyn til, om udstyrets tilsigtede brug omfatter behandling af børn, gravide eller ammende kvinder eller behandling af andre patientgrupper, der anses for særligt sårbare over for sådanne stoffer og/eller materialer, og
d)
de seneste retningslinjer fra relevante videnskabelige komitéer, hvis de er hensigtsmæssige og tilgængelige, i overensstemmelse med punkt 10.4.3 og 10.4.4.
10.4.3.   Retningslinjer for ftalater
Med henblik på punkt 10.4 giver Kommissionen hurtigst muligt og senest 26. maj 2018 den relevante videnskabelige komité mandat til at udarbejde retningslinjer, der skal foreligge før 26. maj 2020. Komitéens mandat skal som minimum omfatte en vurdering af forholdet mellem fordele og risici forbundet med tilstedeværelsen af ftalater, der tilhører en af de grupper af stoffer, der er omhandlet i punkt 10.4.1, litra a) og b). Vurderingen af forholdet mellem fordele og risici skal tage hensyn til det erklærede formål og konteksten for udstyrets brug samt tilgængelige alternative stoffer og alternative materialer, design eller behandlinger på sundhedsområdet. Retningslinjerne opdateres, når det anses for hensigtsmæssigt på grundlag af den seneste videnskabelige dokumentation, men mindst hvert femte år.
10.4.4.   Retningslinjer for andre CMR-stoffer og hormonforstyrrende stoffer
Kommissionen giver efterfølgende den relevante videnskabelige komité mandat til at udarbejde retningslinjer, jf. punkt 10.4.3, også for andre stoffer, der er omhandlet i punkt 10.4.1, litra a) og b), hvis det er relevant.
10.4.5.   Mærkning
Når udstyr, dele heraf eller materialer, der anvendes heri, jf. punkt 10.4.1, indeholder de stoffer, der er omhandlet i punkt 10.4.1, litra a) eller b), i en koncentration på over 0,1 vægtprocent, skal tilstedeværelsen af disse stoffer mærkes på selve udstyret og/eller på emballagen for hver enhed, eller, hvor det er hensigtsmæssigt, på salgsemballagen i form af en liste over disse stoffer. Hvis den tilsigtede brug for dette udstyr er behandling af børn, gravide eller ammende kvinder eller behandling af andre patientgrupper, der anses for særligt sårbare over for sådanne stoffer og/eller materialer, skal brugsanvisningen indeholde oplysninger om tilbageværende risici for disse patientgrupper og, hvor det er relevant, om passende sikkerhedsforanstaltninger.
10.5.   Udstyret skal designes og fremstilles på en sådan måde, at de risici, som opstår ved utilsigtet indtrængen af stoffer i udstyret begrænses så meget som muligt, idet der tages hensyn til udstyret og de omgivelser, hvori det skal anvendes.
10.6.   Udstyr skal designes og fremstilles på en sådan måde, at de risici, som er forbundet med størrelsen og egenskaberne af partiklerne, der frigives eller kan frigives til patientens eller brugerens legeme, begrænses så meget som muligt, medmindre de kun kommer i berøring med intakt hud. Der skal især fokuseres på nanomaterialer.
11.   Infektion og mikrobiel kontaminering
11.1.   Udstyr og deres fremstillingsprocesser skal designes på en sådan måde, at infektionsfaren fjernes eller begrænses så meget som muligt for patienter, brugere og eventuelt andre personer. Designet skal:
a)
begrænse risici forbundet med utilsigtede snit og prik, såsom kanylestikskader, så meget som muligt og i det omfang, det er relevant
b)
gøre det let og sikkert at håndtere udstyret
c)
så vidt det er muligt mindske mikrobiel lækage fra udstyret og/eller mikrobiel eksponering under brugen, og
d)
forhindre mikrobiel kontaminering af udstyret eller dets indhold såsom prøver eller væsker.
11.2.   Udstyret skal om nødvendigt designes til at lette sikker rengøring, desinfektion og/eller gensterilisering.
11.3.   Udstyr, der er mærket som værende i en bestemt mikrobiel tilstand skal designes, fremstilles og emballeres på en sådan måde, at det sikres, at det forbliver i den tilstand, når det bringes i omsætning, og på de af fabrikanten fastsatte opbevarings- og transportbetingelser.
11.4.   Udstyr, der leveres i steril tilstand, skal designes, fremstilles og emballeres på en sådan passende måde, at det sikres, at det er sterilt, når det bringes i omsætning, og at det, medmindre den emballage, der har som formål at opretholde dets sterile tilstand, beskadiges, under de af fabrikanten angivne opbevarings- og transportbetingelser forbliver sterilt, indtil emballagen åbnes på brugsstedet. Det skal sikres, at integriteten af emballagen er helt tydelig for slutbrugeren.
11.5.   Udstyr, der er mærket som sterilt, skal behandles, fremstilles, emballeres og steriliseres under anvendelse af hensigtsmæssige validerede metoder.
11.6.   Udstyr, der skal steriliseres, skal fremstilles og emballeres under passende og kontrollerede betingelser og i passende og kontrollerede faciliteter.
11.7.   Emballagesystemer for ikkesterilt udstyr skal bevare produktets integritet og renhed og, når udstyret er beregnet til at blive steriliseret inden anvendelsen, mindske faren for mikrobiel kontaminering mest muligt; emballagesystemet skal være afpasset efter den steriliseringsmetode, som fabrikanten har angivet.
11.8.   Mærkning på udstyret skal gøre det muligt at skelne mellem identisk eller tilsvarende udstyr, som bringes i omsætning i både steril og ikkesteril tilstand, ud over det symbol, der anvendes til at angive, at udstyr er sterilt.
12.   Udstyr, som indeholder et stof, der anses for at være et lægemiddel, og udstyr, der består af stoffer eller af kombinationer af stoffer, der absorberes af eller fordeles lokalt i det menneskelige legeme
12.1.   For så vidt angår udstyr som omhandlet i artikel 1, stk. 8, første afsnit, skal kvaliteten, sikkerheden og nyttevirkningen af et stof, der anvendt alene kan betragtes som et lægemiddel i henhold til artikel 1, nr. 2), i direktiv 2001/83/EF, verificeres tilsvarende efter metoderne i bilag I til direktiv 2001/83/EF, som krævet i den relevante overensstemmelsesvurderingsprocedure i henhold til denne forordning.
12.2.   Udstyr, der består af stoffer eller af en kombination af stoffer, der er bestemt til at blive indgivet i det menneskelige legeme, og som absorberes af eller fordeles lokalt i det menneskelige legeme, skal, hvor det er relevant, og på en måde, der er begrænset til de aspekter, der ikke er omfattet af denne forordning, opfylde de relevante krav i bilag I til direktiv 2001/83/EF med hensyn til evaluering af absorption, fordeling, metabolisering, udskillelse, lokal tolerance, toksicitet, interaktion med andet udstyr, lægemidler eller andre stoffer og risikoen for bivirkninger, som krævet i den relevante overensstemmelsesvurderingsprocedure i henhold til denne forordning.
13.   Udstyr, som indeholder materialer af biologisk oprindelse
13.1.   For udstyr, der er fremstillet ved anvendelse af derivater af væv eller celler af human oprindelse, som er ikkelevedygtige eller er gjort ikkelevedygtige, og som er omfattet af denne forordning i overensstemmelse med artikel 1, stk. 6, litra g), gælder følgende:
a)
Donation, udtagning og testning af væv og celler skal ske i overensstemmelse med direktiv 2004/23/EF.
b)
Behandling, præservering og enhver anden håndtering af disse væv og celler eller derivater heraf skal foregå på en sådan måde, at der opnås sikkerhed for patienter, brugere og eventuelt andre personer. Navnlig skal sikkerheden tilgodeses i forbindelse med vira og andre overførbare agenser gennem hensigtsmæssige metoder til tilvejebringelse og gennem anvendelse af validerede metoder til eliminering eller inaktivering under fremstillingsprocessen.
c)
Sporbarhedssystemet for det pågældende udstyr skal være komplementært og kompatibelt med de krav til sporbarhed og databeskyttelse, der er fastsat i direktiv 2004/23/EF og direktiv 2002/98/EF.
13.2.   For udstyr, der er fremstillet ved anvendelse af væv eller celler af animalsk oprindelse eller af derivater heraf, som er ikkelevedygtige, eller som er gjort ikkelevedygtige, gælder følgende:
a)
Hvis det er muligt under hensyntagen til dyrearterne, skal animalske væv og celler eller derivater heraf stamme fra dyr, der har været underkastet veterinærkontrol, der er tilrettelagt ud fra, hvorledes vævene tænkes anvendt. Oplysninger om dyrenes geografiske oprindelse skal opbevares af fabrikanterne.
b)
Tilvejebringelse, behandling, præservering, testning og håndtering af væv, celler og stoffer af animalsk oprindelse eller derivater heraf skal foregå på en sådan måde, at der opnås sikkerhed for patienter, brugere og eventuelt andre personer. Navnlig skal sikkerheden tilgodeses i forbindelse med vira og andre smitstoffer gennem anvendelse af validerede metoder til eliminering eller inaktivering af vira under fremstillingsprocessen, undtagen når brugen af sådanne metoder vil føre til uacceptable forringelser, der forværrer de kliniske fordele ved udstyret.
c)
For så vidt angår udstyr, der er fremstillet ved anvendelse af animalske væv eller celler eller derivater heraf som omhandlet i forordning (EU) nr. 722/2012, finder de særlige krav, der er fastsat i nævnte forordning, anvendelse.
13.3.   For udstyr, der er fremstillet ved anvendelse af ikkelevedygtige biologiske stoffer, bortset fra dem, der er omhandlet i punkt 13.1 og 13.2, skal behandling, præservering, testning og håndtering af disse stoffer foregå på en sådan måde, at der opnås sikkerhed for patienter, brugere og eventuelt andre personer, herunder i kæden for affaldsbortskaffelse. Navnlig skal sikkerheden tilgodeses i forbindelse med vira og andre overførbare agenser gennem hensigtsmæssige metoder til tilvejebringelse og gennem anvendelse af validerede metoder til eliminering eller inaktivering under fremstillingsprocessen.
14.   Konstruktion af udstyr og interaktion med dets omgivelser
14.1.   Når udstyr er beregnet til at skulle anvendes sammen med andet udstyr eller andre anordninger, skal hele kombinationen, herunder sammenkoblingssystemet, være sikker og designet på en sådan måde, at den ikke kan skade udstyrets angivne ydeevne. Enhver restriktion med hensyn til anvendelsen af sådanne kombinationer skal være anført på mærkningen og/eller brugsanvisningen. Tilslutninger, f.eks. væsker, overførsel af luftarter, elektrisk eller mekanisk kobling, som skal betjenes af brugeren, skal designes og konstrueres på en sådan måde, at enhver mulig fare, f.eks. fejltilslutning, mindskes mest muligt.
14.2.   Udstyr skal designes og fremstilles på en sådan måde, at følgende risici udelukkes eller begrænses, i det omfang det er muligt:
a)
risikoen for skader som følge af udstyrets fysiske karakteristika, herunder forholdet mellem volumen og tryk, dimensionale og eventuelt ergonomiske karakteristika
b)
risici i forbindelse med eksterne påvirkninger eller omgivelsesmæssige forhold, som med rimelighed kan forudses, såsom risici i forbindelse med magnetfelter, elektrisk og elektromagnetisk påvirkning udefra, elektrostatiske udladninger, stråling i forbindelse med diagnostiske eller terapeutiske procedurer, tryk, fugtighed, temperatur, tryk- og accelerationsudsving eller radiosignalinterferens
c)
risici i forbindelse med anvendelsen af udstyret, når det kommer i kontakt med materialer, væsker og stoffer, herunder luftarter, som det eksponeres for under normale anvendelsesvilkår
d)
risiciene i forbindelse med mulig negativ interaktion mellem software og det IT-miljø, som det fungerer og interagerer i
e)
risikoen for utilsigtet indtrængen af stoffer i udstyret
f)
risikoen for gensidig interferens med andet udstyr, som normalt anvendes i de pågældende afprøvninger eller til den pågældende behandling, og
g)
risici, der opstår, hvor vedligeholdelse og kalibrering ikke er mulig (som ved implantater), som følge af de anvendte materialers ældning eller forringelse af præcision i en given måle- eller kontrolmekanisme.
14.3.   Udstyr skal designes og fremstilles på en sådan måde, at risikoen for brand eller eksplosion begrænses mest muligt ved normal anvendelse og ved første fejlforekomst. Opmærksomheden skal især rettes mod udstyr, hvis tilsigtede brug indebærer, at det udsættes for eller anvendes i forbindelse med brændbare eller eksplosive eller brandnærende stoffer.
14.4.   Udstyr skal designes og fremstilles på en sådan måde, at tilpasning, kalibrering og vedligeholdelse kan ske på en sikker og effektiv måde.
14.5.   Udstyr, der er beregnet til at skulle fungere sammen med andet udstyr eller andre produkter, skal designes og fremstilles på en sådan måde, at interoperabiliteten og kompatibiliteten er pålidelig og sikker.
14.6.   Måle-, monitorerings- og displayindretninger skal designes og fremstilles efter ergonomiske principper under hensyntagen til det erklærede formål, brugerne og de omgivelsesmæssige forhold, som det er tilsigtet, at udstyret skal bruges under.
14.7.   Udstyr skal designes og fremstilles på en sådan måde, at det er let for brugeren, patienten eller en anden person at bortskaffe udstyret og relateret affald på en sikker måde. Med henblik herpå identificerer og tester fabrikanter procedurer og foranstaltninger, som følge af hvilke deres udstyr kan bortskaffes sikkert efter brug. Sådanne procedurer skal beskrives i brugsanvisningen.
15.   Udstyr med en diagnostisk funktion eller målefunktion
15.1.   Diagnostisk udstyr og udstyr med målefunktion skal designes og fremstilles på en sådan måde, at der kan foretages en tilstrækkelig nøjagtig, præcis og stabil måling eller diagnosticering til det erklærede formål, på grundlag af relevante videnskabelige og tekniske metoder. Tolerancerne angives af fabrikanten.
15.2.   Målinger, der udføres af udstyr med målefunktioner, skal udtrykkes i forskriftsmæssige enheder, der er i overensstemmelse med bestemmelserne i Rådets direktiv 80/181/EØF 
(
4
)
.
16.   Strålingsbeskyttelse
16.1.   Generelt
a)
Udstyr skal designes, fremstilles og emballeres på en sådan måde, at den stråling, som patienter, brugere og andre personer udsættes for, begrænses, i det omfang det er muligt, og på en måde, der er forenelig med udstyrets erklærede formål, idet den strålingsdosis, der er foreskrevet som passende til behandlings- eller diagnosticeringsformål, dog ikke må begrænses.
b)
Brugsanvisningen til udstyr, som udsender farlig eller potentielt farlig stråling, skal indeholde præcise oplysninger om, hvilken art stråling der udsendes, hvorledes patient og bruger kan beskyttes, og hvorledes forkert brug og fare i forbindelse med installering kan begrænses så meget som muligt og i det omfang, det er relevant. Desuden angives oplysninger om modtagekontrol, testning af ydeevne og acceptkriterier samt vedligeholdelsesprocedure.
16.2.   Tilsigtet stråling
a)
Når udstyr er designet til at udsende farlige eller potentielt farlige ioniserende og/eller ikkeioniserende strålingsdoser til et specifikt medicinsk formål, hvis fordele anses at opveje den fare, der er forbundet med bestrålingen, skal brugeren kunne styre bestrålingen. Sådant udstyr skal designes og fremstilles på en sådan måde, at de relevante variable parametres reproducerbarhed sikres inden for en acceptabel tolerance.
b)
Når udstyr er beregnet til at udsende farlig eller potentielt farlig ioniserende og/eller ikkeioniserende stråling, skal det så vidt muligt være forsynet med visuelle og/eller hørbare indikatorer, som markerer, at der udsendes stråling.
16.3.   Udstyr skal designes og fremstilles på en sådan måde, at patienters, brugeres og andre personers eksponering for utilsigtet spredt stråling mindskes så meget som muligt. Når det er muligt og hensigtsmæssigt, skal der udvælges metoder, der reducerer den stråling, som patienter, brugere og eventuelt andre berørte personer udsættes for.
16.4.   Ioniserende stråling
a)
Udstyr, der er beregnet til at udsende ioniserende stråling, designes og fremstilles under hensyntagen til kravene i direktiv 2013/59/Euratom om fastlæggelse af grundlæggende sikkerhedsnormer til beskyttelse mod de farer, som er forbundet med udsættelse for ioniserende stråling.
b)
Udstyr, som er beregnet til at udsende ioniserende stråling, skal designes og fremstilles på en sådan måde, at strålingsdosis, strålingsgeometri og strålingskvalitet under hensyntagen til den tilsigtede brug så vidt muligt kan reguleres og styres og, hvis det er muligt, monitoreres i forbindelse med behandling.
c)
Udstyr, som udsender ioniserende stråling, og som er beregnet til røntgendiagnostik, skal designes og fremstilles på en sådan måde, at der opnås en output- og/eller billedkvalitet, der er egnet til det pågældende medicinske formål, samtidig med at patienten og brugeren udsættes for den mindst mulige stråling.
d)
Udstyr, som udsender ioniserende stråling og er beregnet til terapeutisk radiologi, skal designes og fremstilles på en sådan måde, at den udsendte dosis samt strålingstype, energi og, hvor det er relevant, strålingskvalitet kan monitoreres og styres sikkert.
17.   Elektroniske programmerbare systemer –udstyr, der indeholder elektroniske programmerbare systemer, og software, der er udstyr i sig selv
17.1.   Udstyr, der indeholder elektroniske programmerbare systemer, herunder software, eller software, der er udstyr i sig selv, skal designes på en sådan måde, at repeterbarhed, pålidelighed og ydeevne sikres under hensyntagen til deres tilsigtede brug. Hvis der opstår en første fejlforekomst, skal der træffes passende forholdsregler til at fjerne de dermed forbundne risici eller forringelsen af ydeevne eller begrænse risiciene og forringelsen så meget som muligt.
17.2.   For udstyr, der inkorporerer software, eller for software, der er udstyr i sig selv, skal softwaren udvikles og fremstilles i overensstemmelse med det aktuelle tekniske niveau, idet der tages hensyn til principperne for udviklingslivscyklus, risikostyring, herunder informationssikkerhed, verifikation og validering.
17.3.   Software, der er nævnt i dette punkt, og som er bestemt til at skulle anvendes sammen med mobile databehandlingsplatforme, skal udvikles og fremstilles under hensyntagen til de specifikke forhold, der gør sig gældende for mobile platforme (f.eks. skærmens størrelse og kontrastratio), og til eksterne faktorer i forbindelse med dens anvendelse (skiftende lys- eller støjniveau i omgivelserne).
17.4.   Fabrikanten skal fastlægge mindstekrav til hardware, IT-netværksegenskaber og IT-sikkerhedsforanstaltninger, herunder beskyttelse mod uautoriseret adgang, der er nødvendige for at køre softwaren som tilsigtet.
18.   Aktivt udstyr og udstyr, der er tilsluttet hertil
18.1.   Hvis der for ikkeimplantabelt aktivt udstyr opstår en første fejlforekomst, skal der træffes passende forholdsregler til at fjerne de dermed forbundne risici eller begrænse dem så meget som muligt.
18.2.   Udstyr med intern energiforsyning, som er afgørende for patientens sikkerhed, skal være forsynet med en indikator, som giver mulighed for at vurdere energiforsyningens tilstand, og en passende advarsel eller indikation, hvis energiforsyningskapaciteten bliver kritisk. En sådan advarsel eller indikation skal i påkommende tilfælde gives, inden energiforsyningen bliver kritisk.
18.3.   I udstyr, hvor en patients sikkerhed afhænger af en ekstern energikilde, skal der være indbygget et alarmsystem, som gør opmærksom på ethvert energisvigt.
18.4.   Udstyr, som skal monitorere en eller flere kliniske parametre ved en patient, skal være forsynet med passende alarmsystemer, der gør det muligt at advare brugeren om situationer, der vil kunne medføre patientens død eller en alvorlig forringelse af patientens helbredstilstand.
18.5.   Udstyr skal designes og fremstilles på en sådan måde, at risikoen for at skabe elektromagnetisk interferens, som kan indvirke negativt på anvendelsen af det pågældende udstyr eller andet udstyr eller andre anordninger i de tilsigtede omgivelser, begrænses så meget som muligt.
18.6.   Udstyr skal designes og fremstilles på en sådan måde, at det har en iboende immunitet over for elektromagnetisk interferens, der er tilstrækkelig til, at det kan fungere i overensstemmelse med sit formål.
18.7.   Udstyr skal designes og fremstilles på en sådan måde, at det i videst muligt omfang undgås, at patienter, brugere eller andre personer udsættes for risikoen for utilsigtede elektriske stød både ved normal anvendelse og i tilfælde af første fejlforekomst i udstyret, når udstyret installeres og vedligeholdes som angivet af fabrikanten.
18.8.   Udstyr skal designes og fremstilles på en sådan måde, at der i videst muligt omfang beskyttes mod uautoriseret adgang, som kan hindre udstyret i at fungere efter hensigten.
19.   Særlige krav til aktivt, implantabelt udstyr
19.1.   Aktivt, implantabelt udstyr skal designes og fremstilles på en sådan måde, at følgende udelukkes eller mindskes mest muligt:
a)
risici ved anvendelse af energikilder, navnlig i forbindelse med udstyrets isolering, lækstrømme og overophedning, når der anvendes elektricitet
b)
risici i forbindelse med behandling på sundhedsområdet, navnlig som følge af, at der anvendes defibrillator eller højfrekvent kirurgisk udstyr, og
c)
risici, der kan opstå, når vedligeholdelse og kalibrering ikke er mulig, herunder i forbindelse med:
—
for stor stigning i lækstrømme
—
ældning af de anvendte materialer
—
for stor forøgelse af udstyrets varmeudvikling
—
mindre nøjagtighed i en af måle- eller kontrolmekanismerne.
19.2.   Aktivt, implantabelt udstyr skal designes og fremstilles på en sådan måde, at det sikrer
—
udstyrets kompatibilitet med de stoffer, det er beregnet til at administrere, hvor det er relevant, og
—
energikildens pålidelighed.
19.3.   Aktivt, implantabelt udstyr og i givet fald dets komponenter skal kunne identificeres på en sådan måde, at alle nødvendige foranstaltninger kan træffes, hvis der viser sig at være en potentiel risiko forbundet med udstyret eller dets komponenter.
19.4.   Aktivt, implantabelt udstyr skal være forsynet med en kode, ved hjælp af hvilken udstyret og dets fabrikant kan identificeres entydigt (navnlig med hensyn til type af udstyr og fremstillingsår); koden skal om nødvendigt kunne læses uden kirurgisk indgreb.
20.   Beskyttelse mod mekaniske og termiske risici
20.1.   Udstyr skal designes og fremstilles på en sådan måde, at patienterne og brugerne beskyttes mod mekaniske risici f.eks. i forbindelse med modstand mod bevægelse, ustabilitet og bevægelige dele.
20.2.   Udstyr skal designes og fremstilles på en sådan måde, at risici som følge af vibrationer fra udstyret reduceres mest muligt under hensyntagen til den tekniske udvikling og eksisterende midler til at reducere vibrationerne, navnlig ved kilden, medmindre vibrationerne udgør en del af den angivne ydeevne.
20.3.   Udstyr skal designes og fremstilles på en sådan måde, at risici som følge af støjemissioner reduceres mest muligt under hensyntagen til den tekniske udvikling og eksisterende midler til at reducere støjen, navnlig ved kilden, medmindre støjemissionerne udgør en del af den angivne ydeevne.
20.4.   Terminaler og konnektorer til elektricitet, gas eller hydrauliske og pneumatiske energikilder, som skal betjenes af brugeren eller en anden person, skal designes og konstrueres på en sådan måde, at enhver mulig risiko mindskes mest muligt.
20.5.   Sandsynlige fejl ved montering eller genmontering af visse dele, som kan medføre risici, skal umuliggøres ved designet og konstruktion af disse dele, og hvis dette ikke lader sig gøre, ved oplysninger, der anføres på selve delene og/eller deres afdækning.
De samme oplysninger skal være anført på de bevægelige dele og/eller deres afdækning, når det er nødvendigt at kende bevægelsesretningen for at undgå en risiko.
20.6.   Tilgængelige dele af udstyr (bortset fra dele eller områder, der skal frembringe varme eller nå givne temperaturer) og deres omgivelser må ikke nå op på temperaturer, som kan udgøre en fare ved normal anvendelse.
21.   Beskyttelse mod de risici, som udstyr, der tilfører energi eller stoffer, kan udgøre for patienten eller brugeren
21.1.   Det udstyr, der er beregnet til at tilføre energi eller stoffer til en patient, skal designes og konstrueres på en sådan måde, at den mængde, der skal leveres, kan fastsættes og opretholdes med en præcision, der er tilstrækkelig stor til at beskytte patientens og brugerens sikkerhed.
21.2.   Udstyr skal være forsynet med et system, der forhindrer og/eller markerer enhver mangelfuldhed i mængden af den energi eller de stoffer, der leveres, som kan indebære en fare. Udstyr skal være forsynet med et system, der i videst muligt omfang forhindrer utilsigtet frigørelse af farlige mængder energi eller stoffer fra en energikilde og/eller stofkilde.
21.3.   Det skal være klart angivet på udstyret, hvorledes betjeningspaneler og indikatorer virker. Når der på udstyr er angivet nødvendige brugsanvisninger, eller der er angivet brugs- eller justeringsparametre ved hjælp af et visuelt system, skal sådanne oplysninger være forståelige for brugeren og i givet fald for patienten.
22.   Beskyttelse mod risici i forbindelse med medicinsk udstyr, der af fabrikanten er bestemt til at kunne anvendes af lægmand
22.1.   Udstyr bestemt til at kunne anvendes af lægmand skal designes og fremstilles på en sådan måde, at det har en passende ydeevne i forhold til sit erklærede formål og under hensyntagen til de færdigheder og midler, en lægmand har, og til de påvirkninger, der skyldes den variation, som med rimelighed kan forventes i en lægmands teknik og omgivelser. Fabrikantens oplysninger og instruktioner skal være lette at forstå og anvende for en lægmand.
22.2.   Udstyr bestemt til at kunne anvendes af lægmand skal designes og fremstilles på en sådan måde, at
—
det om nødvendigt efter passende uddannelse og/eller oplysninger kan anvendes sikkert og korrekt i alle håndteringsfaser af den tilsigtede bruger
—
risikoen for utilsigtede snit og prik, såsom kanylestikskader, begrænses så meget som muligt og i det omfang, det er relevant, og
—
risikoen for, at den tilsigtede bruger begår fejl i forbindelse med håndtering af udstyret og eventuel fortolkning af resultatet, mindskes mest muligt.
22.3.   Udstyr bestemt til at kunne anvendes af lægmand skal, hvor det er hensigtsmæssigt, omfatte en metode, hvorved den pågældende lægmand
—
kan verificere, at udstyret på det tidspunkt, hvor det bruges, har den tilsigtede ydeevne, og
—
hvis det er relevant, advares, hvis der ikke er opnået et gyldigt resultat med udstyret.
KAPITEL III
KRAV TIL DE OPLYSNINGER, DER GIVES SAMMEN MED UDSTYRET
23.   Mærkning og brugsanvisning
23.1.   Generelle krav til fabrikantens oplysninger
Hvert udstyr skal ledsages af de oplysninger, der er nødvendige for at identificere udstyret og dets fabrikant, og af alle oplysninger vedrørende sikkerhed og ydeevne, der er relevante for brugere eller eventuelt andre personer. Disse oplysninger kan fremgå af selve udstyret, af emballagen eller af brugsanvisningen og skal, hvis fabrikanten har et websted, gøres tilgængelige og opdateres på webstedet, idet der tages hensyn til følgende:
a)
Mediet, formatet, indholdet, læsbarheden og placeringen af mærkningen og brugsanvisningen skal være afpasset efter det pågældende udstyr, dets erklærede formål og den eller de tilsigtede brugeres teknologiske viden, erfaring og uddannelse. Navnlig brugsanvisningen skal affattes på en måde, som let forstås af den tilsigtede bruger, og den skal eventuelt suppleres med tegninger og diagrammer.
b)
De oplysninger, som mærkningen skal indeholde, skal findes på selve udstyret. Hvis dette ikke er praktisk muligt eller hensigtsmæssigt, kan nogle eller alle oplysningerne anføres på emballagen til hver enhed og/eller på emballagen til flere udstyr.
c)
Mærkningen skal være i et menneskeligt læsbart format og kan suppleres med maskinlæsbare oplysninger såsom radiofrekvensidentifikation (RFID) eller stregkoder.
d)
Udstyr skal leveres med en brugsanvisning. Undtagelsesvis kræves der ingen brugsanvisning for udstyr i klasse I og klasse IIa, hvis sådant udstyr kan bruges sikkert uden en brugsanvisning, og medmindre andet er fastsat i andetsteds under dette punkt.
e)
Hvor flere udstyr leveres til en enkelt bruger og/eller et enkelt sted, kan der udleveres et eksemplar af brugsanvisningen, hvis dette er aftalt med køber, der under alle omstændigheder kan anmode om at få udleveret yderligere eksemplarer uden vederlag.
f)
Brugsanvisningen kan udleveres til brugeren i ikkepapirformat (f.eks. elektronisk) i det omfang og kun på de betingelser, der er fastsat i forordning (EU) nr. 207/2012 eller i alle efterfølgende gennemførelsesbestemmelser, som er vedtaget i henhold til nærværende forordning.
g)
Oplysninger om tilbageværende risici, som skal meddeles brugeren og/eller anden person, medtages som begrænsninger, kontraindikationer, forholdsregler eller advarsler i fabrikantens oplysninger.
h)
Hvis det er hensigtsmæssigt, skal fabrikantens oplysninger anføres ved hjælp af internationalt anerkendte symboler. Alle symboler eller identifikationsfarver skal være i overensstemmelse med de harmoniserede standarder eller fælles specifikationer. Hvis der ikke findes nogen harmoniserede standarder eller fælles specifikationer på det pågældende område, skal symboler og farver være beskrevet i den dokumentation, som ledsager udstyret.
23.2.   Oplysninger på mærkningen
Mærkningen skal indeholde alle de følgende oplysninger:
a)
udstyrets navn eller handelsnavn
b)
de angivelser, som er absolut nødvendige for, at brugeren kan identificere udstyret og emballagens indhold, og, hvor det ikke er indlysende for brugeren, udstyrets erklærede formål
c)
fabrikantens navn, registrerede firmanavn eller registrerede varemærke og adressen på det registrerede forretningssted
d)
den autoriserede repræsentants navn og adresse på den autoriserede repræsentants registrerede forretningssted, hvis fabrikanten har sit registrerede forretningssted uden for Unionen
e)
hvis det er relevant, en angivelse af, at udstyret indeholder eller inkorporerer
—
et lægemiddel, herunder et humant blod- eller plasmaderivat, eller
—
væv eller celler af human oprindelse eller derivater heraf, eller
—
væv eller celler af animalsk oprindelse eller derivater heraf, som omhandlet i forordning (EU) nr. 722/2012
f)
hvis det er relevant, oplysninger mærket i overensstemmelse med punkt 10.4.5.
g)
ordene »LOTNUMMER« eller »SERIENUMMER« eller et tilsvarende symbol efterfulgt af udstyrets lotnummer eller serienummer
h)
UDI-bæreren, jf. artikel 27, stk. 4, og bilag VII, del C
i)
en entydig angivelse af fristen for sikker anvendelse eller implantation af udstyret, angivet med mindst år og måned, hvor det er relevant
j)
fremstillingsdatoen, hvis der ikke er nogen angivelse af den dato, frem til hvilken det er sikkert at anvende udstyret. Denne fremstillingsdato kan indgå i lotnummeret eller serienummeret, hvis datoen et let at identificere
k)
angivelse af særlige betingelser vedrørende opbevaring og/eller håndtering
l)
hvis udstyret leveres i steril tilstand, en angivelse af dets sterile tilstand og steriliseringsmetoden
m)
advarsler eller forholdsregler, som det er nødvendigt omgående at meddele brugeren af udstyret og andre personer. Disse oplysninger kan under hensyntagen til de tilsigtede brugere holdes på et minimum, og i så fald anføres mere detaljerede oplysninger i brugsanvisningen
n)
hvis udstyret er beregnet til engangsbrug, en angivelse af dette. En fabrikants angivelse af engangsbrug skal være konsekvent i hele Unionen
o)
hvis udstyret er engangsudstyr, der er blevet oparbejdet, en angivelse af dette, samt af hvor mange oparbejdningscyklusser der allerede er udført, og eventuelle begrænsninger med hensyn til antallet af oparbejdningscyklusser
p)
hvis udstyret er efter mål, påtegningen »udstyr efter mål«
q)
angivelse af, at udstyret er medicinsk udstyr. Hvis udstyret udelukkende er bestemt til klinisk afprøvning, påtegningen »udelukkende til klinisk afprøvning«
r)
for så vidt angår udstyr, der består af stoffer eller af en kombination af stoffer, der er bestemt til at blive indgivet i det menneskelige legeme via en legemsåbning eller påført huden, og som absorberes af eller fordeles lokalt i det menneskelige legeme, den overordnede kvalitative sammensætning af udstyret og kvantitative oplysninger om den eller de vigtigste bestanddele, der skal sikre opnåelsen af den tilsigtede hovedvirkning
s)
for aktivt, implantabelt udstyr, serienummeret og, for andet implantabelt udstyr, serienummeret eller lotnummeret.
23.3.   Oplysninger på den emballage, der opretholder udstyrets sterile tilstand (»steril emballage«)
Følgende oplysninger skal anføres på den sterile emballage:
a)
oplysninger, der gør det muligt at genkende den sterile emballage som sådan
b)
en erklæring om, at udstyret er i steril tilstand
c)
steriliseringsmetoden
d)
fabrikantens navn og adresse
e)
en beskrivelse af udstyret
f)
hvis udstyret er bestemt til klinisk afprøvning, påtegningen: »udelukkende til klinisk afprøvning«
g)
hvis udstyret er efter mål, påtegningen »udstyr efter mål«
h)
fremstillingsmåned og -år
i)
en entydig angivelse af fristen for sikker anvendelse eller implantation af udstyret, angivet med mindst år og måned, og
j)
en anvisning om at se i brugsanvisningen, hvad man skal gøre, hvis den sterile emballage er beskadiget eller utilsigtet er blevet åbnet inden brug.
23.4.   Oplysninger i brugsanvisningen
Brugsanvisningen skal indeholde alle de følgende oplysninger:
a)
de angivelser, der er omhandlet i punkt 23.2, litra a), c), e), f), k), l), n) og r)
b)
udstyrets erklærede formål med en klar specifikation af indikationer, kontraindikationer, patientmålgruppe eller -grupper og tilsigtede brugere, alt efter omstændighederne
c)
hvis det er relevant, en specifikation af de kliniske fordele, der kan forventes
d)
hvis det er relevant, links til sammenfatningen af sikkerhed og klinisk ydeevne, jf. artikel 32
e)
udstyrets ydeevnekarakteristika
f)
hvis det er relevant, oplysninger, der gør det muligt for sundhedspersoner at verificere, om udstyret er egnet, og vælge det tilhørende software og tilbehør
g)
eventuelle tilbageværende risici, kontraindikationer og alle uønskede bivirkninger, herunder oplysninger til patienterne herom
h)
de specifikationer, der er nødvendige for, at brugeren kan anvende udstyret korrekt, f.eks. hvis udstyret har en målefunktion, den opgivne grad af nøjagtighed
i)
oplysninger om eventuel forberedende behandling eller håndtering af udstyret, inden udstyret er klar til anvendelse eller under dets brug, f.eks. sterilisering, endelig samling, kalibrering mv., herunder de desinficeringsniveauer, der kræves for at sikre patientsikkerheden, og alle de tilgængelige metoder til opfyldelse af disse desinficeringsniveauer
j)
eventuelle krav om særlige faciliteter eller særlig uddannelse eller særlige kvalifikationer til brugeren af udstyret og/eller andre personer
k)
de oplysninger, der er nødvendige for at verificere, om udstyret er installeret korrekt og er klar til at fungere sikkert og som tiltænkt af fabrikanten, samt, hvis det er relevant:
—
oplysninger om arten og hyppigheden af forebyggende og regelmæssig vedligeholdelse, og eventuel forberedende rengøring eller desinficering
—
identifikation af alle forbrugskomponenter, og oplysninger om, hvordan de udskiftes
—
oplysninger om nødvendig kalibrering for at sikre, at udstyret fungerer korrekt og sikkert i hele sin forventede levetid, og
—
metoder til eliminering af de risici, som personer, der beskæftiger sig med installering, kalibrering eller vedligeholdelse af udstyr, er udsat for
l)
hvis udstyret leveres i steril tilstand, anvisninger, i tilfælde af brud på eller utilsigtet åbning af den sterile emballage inden brug
m)
hvis udstyret leveres i ikkesteril tilstand i den hensigt, at det skal steriliseres inden brugen, passende instruktioner vedrørende sterilisering
n)
for genanvendeligt udstyr oplysninger om, hvilke metoder der bør anvendes, for at genanvendelse kan finde sted, herunder rengøring, desinfektion, emballering og i givet fald den validerede gensteriliseringsmetode, der er relevant for den eller de medlemsstater, hvor udstyret er bragt i omsætning. Der skal forelægges oplysninger til fastlæggelse af, hvornår udstyret ikke længere bør genanvendes, f.eks. tegn på materialeforringelse eller det maksimale antal tilladte genanvendelser
o)
hvis det er relevant, oplysninger om, at udstyret kun kan genanvendes, hvis det på fabrikantens ansvar er blevet istandsat for at opfylde de generelle krav til sikkerhed og ydeevne
p)
hvis det af udstyret fremgår, at det er beregnet til engangsbrug, skal der vedlægges oplysninger om de kendte karakteristika og tekniske faktorer, som fabrikanten har kendskab til kan udgøre en risiko, hvis udstyret genanvendes. Disse oplysninger skal være baseret på en specifik del af fabrikantens risikostyringsdokumentation, hvor sådanne karakteristika og tekniske faktorer skal være detaljeret beskrevet. Såfremt der i overensstemmelse med punkt 23.1, litra d), ikke kræves en brugsanvisning, skal oplysningerne stilles til rådighed for brugeren efter anmodning
q)
for udstyr, der er bestemt til at blive brugt sammen med andet udstyr og/eller anordninger til generelle formål:
—
oplysninger til identifikation af sådant medicinsk udstyr eller sådanne medicinske anordninger for at opnå en sikker kombination og/eller
—
oplysninger om eventuelle kendte begrænsninger for kombinationer af udstyr og anordninger
r)
hvis udstyret udsender stråling med et medicinsk formål:
—
detaljerede oplysninger om strålingens art, type og i givet fald intensitet og fordeling
—
oplysninger om, hvordan patienten, brugeren eller anden person beskyttes mod utilsigtet stråling under udstyrets anvendelse
s)
oplysninger, der gør det muligt for brugeren og/eller patienten at blive underrettet om eventuelle advarsler, forholdsregler, kontraindikationer, foranstaltninger, der skal træffes, og begrænsninger i anvendelsen af udstyret. Disse oplysninger skal, hvis det er relevant, gøre det muligt for brugeren at orientere patienten om eventuelle advarsler, forholdsregler, kontraindikationer, foranstaltninger, der skal træffes, og begrænsninger i anvendelsen af udstyret. Oplysningerne skal i givet fald omfatte:
—
advarsler, forholdsregler og/eller foranstaltninger, der skal træffes i tilfælde af funktionsfejl ved udstyret eller ændringer i dets ydeevne, der kan påvirke sikkerheden
—
advarsler, forholdsregler og/eller foranstaltninger, der skal træffes i forbindelse med eksponering for eksterne påvirkninger, som med rimelighed kan forudses, såsom magnetfelter, elektrisk og elektromagnetisk påvirkning udefra, elektrostatiske udladninger, stråling i forbindelse med diagnostiske eller terapeutiske procedurer, tryk, fugt eller temperatur
—
advarsler, forholdsregler og/eller foranstaltninger, der skal træffes i forbindelse med risikoen for interferens som følge af udstyrets tilstedeværelse, som med rimelighed kan forudses, ved specifikke diagnostiske undersøgelser, evalueringer, terapeutiske behandlingsformer eller andre procedurer såsom elektromagnetisk interferens, der udsendes af udstyret, og som påvirker andet materiel
—
hvis udstyret er bestemt til at administrere lægemidler, væv eller celler af human eller animalsk oprindelse, eller derivater heraf, eller biologiske stoffer, enhver begrænsning eller inkompatibilitet i valget af stoffer, der kan administreres
—
advarsler, forholdsregler og/eller begrænsninger vedrørende lægemidler eller biologisk materiale, der er inkorporeret i udstyret som en integreret del af udstyret, og
—
forholdsregler vedrørende materialer, der er inkorporeret i udstyret, og som indeholder eller består af CMR-stoffer eller hormonforstyrrende stoffer, eller som kan medføre overfølsomhed eller en allergisk reaktion hos patient eller bruger
t)
for så vidt angår udstyr, der består af stoffer eller af en kombination af stoffer, der er bestemt til at blive indgivet i det menneskelige legeme, og som absorberes af eller fordeles lokalt i det menneskelige legeme, advarsler og forholdsregler, hvis det er relevant, forbundet med den overordnede profil for interaktion mellem udstyret og dets metabolitter og andet udstyr, lægemidler og andre stoffer samt kontraindikationer, uønskede bivirkninger og risici vedrørende overdosering
u)
for så vidt angår implantabelt udstyr, de overordnede kvalitative og kvantitative oplysninger om de materialer og stoffer, som patienter kan udsættes for
v)
advarsler eller forholdsregler, der skal træffes for at fremme sikker bortskaffelse af udstyret, dets tilbehør og eventuelle hjælpematerialer. Disse oplysninger skal i givet fald omfatte:
—
infektionsfare eller mikrobielle farer såsom eksplantater, nåle eller kirurgisk udstyr, der er forurenet med potentielt smittefarlige stoffer af human oprindelse, og
—
fysiske farer, f.eks. fra spidse eller skarpe instrumenter
Såfremt der i overensstemmelse med punkt 23.1, litra d), ikke kræves en brugsanvisning, skal oplysningerne stilles til rådighed for brugeren efter anmodning.
w)
for udstyr bestemt til at kunne anvendes af lægfolk, de tilfælde, hvor brugeren bør konsultere en sundhedsperson
x)
for udstyr, der er omfattet af denne forordning i henhold til artikel 1, stk. 2, oplysninger om manglende kliniske fordele og de risici, der er forbundet med brug af udstyret
y)
dato for udstedelse af brugsanvisningen eller, hvis den er blevet revideret, dato og referencenummer for seneste revision af brugsanvisningen
z)
en meddelelse til brugeren og/eller patienten om, at enhver alvorlig hændelse, der er indtruffet i forbindelse med udstyret, bør indberettes til fabrikanten og den kompetente myndighed i den medlemsstat, hvor brugeren og/eller patienten er etableret
aa)
oplysninger, der skal gives til patienter med implanteret udstyr, jf. artikel 18
ab)
for udstyr, der indeholder elektroniske programmerbare systemer, herunder software, eller software, der er udstyr i sig selv, mindstekrav til hardware, IT-netværksegenskaber og IT-sikkerhedsforanstaltninger, herunder beskyttelse mod uautoriseret adgang, der er nødvendige for at køre softwaren som tilsigtet.
(
1
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 1272/2008 af 16. december 2008 om klassificering, mærkning og emballering af stoffer og blandinger og om ændring og ophævelse af direktiv 67/548/EØF og 1999/45/EF og om ændring af forordning (EF) nr. 1907/2006 (
EUT L 353 af 31.12.2008, s. 1
).
(
2
)
  Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 af 18. december 2006 om registrering, vurdering og godkendelse af samt begrænsninger for kemikalier (REACH) (
EUT L 396 af 30.12.2006, s. 1
).
(
3
)
  Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter (
EUT L 167 af 27.6.2012, s. 1
).
(
4
)
  Rådets direktiv 80/181/EØF af 20. december 1979 om indbyrdes tilnærmelse af medlemsstaternes lovgivning om måleenheder og om ophævelse af direktiv 71/354/EØF (
EFT L 39 af 15.2.1980, s. 40
).
BILAG II
TEKNISK DOKUMENTATION
Den tekniske dokumentation og, hvis det er relevant, sammenfatningen heraf, som skal udarbejdes af fabrikanten, skal fremlægges på en tydelig, organiseret og utvetydig måde og være let at søge i og skal navnlig omfatte elementerne i dette bilag.
1.   UDSTYR: BESKRIVELSE OG SPECIFIKATION, HERUNDER VARIANTER OG TILBEHØR
1.1.   Udstyr: beskrivelse og specifikation
a)
produkt- eller handelsnavn og en generel beskrivelse af udstyret, herunder dets erklærede formål og tilsigtede brugere
b)
den grundlæggende UDI-DI, jf. bilag VI, del C, som fabrikanten tildeler det pågældende udstyr, så snart identifikationen af udstyret baseres på et UDI-system, eller en anden tydelig identifikation ved hjælp af produktkode, katalognummer eller anden entydig reference, som muliggør sporing
c)
den tilsigtede patientpopulation og de sygdomstilstande, der skal diagnosticeres, behandles og/eller monitoreres og andre forhold, såsom patientudvælgelseskriterier, indikationer, kontraindikationer, advarsler
d)
principper for udstyrets funktion og om nødvendigt dets videnskabeligt påviste virkningsmåde
e)
rationalet for kvalificeringen af produktet som udstyr
f)
udstyrets risikoklasse og begrundelsen for den eller de klassificeringsregler, der er anvendt i overensstemmelse med bilag VIII
g)
en redegørelse for eventuelle helt nye egenskaber
h)
en beskrivelse af tilbehør til udstyr, andet udstyr og andre produkter, som ikke er udstyr, som er bestemt til at skulle anvendes sammen med udstyret
i)
en beskrivelse af eller fuldstændig liste over de forskellige konfigurationer/varianter af udstyret, som er bestemt til at blive gjort tilgængelige på markedet
j)
en generel beskrivelse af de vigtigste funktionelle elementer, f.eks. udstyrets enkeltdele/komponenter (herunder software, hvis det er relevant), dets udformning, sammensætning, funktion og, hvis det er relevant, dets kvantitative og kvalitative sammensætning. Hvis det er relevant, skal dette omfatte visuelle fremstillinger på mærkningen (f.eks. diagrammer, fotografier og tegninger) med tydelig angivelse af vigtige enkeltdele/komponenter, herunder forklaringer, der er nødvendige for at forstå tegningerne og diagrammerne
k)
en beskrivelse af de råmaterialer, der er inkorporeret i de vigtigste funktionelle elementer, og dem, der enten er i direkte kontakt med det menneskelige legeme eller i indirekte kontakt med legemet, f.eks. under ekstrakorporal cirkulation af legemsvæsker
l)
tekniske specifikationer, f.eks. karakteristika, dimensioner og ydeevne, for udstyret og eventuelle varianter/konfigurationer og tilbehør, der typisk optræder i den produktspecifikation, der gøres tilgængelig for brugeren, f.eks. i brochurer, kataloger og lignende.
1.2.   Henvisning til tidligere og tilsvarende generationer af udstyret
a)
en oversigt over den eller de tidligere generationer af det udstyr, som fabrikanten har fremstillet, hvis der findes sådant udstyr
b)
en oversigt over identificeret tilsvarende udstyr, der er tilgængeligt på EU-markedet eller internationale markeder, hvis der findes sådant udstyr.
2.   OPLYSNINGER, SOM FABRIKANTEN SKAL FREMLÆGGE
Et komplet sæt af:
—
mærkningen på udstyret og på dets emballage, f.eks. emballagen for hver enhed, salgsemballagen og transportemballagen i tilfælde af særlige forvaltningsforhold, på de sprog, der accepteres i de medlemsstater, hvor det er hensigten at sælge udstyret, og
—
brugsanvisningen på de sprog, der accepteres i de medlemsstater, hvor det er hensigten at sælge udstyret.
3.   DESIGN- OG FREMSTILLINGSOPLYSNINGER
a)
oplysninger, der gør det muligt at forstå de designfaser, som udstyret har gennemgået
b)
fuldstændige oplysninger og specifikationer, herunder fremstillingsprocesserne og deres validering, deres adjuvanser, den løbende monitorering og prøvningen af slutproduktet. Data skal inddrages fuldt ud i den tekniske dokumentation
c)
identifikation af alle faciliteter, herunder leverandører og underentreprenører, hvor der udføres design- og fremstillingsaktiviteter.
4.   GENERELLE KRAV TIL SIKKERHED OG YDEEVNE
Dokumentationen skal indeholde oplysninger til påvisning af overensstemmelse med de generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I, og som gælder for udstyret, under hensyntagen til dets erklærede formål og skal indeholde en begrundelse, validering og verifikation af de løsninger, der er valgt til at opfylde disse krav. Påvisningen af overensstemmelse skal indeholde:
a)
de generelle krav til sikkerhed og ydeevne, der gælder for udstyret, og en redegørelse for, hvorfor andre krav ikke gælder
b)
den eller de metoder, der er anvendt for at påvise overensstemmelse med hvert af de gældende generelle krav til sikkerhed og ydeevne
c)
de harmoniserede standarder, fælles specifikationer eller andre løsninger, der er anvendt, og
d)
den nøjagtige identitet af de kontrollerede dokumenter, der dokumenterer overensstemmelse med de enkelte harmoniserede standarder eller fælles specifikationer eller en anden anvendt metode til påvisning af overensstemmelse med de generelle krav til sikkerhed og ydeevne. De i dette litra nævnte oplysninger skal indeholde en krydshenvisning til placeringen af denne dokumentation i den fuldstændige tekniske dokumentation og, hvis det er relevant, en sammenfatning af den tekniske dokumentation.
5.   ANALYSE AF FORHOLDET MELLEM FORDELE OG RISICI SAMT RISIKOSTYRING
Dokumentationen skal indeholde oplysninger om:
a)
analysen af forholdet mellem fordele og risici, jf. bilag I, punkt 1 og 8, og
b)
de valgte løsninger og resultaterne af risikostyringen, jf. bilag I, punkt 3.
6.   PRODUKTVERIFIKATION OG -VALIDERING
Dokumentationen skal omfatte resultaterne og kritiske analyser af alle verifikationer og valideringstest og/eller undersøgelser, der er foretaget for at påvise, at udstyret er i overensstemmelse med denne forordnings krav og navnlig de gældende generelle krav til sikkerhed og ydeevne.
6.1.   Prækliniske og kliniske data
a)
resultaterne af forsøg, f.eks. tekniske forsøg, laboratorieforsøg, forsøg med simuleret anvendelse og dyreforsøg, og evaluering af offentliggjort litteratur gældende for udstyret, under hensyntagen til dets erklærede formål, eller for tilsvarende udstyr vedrørende udstyrets prækliniske sikkerhed og dets overensstemmelse med specifikationerne
b)
detaljerede oplysninger om testdesign, fuldstændige forsøgs- eller undersøgelsesprotokoller, dataanalysemetoder samt dataresuméer og konklusioner især vedrørende:
—
udstyrets bioforligelighed, herunder identifikation af alt materiale i direkte eller indirekte kontakt med patienten eller brugeren
—
fysisk, kemisk og mikrobiologisk karakterisering
—
elektrisk sikkerhed og elektromagnetisk kompatibilitet
—
softwareverifikation og -validering (beskrivelse af softwaredesign og udviklingsproces og dokumentation for validering af softwaren, som anvendt i det færdige udstyr. Disse oplysninger skal typisk omfatte et sammendrag af resultaterne af al verifikation, validering og forsøg, der er gennemført både internt og i simulerede omgivelser eller hos den faktiske bruger inden den endelige frigivelse. De skal også omfatte alle de forskellige hardwarekonfigurationer og i givet fald styresystemer angivet i fabrikantens oplysninger)
—
stabilitet, herunder holdbarhed, og
—
ydeevne og sikkerhed.
Hvor det er relevant, skal der påvises overensstemmelse med bestemmelserne i Europa-Parlamentets og Rådets direktiv 2004/10/EF 
(
1
)
.
Hvis der ikke er blevet gennemført nye forsøg, skal dokumentationen omfatte et rationale for denne beslutning. Et eksempel på et sådant rationale kan være, at der blev gennemført bioforligelighedsforsøg på identiske materialer, hvis disse materialer var inkorporeret i en tidligere version af det udstyr, der lovligt er bragt i omsætning eller ibrugtaget
c)
den kliniske evalueringsrapport og opdateringer heraf og den kliniske evalueringsplan, jf. artikel 61, stk. 12, og bilag XIV, del A
d)
PMCF-planen og PMCF-evalueringsrapporten, jf. bilag XIV, del B, eller en begrundelse for, hvorfor PMCF ikke er relevant.
6.2.   Yderligere oplysninger, der kræves i særlige tilfælde
a)
Hvis udstyr som en integreret bestanddel indeholder et stof, der anvendt alene kan betragtes som et lægemiddel ifølge artikel 1, nr. 2), i direktiv 2001/83/EF, herunder et lægemiddel fremstillet på basis af blod eller plasma fra mennesker, jf. artikel 1, stk. 8, første afsnit, en angivelse af dette. I dette tilfælde skal dokumentationen identificere kilden til det pågældende stof og indeholde oplysninger om de test, der er udført for at vurdere dets sikkerhed, kvalitet og nyttevirkning, under hensyntagen til udstyrets formål.
b)
Hvis udstyr er fremstillet ved anvendelse af væv eller celler af human eller animalsk oprindelse eller af derivater heraf og er omfattet af denne forordning i overensstemmelse med artikel 1, stk. 6, litra f) og g), og hvis udstyr som en integreret bestanddel indeholder væv eller celler af human oprindelse eller af derivater heraf, som har en virkning ud over den, som udstyret har, og er omfattet af denne forordning i overensstemmelse med artikel 1, stk. 10, første afsnit, en angivelse af dette. I et sådant tilfælde skal dokumentationen identificere alle materialer af human eller animalsk oprindelse, der er anvendt, og give detaljerede oplysninger om overensstemmelse med bilag I, henholdsvis punkt 13.1 eller 13.2.
c)
For så vidt angår udstyr, der består af stoffer eller af kombinationer af stoffer, der er bestemt til at blive indgivet i det menneskelige legeme, og som absorberes af eller fordeles lokalt i det menneskelige legeme, detaljerede oplysninger, herunder testdesign, fuldstændige forsøgs- eller undersøgelsesprotokoller, dataanalysemetoder samt dataresuméer og konklusioner om undersøgelser vedrørende:
—
absorption, fordeling, metabolisering og udskillelse
—
mulige interaktioner for disse stoffer, eller for deres metabolitter i det menneskelige legeme, med andet udstyr, lægemidler eller andre stoffer, under hensyntagen til målpopulationen, og dets tilknyttede sygdomstilstand
—
lokal tolerance, og
—
toksicitet, herunder toksicitet ved enkeltindgift, toksicitet ved gentagen indgift, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet, som gælder afhængigt af niveauet og arten af eksponering for udstyret.
Hvis der ikke findes sådanne undersøgelser, gives der en begrundelse.
d)
For udstyr, der indeholder CMR-stoffer eller hormonforstyrrende stoffer, jf. bilag I, punkt 10.4.1, begrundelsen i nævnte bilags punkt 10.4.2.
e)
For udstyr, der bringes i omsætning i steril eller defineret mikrobiologisk tilstand, en beskrivelse af de miljømæssige betingelser for de yderligere faser i fremstillingsprocessen. For udstyr, der bringes i omsætning i steril tilstand, en beskrivelse af de anvendte metoder, herunder valideringsrapporterne, med hensyn til emballage, sterilisering og opretholdelse af den sterile tilstand. Valideringsrapporten skal omhandle test af mikrobiel belastning, pyrogentest og, hvis det er relevant, test for restkoncentrationer af steriliseringsmidler.
f)
For udstyr, der bringes i omsætning med en målefunktion, en beskrivelse af de metoder, der er anvendt for at sikre den nøjagtighed, som er angivet i specifikationerne.
g)
Hvis udstyret skal tilsluttes andet udstyr for at kunne fungere efter hensigten, en beskrivelse af denne kombination/konfiguration, herunder dokumentation for, at det opfylder de generelle krav til sikkerhed og ydeevne, når det er tilsluttet udstyr, som har de karakteristika, der er anført af fabrikanten.
(
1
)
  Europa-Parlamentets og Rådets direktiv 2004/10/EF af 11. februar 2004 om indbyrdes tilnærmelse af lovgivning om anvendelsen af principper for god laboratoriepraksis og om kontrol med deres anvendelse ved forsøg med kemiske stoffer (
EUT L 50 af 20.2.2004, s. 44
).
BILAG III
TEKNISK DOKUMENTATION OM OVERVÅGNING, EFTER AT UDSTYRET ER BRAGT I OMSÆTNING
Den tekniske dokumentation om overvågning, efter at udstyret er bragt i omsætning, som skal udarbejdes af fabrikanten i overensstemmelse med artikel 83-86, fremlægges på en tydelig, organiseret og utvetydig måde, som er let at søge i, og skal navnlig indeholde de elementer, der er beskrevet i dette bilag:
1.1.   Planen for overvågning, efter at udstyret er bragt i omsætning, der er udarbejdet i overensstemmelse med artikel 84.
Fabrikanten skal i en plan for overvågning, efter at udstyret er bragt i omsætning, dokumentere, at den opfylder den i artikel 83 omhandlede forpligtelse.
a)
Planen for overvågning, efter at udstyret er bragt i omsætning, skal omhandle indsamling og anvendelse af tilgængelige oplysninger, navnlig:
—
oplysninger om alvorlige hændelser, herunder oplysninger fra periodiske opdaterede sikkerhedsindberetninger og sikkerhedsrelaterede korrigerende handlinger
—
registre over hændelser, der ikke er alvorlige, og data om alle uønskede bivirkninger
—
oplysninger fra indberetning af tendenser
—
relevant speciallitteratur, teknisk litteratur, databaser og/eller registre
—
oplysninger, herunder feedback og klager, fra brugere, distributører og importører, og
—
offentligt tilgængelige oplysninger om tilsvarende medicinsk udstyr.
b)
Planen for overvågning, efter at udstyret er bragt i omsætning, skal mindst omfatte:
—
en proaktiv og systematisk proces for indsamling af de i litra a) omhandlede oplysninger. Processen skal give mulighed for en korrekt karakterisering af udstyrets ydeevne og også gøre det muligt at foretage en sammenligning mellem udstyret og tilsvarende produkter på markedet
—
effektive og hensigtsmæssige metoder og processer til at vurdere de indsamlede data
—
passende indikatorer og tærskelværdier, der skal anvendes i den fortsatte revurdering af analysen af forholdet mellem fordele og risici og af risikostyringen, jf. bilag I, punkt 3
—
effektive og hensigtsmæssige metoder og værktøjer til at undersøge klager og analysere markedsrelaterede erfaringer på området
—
metoder og protokoller til at behandle hændelser, der er omfattet af indberetningen af tendenser, jf. artikel 88, herunder de metoder og protokoller, der skal anvendes til at fastlægge enhver statistisk signifikant stigning i hyppigheden eller alvoren af hændelser samt observationsperioden
—
metoder og protokoller til at kommunikere effektivt med de kompetente myndigheder, bemyndigede organer, erhvervsdrivende og brugere
—
henvisning til procedurer til at opfylde fabrikantens forpligtelser som fastsat i artikel 83, 84 og 86
—
systematiske procedurer til at identificere og iværksætte passende foranstaltninger, herunder korrigerende handlinger
—
effektive værktøjer til at spore og identificere udstyr, for hvilke korrigerende handlinger kan være nødvendige, og
—
en PMCF-plan, jf. bilag XIV, del B, eller en begrundelse for, hvorfor PMCF ikke er relevant.
1.2.   Den periodiske opdaterede sikkerhedsindberetning, jf. artikel 86, og rapporten om overvågning, efter at udstyret er bragt i omsætning, jf. artikel 85.
BILAG IV
EU-OVERENSSTEMMELSESERKLÆRING
EU-overensstemmelseserklæringen skal indeholde følgende oplysninger:
1.
fabrikantens navn, registrerede firmanavn eller registrerede varemærke og, hvis det allerede er udstedt, SRN, jf. artikel 31, og, hvis det er relevant, dennes autoriserede repræsentant og adressen på deres registrerede forretningssted, hvor de kan kontaktes og fysisk kan lokaliseres
2.
en erklæring om, at EU-overensstemmelseserklæringen udstedes på fabrikantens ansvar
3.
den grundlæggende UDI-DI, jf. bilag VI, del C
4.
produkt- og handelsnavn, produktkode, katalognummer eller anden entydig reference, der gør det muligt at identificere og spore det udstyr, der er omfattet af EU-overensstemmelseserklæringen, f.eks. et fotografi, hvis det er relevant, samt udstyrets erklærede formål. Med undtagelse af produkt- eller handelsnavnet kan de oplysninger, som muliggør identifikation og sporing, fremgå af den grundlæggende UDI-DI, der er omhandlet i punkt 3
5.
udstyrets risikoklasse i overensstemmelse med reglerne i bilag VIII
6.
en erklæring om, at det udstyr, der er omfattet af denne erklæring, er i overensstemmelse med denne forordning og eventuelt med al anden relevant EU-lovgivning, der fastsætter bestemmelser om udstedelse af en EU-overensstemmelseserklæring
7.
referencer til eventuelle fælles specifikationer, der er anvendt, og som der erklæres overensstemmelse med
8.
hvis det er relevant, navnet og identifikationsnummeret på det bemyndigede organ, en beskrivelse af den gennemførte overensstemmelsesvurderingsprocedure og identifikation af den eller de udstedte certifikater
9.
i givet fald yderligere oplysninger
10.
udstedelsessted og -dato for erklæringen, navn og stilling på den person, der har underskrevet den, samt en angivelse af, for hvem og på hvis vegne vedkommende har underskrevet, og underskrift.
BILAG V
CE-OVERENSSTEMMELSESMÆRKNING
1.
CE-mærkningen består af bogstaverne »CE« i henhold til følgende model:
2.
Hvis CE-mærkningen formindskes eller forstørres, skal modellens størrelsesforhold, som anført ovenfor, overholdes.
3.
De forskellige dele, der indgår i CE-mærkningen, skal så vidt muligt have samme lodrette størrelse og skal mindst være 5 mm høje. Denne minimumsstørrelse kan fraviges for småt udstyr.
BILAG VI
OPLYSNINGER, DER SKAL INDSENDES VED REGISTRERING AF UDSTYR OG ERHVERVSDRIVENDE, JF. ARTIKEL 29, STK. 4, OG ARTIKEL 31, CENTRALE DATAELEMENTER, DER SAMMEN MED UDI-DI SKAL INDSENDES TIL UDI-DATABASEN, JF. ARTIKEL 28 OG 29, OG UDI-SYSTEMET
DEL A
OPLYSNINGER, DER SKAL INDSENDES VED REGISTRERING AF UDSTYR OG ERHVERVSDRIVENDE, JF. ARTIKEL 29, STK. 4, OG ARTIKEL 31
Fabrikanter eller eventuelle autoriserede repræsentanter og eventuelle importører skal forelægge de oplysninger, der er omhandlet i punkt 1, og skal sikre, at de oplysninger om deres udstyr, der er omhandlet i punkt 2, er fuldstændige, korrekte og opdateret af den relevante part:
1.   Oplysninger om den erhvervsdrivende
1.1.
typen af erhvervsdrivende (fabrikant, autoriseret repræsentant eller importør)
1.2.
den erhvervsdrivendes navn, adresse og kontaktoplysninger
1.3.
hvis oplysninger forelægges af en anden person på vegne af en af de erhvervsdrivende, der er nævnt i punkt 1.1, denne persons navn, adresse og kontaktoplysninger
1.4.
navn, adresse og kontaktoplysninger på den eller de personer, der er ansvarlige for overholdelse af reguleringen, jf. artikel 15
2.   Oplysninger om udstyret
2.1.
den grundlæggende UDI-DI
2.2.
type, nummer og udløbsdato for det certifikat, der er udstedt af det bemyndigede organ, og navn eller identifikationsnummer på det pågældende bemyndigede organ og linket til de oplysninger, der er anført på certifikatet, og som det bemyndigede organ har indført i det elektroniske system for bemyndigede organer og certifikater
2.3.
den medlemsstat, hvor udstyret skal bringes i omsætning eller er blevet bragt i omsætning i Unionen
2.4.
for udstyr i klasse IIa, klasse IIb eller klasse III: de medlemsstater, hvor udstyret er blevet gjort tilgængeligt eller skal gøres tilgængeligt
2.5.
udstyrets risikoklasse
2.6.
oparbejdet engangsudstyr (ja/nej)
2.7.
tilstedeværelse af et stof, der anvendt alene kan betragtes som et lægemiddel, og navnet på dette stof
2.8.
tilstedeværelse af et stof, der anvendt alene kan betragtes som et lægemiddel fremstillet på basis af blod eller plasma fra mennesker, og navnet på dette stof
2.9.
tilstedeværelse af væv eller celler af human oprindelse eller derivater heraf (ja/nej)
2.10.
tilstedeværelse af væv eller celler af human oprindelse eller derivater heraf, som omhandlet i forordning (EU) nr. 772/2012 (ja/nej)
2.11.
hvis det er relevant, det individuelle identifikationsnummer for den eller de kliniske afprøvninger, der er gennemført i forbindelse med udstyret eller et link til registreringen af den kliniske afprøvning i det elektroniske system for kliniske afprøvninger
2.12.
for udstyr, der er opført i bilag XVI, specificering af, om udstyret har et erklærede formål, der ikke er medicinsk
2.13.
for udstyr, der er designet og fremstillet af en anden fysisk eller juridisk person, jf. artikel 10, stk. 15, navn, adresse og kontaktoplysninger på den pågældende fysiske eller juridiske person
2.14.
for udstyr i klasse III eller implantabelt udstyr, sammenfatning af sikkerhed og klinisk ydeevne
2.15.
udstyrets status (på markedet, ikke længere i omsætning, trukket tilbage, der er indledt sikkerhedsrelaterede korrigerende handlinger).
DEL B
CENTRALE DATAELEMENTER, DER SAMMEN MED UDI-DI SKAL INDSENDES TIL UDI-DATABASEN, JF. ARTIKEL 28 OG 29
Fabrikanten skal indsende UDI-DI og alle de følgende oplysninger om fabrikanten og udstyret til UDI-databasen:
1.
mængde pr. emballagekonfiguration
2.
den grundlæggende UDI-DI, jf. artikel 29, og eventuelle supplerende UDI-DI'er
3.
den måde, hvorpå fremstillingen af udstyret kontrolleres (udløbsdato eller fremstillingsdato, lotnummer, serienummer)
4.
hvis det er relevant, UDI-DI for brugsenheden (hvis der ikke er en UDI-mærkning på udstyrets brugsenhed, skal brugsenheden tildeles en DI for at knytte brugen af udstyret til en patient)
5.
fabrikantens navn og adresse (som anført på mærkningen)
6.
SRN udstedt i henhold til artikel 31, stk. 2
7.
hvis det er relevant, den autoriserede repræsentants navn og adresse (som anført på mærkningen)
8.
nomenklaturkoden for medicinsk udstyr, jf. artikel 26
9.
udstyrets risikoklasse
10.
hvis det er relevant, navn eller handelsnavn
11.
hvis det er relevant, udstyrsmodel, reference eller katalognummer
12.
hvis det er relevant, klinisk størrelse (herunder volumen, længde, gauge, diameter)
13.
yderligere produktbeskrivelse (valgfrit)
14.
hvis det er relevant, betingelser vedrørende opbevaring og/eller håndtering (som angivet på mærkningen eller i brugsanvisningen)
15.
hvis det er relevant, yderligere handelsnavne for udstyret
16.
mærket som engangsudstyr (ja/nej)
17.
i givet fald, det maksimale antal genanvendelser
18.
udstyr mærket som sterilt (ja/nej)
19.
behov for sterilisering inden anvendelse (ja/nej)
20.
indeholdende latex (ja/nej)
21.
hvis det er relevant, oplysninger mærket i overensstemmelse med bilag I, punkt 10.4.5
22.
URL for yderligere oplysninger, f.eks. brugsanvisning i elektronisk form (valgfrit)
23.
hvis det er relevant, kritiske advarsler og kontraindikationer
24.
udstyrets status (på markedet, ikke længere i omsætning, trukket tilbage, der er indledt sikkerhedsrelaterede korrigerende handlinger).
DEL C
UDI-SYSTEMET
1.   Definitioner
Automatisk identifikation og datafangst (»AIDC«)
AIDC er en teknologi, der anvendes til automatisk datafangst. AIDC-teknologier omfatter stregkoder, chipkort, biometri og RFID.
Grundlæggende UDI-DI
Den grundlæggende UDI-DI er en udstyrsmodels primære identifikationskode. Det er den DI, der er tildelt udstyrets brugsenhed. Det er den vigtigste kode til registreringer i UDI-databasen, og den fremgår af relevante certifikater og EU-overensstemmelseserklæringer.
Brugsenhedens DI
Brugsenhedens DI tjener til at knytte brugen af udstyret til en patient i tilfælde, hvor der ikke er en UDI-mærkning på det pågældende udstyrs brugsenhed, f.eks. når flere enheder af samme udstyr er pakket sammen.
Konfigurerbart udstyr
Konfigurerbart udstyr er udstyr, der består af flere komponenter, som fabrikanten kan samle i flere konfigurationer. De enkelte komponenter kan være udstyr i sig selv.
Konfigurerbart udstyr omfatter computertomografisystemer, ultralydssystemer, anæstesisystemer, systemer til fysiologisk monitorering og et radiologisk informationssystem (RIS).
Konfiguration
Konfiguration er en kombination af udstyrsdele, som angivet af fabrikanten, der fungerer sammen som udstyr for at opnå et formål. Kombinationen af dele kan ændres, justeres eller tilpasses for at opfylde specifikke behov.
Konfigurationer omfatter bl.a.:
—
stativer, rør, borde, konsoller og andre udstyrsdele, der kan konfigureres/kombineres for at opnå en tilsigtet funktion ved computertomografi
—
ventilatorer, respirationskredsløb og fordampere, der kombineres for at opnå en tilsigtet funktion ved anæstesi.
UDI-DI
UDI-DI er en unik numerisk eller alfanumerisk kode, der er specifik for en udstyrsmodel, og som også anvendes som »adgangskode« til de oplysninger, der er lagret i UDI-databasen.
Menneskeligt læsbar fortolkning (»HRI«)
HRI er en læselig tolkning af de datategn, der er kodet ind i UDI-bæreren.
Emballageniveauer
Ved emballageniveauer forstås de forskellige udstyrsemballageniveauer, der indeholder et fastlagt antal udstyr, f.eks. hver æske eller beholder.
UDI-PI
UPI-PI er en numerisk eller alfanumerisk kode, der identificerer enheden af udstyrets produktion.
De forskellige typer UDI-PI omfatter serienummer, lotnummer, softwareidentifikation og fremstillings- eller udløbsdato eller begge datoangivelser.
Radiofrekvensidentifikation (RFID)
RFID er en teknologi, der anvender kommunikation ved hjælp af radiobølger for at udveksle data mellem en læser og et elektronisk mærke, der er fastgjort til en genstand, med henblik på identifikation.
Fragtbeholdere
En fragtbeholder er en beholder, hvor sporbarheden kontrolleres ved hjælp af en proces, der er specifik for logistiksystemer.
Unik udstyrsidentifikationskode (UDI)
UDI er en række numeriske eller alfanumeriske tegn, der skabes gennem en globalt anerkendt udstyrsidentifikations- og kodningsstandard. Den muliggør entydig identifikation af et specifikt udstyr på markedet. UDI består af UDI-DI og UDI-PI.
Ordet »unik« indebærer ikke, at hver produktionsenhed udstyres med et serienummer.
UDI-bærer
UDI-bæreren er den metode, der anvendes til formidling af UDI ved hjælp af AIDC og, hvis det er relevant, dens HRI.
UDI-bærere omfatter bl.a. en endimensional/lineær stregkode, en todimensional stregkode/matrixstregkode og RFID.
2.   Generelle krav
2.1.   Anbringelsen af UDI'en er et yderligere krav — den erstatter ikke andre mærkningskrav, der er fastsat i denne forordnings bilag I.
2.2.   Fabrikanten skal tildele og opretholde unikke UDI'er på sit udstyr.
2.3.   Det er kun fabrikanten, der må anbringe UDI'en på udstyret eller dets emballage.
2.4.   Kun de kodningsstandarder, der fastsættes af de udstedende enheder, som Kommissionen har udpeget i henhold til artikel 27, stk. 2, må anvendes.
3.   UDI
3.1.   En UDI skal tildeles selve udstyret eller dets emballage. Højere emballageniveauer skal have deres egen UDI.
3.2.   Fragtbeholder er fritaget fra kravet i punkt 3.1. Som et eksempel kræves der ikke en UDI på en logistikenhed; hvis en sundhedstjenesteyder bestiller flere udstyr ved hjælp af det enkelte udstyrs UDI eller modelnummer, og fabrikanten anbringer de pågældende udstyr i en beholder med henblik på fragt eller for at beskytte udstyr, der er emballeret enkeltvis, er beholderen (logistikenheden) ikke omfattet af UDI-krav.
3.3.   UDI'en skal indeholde to dele: en UDI-DI og en UDI-PI.
3.4.   UDI-DI'en skal være unik på hvert udstyrsemballageniveau.
3.5.   Hvis et lotnummer, et serienummer, en softwareidentifikation eller en udløbsdato fremgår af mærkningen, skal det/den være en del af UDI-PI'en. Hvis der også er en fremstillingsdato på mærkningen, er det ikke nødvendigt at medtage den i UDI-PI'en. Hvis der kun er en fremstillingsdato på mærkningen, skal denne anvendes som UDI-PI.
3.6.   Hver komponent, der betragtes som udstyr og er kommercielt tilgængelig i sig selv, skal tildeles en separat UDI, medmindre komponenterne er en del af et konfigurerbart udstyr, der er mærket med sin egen UDI.
3.7.   System- og behandlingspakker, jf. artikel 22, skal tildeles og være forsynet med deres egen UDI.
3.8.   Fabrikanten skal tildele UDI'en til udstyr i overensstemmelse med den relevante kodningsstandard.
3.9.   En ny UDI-DI kræves, når der er en ændring, som kan føre til fejlagtig identifikation af udstyret og/eller tvetydighed med hensyn til dens sporbarhed, især kræver enhver ændring af et af følgende dataelementer i UDI-databasen en ny UDI-DI:
a)
navn eller handelsnavn
b)
udstyrsversion eller -model
c)
mærket som engangsudstyr
d)
emballeret sterilt
e)
behov for sterilisering inden anvendelse
f)
antal udstyr leveret i en emballage
g)
kritiske advarsler og kontraindikationer: f.eks. indeholdende latex eller DEHP.
3.10.   Fabrikanter, der omemballerer og/eller ommærker udstyr med deres eget mærke, skal opbevare originaludstyrsfabrikantens UDI.
4.   UDI-bærer
4.1.   UDI-bæreren (AIDC- og HRI-præsentation af UDI'en) skal anbringes på mærkningen eller på selve udstyret og på alle højere udstyrsemballageniveauer. Højere niveauer omfatter ikke fragtbeholder.
4.2.   Hvis der er betydelig pladsmangel på brugsenhedens emballage, kan UDI-bæreren anbringes på det næste højere emballageniveau.
4.3.   For så vidt angår engangsudstyr i klasse I og IIa, der er emballeret og mærket enkeltvis, kræves det ikke, at UDI-bæreren er anført på emballagen, men den skal være anført på et højere emballageniveau, f.eks. en æske med flere udstyr, der er emballeret enkeltvis. Når sundhedstjenesteyderen, f.eks. i hjemmeplejemiljøer, imidlertid ikke forventes at have adgang til det højere udstyrsemballageniveau, skal UDI'en anbringes på det enkelte udstyrs emballage.
4.4.   For så vidt angår udstyr, der udelukkende er beregnet til detailsalgssteder, kræves det ikke, at UDI-PI'erne i AIDC fremgår af salgsstedets emballage.
4.5.   Når andre AIDC-bærere end UDI-bæreren udgør en del af produktmærkningen, skal UDI-bæreren være umiddelbart identificerbar.
4.6.   Hvis der anvendes lineære stregkoder, kan UDI-DI'en og UDI-PI'en sammenkædes eller ikkesammenkædes i to eller flere stregkoder. Der skal kunne skelnes mellem alle dele og elementer af den lineære stregkode, og de skal kunne identificeres.
4.7.   Hvis der er betydelige begrænsninger for anvendelsen af både AIDC og HRI på mærkningen, kræves det kun, at AIDC-formatet fremgår af mærkningen. For så vidt angår udstyr, der er beregnet til at blive anvendt uden for sundhedsfaciliteter, såsom udstyr til hjemmepleje, skal HRI'en dog fremgå af mærkningen, selv om det medfører, at der ikke er plads til AIDC'en.
4.8.   HRI-formatet skal følge de regler, som den enhed, der har udstedt UDI-koden, har fastsat.
4.9.   Hvis fabrikanten anvender RFID-teknologi, skal en lineær eller todimensional stregkode i overensstemmelse med den standard, som de udstedende enheder har fastsat, også fremgå af mærkningen.
4.10.   Udstyr, der kan genanvendes, skal være forsynet med en UDI-bærer på selve udstyret. UDI-bæreren for genanvendeligt udstyr, der kræver rengøring, desinfektion, sterilisering eller istandsættelse mellem patientanvendelser skal være permanent og læsbar efter hver udført proces, således at udstyret er klar til senere anvendelse i hele udstyrets forventede levetid. Kravene i dette punkt finder ikke anvendelse på udstyr i følgende tilfælde:
a)
Enhver form for direkte mærkning vil påvirke udstyrets sikkerhed eller ydeevne.
b)
Udstyret kan ikke mærkes direkte, da det ikke er teknisk muligt.
4.11.   UDI-bæreren skal være læsbar ved normal anvendelse og i hele udstyrets forventede levetid.
4.12.   Hvis UDI-bæreren er umiddelbart læsbar gennem udstyrets emballage, eller hvis en AIDC kan scannes gennem udstyrets emballage, kræves det ikke, at UDI-bæreren anbringes på emballagen.
4.13.   Med hensyn til enkelt færdigt udstyr, der består af flere dele, som skal samles inden deres første anvendelse, er det tilstrækkeligt at anbringe UDI-bæreren på en af disse dele.
4.14.   UDI-bæreren skal anbringes på en sådan måde, at der er adgang til AIDC'en ved normal anvendelse og opbevaring.
4.15.   Stregkodebærere, der indeholder både en UDI-DI og en UDI-PI, kan også indeholde data, der er vigtige med henblik på anvendelse af udstyret, eller andre data.
5.   Generelle principper for UDI-databasen
5.1.   UDI-databasen skal understøtte anvendelsen af alle vigtige dataelementer i UDI-databasen, jf. dette bilags del B.
5.2.   Fabrikanter er ansvarlige for den første indsendelse og opdateringer af identificerende oplysninger og udstyrets øvrige dataelementer i UDI-databasen.
5.3.   Hensigtsmæssige metoder/procedurer til validering af de indsendte data skal anvendes.
5.4.   Fabrikanter skal regelmæssigt verificere, om alle de data, der er relevante for udstyr, som de har bragt i omsætning, bortset fra udstyr, som ikke længere er tilgængeligt på markedet, er korrekte.
5.5.   Tilstedeværelsen af udstyrets UDI-DI i UDI-databasen skal ikke forstås således, at udstyret er i overensstemmelse med denne forordning.
5.6.   Databasen skal gøre det muligt at forbinde alle udstyrsemballageniveauer.
5.7.   Data for nye UDI-DI'er skal være tilgængelige, når udstyret bringes i omsætning.
5.8.   Fabrikanter skal opdatere den relevante UDI-databaseregistrering inden for 30 dage, efter at der er foretaget en ændring af et element, som ikke kræver en ny UDI-DI.
5.9.   Internationalt anerkendte standarder for dataindgivelse og -opdateringer skal, hvor det er muligt, anvendes af UDI-databasen.
5.10.   UDI-databasens brugergrænseflade skal være tilgængelig på alle officielle EU-sprog. Anvendelsen af fritekstfelter skal dog mindskes for at begrænse oversættelsesbehovet.
5.11.   Data vedrørende udstyr, der ikke længere er tilgængeligt på markedet, skal opbevares i UDI-databasen.
6.   Regler for specifikke udstyrstyper
6.1.   Implantabelt udstyr
6.1.1.
Implantabelt udstyr skal på laveste emballageniveau (»enhedspakker«) identificeres eller AIDC-mærkes med en UDI (UDI-DI + UDI-PI).
6.1.2.
UDI-PI'en skal som minimum have følgende karakteristika:
a)
serienummeret for det aktive, implantable udstyr
b)
serienummeret eller lotnummeret for andet implantabelt udstyr.
6.1.3.
Det implantable udstyrs UDI skal kunne identificeres inden implantation.
6.2.   Genanvendeligt udstyr, der kræver rengøring, desinfektion, sterilisering eller istandsættelse mellem anvendelser
6.2.1.   Sådant udstyrs UDI skal anbringes på udstyret og være læsbar efter hver behandling, således at udstyret er klar til næste anvendelse.
6.2.2.   UDI-PI-karakteristikaene, f.eks. lot- eller serienummer, skal defineres af fabrikanten.
6.3.   System- og behandlingspakker, jf. artikel 22
6.3.1.   Den i artikel 22 omhandlede fysiske eller juridiske person er ansvarlig for at gøre system- eller behandlingspakken identificerbar med en UDI, herunder både UDI-DI og UDI-PI.
6.3.2.   Udstyrsindholdet af system- eller behandlingspakker skal være forsynet med en UDI-bærer på sin emballage eller på selve udstyret.
Fritagelser:
a)
For så vidt angår det enkelte engangsudstyr, hvis anvendelse normalt er kendt for de tilsigtede brugere, og som er indeholdt i en system- eller behandlingspakke, og som ikke er bestemt til individuel anvendelse uden for system- eller behandlingspakkens kontekst, kræves det ikke, at det er forsynet med sin egen UDI-bærer.
b)
For så vidt angår udstyr, der er fritaget for at skulle være forsynet med en UDI-bærer på det relevante emballageniveau, kræves det ikke, at det er forsynet med en UDI-bærer, når det indgår i en system- eller behandlingspakke.
6.3.3.   UDI-bærerens placering på system- eller behandlingspakker
a)
System- eller behandlingspakkens UDI-bærer skal som hovedregel anbringes på ydersiden af emballagen.
b)
UDI-bæreren skal være læsbar eller, for så vidt angår AIDC, kunne scannes, uanset om den er anbragt på ydersiden af system- eller behandlingspakkens emballage eller på indersiden af en gennemsigtig emballage.
6.4.   Konfigurerbart udstyr:
6.4.1.   En UDI skal tildeles det konfigurerbare udstyr i sin helhed og skal benævnes det konfigurerbare udstyrs UDI.
6.4.2.   Det konfigurerbare udstyrs UDI-DI skal tildeles til grupper af konfigurationer, ikke til den enkelte konfiguration i gruppen. En gruppe af konfigurationer defineres som samlingen af mulige konfigurationer for et givet udstyr som beskrevet i den tekniske dokumentation.
6.4.3.   Det konfigurerbare udstyrs UDI-PI skal tildeles hvert enkelt konfigurerbare udstyr.
6.4.4.   Bæreren af det konfigurerbare udstyrs UDI skal anbringes på den samling, som med mindst sandsynlighed skal udskiftes i systemets levetid, og skal identificeres som det konfigurerbare udstyrs UDI.
6.4.5.   Hver komponent, der betragtes som udstyr og er kommercielt tilgængelig i sig selv, skal tildeles en separat UDI.
6.5.   Udstyrssoftware
6.5.1.   UDI-tildelingskriterier
UDI'en skal tildeles på udstyrssoftwarens systemniveau. Det er kun software, der i sig selv er kommercielt tilgængelig, og software, der i sig selv er udstyr, som er omfattet af dette krav.
Softwareidentifikationen skal betragtes som kontrolmekanismen vedrørende fremstilling og skal anføres i UDI-PI'en.
6.5.2.   Der kræves en ny UDI-DI, når der er en ændring, som påvirker:
a)
den oprindelige ydeevne
b)
softwarens sikkerhed eller tilsigtede brug
c)
tolkningen af data.
Sådanne ændringer omfatter nye eller ændrede algoritmer eller databasestrukturer, ny eller ændret betjeningsplatform eller arkitektur eller nye brugergrænseflader eller nye kanaler til interoperabilitet.
6.5.3.   Mindre softwareændringer kræver kun en ny UDI-PI og ikke en ny UDI-DI.
Mindre softwareændringer er generelt forbundet med fejlrettelser, forbedringer af brugbarheden, der ikke sker af sikkerhedshensyn, sikkerhedsrettelser eller funktionseffektivitet.
Mindre softwareændringer skal identificeres ved en fabrikantspecifik form for identifikation.
6.5.4.   Kriterier for UDI'ens placering i forbindelse med software
a)
Når softwaren leveres på et fysisk medium, f.eks. CD eller DVD, skal hvert emballageniveau være forsynet med den menneskeligt læsbare præsentation og AIDC-præsentationen af den fuldstændige UDI. Den UDI, der anbringes på det fysiske medium, der indeholder softwaren, og dens emballage, skal være identisk med den UDI, der tildeles softwaren på systemniveau.
b)
UDI'en skal angives på en skærm, der er umiddelbart tilgængelig for brugeren, i et letlæseligt, almindeligt tekstformat, f.eks. en »about«-fil eller medtaget på opstartsskærmen.
c)
Software, der mangler en brugergrænseflade, f.eks. middleware til billedomdannelse, skal kunne overføre UDI'en via en programmeringsgrænseflade for applikationer (API).
d)
Det er kun den menneskeligt læsbare del af UDI'en, der er påkrævet på softwarens elektroniske skærme. UDI-mærkningen med AIDC er ikke påkrævet på de elektroniske skærme, f.eks. en about-menu, splash-skærm osv.
e)
Det menneskeligt læsbare format af UDI'en til softwaren skal indeholde applikationsidentifikationskoderne (AI) for den standard, der anvendes af de udstedende enheder, for at bistå brugeren med at identificere UDI'en og fastlægge, hvilken standard der anvendes til at oprette UDI'en.
BILAG VII
KRAV, SOM SKAL VÆRE OPFYLDT AF DE BEMYNDIGEDE ORGANER
1.   ORGANISATORISKE OG GENERELLE KRAV
1.1.   Retlig status og organisationsstruktur
1.1.1.   Hvert bemyndigede organ skal oprettes i henhold til en medlemsstats nationale ret eller i henhold til retten i et tredjeland, som Unionen har indgået aftale med herom. Dets status som juridisk person og retlige status skal dokumenteres fuldt ud. Sådan dokumentation skal omfatte oplysninger om ejerskab og de juridiske eller fysiske personer, der udøver kontrol med det bemyndigede organ.
1.1.2.   Hvis det bemyndigede organ er en retlig enhed, der er en del af en større organisation, skal denne organisations aktiviteter samt dens organisationsstruktur og ledelse og forholdet til det bemyndigede organ tydeligt dokumenteres. I sådanne tilfælde finder kravene i punkt 1.2 anvendelse på både det bemyndigede organ og den organisation, som det tilhører.
1.1.3.   Hvis et bemyndiget organ helt eller delvis ejer retlige enheder, der er etableret i en medlemsstat eller i et tredjeland, eller er ejet af en anden retlig enhed, skal disse enheders aktiviteter og ansvarsområder samt deres retlige og operationelle forbindelser med det bemyndigede organ være klart defineret og dokumenteret. Personalet i de enheder, der udfører overensstemmelsesvurderingsaktiviteter i henhold til denne forordning, er omfattet af de gældende krav i denne forordning.
1.1.4.   Det bemyndigede organs organisationsstruktur, ansvarsfordeling, rapporteringsveje og drift skal være af en sådan art, at de sikrer, at der er tillid til det bemyndigede organs arbejde og til resultaterne af dets overensstemmelsesvurderingsaktiviteter.
1.1.5.   Det bemyndigede organ skal tydeligt dokumentere sin organisationsstruktur samt funktioner, ansvar og myndighed for så vidt angår dets øverste ledelse og andet personale, der kan have indflydelse på det bemyndigede organs arbejde og resultaterne af dets overensstemmelsesvurderingsaktiviteter.
1.1.6.   Det bemyndigede organ skal identificere de personer i den øverste ledelse, der har den overordnede myndighed og det samlede ansvar for hvert af følgende:
—
tilvejebringelsen af tilstrækkelige ressourcer til overensstemmelsesvurderingsaktiviteter
—
udviklingen af procedurer og politikker for driften af det bemyndigede organ
—
tilsynet med det bemyndigede organs gennemførelse af procedurer, politikker og kvalitetsstyringssystemer
—
tilsynet med det bemyndigede organs finanser
—
de aktiviteter og beslutninger, som det bemyndigede organ træffer, herunder kontraktmæssige aftaler
—
fordelingen af beføjelser til personale og/eller udvalg, hvis det er relevant, med henblik på at udføre bestemte aktiviteter
—
interaktionen med den nationale myndighed med ansvar for bemyndigede organer og forpligtelserne vedrørende kommunikation med andre kompetente myndigheder, Kommissionen og andre bemyndigede organer.
1.2.   Uafhængighed og uvildighed
1.2.1.   Det bemyndigede organ skal være et tredjepartsorgan, der er uafhængigt af fabrikanten af det produkt, i forbindelse med hvilket det udfører overensstemmelsesvurderingsaktiviteter. Det bemyndigede organ skal ligeledes være uafhængigt af andre erhvervsdrivende, der har en interesse i udstyret, såvel som alle konkurrenter til fabrikanten. Dette forhindrer ikke, at det bemyndigede organ udfører overensstemmelsesvurderingsaktiviteter for konkurrerende fabrikanter.
1.2.2.   Det bemyndigede organ skal være organiseret og arbejde på en sådan måde, at der i dets arbejde sikres uafhængighed, objektivitet og uvildighed. Det bemyndigede organ skal dokumentere og gennemføre en struktur og procedurer til sikring af uvildighed og til fremme og anvendelse af principperne om uvildighed i hele dets organisation, hos alt deres personale og i alle dets vurderingsaktiviteter. Sådanne procedurer skal sikre identifikation, undersøgelse og løsning af alle tilfælde, hvor en interessekonflikt kan opstå, herunder deltagelse i konsulenttjenester på udstyrsområdet forud for ansættelse hos det bemyndigede organ. Undersøgelsen, resultatet og dets løsning skal dokumenteres.
1.2.3.   Det bemyndigede organ, dets øverste ledelse og det personale, der er ansvarligt for at foretage overensstemmelsesvurdering, må ikke
a)
være designer, fabrikant, leverandør, montør, køber, ejer eller reparatør af det udstyr, som de vurderer, eller autoriseret repræsentant for nogen af disse parter. En sådan restriktion forhindrer ikke køb og anvendelse af vurderet udstyr, der er nødvendigt for det bemyndigede organs aktiviteter og gennemførelse af overensstemmelsesvurderingen eller anvendelse af sådant udstyr i personligt øjemed
b)
være involveret i design, fremstilling eller konstruktion, markedsføring, installering og anvendelse eller vedligeholdelse af det udstyr, som de er udpeget til, eller repræsentere parter, der er involveret i disse aktiviteter.
c)
deltage i nogen aktivitet, som kan være i strid med deres objektivitet og integritet i forbindelse med de overensstemmelsesvurderingsaktiviteter, som de er udpeget til
d)
tilbyde eller levere nogen tjeneste, der kan skade tilliden til deres uafhængighed, uvildighed og objektivitet. De må navnlig ikke tilbyde eller yde konsulenttjenester til fabrikanten, dennes autoriserede repræsentant, en leverandør eller en konkurrent, med hensyn til design, konstruktion, markedsføring eller vedligeholdelse af udstyr eller processer, der er genstand for vurdering, og
e)
være forbundet med en organisation, der selv leverer konsulenttjenester som omhandlet i litra d). En sådan restriktion forhindrer ikke generelle uddannelsesaktiviteter, der ikke er kundespecifikke, og som vedrører regulering af udstyr eller tilknyttede standarder.
1.2.4.   Deltagelse i konsulenttjenester på udstyrsområdet forud for ansættelse hos et bemyndiget organ skal dokumenteres fuldt ud på ansættelsestidspunktet, og potentielle interessekonflikter skal monitoreres og løses i henhold til dette bilag. Personale, der tidligere var ansat hos eller leverede konsulenttjenester på udstyrsområdet til denne bestemte kunde forud for ansættelse hos et bemyndiget organ, må ikke tildeles overensstemmelsesvurderingsaktiviteter for denne bestemte kunde eller virksomheder, der hører til den samme koncern, i en periode på tre år.
1.2.5.   Det skal sikres, at bemyndigede organer, deres øverste ledelse og vurderingspersonalet arbejder uvildigt. Lønniveauet for den øverste ledelse og vurderingspersonalet hos et bemyndiget organ og underentreprenører, der deltager i vurderingsaktiviteter, må ikke være afhængigt af resultatet af vurderingerne. Bemyndigede organer skal offentliggøre den øverste ledelses interesseerklæringer.
1.2.6.   Hvis et bemyndiget organ er ejet af en offentlig enhed eller institution, skal det sikres og dokumenteres, at det er uafhængigt, og at der ikke er interessekonflikter mellem den nationale myndighed med ansvar for bemyndigede organer og/eller den kompetente myndighed på den ene side og det bemyndigede organ på den anden side.
1.2.7.   Det bemyndigede organ skal sikre og dokumentere, at dets dattervirksomheders, underentreprenørers eller eventuelle tilknyttede organers aktiviteter, herunder dets ejeres aktiviteter, ikke påvirker dets uafhængighed og uvildighed eller objektiviteten af dets overensstemmelsesvurderingsaktiviteter.
1.2.8.   Det bemyndigede organ skal udøve sin virksomhed i overensstemmelse med et sæt sammenhængende, reelle og rimelige vilkår og betingelser, idet der tages hensyn til interesser hos små og mellemstore virksomheder som defineret i henstilling 2003/361/EF for så vidt angår gebyrer.
1.2.9.   Kravene i dette punkt forhindrer ikke, at der udveksles tekniske oplysninger og reguleringsmæssige retningslinjer mellem et bemyndiget organ og en fabrikant, der ansøger om en overensstemmelsesvurdering.
1.3.   Fortrolighed
1.3.1.   Det bemyndigede organ skal have indført dokumenterede procedurer, der sikrer, at personale, udvalg, dattervirksomheder, underentreprenører og eventuelle tilknyttede organer eller personalet i eksterne organer behandler de oplysninger, som det kommer i besiddelse af under udførelsen af overensstemmelsesaktiviteterne, fortroligt, medmindre videregivelse af oplysningerne er fastsat ved lov.
1.3.2.   Et bemyndiget organs personale har tavshedspligt ved udførelsen af sine opgaver i henhold til denne forordning eller enhver bestemmelse i en national ret, der gennemfører den, undtagen over for myndigheder med ansvar for de bemyndigede organer, de kompetente myndigheder for medicinsk udstyr i medlemsstaterne eller Kommissionen. Ejendomsrettigheder skal beskyttes. Det bemyndigede organ skal have indført dokumenterede procedurer med hensyn til kravene i dette punkt.
1.4.   Erstatningsansvar
1.4.1.   Det bemyndigede organ skal tegne en passende ansvarsforsikring for dets overensstemmelsesvurderingsaktiviteter, medmindre den pågældende medlemsstat er ansvarlig i henhold til national ret, eller medlemsstaten er direkte ansvarlig for overensstemmelsesvurderingen.
1.4.2.   Omfanget og den samlede finansielle værdi af ansvarsforsikringen skal svare til niveauet og den geografiske rækkevidde af det bemyndigede organs aktiviteter og svare til risikoprofilen af det udstyr, der certificeres af det bemyndigede organ. Ansvarsforsikringen dækker tilfælde, hvor det bemyndigede organ kan være tvunget til at tilbagekalde, begrænse eller suspendere certifikater.
1.5.   Finansielle krav
Det bemyndigede organ skal råde over de finansielle ressourcer, der er nødvendige for at gennemføre dets overensstemmelsesvurderingsaktiviteter inden for rammerne af dets udpegelse og dertil knyttede forretningsaktiviteter. Det skal dokumentere og forelægge oplysninger om dets finansielle kapacitet og dets langsigtede økonomiske levedygtighed, idet der, hvor det er relevant, tages hensyn til de særlige omstændigheder, der gør sig gældende i en indledende opstartsfase.
1.6.   Deltagelse i koordineringsaktiviteter
1.6.1.   Det bemyndigede organ skal deltage i eller sikre, at dets vurderingspersonale informeres om eventuelle relevante standardiseringsaktiviteter og om aktiviteterne i den i artikel 49 nævnte koordineringsgruppe af bemyndigede organer, og at dets personale, som foretager vurderinger og træffer beslutninger, informeres om al relevant lovgivning, alle relevante vejledningsdokumenter og alle relevante dokumenter om bedste praksis, der vedtages inden for rammerne af denne forordning.
1.6.2.   Det bemyndigede organ skal tage hensyn til vejledningsdokumenter og dokumenter om bedste praksis.
2.   KRAV TIL KVALITETSSTYRING
2.1.   Det bemyndigede organ skal etablere, dokumentere, implementere, vedligeholde og drive et kvalitetsstyringssystem, der er hensigtsmæssigt i forhold til arten og omfanget af dets overensstemmelsesvurderingsaktiviteter og til det område, som disse aktiviteter dækker, og som kan understøtte og dokumentere, at kravene i denne forordning konsekvent opfyldes.
2.2.   Det bemyndigede organs kvalitetsstyringssystem skal mindst omfatte følgende:
—
struktur af styringssystemet og dokumentation, herunder politikker og mål for dets aktiviteter
—
politikker for opgave- og ansvarsfordeling blandt personalet
—
vurderings- og beslutningsprocesser i overensstemmelse med de opgaver, ansvarsområder og funktioner, som det bemyndigede organs personale og den øverste ledelse varetager
—
planlægning, udførelse, evaluering og om nødvendigt tilpasning af dets overensstemmelsesvurderingsprocedurer
—
kontrol af dokumenter
—
kontrol af registre
—
gennemgang af ledelsesforhold
—
interne audit
—
korrigerende og forebyggende handlinger
—
klager og appeller, og
—
løbende efter- og videreuddannelse.
Hvor dokumenter anvendes på forskellige sprog, skal det bemyndigede organ sikre og kontrollere, at de har det samme indhold.
2.3.   Det bemyndigede organs øverste ledelse skal sikre, at kvalitetsstyringssystemet forstås fuldt ud, gennemføres og vedligeholdes i hele det bemyndigede organs organisation, herunder i datterselskaber og hos underentreprenører, som deltager i overensstemmelsesvurderingsaktiviteter i henhold til denne forordning.
2.4.   Det bemyndigede organ skal kræve, at alt personale formelt forpligter sig med en underskrift eller tilsvarende til at overholde de procedurer, der fastsættes af det bemyndigede organ. Denne forpligtelse dækker aspekter vedrørende fortrolighed og uafhængighed fra kommercielle og andre interesser og enhver eksisterende eller tidligere tilknytning til kunder. Personalet skal udfylde skriftlige erklæringer om, at de overholder principperne om tavshedspligt, uafhængighed og uvildighed.
3.   RESSOURCEKRAV
3.1.   Generelt
3.1.1.   Bemyndigede organer skal være i stand til at udføre alle de opgaver, som de pålægges ved denne forordning, med den størst mulig faglige integritet og den nødvendige kompetence på det specifikke område, uanset om disse opgaver udføres af bemyndigede organer selv eller på deres vegne og på deres ansvar.
Bemyndigede organer skal navnlig have det personale og råde over eller have adgang til alt udstyr, alle faciliteter og al kompetence, som skal være til stede for på fyldestgørende måde at kunne udføre de tekniske, videnskabelige og administrative opgaver, der er forbundet med de overensstemmelsesvurderingsaktiviteter, som de er udpeget til at udføre.
Dette krav forudsætter, at det bemyndigede organ til enhver tid og for hver overensstemmelsesvurderingsprocedure og hver type udstyr, som det er udpeget til, har permanent adgang til tilstrækkeligt administrativt, teknisk og videnskabeligt personale med erfaring og viden vedrørende det relevante udstyr og de tilhørende teknologier. Et sådant personale skal være tilstrækkeligt stort til at sikre, at det pågældende bemyndigede organ kan udføre de overensstemmelsesvurderingsopgaver, herunder vurderingen af udstyrets medicinske funktion, kliniske evalueringer, ydeevne og sikkerhed, som det er udpeget til, under hensyntagen til kravene i denne forordning, navnlig kravene i bilag I.
Et bemyndiget organs samlede kompetencer skal gøre det muligt for det at vurdere de typer udstyr, som det er udpeget til. Det bemyndigede organ skal have tilstrækkelige interne kompetencer til kritisk at kunne evaluere vurderinger, som foretages af eksterne eksperter. Opgaver, som et bemyndiget organ ikke må overdrage til en underentreprenør, er fastsat i punkt 4.1.
Personale, der er med til at lede udførelsen af et bemyndiget organs overensstemmelsesvurderingsaktiviteter i forbindelse med udstyr, skal have passende viden til at kunne oprette og drive et system til udvælgelse af det personale, der skal foretage vurderinger og verifikationer, til verifikation af dets kompetencer, til godkendelse til og tildeling af dets opgaver, til tilrettelæggelse af dets indledende og løbende uddannelse, til tildeling af dets pligter og til at føre tilsyn med dette personale for at sikre, at personale, der administrerer og udfører vurderinger og verifikationer, er kompetent til at udføre de opgaver, der kræves af det.
Det bemyndigede organ skal udpege mindst én person inden for deres øverste ledelse, der har det overordnede ansvar for alle overensstemmelsesvurderingsaktiviteter i forbindelse med udstyr.
3.1.2.   Det bemyndigede organ skal sikre, at det personale, der deltager i overensstemmelsesaktiviteterne, opretholder sine kvalifikationer og sin ekspertise ved at indføre et system til udveksling af erfaring og et løbende uddannelsesprogram.
3.1.3.   Det bemyndigede organ skal klart dokumentere omfanget af og begrænsningerne for de opgaver og ansvarsområder og godkendelsesniveau, som det personale, herunder alle underentreprenører og eksterne eksperter, der deltager i overensstemmelsesvurderingsaktiviteterne, har, og informere dette personale herom.
3.2.   Kvalifikationskriterier for personale
3.2.1.   Det bemyndigede organ udarbejder og dokumenterer kvalifikationskriterier og procedurer for udvælgelse og godkendelse af personer, der deltager i overensstemmelsesvurderingsaktiviteter, herunder med hensyn til viden, erfaring og andre krævede kompetencer, og for den krævede grund- og videreuddannelse. Kvalifikationskriterierne skal omfatte de forskellige funktioner i overensstemmelsesvurderingsproceduren såsom audit, evaluering eller prøvning af produktet, teknisk dokumentation og beslutningstagning samt det udstyr, de teknologier og de områder såsom bioforligelighed, sterilisering, væv og celler af human og animalsk oprindelse og klinisk evaluering, som er omfattet af rammerne for udpegelsen.
3.2.2.   Kvalifikationskriterierne, jf. punkt 3.2.1, skal henvise til rammerne for et bemyndiget organs udpegelse i overensstemmelse med den beskrivelse heraf, som medlemsstaten bruger i forbindelse med den notifikation, der er omhandlet i artikel 42, stk. 3, og være tilstrækkeligt detaljerede med hensyn til de krævede kvalifikationer inden for de enkelte underområder i beskrivelsen af rammerne for udpegelsen.
Der skal fastsættes særlige kvalifikationskriterier i det mindste for vurdering af:
—
præklinisk evaluering
—
klinisk evaluering
—
væv og celler af human og animalsk oprindelse
—
funktionel sikkerhed,
—
software
—
emballage
—
udstyr, der som en integreret bestanddel indeholder et lægemiddel,
—
udstyr, der består af stoffer eller af kombinationer af stoffer, der absorberes af eller fordeles lokalt i det menneskelige legeme.
—
de forskellige typer steriliseringsprocesser
3.2.3.   Det personale, der er ansvarligt for at udarbejde kvalifikationskriterier og godkende det personale, der skal udføre specifikke overensstemmelsesvurderingsaktiviteter, skal være ansat af selve det bemyndigede organ og må ikke være eksterne eksperter eller underentreprenører. Det skal have dokumenteret viden og erfaring inden for alle følgende områder:
—
EU-lovgivning om udstyr og relevante vejledningsdokumenter
—
overensstemmelsesvurderingsprocedurerne i denne forordning
—
et bredt videngrundlag inden for udstyrsteknologier og design og fremstilling af udstyr
—
det bemyndigede organs kvalitetsstyringssystem, procedurer i forbindelse hermed og de påkrævede kvalifikationskriterier
—
uddannelse af relevans for personale, der deltager i overensstemmelsesvurderingsaktiviteter i forbindelse med udstyr
—
passende erfaring inden for overensstemmelsesvurderinger i henhold til denne forordning eller tidligere gældende ret i et bemyndiget organ.
3.2.4.   Bemyndigede organer skal til enhver tid råde over personale med relevant klinisk ekspertise, og dette personale skal om muligt være ansat af det bemyndigede organ selv. Dette personale skal integreres i hele det bemyndigede organs vurderings- og beslutningsproces med henblik på at:
—
identificere de tilfælde, hvor der kræves input fra specialister til vurdering af den kliniske evaluering, som er foretaget af fabrikanten, og identificere tilstrækkeligt kvalificerede eksperter
—
sørge for passende uddannelse af eksterne kliniske eksperter i de relevante krav i denne forordning, fælles specifikationer, vejledning og harmoniserede standarder og sikre, at de eksterne kliniske eksperter har fuldt kendskab til baggrunden for og konsekvenserne af deres vurdering og rådgivning
—
kunne gennemgå og på et videnskabeligt grundlag anfægte de kliniske data, der er indeholdt i den kliniske evaluering, og eventuelle tilknyttede kliniske afprøvninger og på passende vis vejlede eksterne kliniske eksperter i vurderingen af den kliniske evaluering, som fabrikanten har forelagt
—
kunne evaluere på et videnskabeligt grundlag og om nødvendigt anfægte den fremlagte kliniske evaluering og resultaterne af de eksterne kliniske eksperters vurdering af fabrikantens kliniske evaluering
—
kunne sikre sammenlignelighed af og konsistens i de vurderinger af kliniske evalueringer, der foretages af kliniske eksperter
—
kunne foretage en vurdering af fabrikantens kliniske evaluering og en klinisk bedømmelse af udtalelsen fra enhver ekstern ekspert og komme med en anbefaling til det bemyndigede organs beslutningstager, og
—
kunne udarbejde de journaler og rapporter, som dokumenterer, at de relevante overensstemmelsesvurderinger er korrekt udført.
3.2.5.   Det personale, der er ansvarligt for at foretage den produktrelaterede kontrol (produktkontrollanter) såsom kontrol af den tekniske dokumentation eller typeafprøvning, herunder aspekter såsom klinisk evaluering, biologisk sikkerhed, sterilisering og softwarevalidering, skal have alle følgende dokumenterede kvalifikationer:
—
en afsluttet uddannelse fra et universitet eller en faghøjskole eller tilsvarende inden for et relevant fag, f.eks. medicin, farmaci, ingeniørvidenskab eller andre relevante videnskaber
—
fire års erhvervserfaring på området for sundhedsprodukter eller relaterede aktiviteter såsom fremstilling, audit eller forskning, hvoraf de to år skal være inden for design, fremstilling, afprøvning og brug af det udstyr eller den teknologi, der skal vurderes, eller vedrøre de videnskabelige aspekter, der skal vurderes
—
kendskab til lovgivning om udstyr, herunder de generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I
—
tilstrækkeligt kendskab til og erfaring med relevante harmoniserede standarder, fælles specifikationer og vejledningsdokumenter
—
tilstrækkeligt kendskab til og erfaring med risikostyring og tilknyttede standarder for udstyr og vejledningsdokumenter
—
tilstrækkeligt kendskab til og erfaring med klinisk evaluering
—
tilstrækkeligt kendskab til det udstyr, som de vurderer
—
tilstrækkeligt kendskab til og erfaring med de overensstemmelsesvurderingsprocedurer, der er fastsat i bilag IX-XI, navnlig vedrørende de aspekter af disse procedurer, som det er ansvarligt for, og den nødvendige godkendelse til at udføre disse vurderinger
—
den nødvendige færdighed i at udarbejde de journaler og rapporter, som dokumenterer, at de relevante overensstemmelsesvurderinger er korrekt udført.
3.2.6.   Det personale, der er ansvarligt for at foretage audit af fabrikantens kvalitetsstyringssystem, (auditorer på stedet) skal have alle følgende dokumenterede kvalifikationer:
—
en afsluttet uddannelse fra et universitet eller en faghøjskole eller tilsvarende inden for et relevant fag såsom medicin, farmaci, ingeniørvidenskab eller andre relevante videnskaber
—
fire års erhvervserfaring på området for sundhedsprodukter eller relaterede aktiviteter såsom fremstilling, audit eller forskning, hvoraf de to år skal være inden for kvalitetsstyring
—
tilstrækkeligt kendskab til lovgivning om udstyr samt tilknyttede harmoniserede standarder, fælles specifikationer og vejledningsdokumenter
—
tilstrækkeligt kendskab til og erfaring med risikostyring og tilknyttede standarder for udstyr og vejledningsdokumenter
—
tilstrækkeligt kendskab til kvalitetsstyringssystemer og tilknyttede standarder og vejledningsdokumenter
—
tilstrækkeligt kendskab til og erfaring med de overensstemmelsesvurderingsprocedurer, der er fastsat i bilag IX-XI, navnlig vedrørende de aspekter af disse procedurer, som det er ansvarligt for, og den nødvendige godkendelse til at udføre disse vurderinger
—
uddannelse i auditmetoder, som giver dem mulighed for at anfægte kvalitetsstyringssystemer
—
den nødvendige færdighed i at udarbejde de journaler og rapporter, som dokumenterer, at de relevante overensstemmelsesvurderinger er korrekt udført.
3.2.7.   Det personale, der har det overordnede ansvar for den endelige gennemgang og beslutningstagning vedrørende certificeringen, skal være ansat af det bemyndigede organ selv og må ikke være eksterne eksperter eller underentreprenører. Dette personale skal tilsammen have dokumenteret viden og omfattende erfaring inden for alle følgende områder:
—
lovgivning om udstyr og relevante vejledningsdokumenter
—
overensstemmelsesvurderinger af udstyr med relevans for denne forordning
—
typer af kvalifikationer, erfaringer og ekspertise med relevans for overensstemmelsesvurderingen af udstyr
—
et bredt videngrundlag inden for udstyrsteknologier, herunder tilstrækkelig erfaring med overensstemmelsesvurdering af udstyr, der evalueres med henblik på certificering, udstyrsindustrien og design og fremstilling af udstyr
—
det bemyndigede organs kvalitetsstyringssystem, procedurer i forbindelse hermed og de påkrævede kvalifikationer for involveret personale
—
den nødvendige færdighed i at udarbejde journaler og rapporter, som dokumenterer, at overensstemmelsesvurderingerne er korrekt udført.
3.3.   Dokumentation for personalets kvalifikationer, uddannelse og godkendelse
3.3.1.   Det bemyndigede organ skal have en procedure for fuldt ud at kunne dokumentere kvalifikationerne hos hver medarbejder, der deltager i overensstemmelsesvurderingsaktiviteter, og opfyldelsen af de kvalifikationskriterier, der er omhandlet i punkt 3.2. I særlige tilfælde, hvor opfyldelsen af de kvalifikationskriterier, der er fastsat i punkt 3.2, ikke fuldt ud kan dokumenteres, skal det bemyndigede organ begrunde over for den nationale myndighed med ansvar for bemyndigede organer, at disse medarbejdere er godkendt til at udføre specifikke overensstemmelsesvurderingsaktiviteter.
3.3.2.   For alt det personale, der er nævnt i punkt 3.2.3.-3.2.7, skal det bemyndigede organ oprette og opdatere:
—
et skema med detaljerede oplysninger om personalets godkendelse og ansvarsområder med hensyn til overensstemmelsesvurderingsaktiviteter, og
—
registre, der dokumenterer det krævede kendskab til og erfaring med overensstemmelsesvurderingsaktiviteter, som det er godkendt til. Registrene skal indeholde et rationale for fastlæggelsen af ansvarsområdet for hver person, der indgår i vurderingspersonalet, og fortegnelser over de overensstemmelsesvurderingsaktiviteter, som hver medarbejder har udført.
3.4.   Underentreprenører og eksterne eksperter
3.4.1.   Bemyndigede organer kan, uden at det berører punkt 3.2, overdrage bestemte klart definerede dele af en overensstemmelsesvurderingsaktivitet til en underentreprenør.
Underentrepriser i forbindelse med audit af kvalitetsstyringssystemer eller af den produktrelaterede kontrol som helhed er ikke tilladt, men dele af disse aktiviteter kan dog udføres af underentreprenører og eksterne auditorer og eksperter, der arbejder på vegne af det bemyndigede organ. Det pågældende bemyndigede organ bevarer det fulde ansvar for at kunne fremlægge relevant dokumentation for underentreprenørers og eksperters kompetence til at udføre deres specifikke opgaver, for at træffe en beslutning, der er baseret på en underentreprenørs vurdering, og for det arbejde, som underentreprenører og eksperter udfører på dets vegne.
Følgende aktiviteter kan ikke gives i underentreprise af bemyndigede organer:
—
gennemgang af eksterne eksperters kvalifikationer og tilsyn med deres arbejde
—
audit- og certificeringsaktiviteter, hvor den pågældende underentreprise er til audit- og certificeringsorganisationer
—
tildeling af arbejde til eksterne eksperter i forbindelse med specifikke overensstemmelsesvurderingsaktiviteter, og
—
endelig evaluering og beslutningstagningsfunktioner.
3.4.2.   Hvis et bemyndiget organ overdrager bestemte overensstemmelsesvurderingsaktiviteter enten til en organisation eller en fysisk person, skal det have retningslinjer for, på hvilke betingelser underentreprisen kan finde sted, og sikre, at:
—
underentreprenøren opfylder de relevante krav i dette bilag
—
underentreprenører og eksterne eksperter ikke videregiver opgaver i underentreprise til organisationer eller personale, og
—
den fysiske eller juridiske person, der ansøgte om en overensstemmelsesvurdering, er blevet informeret om de krav, der er nævnt i første og andet led.
Enhver underentreprise eller høring af eksternt personale skal være veldokumenteret, må ikke involvere nogen mellemmænd og skal være underlagt en skriftlig aftale, der blandt andet dækker tavshedspligt og interessekonflikter. Det pågældende bemyndigede organ har det fulde ansvar for de opgaver, der udføres af underentreprenører.
3.4.3.   Når underentreprenører eller eksterne eksperter anvendes i forbindelse med en overensstemmelsesvurdering, især hvad angår nyt, invasivt og implantabelt udstyr eller teknologier, skal det pågældende bemyndigede organ på hvert enkelt produktområde, for hvilket det er udpeget, råde over interne kompetencer, der er tilstrækkelige til at lede den samlede overensstemmelsesvurdering, verificere ekspertvurderingernes hensigtsmæssighed og gyldighed og træffe afgørelse om certificering.
3.5.   Tilsyn med kompetencer, uddannelse og udveksling af erfaringer
3.5.1.   Det bemyndigede organ fastlægger procedurerne for den indledende evaluering og det løbende tilsyn med kompetencerne, overensstemmelsesvurderingsaktiviteterne og det arbejde, der udføres af det interne og eksterne personale og de underentreprenører, der deltager i overensstemmelsesvurderingsaktiviteter.
3.5.2.   Bemyndigede organer skal med regelmæssige mellemrum gennemgå sit personales kompetencer, identificere uddannelsesbehov og udarbejde en uddannelsesplan, således at det krævede niveau for kvalifikationer og viden for enkeltpersoner kan opretholdes. Denne gennemgang skal som minimum verificere, at personalet:
—
er bevidst om gældende EU-lovgivning og national lovgivning om udstyr, relevante harmoniserede standarder, fælles specifikationer, vejledningsdokumenter og resultaterne af koordineringsaktiviteterne, jf. punkt 1.6, og
—
deltager i intern udveksling af erfaringer og det løbende uddannelsesprogram, jf. punkt 3.1.2.
4.   PROCESKRAV
4.1.   Generelt
Det bemyndigede organ skal have indført dokumenterede processer og tilstrækkeligt detaljerede procedurer for gennemførelse af hver overensstemmelsesvurderingsaktivitet, som det er udpeget til, herunder de enkelte trin, fra aktiviteter før indsendelse af en ansøgning til beslutningstagning og tilsyn, idet der tages hensyn til udstyrets respektive specifikke forhold, når det er nødvendigt.
Kravene i punkt 4.3, 4.4, 4.7 og 4.8 skal opfyldes som led i bemyndigede organers interne aktiviteter, som ikke gives i underentreprise.
4.2.   Bemyndigede organers pristilbud og aktiviteter før indsendelse af en ansøgning
Det bemyndigede organ skal:
a)
offentliggøre en offentligt tilgængelig beskrivelse af den ansøgningsprocedure, som fabrikanterne kan certificeres efter af det. Denne beskrivelse skal angive, hvilke sprog, der kan bruges til indsendelse af dokumentation og til eventuel tilknyttet korrespondance
b)
have dokumenterede procedurer vedrørende og dokumenterede oplysninger om gebyrer, der opkræves for specifikke overensstemmelsesvurderingsaktiviteter, og eventuelle andre finansielle betingelser vedrørende bemyndigede organers vurderingsaktiviteter i forbindelse med udstyr
c)
have dokumenterede procedurer vedrørende reklamer for deres overensstemmelsesvurderingstjenester. Disse procedurer skal sikre, at reklameaktiviteter eller salgsfremmende aktiviteter på ingen måde antyder eller kan føre til den følgeslutning, at deres overensstemmelsesvurdering giver fabrikanterne tidligere markedsadgang, eller at den er hurtigere, nemmere eller mindre streng end hos andre bemyndigede organer
d)
have dokumenterede procedurer, der kræver en gennemgang af oplysningerne før indsendelse af ansøgningen, herunder den foreløbige verifikation af, om produktet er omfattet af denne forordning, og dets klassificering forud for angivelse af et pristilbud til fabrikanten vedrørende en bestemt overensstemmelsesvurdering, og
e)
sikre, at alle kontrakter vedrørende overensstemmelsesvurderingsaktiviteter, der er omfattet af denne forordning, indgås direkte mellem fabrikanten og det bemyndigede organ og ikke med nogen anden organisation.
4.3.   Ansøgningsgennemgang og kontrakt
Det bemyndigede organ skal kræve en formel ansøgning, der er underskrevet af en fabrikant eller en autoriseret repræsentant, og som indeholder samtlige de oplysninger og erklæringer fra fabrikanten, der kræves i den relevante overensstemmelsesvurdering, jf. bilag IX-XI.
Kontrakten mellem et bemyndiget organ og en fabrikant skal have form af en skriftlig aftale, som begge parter har underskrevet. Den skal opbevares af det bemyndigede organ. Denne kontrakt skal indeholde klare vilkår og betingelser og indeholde forpligtelser, der gør det muligt for det bemyndigede organ at handle som krævet i denne forordning, herunder en forpligtelse for fabrikanten til at underrette det bemyndigede organ om indberetninger i forbindelse med sikkerhedsovervågning, det bemyndigede organs ret til at suspendere, begrænse eller tilbagekalde certifikater, der er udstedt, og det bemyndigede organs pligt til at opfylde sine oplysningskrav.
Det bemyndigede organ skal have dokumenterede procedurer for at gennemgå ansøgninger, der vedrører:
a)
disse ansøgningers fuldstændighed med hensyn til kravene i den relevante overensstemmelsesvurderingsprocedure, jf. det tilsvarende bilag, efter hvilken der er søgt om godkendelse
b)
verifikationen af kvalificeringen af de produkter, der er omfattet af disse ansøgninger, som udstyr og deres respektive klassificeringer
c)
hvorvidt de overensstemmelsesvurderingsprocedurer, som ansøgeren har valgt, kan anvendes på det pågældende udstyr i henhold til denne forordning
d)
det bemyndigede organs mulighed for at vurdere ansøgningen på grundlag af dets udpegelse, og
e)
tilstedeværelsen af tilstrækkelige og passende ressourcer.
Resultatet af hver gennemgang af en ansøgning skal dokumenteres. Afslag på eller tilbagetrækninger af ansøgninger meddeles til det elektroniske system, der er nævnt i artikel 57, og skal være tilgængelige for andre bemyndigede organer.
4.4.   Tildeling af ressourcer
Det bemyndigede organ skal have dokumenterede procedurer til sikring af, at alle overensstemmelsesvurderingsaktiviteter udføres af behørigt godkendt og kvalificeret personale, der har tilstrækkelig erfaring med evaluering af udstyr, systemer og processer og tilhørende dokumentation, der er genstand for overensstemmelsesvurdering.
For hver ansøgning fastlægger det bemyndigede organ de ressourcer, der er behov for, og identificerer en person, der har ansvaret for at sikre, at vurderingen af den enkelte ansøgning er udført i overensstemmelse med de relevante procedurer, og for at sikre, at der anvendes passende ressourcer, herunder personale, til hver af vurderingsopgaverne. Fordelingen af de opgaver, der skal udføres som en del af overensstemmelsesvurderingen, og eventuelle efterfølgende ændringer af denne fordeling skal dokumenteres.
4.5.   Overensstemmelsesvurderingsaktiviteter
4.5.1.   Generelt
Det bemyndigede organ og dets personale skal udføre overensstemmelsesvurderingsaktiviteterne med den størst mulige faglige integritet og den nødvendige tekniske og videnskabelige kompetence på de specifikke områder.
Det bemyndigede organ skal råde over ekspertise, faciliteter og dokumenterede procedurer, der er tilstrækkelige til på effektiv vis at gennemføre de overensstemmelsesvurderingsaktiviteter, som det pågældende bemyndigede organ er udpeget til, under hensyntagen til de relevante krav, der er fastsat i bilag IX-XI, og navnlig alle de følgende krav:
—
hensigtsmæssigt planlægge gennemførelsen af hvert enkelt projekt
—
sikre, at vurderingsholdene er sammensat på en sådan måde, at de har tilstrækkelig erfaring med den pågældende teknologi, og at de hele tiden er objektive og uvildige, og sørge for at vurderingsholdenes medlemmer roterer med passende mellemrum
—
specificere et rationale for fastsættelsen af frister for afslutningen af overensstemmelsesvurderingsaktiviteter
—
vurdere fabrikantens tekniske dokumentation og de løsninger, der er valgt for at opfylde kravene i bilag I
—
gennemgå fabrikantens procedurer og dokumentation vedrørende evalueringen af prækliniske aspekter
—
gennemgå fabrikantens procedurer og dokumentation vedrørende klinisk evaluering
—
se på grænsefladen mellem fabrikantens risikostyringsproces og dens vurdering og analyse af den prækliniske og kliniske evaluering og evaluere deres relevans for påvisningen af overensstemmelse med de relevante krav i bilag I
—
følge de i bilag IX, punkt 5.2-5.4, omhandlede specifikke procedurer
—
for så vidt angår udstyr i klasse IIa eller IIb vurdere den tekniske dokumentation for udstyr, der er udvalgt på et repræsentativt grundlag
—
planlægge og regelmæssigt foretage passende tilsynsaudit og evalueringer, udføre eller anmode om bestemte prøver for at verificere, om kvalitetsstyringssystemet fungerer korrekt, og udføre uanmeldte audit på stedet
—
i forbindelse med udtagning af udstyrsprøver verificere, at det fremstillede udstyr er i overensstemmelse med den tekniske dokumentation; med henblik på dette krav defineres de relevante prøveudtagningskriterier og den relevante prøvningsprocedure inden prøveudtagningen
—
evaluere og verificere, at fabrikanten opfylder kravene i de relevante bilag.
Det bemyndigede organ skal, når det er relevant, tage hensyn til tilgængelige fælles specifikationer, vejledningsdokumenter og dokumenter om bedste praksis og harmoniserede standarder, også selv om fabrikanten ikke har angivet, at disse er overholdt.
4.5.2.   Audit af kvalitetsstyringssystemer
a)
Som led i vurderingen af kvalitetsstyringssystemer skal et bemyndiget organ forud for en audit og i overensstemmelse med sine dokumenterede procedurer:
—
vurdere den dokumentation, der er fremlagt i overensstemmelse med det relevante bilag om overensstemmelsesvurdering, og udarbejde et auditprogram, der klart identificerer antallet og rækkefølgen af aktiviteter, der er nødvendige for at påvise fuld dækning af en fabrikants kvalitetsstyringssystem og for at afgøre, om det opfylder kravene i denne forordning
—
identificere forbindelserne mellem og fordelingen af ansvarsområder blandt de forskellige fremstillingssteder og identificere fabrikantens relevante leverandører og/eller underentreprenører og overveje behovet for specifikt at udføre audit af disse leverandører eller underentreprenører eller begge
—
klart definere, for hver audit, der er identificeret i auditprogrammet, audittens mål, kriterier og omfang og udarbejde en auditplan, der fyldestgørende behandler og tager hensyn til de specifikke krav til det udstyr, de teknologier og processer, der er involveret
—
for udstyr i klasse IIa og IIb udarbejde og opdatere en plan for stikprøveudvælgelse med henblik på vurdering af teknisk dokumentation, jf. bilag II og III, der dækker omfanget af sådant udstyr, der er omfattet af fabrikantens ansøgning. Denne plan skal sikre, at der udtages stikprøver af alt udstyr, der er omfattet af certifikatet, gennem certifikatets gyldighedsperiode, og
—
udvælge og fordele behørigt kvalificeret og bemyndiget personale til at udføre individuelle audit. De respektive roller, ansvarsområder og beføjelser, som holdets medlemmer har, skal være klart defineret og dokumenteret.
b)
På grundlag af det auditprogram, som det bemyndigede organ har udarbejdet, skal det i overensstemmelse med sine dokumenterede procedurer:
—
foretage audit af fabrikantens kvalitetsstyringssystem med henblik på at verificere, at kvalitetsstyringssystemet sikrer, at det omfattede udstyr er i overensstemmelse med de relevante bestemmelser i denne forordning, som finder anvendelse på udstyr i samtlige faser fra design til den kvalitetskontrol og løbende tilsyn, og skal fastslå, om kravene i denne forordning er opfyldt
—
på grundlag af den relevante tekniske dokumentation og for at fastslå, om fabrikanten opfylder kravene i det relevante bilag om overensstemmelsesvurdering, gennemgå og foretage audit af fabrikantens processer/undersystemer, navnlig for:
—
design og udvikling
—
produktion og proceskontrol
—
produktdokumentation
—
verifikation af indkøb, herunder verifikation af indkøbt udstyr,
—
korrigerende og forebyggende handlinger, herunder med henblik på overvågningen, efter at udstyret er bragt i omsætning, og
—
PMCF,
og gennemgå og foretage audit af krav og bestemmelser vedtaget af fabrikanten, herunder i forhold til at opfylde de generelle krav til sikkerhed og ydeevne fastsat i bilag I.
Der skal udtages stikprøver af dokumentationen på en sådan måde, at de risici, der er forbundet med udstyrets tilsigtede brug, kompleksiteten af fremstillingsteknologierne, omfanget og klasserne af fremstillet udstyr og alle tilgængelige oplysninger om overvågning, efter at udstyret er bragt i omsætning, afspejles
—
hvis det ikke allerede er omfattet af auditprogrammet, foretage audit af proceskontrollen i lokalerne hos fabrikantens leverandører, når overensstemmelsen af det færdige udstyr er betydeligt påvirket af leverandørernes aktiviteter, og navnlig når fabrikanten ikke kan påvise tilstrækkelig kontrol med sine leverandører
—
foretage vurderinger af den tekniske dokumentation på grundlag af dets plan for stikprøveudvælgelse og under hensyntagen til punkt 4.5.4 og 4.5.5 for prækliniske og kliniske evalueringer, og
—
sikre, at auditresultaterne er hensigtsmæssigt og konsekvent klassificeret i overensstemmelse med kravene i denne forordning og med relevante standarder eller med dokumenter om bedste praksis, som er udarbejdet eller vedtaget af MDCG.
4.5.3.   Produktverifikation
Vurdering af den tekniske dokumentation
For så vidt angår vurderingen af den tekniske dokumentation i overensstemmelse med bilag IX, kapitel II, skal bemyndigede organer råde over tilstrækkelig ekspertise, faciliteter og dokumenterede procedurer for:
—
tildeling af behørigt kvalificeret og bemyndiget personale til undersøgelse af de individuelle aspekter såsom anvendelse af udstyret, bioforligelighed, klinisk evaluering, risikostyring og sterilisering, og
—
vurderingen af designets overensstemmelse med denne forordning og under hensyntagen til punkt 4.5.4-4.5.6. Den vurdering skal omfatte undersøgelse af fabrikanters gennemførelse af de indledende kontroller, kontroller under fremstillingen og de endelige kontroller og resultaterne heraf. Hvis der er behov for yderligere prøvninger eller anden dokumentation med henblik på at vurdere overensstemmelse med kravene i denne forordning, gennemfører det pågældende bemyndigede organ passende fysiske prøvninger eller laboratorieprøvninger i forbindelse med udstyret eller anmoder fabrikanten om at foretage disse prøvninger.
Typeafprøvning
Det bemyndigede organ skal råde over dokumenterede procedurer, tilstrækkelig ekspertise og faciliteter til typeafprøvning af udstyr i overensstemmelse med bilag X, herunder kapacitet til at:
—
undersøge og vurdere den tekniske dokumentation under hensyntagen til punkt 4.5.4-4.5.6 og verificere, at typen er fremstillet i overensstemmelse med denne dokumentation
—
udarbejde en afprøvningsplan, der udpeger alle relevante og kritiske parametre, der skal prøves af det bemyndigede organ eller på dets ansvar
—
dokumentere sit rationale for udvælgelsen af disse parametre
—
udføre de nødvendige undersøgelser og prøvninger for at verificere, om de løsninger, som fabrikanten har anvendt, opfylder de generelle krav til sikkerhed og ydeevne fastsat i bilag I. Sådanne undersøgelser og prøvninger skal omfatte alle prøvninger, der er nødvendige for at verificere, at fabrikanten faktisk har anvendt de relevante standarder, som denne har valgt at anvende
—
aftale med ansøgeren, hvor de nødvendige prøvninger gennemføres, hvis de ikke udføres direkte af det bemyndigede organ, og
—
tage det fulde ansvar for prøvningsresultater. De prøvningsrapporter, som fabrikanten indsender, skal kun tages i betragtning, hvis de er udstedt af overensstemmelsesvurderingsorganer, der er kompetente og uafhængige af fabrikanten.
Verifikation ved undersøgelse og prøvning af hvert produkt
Det bemyndigede organ skal:
a)
have dokumenterede procedurer, tilstrækkelig ekspertise og faciliteter til verifikation ved undersøgelse og prøvning af hvert enkelt produkt i overensstemmelse med bilag XI, del B
b)
udarbejde en afprøvningsplan, der udpeger alle relevante og kritiske parametre, der skal prøves af det bemyndigede organ eller på dets ansvar med henblik på at:
—
verificere, for udstyr i klasse IIb, at udstyret er i overensstemmelse med den type, der er beskrevet i EU-typeafprøvningscertifikatet, samt med de krav i denne forordning, der finder anvendelse for dette udstyr
—
bekræfte, for udstyr i klasse IIa, overensstemmelsen med den tekniske dokumentation, der er er omhandlet i bilag II og III, samt med de krav i denne forordning, der finder anvendelse for dette udstyr
c)
dokumentere sit rationale for udvælgelsen af disse parametre som nævnt i litra b)
d)
have dokumenterede procedurer til at foretage de nødvendige vurderinger og prøvninger for at verificere, at udstyret er i overensstemmelse med kravene i denne forordning, ved undersøgelse og prøvning af hvert enkelt produkt som specificeret i bilag XI, punkt 15
e)
have dokumenterede procedurer til at kunne indgå en aftale med ansøgeren om, hvornår og hvor de nødvendige prøvninger, der ikke skal udføres af det bemyndigede organ selv, skal gennemføres, og
f)
påtage sig det fulde ansvar for prøvningsresultater i overensstemmelse med dokumenterede procedurer; de prøvningsrapporter, som fabrikanten indsender, skal kun tages i betragtning, hvis de er udstedt af overensstemmelsesvurderingsorganer, der er kompetente og uafhængige af fabrikanten.
4.5.4.   Vurdering af præklinisk evaluering
Det bemyndigede organ skal have indført dokumenterede procedurer for gennemgang af fabrikantens procedurer og dokumentation vedrørende evalueringen af prækliniske aspekter. Det bemyndigede organ skal undersøge, validere og verificere, at fabrikantens procedurer og dokumentation i tilstrækkelig grad omfatter:
a)
planlægningen, gennemførelsen, vurderingen, rapporteringen og, hvor det er relevant, opdateringen af den prækliniske evaluering, navnlig af
—
de videnskabelige prækliniske litteratursøgninger, og
—
den prækliniske prøvning, f.eks. laboratorieprøvning, prøvning af simuleret brug, computermodellering, anvendelse af dyremodeller
b)
arten og varigheden af legemskontakt og de specifikke tilknyttede biologiske risici
c)
grænsefladen med risikostyringsprocessen, og
d)
vurderingen og analysen af de disponible prækliniske data og deres relevans med hensyn til at påvise overensstemmelse med de relevante krav i bilag I.
Det bemyndigede organs vurdering af prækliniske evalueringsprocedurer og dokumentation skal tage højde for resultaterne af litteratursøgninger og al udført validering, verifikation og prøvning og dragne konklusioner og typisk omfatte overvejelser vedrørende brug af alternative materialer og stoffer og tage hensyn til det færdige udstyrs emballage og stabilitet, herunder holdbarhed. Hvis en fabrikant ikke har gennemført ny prøvning, eller hvor der er afvigelser fra procedurerne, skal det pågældende bemyndigede organ kritisk gennemgå den begrundelse, som fabrikanten fremlægger.
4.5.5.   Vurdering af klinisk evaluering
Det bemyndigede organ skal have indført dokumenterede procedurer for vurdering af fabrikantens procedurer og dokumentation vedrørende klinisk evaluering for både den indledende overensstemmelsesvurdering og på løbende basis. Det bemyndigede organ undersøger, validerer og verificerer, at fabrikanternes procedurer og dokumentation i tilstrækkelig grad omfatter:
—
planlægningen, gennemførelsen, vurderingen, rapporteringen og opdateringen af den kliniske evaluering som omhandlet i bilag XIV
—
overvågning, efter at udstyret er bragt i omsætning, og PMCF
—
grænsefladen med risikostyringsprocessen
—
vurderingen og analysen af de disponible prækliniske data og deres relevans med hensyn til at påvise overensstemmelse med de relevante krav i bilag I, og
—
de konklusioner, der drages, med hensyn til den kliniske dokumentation, og udarbejdelse af den kliniske evalueringsrapport.
Disse procedurer, der er nævnt i første afsnit, skal tage hensyn til tilgængelige fælles specifikationer, vejledningsdokumenter og dokumenter om bedste praksis.
Det bemyndigede organs vurdering af den kliniske evaluering, jf. bilag XIV, skal omfatte:
—
den tilsigtede brug, som fabrikanten har anført, og angivelser om udstyret, som denne har fastsat
—
planlægningen af den kliniske evaluering
—
litteratursøgningsmetoden
—
relevant dokumentation fra litteratursøgningen
—
den kliniske afprøvning
—
gyldighed af ækvivalens angivet i forhold til andet udstyr, påvisning af ækvivalens, egnethed og resultatdata fra tilsvarende og lignende udstyr
—
overvågning, efter at udstyret er bragt i omsætning, og PMCF
—
den kliniske evalueringsrapport, og
—
begrundelser for ikke at udføre kliniske afprøvninger eller PMCF
I forbindelse med kliniske data fra kliniske afprøvninger, der indgår i den kliniske evaluering, skal det pågældende bemyndigede organ sikre, at fabrikantens konklusioner er gyldige i lyset af den godkendte kliniske afprøvningsplan.
Det bemyndigede organ skal sikre, at den kliniske evaluering i tilstrækkelig grad dækker de relevante krav til sikkerhed og ydeevne, der er fastlagt i bilag I, at den er bragt i overensstemmelse med kravene om risikostyring, at den udføres i overensstemmelse med bilag XIV, og at den er korrekt afspejlet i de oplysninger, der er givet om udstyret.
4.5.6.   Specifikke procedurer
Det bemyndigede organ skal have dokumenterede procedurer, tilstrækkelig ekspertise og faciliteter til de procedurer, der er fastlagt i bilag IX, punkt 5 og 6, bilag X, punkt 6, og bilag XI, punkt 16, som det er udpeget til.
For så vidt angår udstyr, der er fremstillet ved anvendelse af animalsk væv eller celler eller derivater heraf såsom TSE-modtagelige arter, som omhandlet i forordning (EU) nr. 722/2012, skal det bemyndigede organ have indført dokumenterede procedurer, der opfylder kravene i denne forordning, herunder udarbejdelse af en sammenfattende evalueringsrapport for den relevante kompetente myndighed.
4.6.   Indberetning
Det bemyndigede organ skal:
—
sikre, at alle trin i overensstemmelsesvurderingen er dokumenteret, så vurderingens konklusioner er klare og påviser overensstemmelse med kravene i denne forordning og kan udgøre objektiv dokumentation for en sådan overensstemmelse for personer, der ikke selv er involveret i vurderingen, f.eks. personale i udpegende myndigheder
—
sikre, at registre, der er tilstrækkelige til at give et tydeligt auditspor, er tilgængelige for audit af kvalitetsstyringssystemet
—
tydeligt dokumentere konklusionerne af dets vurdering af klinisk evaluering i en vurderingsrapport om klinisk evaluering, og
—
for hvert specifikt projekt forelægge en detaljeret rapport, der skal være baseret på et standardformat, der omfatter et mindstemål af elementer, der bestemmes af MDCG.
Det bemyndigede organs rapport skal:
—
klart dokumentere resultatet af dets vurdering og drage klare konklusioner af verifikationen af fabrikantens overensstemmelse med kravene i denne forordning
—
fremsætte en anbefaling om en endelig gennemgang og om en afsluttende beslutning, der skal foretages af det bemyndigede organ; denne anbefaling skal være underskrevet af den ansvarlige medarbejder i det bemyndigede organ, og
—
fremsendes til den pågældende fabrikant.
4.7.   Endelig gennemgang
Det bemyndigede organ skal, inden det træffer en endelig afgørelse:
—
sikre, at det personale, der er udpeget til den endelige gennemgang og beslutningstagning vedrørende specifikke projekter, er behørigt godkendt og forskelligt fra det personale, der har foretaget vurderingerne
—
verificere, at indberetningen eller indberetningerne og tilhørende dokumentation, der kræves for at kunne træffe en beslutning, herunder vedrørende afhjælpning af mangler, der er konstateret i forbindelse med vurderingen, er fuldstændig(e) og tilstrækkelig(e) med hensyn til anvendelsesområdet, og
—
verificere, at der ikke er mangler, der ikke er afhjulpet, som forhindrer udstedelse af et certifikat.
4.8.   Afgørelser og certificering
Det bemyndigede organ skal have dokumenterede procedurer for beslutningstagning, herunder vedrørende fordeling af ansvar for udstedelse, suspension, begrænsning og tilbagekaldelse af certifikater. Disse procedurer skal omfatte underretningskravene i kapitel V i denne forordning. Procedurerne skal gøre det muligt for det pågældende bemyndigede organ at:
—
beslutte, om denne forordnings krav er opfyldt på grundlag af dokumentationsvurderingen og yderligere tilgængelige oplysninger
—
beslutte, om planen om overvågning, efter at udstyret er bragt i omsætning, herunder PMCF-planen, er fyldestgørende, på grundlag af resultaterne af dets vurdering af den kliniske evaluering og risikostyringen
—
træffe beslutning om specifikke milepæle for det bemyndigede organs yderligere gennemgang af den opdaterede kliniske evaluering
—
beslutte, om særlige betingelser eller bestemmelser skal defineres med henblik på certificeringen
—
træffe beslutning om en certificeringsperiode på højst fem år på grundlag af nyhedsværdien, risikoklassificeringen, den kliniske evaluering og konklusionerne af risikoanalysen af udstyret
—
dokumentere beslutningstagning og godkendelsestrin klart, herunder godkendelse ved underskrift af de ansvarlige medarbejdere
—
dokumentere ansvarsområder og mekanismer for meddelelse af beslutninger klart, navnlig såfremt den endelige underskriver af et certifikat adskiller sig fra beslutningstageren eller beslutningstagerne eller ikke opfylder de krav, der er fastlagt i punkt 3.2.7
—
udstede et certifikat eller certifikater i overensstemmelse med mindstekravene i bilag XIII med en gyldighedsperiode på højst fem år og angive, om der gælder særlige betingelser eller begrænsninger i forbindelse med certificeringen
—
udstede et certifikat eller certifikater udelukkende til ansøgeren og ikke at udstede certifikater, der dækker flere enheder, og
—
sikre, at fabrikanten underrettes om resultatet af vurderingen og den heraf følgende beslutning, og at de indlæses i det elektroniske system, jf. artikel 57.
4.9.   Ændringer
Det bemyndigede organ skal have indført dokumenterede procedurer og kontraktlige aftaler med fabrikanter vedrørende fabrikanternes oplysningskrav og vurderingen af ændringer af:
—
det godkendte kvalitetsstyringssystem eller de godkendte kvalitetsstyringssystemer eller i det udvalg af produkter, der er omfattet
—
det godkendte design af udstyr
—
den tilsigtede brug af eller angivelser angående udstyret
—
den godkendte udstyrstype, og
—
ethvert stof, der indgår i eller benyttes til fremstilling af udstyr, og som er underlagt de specifikke procedurer i henhold til punkt 4.5.6.
Procedurerne og de kontraktlige aftaler, der er omhandlet i første afsnit, skal omfatte foranstaltninger til kontrol af betydningen af de ændringer, der er omhandlet i første afsnit.
Det pågældende bemyndigede organ skal i overensstemmelse med sine dokumenterede procedurer:
—
sikre, at fabrikanterne fremlægger planer om ændringer som omhandlet i første afsnit til forhåndsgodkendelse og relevante oplysninger vedrørende sådanne ændringer
—
vurdere de foreslåede ændringer og verificere, om kvalitetsstyringssystemet eller udstyrets eller udstyrstypens design efter disse ændringer fortsat opfylder kravene i denne forordning, og
—
underrette fabrikanten om sin afgørelse og forelægge en rapport eller, hvis det er relevant, en tillægsrapport, der skal indeholde de begrundede konklusioner af dets vurdering.
4.10.   Overvågningsaktiviteter og tilsyn efter certificering
Det bemyndigede organ skal have dokumenterede procedurer:
—
der fastlægger, hvordan og hvornår der skal gennemføres overvågningsaktiviteter vedrørende fabrikanterne. Disse procedurer skal indeholde foranstaltninger vedrørende uanmeldte audit på stedet hos fabrikanter og, hvis det er relevant, underentreprenører og leverandører, som udfører produktprøvninger, og tilsyn med overholdelsen af eventuelle betingelser, som fabrikanterne er bundet af, og som har forbindelse til certificeringsafgørelser, f.eks. opdateringer af kliniske data med bestemte mellemrum
—
til gennemgang af relevante kilder til videnskabelige og kliniske oplysninger og oplysninger forelagt, efter at udstyret er bragt i omsætning, vedrørende omfanget af deres udpegelse. Disse oplysninger skal tages i betragtning i forbindelse med planlægningen og gennemførelsen af overvågningsaktiviteter, og
—
med henblik på at gennemgå sikkerhedsovervågningsoplysninger, som de har adgang til i henhold til artikel 92, stk. 2, for at vurdere deres eventuelle indvirkning på gyldigheden af gældende certifikater. Resultaterne af evalueringen og eventuelle trufne afgørelser skal være grundigt dokumenterede.
Det pågældende bemyndigede organ skal efter at have modtaget oplysninger om sikkerhedsovervågningssager fra en fabrikant eller kompetente myndigheder træffe afgørelse om, hvilken af følgende muligheder der skal anvendes:
—
ikke at foretage sig noget på det grundlag, at sikkerhedsovervågningssagen helt klart ikke er knyttet til den tildelte certificering
—
observere fabrikantens og den kompetente myndigheds aktiviteter og resultaterne af fabrikantens undersøgelse med henblik på at afgøre, om den udstedte certificering er i fare, eller om passende korrigerende handlinger er foretaget
—
gennemføre ekstraordinære tilsynsforanstaltninger, f.eks. dokumentgennemgange, audit med kort varsel eller uanmeldte audit og produkttestning osv., såfremt det er sandsynligt, at den udstedte certificering er i fare
—
forøge hyppigheden af tilsynsaudit
—
gennemgå specifikke produkter eller processer i forbindelse med den næste audit af fabrikanten, eller
—
træffe alle andre relevante foranstaltninger.
I forbindelse med tilsynsaudit af fabrikanter skal det bemyndigede organ have dokumenterede procedurer for at:
—
foretage tilsynsaudit af fabrikanten mindst en gang om året, hvilket planlægges og udføres i overensstemmelse med de relevante krav i punkt 4.5
—
sikre tilstrækkelig vurdering af fabrikantens dokumentation om og anvendelse af bestemmelserne om sikkerhedsovervågning, overvågning, efter at udstyret er bragt i omsætning, og PMCF
—
udtage stikprøver af og afprøve udstyr og teknisk dokumentation under audit i henhold til foruddefinerede prøveudtagningskriterier og prøvningsprocedurer for at sikre, at fabrikanten løbende anvender det godkendte kvalitetsstyringssystem
—
sikre, at fabrikanten opfylder de dokumentations- og oplysningskrav, der er fastsat i de relevante bilag, og at der i dets procedurer tages hensyn til bedste praksis i gennemførelsen af kvalitetsstyringssystemer
—
sikre, at fabrikanten ikke bruger godkendelsen af kvalitetsstyringssystemer eller udstyr på en vildledende måde
—
indhente tilstrækkelige oplysninger til at fastslå, om kvalitetsstyringssystemet fortsat overholder kravene i denne forordning
—
anmode fabrikanten om at foretage korrektioner, korrigerende handlinger og, hvis det er relevant, forebyggende foranstaltninger ved opdagelse af mangler, og
—
hvis det er nødvendigt, indføre særlige restriktioner for det relevante certifikat eller suspendere eller tilbagekalde det.
Det bemyndigede organ skal, hvis det er angivet som en del af betingelserne for certificering:
—
foretage en tilbundsgående gennemgang af den kliniske evaluering, der senest er opdateret af fabrikanten, på grundlag af fabrikantens overvågning, efter at udstyret er bragt i omsætning, på grundlag af dens PMCF og på grundlag af klinisk litteratur, der er relevant for den tilstand, der behandles med udstyret, eller på klinisk litteratur, der er relevant for tilsvarende udstyr
—
klart dokumentere resultatet af den tilbundsgående gennemgang og henvende sig til fabrikanten med eventuelle specifikke betænkeligheder eller pålægge denne særlige betingelser, og
—
sikre, at den kliniske evaluering, der senest er opdateret, er korrekt afspejlet i brugsanvisningen og, hvis det er relevant, sammenfatningen af sikkerhed og ydeevne.
4.11.   Fornyet certificering
Det bemyndigede organ skal have indført dokumenterede procedurer for gennemgange i forbindelse med fornyet certificering og fornyelse af certifikater. Fornyet certificering af godkendte kvalitetsstyringssystemer eller EU-vurderingscertifikater for teknisk dokumentation eller EU-typeafprøvningscertifikater skal finde sted mindst hvert femte år.
Det bemyndigede organ skal have dokumenterede procedurer for fornyelse af EU-vurderingscertifikater for teknisk dokumentation og EU-typeafprøvningscertifikater, og disse procedurer skal kræve, at den pågældende fabrikant forelægger en oversigt over ændringer og videnskabelige resultater for udstyret, herunder:
a)
alle ændringer af det oprindeligt godkendte udstyr, herunder ændringer, hvorom der endnu ikke er underrettet
b)
erfaringer fra overvågning, efter at udstyret er bragt i omsætning
c)
erfaringer fra risikostyring
d)
erfaringer fra opdatering af dokumentationen for overholdelse af de generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I
e)
erfaringer fra gennemgange af den kliniske evaluering, herunder resultaterne af alle kliniske afprøvninger og PMCF
f)
ændringer af kravene, dele af udstyret eller det videnskabelige eller reguleringsmæssige miljø
g)
ændringer af anvendte eller nye harmoniserede standarder, fælles specifikationer eller tilsvarende dokumenter, og
h)
ændringer inden for medicinsk, videnskabelig og teknisk viden, såsom:
—
nye behandlinger
—
ændringer i testmetoder
—
nye videnskabelige resultater vedrørende materialer og komponenter, herunder resultater vedrørende deres bioforligelighed
—
erfaringer fra undersøgelser af sammenligneligt udstyr
—
data fra registre
—
erfaringer fra kliniske afprøvninger med sammenligneligt udstyr.
Det bemyndigede organ skal have dokumenterede procedurer til at vurdere de oplysninger, der er omhandlet i andet afsnit, og skal være særligt opmærksom på kliniske data fra overvågningen, efter at udstyret er bragt i omsætning, og PMCF-aktiviteter siden den foregående certificering eller fornyede certificering, herunder passende opdateringer af fabrikanters kliniske evalueringsrapporter.
For så vidt angår afgørelsen om fornyet certificering skal det pågældende bemyndigede organ anvende de samme metoder og principper som i forbindelse med den oprindelige certificeringsafgørelse. Om nødvendigt skal der udarbejdes særskilte formularer til fornyet certificering under hensyntagen til de trin, der er udført med henblik på certificering, såsom ansøgning og ansøgningsgennemgang.
BILAG VIII
KLASSIFICERINGSREGLER
KAPITEL I
DEFINITIONER, DER ER SPECIFIKKE FOR KLASSIFICERINGSREGLERNE
1.   VARIGHED AF ANVENDELSEN
1.1.   
»Midlertidig«
: normalt bestemt til at skulle anvendes kontinuerligt i mindre end 60 minutter.
1.2.   
»Kortvarig«
: normalt bestemt til at skulle anvendes kontinuerligt i mellem 60 minutter og 30 dage.
1.3.   
»Langvarig«
: normalt bestemt til at skulle anvendes kontinuerligt i mere end 30 dage.
2.   INVASIVT OG AKTIVT UDSTYR
2.1.   
»Legemsåbning«
: enhver naturlig åbning i legemet, samt den eksterne overflade af øjeæblet eller enhver permanent kunstig åbning, f.eks. en stomi.
2.2.   
»Kirurgisk invasivt udstyr«
:
a)
invasivt udstyr, som trænger ind i legemet gennem legemets overflader, herunder gennem slimhinder i legemsåbninger, ved hjælp af eller i forbindelse med et kirurgisk indgreb, og
b)
udstyr, som trænger ind i legemet på anden måde end gennem en legemsåbning.
2.3.   
»Genanvendeligt kirurgisk instrument«
: et instrument, der uden at være tilsluttet aktivt udstyr er bestemt til kirurgisk anvendelse til at skære, bore, save, bortmejsle, skrabe, afklemme, sammentrække, sammenhæfte og lignende, og som ifølge fabrikanten er bestemt til at blive genanvendt efter at være underkastet passende procedurer såsom rengøring, desinfektion og sterilisering.
2.4.   
»Terapeutisk aktivt udstyr«
: ethvert aktivt udstyr, som anvendes enten alene eller sammen med andet udstyr til at understøtte, ændre, erstatte eller genoprette biologiske funktioner eller strukturer i forbindelse med behandling eller lindring af sygdomme, skader eller handicap.
2.5.   
»Aktivt udstyr, der er bestemt til diagnosticering og monitorering«
: ethvert aktivt udstyr, som anvendes enten alene eller sammen med andet udstyr til at tilvejebringe oplysninger med henblik på detektion, diagnosticering, monitorering eller behandling af fysiologiske tilstande, helbredstilstande, sygdomme eller medfødte misdannelser.
2.6.   
Ved »det centrale kredsløb« forstås følgende blodkar
: 
arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens
 til 
bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior
 og 
vena cava inferior
.
2.7.   
»Centralnervesystemet«
: hjernen, hjernehinderne og rygmarven.
2.8.   
»beskadiget hud eller beskadigede slimhinder«
: et område med hud eller en slimhinde med patologiske ændringer eller ændringer efter sygdom eller sår.
KAPITEL II
GENNEMFØRELSESBESTEMMELSER
3.1.   Klassificeringsreglernes anvendelse er afhængig af udstyrets erklærede formål.
3.2.   Hvis det pågældende udstyr er bestemt til at skulle anvendes sammen med andet udstyr, gælder klassificeringsreglerne særskilt for hvert udstyr. Tilbehør til medicinsk udstyr og til et i bilag XVI anført produkt skal klassificeres selvstændigt, særskilt fra det udstyr, sammen med hvilket de anvendes.
3.3.   Software, som styrer udstyr eller påvirker anvendelsen af udstyr, henhører under samme klasse som det pågældende udstyr.
Hvis softwaren er uafhængig af andet udstyr, klassificeres den selvstændigt.
3.4.   Hvis udstyr ikke er bestemt til udelukkende eller hovedsagelig at skulle anvendes i en specifik del af legemet, skal det behandles og klassificeres efter den specificerede anvendelse, der er mest risikofyldt.
3.5.   Hvis flere regler, eller hvis flere underregler inden for samme regel, finder anvendelse på samme udstyr på grundlag af udstyrets erklærede formål, er det den strengeste regel og underregel, der medfører den højeste klassificering, der finder anvendelse.
3.6.   Ved beregning af varigheden, jf. punkt 1, forstås ved kontinuerlig anvendelse:
a)
den samlede varighed af anvendelsen af det samme udstyr uden hensyn til midlertidig afbrydelse af anvendelsen i forbindelse med en procedure eller midlertidig fjernelse med henblik på f.eks. rengøring eller desinficering af udstyret. Hvorvidt afbrydelsen af anvendelsen eller fjernelsen er midlertidig, fastsættes i forhold til varigheden af anvendelsen forud for og efter den periode, hvor anvendelsen er afbrudt eller udstyret fjernet, og
b)
den akkumulerede anvendelse af udstyr, der af fabrikanten er beregnet til straks at skulle erstattes med andet udstyr af samme type.
3.7.   Udstyr betragtes som udstyr, der muliggør direkte diagnosticering, når det af sig selv diagnosticerer den pågældende sygdom eller tilstand, eller når det tilvejebringer afgørende oplysninger til brug for diagnosticeringen.
KAPITEL III
KLASSIFICERINGSREGLER
4.   IKKEINVASIVT UDSTYR
4.1.   Regel 1
Alt ikkeinvasivt udstyr er klassificeret som klasse I, medmindre en af følgende regler finder anvendelse.
4.2.   Regel 2
Alt ikkeinvasivt udstyr, der er beregnet til kanalisering eller oplagring af blod, legemsvæsker, celler eller væv, væsker eller luftarter med henblik på infusion, administration eller indførelse i legemet, er klassificeret som klasse IIa:
—
hvis det kan tilsluttes aktivt udstyr i klasse IIa, IIb eller III, eller
—
hvis det er beregnet til at skulle anvendes til kanalisering eller oplagring af blod eller andre legemsvæsker eller til oplagring af organer, dele af organer eller legemsceller og væv, med undtagelse af blodposer; blodposer er klassificeret som klasse IIb.
I alle andre tilfælde er sådant udstyr klassificeret som klasse I.
4.3.   Regel 3
Alt ikkeinvasivt udstyr, som har til formål at ændre den biologiske eller kemiske sammensætning af humane væv eller celler, blod, andre legemsvæsker eller andre væsker, der er beregnet til implantation eller administration i legemet, er klassificeret som klasse IIb, medmindre den behandling, hvor udstyret anvendes, består i filtrering, centrifugering eller udveksling af luftarter eller varme, idet det i så fald er klassificeret som klasse IIa.
Alt ikkeinvasivt udstyr, der indeholder et stof eller en blanding af stoffer, der er bestemt til at blive anvendt in vitro i direkte kontakt med humane celler, væv eller organer, der er taget fra det menneskelige legeme eller anvendt in vitro med menneskelige embryoner inden deres implantation eller administration i legemet, er klassificeret som klasse III.
4.4.   Regel 4
Alt ikkeinvasivt udstyr, der kommer i kontakt med beskadiget hud eller beskadigede slimhinder, er klassificeret som:
—
klasse I, hvis det er beregnet til at skulle anvendes som mekanisk barriere, til kompression eller til absorption af ekssudater
—
klasse IIb, hvis det hovedsagelig er beregnet til at skulle anvendes til skader på hud, der går igennem dermis, eller slimhinder og kun kan heles ved sekundær revision
—
klasse IIa, hvis det hovedsagelig er beregnet til at regulere mikromiljøet i beskadiget hud eller beskadigede slimhinder, og
—
klasse IIa i alle andre tilfælde.
Denne regel gælder også invasivt udstyr, der kommer i kontakt med beskadigede slimhinder.
5.   INVASIVT UDSTYR
5.1.   Regel 5
Alt invasivt udstyr i forbindelse med legemsåbninger, som ikke er kirurgisk invasivt udstyr, som ikke er beregnet til at skulle tilsluttes aktivt udstyr, eller som er beregnet til at skulle tilsluttes aktivt udstyr fra klasse I, er klassificeret som:
—
klasse I, hvis det er beregnet til midlertidig brug
—
klasse IIa, hvis det er beregnet til kortvarig brug, medmindre det anvendes i mundhulen ned til strubehovedet, i øregangen ind til trommehinden eller i næsehulen, idet det i så fald klassificeres som klasse I, og
—
klasse IIb, hvis det er beregnet til langvarig brug, medmindre det anvendes i mundhulen ned til strubehovedet, i øregangen ind til trommehinden eller i næsehulen og ikke risikerer at blive absorberet af slimhinderne, idet det i så fald er klassificeret som klasse IIa.
Alt invasivt udstyr i forbindelse med legemsåbninger, som ikke er kirurgisk invasivt udstyr, og som er beregnet til at blive tilsluttet aktivt udstyr i klasse IIa, IIb eller III, er klassificeret som klasse IIa.
5.2.   Regel 6
Alt kirurgisk invasivt udstyr, der er beregnet til midlertidig brug, er klassificeret som klasse IIa, medmindre det:
—
er specielt beregnet til at kontrollere, diagnosticere, monitorere eller korrigere en defekt i hjertet eller i det centrale kredsløb ved direkte kontakt med disse dele af legemet, idet det i så fald er klassificeret som klasse III
—
er genanvendelige kirurgiske instrumenter, idet det i så fald er klassificeret som klasse I
—
er specielt beregnet til at skulle anvendes i direkte kontakt med hjertet eller det centrale kredsløb eller centralnervesystemet, idet det i så fald er klassificeret som klasse III
—
er beregnet til at frembringe energi i form af ioniserende stråling, idet det i så fald er klassificeret som klasse IIb
—
har en biologisk virkning eller helt eller hovedsageligt absorberes, idet det i så fald er klassificeret som klasse IIb, eller
—
er beregnet til at administrere lægemidler ved hjælp af en tilførselsmekanisme, såfremt administrationen af et lægemiddel foregår på en måde, der i lyset af anvendelsesmetoden kan være farlig, idet det i så fald er klassificeret som klasse IIb.
5.3.   Regel 7
Alt kirurgisk invasivt udstyr, der er beregnet til kortvarig brug, er klassificeret som klasse IIa, medmindre det:
—
er specielt beregnet til at kontrollere, diagnosticere, monitorere eller korrigere en defekt i hjertet eller i det centrale kredsløb ved direkte kontakt med disse dele af legemet, idet det i så fald er klassificeret som klasse III
—
er specielt beregnet til at skulle anvendes i direkte kontakt med hjertet eller det centrale kredsløb eller centralnervesystemet, idet det i så fald er klassificeret som klasse III
—
er beregnet til at frembringe energi i form af ioniserende stråling, idet det i så fald er klassificeret som klasse IIb
—
har en biologisk virkning eller helt eller hovedsageligt absorberes, idet det i så fald er klassificeret som klasse III
—
er beregnet til at undergå en kemisk ændring i legemet, idet det i så fald er klassificeret som klasse IIb, medmindre udstyret er anbragt i tænderne, eller
—
er beregnet til at administrere lægemidler, idet det i så fald er klassificeret som klasse IIb.
5.4.   Regel 8
Alt implantabelt udstyr og kirurgisk invasivt udstyr til langvarig brug er klassificeret som klasse IIb, medmindre det:
—
er beregnet til at blive anbragt i tænderne, idet det i så fald er klassificeret som klasse IIa
—
er beregnet til at blive anvendt i direkte kontakt med hjertet, det centrale kredsløb eller centralnervesystemet, idet det i så fald er klassificeret som klasse III
—
har en biologisk virkning eller helt eller hovedsageligt absorberes, idet det i så fald er klassificeret som klasse III
—
er beregnet til at undergå en kemisk ændring i legemet, idet det i så fald er klassificeret som klasse III, medmindre udstyret er anbragt i tænderne
—
er beregnet til at administrere lægemidler, idet det i så fald er klassificeret som klasse III
—
er aktivt, implantabelt udstyr eller tilbehør hertil, idet det i så fald er klassificeret som klasse III
—
er brystimplantater eller kirurgiske net, idet det i så fald er klassificeret som klasse III
—
er totale eller partielle ledproteser, idet det i så fald er klassificeret som klasse III, med undtagelse af tilhørende komponenter såsom skruer, kiler, plader og instrumenter, eller
—
er diskusimplantater eller implantabelt udstyr, der kommer i kontakt med rygsøjlen, idet de i så fald er klassificeret som klasse III, med undtagelse af komponenter såsom skruer, kiler, plader og instrumenter.
6.   AKTIVT UDSTYR
6.1.   Regel 9
Alt terapeutisk aktivt udstyr, der er beregnet til at tilføre eller udveksle energi, er klassificeret som klasse IIa, medmindre dets karakteristika er af en sådan art, at det kan tilføre energi til eller udveksle energi med det menneskelige legeme på en potentielt farlig måde i betragtning af den pågældende energis art, tæthed og anvendelsessted, idet det i så fald er klassificeret som klasse IIb.
Alt aktivt udstyr, der er beregnet til at styre eller monitorere ydeevnen af terapeutisk aktivt udstyr i klasse IIb, eller som er beregnet til direkte at påvirke dette udstyrs ydeevne, er klassificeret som klasse IIb.
Alt aktivt udstyr, der er beregnet til at udsende ioniserende stråling til terapeutiske formål, herunder udstyr, der styrer eller monitorerer sådant udstyr, eller som direkte påvirker dets ydeevne, er klassificeret som klasse IIb.
Alt aktivt udstyr, der er beregnet til at styre, monitorere eller direkte påvirke aktivt, implantabelt udstyrs ydeevne, er klassificeret som klasse III.
6.2.   Regel 10
Aktivt udstyr, der er beregnet til diagnosticering og monitorering, er klassificeret som klasse IIa:
—
hvis det er beregnet til at afgive energi, som absorberes af det menneskelige legeme, bortset fra udstyr, som er beregnet til at belyse patientens legeme ved hjælp af synligt lys, idet det i så fald er klassificeret som klasse I
—
hvis det er beregnet til at afbilde in vivo-fordelingen af radiofarmaka, eller
—
hvis det er beregnet til at muliggøre en direkte diagnosticering eller monitorering af vitale fysiologiske processer, medmindre det er specielt beregnet til at monitorere vitale fysiologiske parametre, og variationer af disse parametre har en sådan karakter, at de kan udgøre en umiddelbar fare for patienten, f.eks. variationer i hjertefunktionen, vejrtrækningen eller centralnervesystemets aktivitet, eller de er beregnet til diagnosticering i kliniske situationer, hvor patienten er i umiddelbar fare, idet det i så fald er klassificeret som klasse IIb.
Aktivt udstyr, der er beregnet til at udsende ioniserende stråling og beregnet til røntgendiagnostik eller -behandling, herunder udstyr til interventionsradiologi, og udstyr, der styrer eller monitorerer sådant udstyr, eller som direkte påvirker dets ydeevne, er klassificeret som klasse IIb.
6.3.   Regel 11
Software, der er beregnet til at tilvejebringe oplysninger, der anvendes til at træffe beslutninger med diagnostiske eller terapeutiske formål, er klassificeret som klasse IIa, medmindre sådanne beslutninger har en virkning, der kan forårsage:
—
dødsfald eller en uoprettelig forringelse af en persons sundhedstilstand, idet det i så fald henhører under klasse III, eller
—
en alvorlig forringelse af en persons sundhedstilstand eller et kirurgisk indgreb, idet det i så fald er klassificeret som klasse IIb.
Software, der er beregnet til at monitorere fysiologiske processer, er klassificeret som klasse IIa, medmindre det er beregnet til at monitorere vitale fysiologiske parametre, hvor variationer af disse parametre har en sådan karakter, at de kan udgøre en umiddelbar fare for patienten, idet det i så fald er klassificeret som klasse IIb.
Alt andet software er klassificeret som klasse I.
6.4.   Regel 12
Alt aktivt udstyr, der er beregnet til at administrere og/eller fjerne lægemidler, legemsvæsker eller andre stoffer til eller fra legemet, er klassificeret som klasse IIa, medmindre dette foregår på en måde, der er potentielt farlig i betragtning af de anvendte stoffer, den berørte del af legemet eller anvendelsesmåden, idet det i så fald er klassificeret som klasse IIb.
6.5.   Regel 13
Alt andet aktivt udstyr er klassificeret som klasse I.
7.   SÆRLIGE REGLER
7.1.   Regel 14
Alt udstyr, der som en integreret bestanddel indeholder et stof, der anvendt alene kan betragtes som et lægemiddel i henhold til definitionen i artikel 1, nr. 2), i direktiv 2001/83/EF, herunder et lægemiddel fremstillet på basis af blod eller plasma fra mennesker som defineret i nævnte direktivs artikel 1, nr. 10), og som har en virkning på organismen ud over den, som udstyret har, er klassificeret som klasse III.
7.2.   Regel 15
Alt udstyr, der anvendes til svangerskabsforebyggelse eller til forebyggelse af seksuelt overførte sygdomme, er klassificeret som klasse IIb, medmindre der er tale om implantabelt udstyr eller invasivt udstyr til langvarig brug, idet det i så fald er klassificeret som klasse III.
7.3.   Regel 16
Alt udstyr, der er specielt beregnet til at desinficere, rengøre, skylle eller i givet fald hydratisere kontaktlinser, er klassificeret som klasse IIb.
Alt udstyr, der er specielt beregnet til at desinficere eller sterilisere medicinsk udstyr, er klassificeret som klasse IIa, medmindre det er desinficeringsopløsninger eller vaskedesinfektorer, der er specielt beregnet til at desinficere invasivt udstyr, som endepunkt i behandlingen, idet det i så fald er klassificeret som klasse IIb.
Denne regel finder ikke anvendelse på udstyr, der er beregnet til at rengøre andet udstyr end kontaktlinser kun ved hjælp af en fysisk indsats.
7.4.   Regel 17
Udstyr, der er specielt beregnet til at registrere diagnostiske billeder genereret ved hjælp af røntgenstråling, er klassificeret som klasse IIa.
7.5.   Regel 18
Alt udstyr, der er fremstillet ved anvendelse af væv eller celler af human eller animalsk oprindelse, som er ikkelevedygtige eller gjort ikkelevedygtige, eller derivater heraf, er klassificeret som klasse III, medmindre sådant udstyr er fremstillet ved anvendelse af væv eller celler af animalsk oprindelse, som er ikkelevedygtige eller gjort ikkelevedygtige, eller af derivater heraf, og er udstyr beregnet til kun at komme i berøring med intakt hud.
7.6.   Regel 19
Alt udstyr, som inkorporerer eller består af nanomaterialer er klassificeret som:
—
klasse III, hvis det udgør en høj eller middelhøj risiko for indre eksponering
—
klasse IIb, hvis det udgør en lav risiko for indre eksponering, og
—
klasse IIa, hvis det udgør en ubetydelig risiko for indre eksponering.
7.7.   Regel 20
Alt invasivt udstyr i forbindelse med legemsåbninger, som ikke er kirurgisk invasivt udstyr, og som er bestemt til at administrere lægemidler via inhalation, er klassificeret som klasse IIa, medmindre dets virkningsmåde har en afgørende indvirkning på effektiviteten og sikkerheden af det administrerede lægemiddel, eller det er bestemt til at behandle alvorlige livstruende tilstande, idet det i så fald er klassificeret som klasse IIb.
7.8.   Regel 21
Udstyr, der består af stoffer eller af kombinationer af stoffer, der er bestemt til at blive indgivet i det menneskelige legeme via en legemsåbning eller påført huden, og som absorberes af eller fordeles lokalt i det menneskelige legeme, klassificeres som:
—
klasse III, hvis det eller dets metabolitter absorberes systemisk af det menneskelige legeme med henblik på at opfylde det erklærede formål
—
klasse III, hvis det opfylder det erklærede formål i maven eller den nedre del af fordøjelseskanalen, og det eller dets metabolitter absorberes systemisk af det menneskelige legeme
—
klasse IIa, hvis det påføres huden, eller hvis det anvendes i næse- eller mundhulen ned til strubehovedet, og opfylder det erklærede formål i disse hulrum, og
—
klasse IIb i alle andre tilfælde.
7.9.   Regel 22
Terapeutisk aktivt udstyr med en integreret eller inkorporeret diagnostisk funktion, som i betydelig grad er bestemmende for udstyrets patientbehandling, såsom lukkede kredsløbssystemer eller automatiske eksterne defibrillatorer, er klassificeret som klasse III.
BILAG IX
OVERENSSTEMMELSESVURDERING BASERET PÅ ET KVALITETSSTYRINGSSYSTEM OG PÅ VURDERING AF TEKNISK DOKUMENTATION
KAPITEL I
KVALITETSSTYRINGSSYSTEM
1.   Fabrikanten skal etablere, dokumentere og implementere et kvalitetsstyringssystem som beskrevet i artikel 10, stk. 9, og sikre dets effektivitet i hele det pågældende udstyrs livscyklus. Fabrikanten sikrer anvendelse af kvalitetsstyringssystemet, jf. punkt 2, og er underlagt audit, jf. punkt 2.3 og 2.4, og tilsyn, jf. punkt 3.
2.   Vurdering af kvalitetsstyringssystemet
2.1.   Fabrikanten skal indsende en ansøgning om vurdering af sit kvalitetsstyringssystem til et bemyndiget organ. Ansøgningen skal indeholde:
—
navnet på fabrikanten og adressen på dennes registrerede forretningssted og angivelse af ethvert andet fremstillingssted, der er omfattet af kvalitetsstyringssystemet, og, hvis fabrikantens ansøgning indsendes af dennes autoriserede repræsentant, navnet på den autoriserede repræsentant og adressen på den autoriserede repræsentants registrerede forretningssted
—
alle relevante oplysninger om det udstyr eller den gruppe af udstyr, som kvalitetsstyringssystemet vedrører
—
en skriftlig erklæring om, at der ikke er indsendt en ansøgning vedrørende det samme udstyrsrelaterede kvalitetsstyringssystem til et andet bemyndiget organ, eller oplysninger om en eventuel tidligere ansøgning vedrørende det samme udstyrsrelaterede kvalitetsstyringssystem
—
et udkast til en EU-overensstemmelseserklæring, jf. artikel 19 og bilag IV, for den udstyrsmodel, der er omfattet af overensstemmelsesvurderingsproceduren
—
dokumentationen vedrørende fabrikantens kvalitetsstyringssystem
—
en dokumenteret beskrivelse af de procedurer, der er indført for at opfylde de forpligtelser, der er forbundet med kvalitetsstyringssystemet og kræves i henhold til denne forordning, og et tilsagn fra den pågældende fabrikant om at anvende disse procedurer
—
en beskrivelse af de procedurer, der er indført for at sikre, at kvalitetsstyringssystemet fortsat vil fungere hensigtsmæssigt og effektivt, og et tilsagn fra fabrikanten om at anvende disse procedurer
—
dokumentationen vedrørende fabrikantens system til overvågning, efter udstyret er bragt i omsætning, og, hvor det er relevant, vedrørende PMCF-planen og de procedurer, der er indført for at sikre overholdelsen af de forpligtelser, der følger af sikkerhedsovervågningsbestemmelserne i artikel 87-92
—
en beskrivelse af de procedurer, der er indført for at opdatere systemet til overvågning, efter udstyret er bragt i omsætning, og, hvis det er relevant, PMCF-planen, og de procedurer, der skal sikre overholdelsen af de forpligtelser, der følger af sikkerhedsovervågningsbestemmelserne, der er fastsat i artikel 87-92, samt et tilsagn fra fabrikanten om at anvende disse procedurer
—
dokumentation om den kliniske evalueringsplan, og
—
en beskrivelse af de procedurer, der er indført for at opdatere den kliniske evalueringsplan under hensyntagen til det aktuelle tekniske niveau.
2.2.   Gennemførelsen af kvalitetsstyringssystemet skal sikre overensstemmelse med denne forordning. Alle de elementer, krav og bestemmelser, som fabrikanten tager hensyn til i sit kvalitetsstyringssystem, skal dokumenteres på systematisk og overskuelig måde i form af en kvalitetsmanual og skriftlige politikker og procedurer som f.eks. kvalitetsprogrammer, -planer og -registre.
Desuden skal den dokumentation, der skal fremlægges til vurdering af kvalitetsstyringssystemet, indeholde en fyldestgørende beskrivelse af navnlig:
a)
fabrikantens kvalitetsmålsætninger
b)
virksomhedens opbygning, herunder:
—
organisationsstrukturer med fordeling af personaleansvar i forbindelse med kritiske procedurer, ledelsens ansvarsområder samt dens organisationsmæssige beføjelser
—
metoderne til monitorering af, om kvalitetsstyringssystemet fungerer effektivt, og navnlig om systemet er egnet til at opnå den ønskede kvalitet med hensyn til design og udstyret, herunder kontrol med udstyr, som ikke er i overensstemmelse med kravene
—
metoderne til monitorering af, at kvalitetsstyringssystemet fungerer effektivt, hvis designet, fremstillingen og/eller den endelige verifikation og prøvning af udstyret eller dele af enhver af disse processer udføres af en anden part, og navnlig typen og omfanget af den kontrol, der føres med den anden part, og
—
hvis fabrikanten ikke har noget registreret forretningssted i en medlemsstat, et udkast til den fuldmagt vedrørende udpegelsen af en autoriseret repræsentant og en erklæring fra den autoriserede repræsentant om, at denne har til hensigt at acceptere fuldmagten
c)
fremgangsmåder og teknikker for monitorering, verifikation, validering og kontrol af udstyrets design og dokumentation, data og registreringer i forbindelse med disse fremgangsmåder og teknikker. Disse fremgangsmåder og teknikker omfatter specifikt:
—
strategien for overholdelse af reguleringen, herunder processer til identifikation af relevante lovkrav, kvalifikationer, klassificering, håndtering af ækvivalens, valg og overholdelse af overensstemmelsesvurderingsprocedurer
—
identifikation af gældende generelle krav til sikkerhed og ydeevne og løsninger til opfyldelse heraf under hensyntagen til gældende fælles specifikationer og, hvis det vælges, harmoniserede standarder eller andre passende løsninger
—
risikostyring, jf. bilag I, punkt 3
—
den kliniske evaluering i henhold til artikel 61 og bilag XIV, herunder klinisk opfølgning, efter at udstyret er bragt i omsætning
—
løsninger til opfyldelse af de gældende specifikke krav til design og konstruktion, herunder passende præklinisk evaluering, navnlig kravene i bilag I, kapitel II
—
løsninger til opfyldelse af gældende specifikke krav til oplysninger, der skal forelægges sammen med udstyret, navnlig kravene i bilag I, kapitel III
—
procedurer til identifikation af udstyret, der udarbejdes og opdateres på grundlag af tegninger, specifikationer eller andre relevante dokumenter i alle fremstillingsfaser, og
—
styring af designændringer eller ændringer af kvalitetsstyringssystemet, og
d)
teknikker for verifikation og kvalitetssikring i fremstillingsfasen, herunder navnlig de processer og procedurer, der skal anvendes, navnlig i forbindelse med sterilisering, og relevante dokumenter, og
e)
de relevante prøvninger og forsøg, der skal foretages før, under og efter fremstillingen, den hyppighed, hvormed de skal finde sted, samt det prøveudstyr, der skal anvendes; kalibreringen af prøveudstyret skal dokumenteres på en sådan måde, at der sikres en tilstrækkelig sporbarhed.
Endvidere skal fabrikanten give det bemyndigede organ adgang til den tekniske dokumentation, der er omhandlet i bilag II og III.
2.3.   Audit
Det bemyndigede organ skal foretage en audit af kvalitetsstyringssystemet for at afgøre, om det opfylder kravene i punkt 2.2. Hvis fabrikanten anvender en harmoniseret standard eller fælles specifikationer, der vedrører et kvalitetsstyringssystem, skal det bemyndigede organ vurdere overensstemmelsen med disse standarder eller fælles specifikationer. Det bemyndigede organ skal antage, at et kvalitetsstyringssystem, der er i overensstemmelse med de relevante harmoniserede standarder eller fælles specifikationer, opfylder de krav, der er omfattet af disse standarder eller fælles specifikationer, medmindre det behørigt begrunder, hvorfor det ikke antager dette.
Det bemyndigede organs audithold skal mindst omfatte én person, som tidligere har foretaget auditprocedurer inden for den pågældende teknologi i overensstemmelse med bilag VII, punkt 4.3-4.5. I tilfælde, hvor en sådan erfaring ikke kan konstateres umiddelbart eller ikke forekommer, skal det bemyndigede organ give et dokumenteret rationale for sammensætningen af det pågældende hold. Auditproceduren skal omfatte en inspektion af fabrikantens lokaler og, hvis det er relevant, af lokalerne hos fabrikantens leverandører og/eller underentreprenører for at verificere fremstillingsprocesserne og andre relevante processer.
For udstyr i klasse IIa og IIb skal vurderingen af kvalitetsstyringssystemet endvidere være ledsaget af vurderingen af den tekniske dokumentation for udstyr, der er udvalgt på et repræsentativt grundlag, i overensstemmelse med punkt 4.4-4.8. Ved udvælgelse af repræsentative stikprøver skal det bemyndigede organ tage hensyn til de offentliggjorte retningslinjer, der er udviklet af MDCG i henhold til artikel 105, og navnlig hvor nyskabende teknologien er, ligheder, hvad angår design, teknologi, fremstilling og steriliseringsmetoder, formålet og resultaterne af tidligere relevante vurderinger, f.eks. hvad angår fysiske, kemiske, biologiske eller kliniske egenskaber, som er gennemført i overensstemmelse med denne forordning. Det pågældende bemyndigede organ skal dokumentere rationalet for udvælgelsen af stikprøverne.
Hvis kvalitetsstyringssystemet er i overensstemmelse med de relevante bestemmelser i denne forordning, skal det bemyndigede organ udstede et EU-kvalitetsstyringssystemcertifikat. Det bemyndigede organ underretter fabrikanten om sin afgørelse om at udstede certifikatet. Meddelelsen skal indeholde konklusionerne fra auditten og en begrundet rapport.
2.4.   Den pågældende fabrikant skal underrette det bemyndigede organ, der har godkendt kvalitetsstyringssystemet, om enhver påtænkt væsentlig ændring af dette eller af det udvalg af udstyr, der er omfattet. Det bemyndigede organ vurderer de foreslåede ændringer, fastsætter behovet for yderligere audit og verificerer, at det således ændrede kvalitetssystem stadig opfylder kravene i punkt 2.2. Det meddeler fabrikanten sin afgørelse, som skal indeholde konklusionerne af vurderingen og, hvis det er relevant, konklusionerne af yderligere audit. Godkendelse af en væsentlig ændring af kvalitetsstyringssystemet eller det udvalg af udstyr, der er omfattet, skal have form af et tillæg til EU-kvalitetsstyringssystemcertifikatet.
3.   Tilsynsvurdering gældende for udstyr i klasse IIa, IIb og III
3.1.   Formålet med tilsyn er at sikre, at fabrikanten fuldt ud opfylder de forpligtelser, der følger af det godkendte kvalitetsstyringssystem.
3.2.   Fabrikanten giver det bemyndigede organ tilladelse til at foretage de nødvendige audit, herunder audit på stedet, og giver det alle relevante oplysninger, herunder navnlig:
—
dokumentationen vedrørende kvalitetsstyringssystemet
—
dokumentation for resultater og konklusioner fra anvendelsen af planen for overvågning, efter at udstyret er bragt i omsætning, herunder PMCF-planen, for en repræsentativ stikprøve af udstyr, og af de sikkerhedsovervågningsbestemmelser, der er fastsat i artikel 87-92
—
de oplysninger, som foreskrives i den del af kvalitetsstyringssystemet, der vedrører design, som f.eks. resultater af analyser, beregninger, prøvninger og de valgte løsninger vedrørende risikostyring, jf. bilag I, punkt 4
—
de oplysninger, som foreskrives i den del af kvalitetsstyringssystemet, der vedrører fremstillingen, som f.eks. rapporter om kvalitetskontrol samt afprøvnings- og kalibreringsdata og registreringer om det berørte personales kvalifikationer.
3.3.   Bemyndigede organer foretager regelmæssigt, og mindst en gang hver tolvte måned, passende audit og vurderinger for at sikre sig, at den pågældende fabrikant anvender det godkendte kvalitetsstyringssystem og planen for overvågning, efter at udstyret er bragt i omsætning. Disse audit og vurderinger skal omfatte audit i fabrikantens lokaler og, hvis det er relevant, i lokalerne hos fabrikantens leverandører og/eller underentreprenører. Under sådanne audit på stedet skal det bemyndigede organ om nødvendigt foretage eller lade foretage prøvninger for at kontrollere, om kvalitetsstyringssystemet fungerer tilfredsstillende. Det bemyndigede organ forelægger en tilsynsauditrapport og i givet fald en prøvningsrapport for fabrikanten.
3.4.   Det bemyndigede organ skal mindst én gang hvert femte år stikprøvevis gennemføre uanmeldte audit på stedet hos fabrikanten og, hvis det er relevant, hos fabrikantens leverandører og/eller underentreprenører, som kan kombineres med den periodiske tilsynsvurdering, som er omhandlet i punkt 3.3, eller de kan gennemføres som supplement til denne vurdering. Det bemyndigede organ skal udarbejde en plan for sådanne uanmeldte audit på stedet, men må ikke videregive den til fabrikanten.
Inden for rammerne af sådanne uanmeldte audit på stedet skal det bemyndigede organ teste en passende stikprøve af det udstyr, der er fremstillet, eller en passende stikprøve fra fremstillingsprocessen for at verificere, at det fremstillede udstyr er i overensstemmelse med den tekniske dokumentation, med undtagelse af udstyr som omhandlet i artikel 52, stk. 8, andet afsnit. Forud for uanmeldte audit på stedet skal det bemyndigede organ specificere de relevante prøveudtagningskriterier og den relevante prøvningsprocedure.
I stedet for eller som supplement til prøveudtagningen i andet afsnit skal det bemyndigede organ udtage stikprøver af udstyr fra markedet for at verificere, at det fremstillede udstyr er i overensstemmelse med den tekniske dokumentation, med undtagelse af udstyr som omhandlet i artikel 52, stk. 8, andet afsnit. Forud for prøveudtagningen skal det pågældende bemyndigede organ specificere de relevante prøveudtagningskriterier og den relevante prøvningsprocedure.
Det bemyndigede organ forelægger en rapport over auditten på stedet for den pågældende fabrikant; denne rapport skal i givet fald omfatte resultatet af stikprøvekontrollen.
3.5.   For udstyr i klasse IIa eller IIb skal tilsynsvurderingen også omfatte en vurdering af den tekniske dokumentation som omhandlet i punkt 4.4-4.8, for det pågældende udstyr på grundlag af yderligere repræsentative stikprøver, der er udvalgt i overensstemmelse med det dokumenterede rationale fra det bemyndigede organ i overensstemmelse med punkt 2.3, andet afsnit.
For udstyr i klasse III skal tilsynsvurderingen også omfatte prøvning af de godkendte dele og/eller materialer, som er væsentlige for udstyrets integritet, herunder eventuelt kontrol af, at mængden af fremstillede eller indkøbte dele og/eller materialer svarer til mængden af færdigt udstyr.
3.6.   Det bemyndigede organ skal sikre, at vurderingsholdet er sammensat på en sådan måde, at der er tilstrækkelige erfaringer med den pågældende evaluering af udstyret, systemerne og processerne og fortsat objektivitet og uvildighed sikres; dette omfatter rotation af medlemmerne af vurderingsholdet med passende mellemrum. Som hovedregel må en ledende auditansvarlig hverken lede eller deltage i audit hos den samme fabrikant i mere end tre på hinanden følgende år.
3.7.   Hvis det bemyndigede organ finder en divergens mellem en prøve, der er udtaget af det fremstillede udstyr eller fra markedet, og specifikationerne i den tekniske dokumentation eller det godkendte design, skal det suspendere eller tilbagekalde det relevante certifikat eller fastsætte begrænsninger for det.
KAPITEL II
VURDERING AF DEN TEKNISKE DOKUMENTATION
4.   Vurdering af den tekniske dokumentation for udstyr i klasse III, og for udstyr i klasse IIb som omhandlet i artikel 52, stk. 4, andet afsnit
4.1.   Ud over de forpligtelser, der påhviler fabrikanten i henhold til punkt 2, skal denne til det bemyndigede organ indsende en ansøgning om vurdering af den tekniske dokumentation vedrørende det udstyr, som denne agter at bringe i omsætning eller ibrugtage, og som er omfattet af det kvalitetsstyringssystem, der er omhandlet i punkt 2.
4.2.   I ansøgningen beskrives det pågældende udstyrs design, fremstilling og ydeevne. Ansøgningen skal omfatte den tekniske dokumentation, der er omhandlet i bilag II og III.
4.3.   Det bemyndigede organ behandler ansøgningen ved hjælp af personale, der er ansat af det, og som har dokumenteret viden om og erfaring med den pågældende teknologi og dens kliniske anvendelse. Det bemyndigede organ kan kræve, at ansøgningen suppleres ved udførelse af yderligere prøvninger eller krav om indsendelse af yderligere dokumentation, for at det kan vurdere, om udstyret er i overensstemmelse med de relevante krav i forordningen. Det bemyndigede organ skal gennemføre passende fysiske prøvninger eller laboratorieprøvninger i forbindelse med udstyret eller anmode fabrikanten om at foretage disse undersøgelser.
4.4.   Det bemyndigede organ gennemgår den kliniske dokumentation, som fabrikanten har fremlagt i den kliniske evalueringsrapport og den relaterede kliniske evaluering, som er foretaget. Det bemyndigede organ skal ansætte udstyrskontrollanter med tilstrækkelig klinisk ekspertise og, om nødvendigt, anvende eksterne kliniske eksperter med direkte og aktuel erfaring med det pågældende udstyr eller den kliniske tilstand, som det anvendes i, med henblik på den pågældende gennemgang.
4.5.   Det bemyndigede organ skal i tilfælde, hvor den kliniske dokumentation helt eller delvis er baseret på data fra udstyr, der angives at svare til det udstyr, der er under vurdering, vurdere egnetheden af at anvende sådanne data under hensyntagen til faktorer såsom nye indikationer og innovation. Det bemyndigede organ skal klart dokumentere sine konklusioner om den angivne ækvivalens og om relevansen og tilstrækkeligheden af dataene for at påvise overensstemmelse. For så vidt angår karakteristika for udstyr, der angives som innovativt af fabrikanten, eller nye indikationer, skal det bemyndigede organ vurdere, i hvilket omfang de særlige angivelser understøttes af specifikke prækliniske og kliniske data og risikoanalysen.
4.6.   Det bemyndigede organ skal verificere, at den kliniske dokumentation og den kliniske evaluering er tilstrækkelig, og verificere konklusionerne fra fabrikanten om overensstemmelsen med de relevante generelle krav til sikkerhed og ydeevne. Denne verifikation skal omfatte overvejelser om tilstrækkeligheden af afvejningen af fordele og risici, risikostyringen, brugsanvisningerne, uddannelsen af brugere og fabrikantens plan for overvågning, efter at udstyret er bragt i omsætning, og omfatte en gennemgang af behovet for og tilstrækkeligheden af den PMCF-plan, der foreslås, hvis det er relevant.
4.7.   Det bemyndigede organ skal på baggrund af sin vurdering af den kliniske dokumentation tage stilling til den kliniske evaluering og afvejningen af fordele og risici og til, om der skal fastsættes specifikke milepæle, så det bemyndigede organ kan gennemgå opdateringer af den kliniske dokumentation, der hidrører fra data fra overvågningen, efter at udstyret er bragt i omsætning, og fra PMCF-data.
4.8.   Det bemyndigede organ skal klart dokumentere udfaldet af sin vurdering i vurderingsrapporten om den kliniske evaluering.
4.9.   Det bemyndigede organ sender en rapport om vurderingen af den tekniske dokumentation til fabrikanten, herunder en vurderingsrapport om den kliniske evaluering. Hvis udstyret er i overensstemmelse med de relevante bestemmelser i denne forordning, skal det bemyndigede organ udstede et EU-certifikat for vurdering af teknisk dokumentation. Certifikatet skal indeholde konklusionerne af vurderingen af den tekniske dokumentation, betingelserne for certifikatets gyldighed, de nødvendige oplysninger til identifikation af det godkendte design og, hvis det er relevant, en beskrivelse af udstyrets erklærede formål.
4.10.   Hvis ændringer af det godkendte udstyr kan få indflydelse på udstyrets sikkerhed og ydeevne eller de foreskrevne betingelser for anvendelse af udstyret, skal sådanne ændringer godkendes af det bemyndigede organ, der har udstedt EU-certifikatet for vurdering af teknisk dokumentation. Hvis fabrikanten har planer om at indføre nogen af ovennævnte ændringer, skal denne underrette det bemyndigede organ, der har udstedt EU-certifikatet for vurdering af teknisk dokumentation, herom. Det bemyndigede organ vurderer de påtænkte ændringer og afgør, om de påtænkte ændringer kræver en ny overensstemmelsesvurdering, jf. artikel 52, eller om de kan behandles ved hjælp af et tillæg til EU-certifikatet for vurdering af teknisk dokumentation. I sidstnævnte tilfælde vurderer det bemyndigede organ ændringerne, underretter fabrikanten om sin afgørelse og udsteder, såfremt ændringerne godkendes, et tillæg til EU-certifikatet for vurdering af teknisk dokumentation til fabrikanten.
5.   Særlige yderligere procedurer
5.1.   Vurderingsprocedure for visse former for udstyr i klasse III og klasse IIb
a)
For implantabelt udstyr i klasse III og aktivt udstyr i klasse IIb, der er beregnet til at administrere og/eller fjerne et lægemiddel, som omhandlet i bilag VIII, punkt 6.4 (regel 12), skal det bemyndigede organ, når det har verificeret kvaliteten af de kliniske data, der ligger til grund for fabrikantens kliniske evalueringsrapport som omhandlet i artikel 61, stk. 12, udarbejde en vurderingsrapport om den kliniske evaluering, som fastlægger dets konklusioner med hensyn til den kliniske dokumentation, som fabrikanten har fremlagt, navnlig afvejningen af fordele og risici, den pågældende dokumentations overensstemmelse med udstyrets erklærede formål, herunder den eller de medicinske indikationer og PMCF-planen, som omhandlet i artikel 10, stk. 3, og i bilag XIV, del B.
Det bemyndigede organ sender sin vurderingsrapport om den kliniske evaluering sammen med fabrikantens kliniske evalueringsdokumentation som omhandlet i bilag II, punkt 6.1, litra c) og d), til Kommissionen.
Kommissionen fremsender straks de pågældende dokumenter til det relevante ekspertpanel, der er omhandlet i artikel 106.
b)
Det bemyndigede organ kan blive anmodet om at fremlægge sine konklusioner som omhandlet i litra a) for det pågældende ekspertpanel.
c)
Ekspertpanelet beslutter under Kommissionens tilsyn på grundlag af samtlige følgende kriterier:
i)
hvor nyskabende udstyret eller den relaterede kliniske procedure er, og de mulige større kliniske eller sundhedsmæssige virkninger heraf
ii)
en betydelig negativ ændring i forholdet mellem fordele og risici ved en specifik kategori eller gruppe af udstyr som følge af videnskabeligt underbyggede sundhedsproblemer i forbindelse med komponenter eller udgangsmateriale eller for så vidt angår virkningerne for sundheden, hvis udstyret svigter
iii)
indberetning af et langt større antal alvorlige hændelser i overensstemmelse med artikel 87 i forbindelse med en specifik kategori eller gruppe af udstyr
om det afgiver en videnskabelig udtalelse om det bemyndigede organs vurderingsrapport om den kliniske evaluering på grundlag af den kliniske dokumentation, som fabrikanten har fremlagt, navnlig afvejningen af fordele og risici, den pågældende dokumentations overensstemmelse med den eller de medicinske indikationer og PMCF-planen. Den pågældende videnskabelige udtalelse afgives inden for en frist på 60 dage efter modtagelsen af de i litra a) omhandlede dokumenter fra Kommissionen. Begrundelsen for beslutningen om at afgive en videnskabelig udtalelse på grundlag af kriterierne i nr. i), ii) og iii) medtages i den videnskabelige udtalelse. Hvis de forelagte oplysninger ikke er tilstrækkelige for ekspertpanelet til at nå frem til en konklusion, skal dette angives i den videnskabelige udtalelse.
d)
Ekspertpanelet kan under Kommissionens tilsyn på grundlag af kriterierne i litra c) beslutte ikke at afgive en videnskabelig udtalelse, idet det i så fald hurtigst muligt og i alle tilfælde inden for 21 dage efter modtagelsen af de i litra a) omhandlede dokumenter fra Kommissionen skal underrette det bemyndigede organ herom. Ekspertpanelet skal inden for denne frist forelægge begrundelsen for beslutningen for det bemyndigede organ og Kommissionen, hvorefter det bemyndigede organ kan fortsætte certificeringsproceduren for dette udstyr.
e)
Ekspertpanelet skal senest 21 dage efter modtagelsen af dokumenterne fra Kommissionen meddele Kommissionen via Eudamed, om det har til hensigt at afgive en videnskabelig udtalelse i henhold til litra c), eller om det ikke har til hensigt at afgive en videnskabelig udtalelse i henhold til litra d).
f)
Hvis der ikke er afgivet en udtalelse inden for en periode på 60 dage, må det bemyndigede organ fortsætte certificeringsproceduren for det pågældende udstyr.
g)
Det bemyndigede organ skal tage behørigt hensyn til de synspunkter, der kommer til udtryk i ekspertpanelets videnskabelige udtalelse. Hvis ekspertpanelet finder, at omfanget af den kliniske dokumentation ikke er tilstrækkeligt eller på anden vis giver anledning til alvorlig bekymring om afvejningen af fordele og risici, den pågældende dokumentations overensstemmelse med udstyrets erklærede formål, herunder den eller de medicinske indikationer, og med PMCF-planen, skal det bemyndigede organ om nødvendigt anbefale fabrikanten at begrænse udstyrets erklærede formål til visse grupper af patienter eller til visse medicinske indikationer, og/eller at pålægge en begrænsning af varigheden af certifikatets gyldighed, at gennemføre specifikke PMCF-undersøgelser, at tilpasse brugsanvisningen eller sammenfatningen af sikkerhed og ydeevne eller at fastsætte andre begrænsninger i sin overensstemmelsesvurderingsrapport, alt efter hvad der er relevant. Det bemyndigede organ skal give en fuldstændig begrundelse for de tilfælde, hvor det ikke har fulgt ekspertpanelets anbefalinger i sin overensstemmelsesvurderingsrapport, og Kommissionen skal med forbehold af artikel 109 gøre både den videnskabelige udtalelse fra ekspertpanelet og den skriftlige begrundelse fra det bemyndigede organ offentligt tilgængelige via Eudamed.
h)
Kommissionen skal efter høring af medlemsstaterne og de relevante videnskabelige eksperter fastsætte retningslinjer for ekspertpanelerne med henblik på at sikre en ensartet fortolkning af kriterierne i litra c) inden den 26. maj 2020.
5.2.   Procedure for udstyr, der inkorporerer et lægemiddel
a)
Hvis udstyr, der som en integreret bestanddel indeholder et stof, der anvendt alene kan betragtes som et lægemiddel i henhold til artikel 1, nr. 2), i direktiv 2001/83/EF, herunder et lægemiddel fremstillet på basis af blod eller plasma fra mennesker, og som har en virkning på organismen ud over den, som udstyret har, skal dette stofs kvalitet, sikkerhed og nyttevirkning verificeres efter metoderne i bilag I til direktiv 2001/83/EF.
b)
Inden udstedelsen af et EU-certifikat for vurdering af teknisk dokumentation skal det bemyndigede organ efter at have verificeret stoffets nyttevirkning som en del af udstyret og under hensyntagen til udstyrets erklærede formål anmode en af de kompetente myndigheder, der er udpeget af medlemsstaterne i henhold til direktiv 2001/83/EF, eller EMA, som i dette punkt begge benævnes »den hørte myndighed for lægemidler«, afhængigt af hvilken der er blevet hørt i henhold til dette litra, om en udtalelse om dette stofs kvalitet og sikkerhed, herunder fordele eller risici ved inkorporering af stoffet i udstyret. Hvis udstyret inkorporerer et humant blod- eller plasmaderivat eller et stof, der anvendt alene kan betragtes som et lægemiddel, som udelukkende er omfattet af anvendelsesområdet for bilaget til forordning (EF) nr. 726/2004, skal det bemyndigede organ anmode om udtalelse fra EMA.
c)
Den hørte myndighed for lægemidler skal i sin udtalelse tage hensyn til fremstillingsprocessen og dataene vedrørende nyttevirkningen af inkorporeringen af stoffet i udstyret som fastlagt af det bemyndigede organ.
d)
Den hørte myndighed for lægemidler skal forelægge sin udtalelse for det bemyndigede organ senest 210 dage efter modtagelsen af al nødvendig dokumentation.
e)
Den videnskabelige udtalelse fra den hørte myndighed for lægemidler samt en eventuel opdatering af denne udtalelse skal indgå i det bemyndigede organs dokumentation vedrørende udstyret. Det bemyndigede organ skal tage behørigt hensyn til de synspunkter, der kommer til udtryk i den videnskabelige udtalelse, når det træffer sin afgørelse. Det bemyndigede organ må ikke udstede certifikatet, hvis den videnskabelige udtalelse er negativ, og skal sende sin endelige afgørelse til den hørte myndighed for lægemidler.
f)
Før der foretages nogen ændringer med hensyn til et hjælpestof, der er inkorporeret i udstyr, navnlig i forbindelse med fremstillingsprocessen, skal fabrikanten underrette det bemyndigede organ om ændringerne. Det bemyndigede organ skal anmode om udtalelse fra den hørte myndighed for lægemidler for at kunne bekræfte, at kvaliteten og sikkerheden af det pågældende hjælpestof forbliver uændret. Den hørte myndighed for lægemidler tager højde for data vedrørende nyttevirkningen af inkorporeringen af stoffet i udstyret som fastlagt af det bemyndigede organ, for at sikre at ændringerne ikke har nogen negativ indvirkning på de risici eller fordele, der tidligere er påvist vedrørende inkorporeringen af stoffet i udstyret. Den hørte myndighed for lægemidler afgiver sin udtalelse senest 60 dage efter modtagelse af al nødvendig dokumentation vedrørende ændringerne. Det bemyndigede organ må ikke udstede tillægget til EU-certifikatet for vurdering af teknisk dokumentation, hvis den videnskabelige udtalelse, som den hørte myndighed for lægemidler afgiver, er negativ. Det bemyndigede organ forelægger sin endelige afgørelse for den hørte myndighed for lægemidler.
g)
Hvis den hørte myndighed for lægemidler får oplysninger om hjælpestoffet, der kan indvirke på de risici eller fordele, der tidligere er påvist vedrørende inkorporeringen af stoffet i udstyret, skal den rådgive det bemyndigede organ om, hvorvidt de pågældende oplysninger indvirker på de risici eller fordele, der tidligere er påvist vedrørende inkorporeringen af stoffet i udstyret. Det bemyndigede organ skal tage hensyn til denne rådgivning i forbindelse med den fornyede vurdering af overensstemmelsesvurderingsproceduren.
5.3.   Procedure for udstyr, der er fremstillet ved anvendelse af eller inkorporerer væv eller celler af human eller animalsk oprindelse eller derivater heraf, som er ikkelevedygtige eller gjort ikkelevedygtige
5.3.1.   Væv eller celler af human oprindelse eller derivater heraf
a)
For udstyr, der er fremstillet ved anvendelse af derivater af væv eller celler af human oprindelse, og som er omfattet af denne forordning i overensstemmelse med artikel 1, stk. 6, litra g), og for udstyr, der som en integreret del inkorporerer væv eller celler af human oprindelse eller derivater heraf, som er omfattet af direktiv 2004/23/EF, og som har en virkning ud over den, som udstyret har, skal det bemyndigede organ, inden det udsteder et EU-certifikat for vurdering af teknisk dokumentation, anmode om en videnskabelig udtalelse fra en af de kompetente myndigheder, der i overensstemmelse med direktiv 2004/23/EF er udpeget af medlemsstaterne (»den kompetente myndighed for humane væv og celler«), om forhold forbundet med donationen, udtagningen og testningen af væv eller celler af human oprindelse eller derivater heraf i udstyret. Det bemyndigede organ skal forelægge et resumé af den foreløbige overensstemmelsesvurdering, der bl.a. indeholder oplysninger om de pågældende humane væv eller cellers ikkelevedygtighed, donationen, udtagningen og testningen heraf og risici eller fordele ved inkorporeringen af væv eller celler af human oprindelse eller derivater heraf i udstyret.
b)
Senest 120 dage efter modtagelsen af al nødvendig dokumentation skal den kompetente myndighed for humane væv og celler forelægge sin udtalelse for det bemyndigede organ.
c)
Den videnskabelige udtalelse fra den kompetente myndighed for humane væv og celler og en eventuel opdatering af denne udtalelse skal indgå i det bemyndigede organs dokumentation vedrørende udstyret. Det bemyndigede organ skal tage behørigt hensyn til de synspunkter, der kommer til udtryk i den videnskabelige udtalelse fra den kompetente myndighed for humane væv og celler, når det træffer sin afgørelse. Det bemyndigede organ må ikke udstede certifikatet, hvis denne videnskabelige udtalelse er negativ. Det forelægger sin endelige afgørelse for den berørte kompetente myndighed for humane væv og celler.
d)
Før der foretages nogen ændringer med hensyn til ikkelevedygtige væv eller celler af human oprindelse eller derivater heraf, der er inkorporeret i udstyr, navnlig i forbindelse med donationen, testningen og udtagningen, skal fabrikanten underrette det bemyndigede organ om de påtænkte ændringer. Det bemyndigede organ skal høre den myndighed, der var involveret i den indledende høring, for at bekræfte, at kvaliteten og sikkerheden af de væv eller celler af human oprindelse eller derivater heraf, der er inkorporeret i udstyret, fastholdes. Den pågældende kompetente myndighed for humane væv og celler tager højde for data vedrørende nyttevirkningen af inkorporeringen af vævene eller cellerne af human oprindelse eller derivater heraf i udstyret som fastlagt af det bemyndigede organ for at sikre, at ændringerne ikke har nogen negativ indvirkning på det påviste forhold mellem fordele og risici ved tilsætningen af vævene eller cellerne af human oprindelse eller derivater heraf til udstyret. Den fremlægger sin udtalelse senest 60 dage efter modtagelsen af al nødvendig dokumentation vedrørende de påtænkte ændringer. Det bemyndigede organ må ikke udstede et tillæg til EU-certifikatet for vurdering af teknisk dokumentation, hvis den videnskabelige udtalelse er negativ, og forelægger sin endelige afgørelse for den berørte kompetente myndighed for humane væv og celler.
5.3.2.   Væv eller celler af animalsk oprindelse eller derivater heraf
For så vidt angår udstyr, der er fremstillet ved anvendelse af animalsk væv, som er gjort ikkelevedygtigt, eller ved anvendelse af ikkelevedygtige produkter, der hidrører fra animalsk væv, jf. forordning (EU) nr. 722/2012, anvender det bemyndigede organ de relevante krav, der er fastsat i nævnte forordning.
5.4.   Procedure for udstyr, der består af stoffer eller en kombination af stoffer, der absorberes af eller fordeles lokalt i det menneskelige legeme.
a)
Kvaliteten og sikkerheden af udstyr, der består af stoffer eller af en kombination af stoffer, der er bestemt til at blive indgivet i det menneskelige legeme via en legemsåbning eller påført huden, og som absorberes af eller fordeles lokalt i det menneskelige legeme, skal, hvor det er hensigtsmæssigt og kun med hensyn til de krav, der ikke er omfattet af denne forordning, verificeres i overensstemmelse med de relevante krav i bilag I til direktiv 2001/83/EF for så vidt angår evaluering af absorption, fordeling, metabolisering, udskillelse, lokal tolerance, toksicitet, interaktion med andet udstyr, lægemidler eller andre stoffer og risikoen for bivirkninger.
b)
For så vidt angår udstyr eller dets metabolitter, der absorberes systematisk af det menneskelige legeme med henblik på at opfylde dets erklærede formål, skal den bemyndigede myndighed anmode en af de kompetente myndigheder, der er udpeget af medlemsstaterne i henhold til direktiv 2001/83/EF, eller EMA, som i dette punkt begge benævnes »den hørte myndighed for lægemidler«, afhængigt af hvilken der er blevet hørt i henhold til dette litra, om en videnskabelig udtalelse om udstyrets overholdelse af de relevante krav i bilag I til direktiv 2001/83/EF.
c)
Udtalelsen fra den hørte myndighed for lægemidler skal udarbejdes i løbet af 150 dage efter modtagelse af al nødvendig dokumentation.
d)
Den videnskabelige udtalelse fra den hørte myndighed for lægemidler samt en eventuel opdatering af denne udtalelse skal indgå i det bemyndigede organs dokumentation vedrørende udstyret. Det bemyndigede organ skal tage behørigt hensyn til de synspunkter, der kommer til udtryk i den videnskabelige udtalelse, når det træffer sin afgørelse, og skal forelægge sin endelige afgørelse for den hørte myndighed for lægemidler.
6.   Batchverifikation i forbindelse med udstyr, der som en integreret del inkorporerer et lægemiddel, der anvendt alene betragtes som et lægemiddel fremstillet på basis af blod eller plasma fra mennesker, jf. artikel 1, stk. 8
Efter at have afsluttet fremstillingen af hver batch af udstyr, der som en integreret del inkorporerer et lægemiddel, der anvendt alene betragtes som et lægemiddel fremstillet på basis af humant blod eller plasma, jf. artikel 1, stk. 8, underretter fabrikanten det bemyndigede organ om frigivelsen af denne batch af udstyr og sender organet den officielle attest på frigivelsen af den batch, som det humane blod- eller plasmaderivat, der er anvendt i udstyret, stammer fra; attesten udstedes af et statsligt laboratorium eller et af en medlemsstat udpeget laboratorium, jf. artikel 114, stk. 2, i direktiv 2001/83/EF.
KAPITEL III
ADMINISTRATIVE BESTEMMELSER
7.   Fabrikanten, eller, hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, dennes autoriserede repræsentant skal i mindst 10 år, og for implantabelt udstyr i mindst 15 år, efter at det sidste udstyr er blevet bragt i omsætning, kunne forelægge de kompetente myndigheder:
—
EU-overensstemmelseserklæringen
—
den i punkt 2.1, femte led, omhandlede dokumentation, og navnlig data og registreringer i forbindelse med fremgangsmåderne som omhandlet i punkt 2.2, andet afsnit, litra c)
—
oplysninger om de i punkt 2.4 omhandlede ændringer
—
den i punkt 4.2 omhandlede dokumentation, og
—
de i dette bilag omhandlede afgørelser og rapporter fra det bemyndigede organ.
8.   Hver medlemsstat kræver, at den i punkt 7 omhandlede dokumentation stilles til rådighed for de kompetente myndigheder i den periode, der er angivet i det pågældende punkt, hvis en fabrikant eller dennes autoriserede repræsentant, der er etableret på dens område, går konkurs eller indstiller sine aktiviteter inden udgangen af den pågældende periode.
BILAG X
OVERENSSTEMMELSESVURDERING PÅ GRUNDLAG AF TYPEAFPRØVNING
1.   Ved EU-typeafprøvning forstås den procedure, hvorved et bemyndiget organ konstaterer og certificerer, at udstyr med den dertil hørende tekniske dokumentation og relevante livscyklusprocesser og en tilsvarende stikprøve, som er repræsentativ for den planlagte produktion af udstyr, opfylder de relevante bestemmelser i denne forordning.
2.   Ansøgning
Fabrikanten skal indsende en ansøgning om vurdering til et bemyndiget organ. Ansøgningen skal indeholde:
—
navnet på fabrikanten og adressen på fabrikantens registrerede forretningssted og, hvis ansøgningen indsendes af fabrikantens autoriserede repræsentant, navnet på den autoriserede repræsentant og adressen på dennes registrerede forretningssted
—
den i bilag II og III omhandlede tekniske dokumentation. Ansøgeren stiller en prøve, som er repræsentativ for den planlagte produktion af udstyr (»type«), til rådighed for det bemyndigede organ. Det bemyndigede organ kan om nødvendigt anmode om andre prøver og
—
en skriftlig erklæring om, at der ikke er indsendt en ansøgning vedrørende samme type til et andet bemyndiget organ, eller oplysninger om eventuelt tidligere ansøgninger vedrørende samme type, som et andet bemyndiget organ har givet afslag på, eller som fabrikanten eller dennes autoriserede repræsentant har trukket tilbage, før det andet bemyndigede organ foretog sin endelige vurdering.
3.   Vurdering
Det bemyndigede organ:
a)
behandler ansøgningen ved hjælp af personale, som har dokumenteret viden om og erfaring med den pågældende teknologi og dens kliniske anvendelse. Det bemyndigede organ kan kræve, at ansøgningen suppleres, ved at få gennemført yderligere prøvninger eller ved at anmode om yderligere dokumentation, for at det kan vurdere, om udstyret er i overensstemmelse med de relevante krav i forordningen. Det bemyndigede organ skal gennemføre passende fysiske prøvninger eller laboratorieprøvninger i forbindelse med udstyret eller anmode fabrikanten om at foretage sådanne prøvninger.
b)
undersøger og vurderer den tekniske dokumentation for overensstemmelse med de krav i denne forordning, der er gældende for udstyret, og verificerer, at typen er fremstillet i overensstemmelse hermed; det registrerer ligeledes, hvilke elementer der er designet i overensstemmelse med de relevante standarder i artikel 8 eller de relevante fælles specifikationer, og registrerer, hvilke elementer der er designet, uden at de relevante standarder i artikel 8 eller de relevante fælles specifikationer er blevet anvendt
c)
gennemgår den kliniske dokumentation, som fabrikanten har fremlagt i den kliniske evalueringsrapport i overensstemmelse med bilag XIV, punkt 4. Det bemyndigede organ skal ansætte udstyrskontrollanter med tilstrækkelig klinisk ekspertise og, om nødvendigt, anvende eksterne kliniske eksperter med direkte og aktuel erfaring med det pågældende udstyr eller den kliniske tilstand, som det anvendes i, med henblik på den pågældende gennemgang
d)
vurderer i tilfælde, hvor den kliniske dokumentation delvis eller helt er baseret på data fra udstyr, der angives at ligne eller svare til det udstyr, der er under vurdering, egnetheden af at anvende de pågældende data under hensyntagen til faktorer såsom nye indikationer og innovation. Det bemyndigede organ skal klart dokumentere sine konklusioner om den angivne ækvivalens og om relevansen og tilstrækkeligheden af dataene for at påvise overensstemmelse
e)
skal klart dokumentere udfaldet af sin vurdering i en vurderingsrapport om den prækliniske og kliniske evaluering som led i EU-typeafprøvningsrapporten, jf. litra i)
f)
gennemfører eller lader gennemføre passende vurderinger og nødvendige fysiske prøvninger eller laboratorieprøvninger med henblik på at verificere, om fabrikantens løsninger opfylder de generelle krav til sikkerhed og ydeevne fastlagt i denne forordning, hvis de i artikel 8 nævnte standarder eller de fælles specifikationer ikke er blevet anvendt. Hvis udstyret skal tilsluttes et eller flere andre udstyr for at kunne fungere efter hensigten, skal det dokumenteres, at det opfylder de generelle krav til sikkerhed og ydeevne, når det er tilsluttet det eller de pågældende udstyr, som har de karakteristika, der er anført af fabrikanten
g)
gennemfører eller lader gennemføre passende vurderinger og nødvendige fysiske prøvninger eller laboratorieprøvninger med henblik på at verificere, om de relevante harmoniserede standarder rent faktisk er blevet anvendt i de tilfælde, hvor fabrikanten har valgt at bruge disse standarder
h)
aftaler med ansøgeren, hvor de nødvendige vurderinger og prøvninger skal gennemføres, og
i)
udarbejder en EU-typeafprøvningsrapport om resultaterne af de vurderinger og prøvninger, der er udført i medfør af litra a)-g).
4.   Certifikat
Hvis typen er i overensstemmelse med denne forordning, udsteder det bemyndigede organ en EU-typeafprøvningsattest. Certifikatet skal indeholde fabrikantens navn og adresse, konklusionerne af vurderingen af typeafprøvningen, betingelserne for certifikatets gyldighed samt de nødvendige oplysninger til identifikation af den godkendte type. Certifikatet skal udformes i overensstemmelse med bilag XII. De relevante dele af dokumentationen vedlægges certifikatet, og det bemyndigede organ opbevarer en kopi.
5.   Ændringer af typen
5.1.   Ansøgeren underretter det bemyndigede organ, der har udstedt EU-typeafprøvningscertifikatet, om enhver påtænkt ændring af den godkendte type eller af dens erklærede formål og »brugsbetingelser«.
5.2.   Hvis ændringer af det godkendte udstyr, herunder begrænsninger af dets erklærede formål og brugsbetingelser, kan få indflydelse på overensstemmelse med de generelle krav til sikkerhed og ydeevne eller på de foreskrevne betingelser for anvendelse af produktet, skal sådanne ændringer også godkendes af det bemyndigede organ, som har udstedt EU-typeafprøvningscertifikatet. Det bemyndigede organ undersøger de påtænkte ændringer, underretter fabrikanten om sin afgørelse og udsteder et tillæg til EU-typeafprøvningsrapporten til fabrikanten. Godkendelsen af ændringer af den godkendte type udstedes i form af et tillæg til EU-typeafprøvningscertifikatet.
5.3.   Ændringer af det godkendte udstyrs erklærede formål og brugsbetingelser med undtagelse af begrænsninger af dets erklærede formål og brugsbetingelser kræver ny ansøgning om overensstemmelsesvurdering.
6.   Særlige yderligere procedurer
Bilag IX, punkt 5, finder anvendelse med det forbehold, at enhver henvisning til et EU-certifikat for vurdering af teknisk dokumentation læses som en henvisning til et EU-typeafprøvningscertifikat.
7.   Administrative bestemmelser
Fabrikanten, eller, hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, dennes autoriserede repræsentant skal i mindst 10 år, og for implantabelt udstyr i mindst 15 år, efter at det sidste udstyr er blevet bragt i omsætning, kunne forelægge de kompetente myndigheder:
—
den i punkt 2, andet led, omhandlede dokumentation
—
oplysninger om de i punkt 5 omhandlede ændringer, og
—
kopier af EU-typeafprøvningscertifikaterne, de videnskabelige udtalelser og rapporterne og tillæg/tilføjelser dertil.
Bilag IX, punkt 8, finder anvendelse.
BILAG XI
OVERENSSTEMMELSESVURDERING PÅ GRUNDLAG AF PRODUKTOVERENSSTEMMELSESVERIFIKATION
1.   Formålet med overensstemmelsesvurdering på grundlag af produktoverensstemmelsesverifikation er at sikre, at udstyret er i overensstemmelse med den type, som der er udstedt et EU-typeafprøvningscertifikat for, og at det opfylder de relevante bestemmelser i denne forordning.
2.   Hvis et EU-typegodkendelsescertifikat er udstedt i overensstemmelse med bilag X, kan fabrikanten enten anvende proceduren i del A (kvalitetssikring af produktionen) eller proceduren i del B (produktverifikation) i dette bilag.
3.   Uanset punkt 1 og 2 ovenfor kan procedurerne i dette bilag, kombineret med udarbejdelsen af teknisk dokumentation som anført i bilag II og III, også anvendes af fabrikanter af udstyr i klasse IIa.
DEL A
KVALITETSSIKRING AF PRODUKTIONEN
4.   Fabrikanten sørger for, at det kvalitetsstyringssystem, der er godkendt til fremstillingen af det pågældende udstyr, anvendes og udfører en endelig verificering som angivet i punkt 6, og er underlagt det tilsyn, der er beskrevet i punkt 7.
5.   Når fabrikanten opfylder kravene i punkt 4, udarbejder og opbevarer denne en EU-overensstemmelseserklæring, jf. artikel 19 og bilag IV, for det udstyr, der er omfattet af overensstemmelsesvurderingsproceduren. Ved at udstede en EU-overensstemmelseserklæring anses fabrikanten for at sørge for og for at erklære, at det pågældende udstyr er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet, og opfylder de krav i denne forordning, som udstyret er omfattet af.
6.   Kvalitetsstyringssystem
6.1.   Fabrikanten indsender en ansøgning om vurdering af sit kvalitetsstyringssystem til et bemyndiget organ. Ansøgningen skal indeholde:
—
alle de elementer, der er anført i bilag IX, punkt 2.1
—
den tekniske dokumentation, der er omhandlet i bilag II og III, for de godkendte typer, og
—
en kopi af EU-typeafprøvningscertifikaterne, jf. bilag X, punkt 4; hvis EU-typeafprøvningscertifikaterne er udstedt af samme bemyndigede organ, som ansøgningen indsendes til, skal ansøgningen også omfatte en henvisning til den tekniske dokumentation og opdateringerne heraf og de udstedte certifikater.
6.2.   Kvalitetsstyringssystemet skal implementeres på en sådan måde, at det er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet, og med de bestemmelser i denne forordning, der gælder for udstyret i hver fase. Alle de forhold, krav og bestemmelser, som fabrikanten tager hensyn til i sit kvalitetsstyringssystem, skal dokumenteres på systematisk og overskuelig måde i form af en kvalitetsmanual og skriftlige politikker og procedurer som f.eks. kvalitetsprogrammer, -planer og -registre.
Den pågældende dokumentation skal navnlig indeholde en fyldestgørende beskrivelse af alle de elementer, der er anført i bilag IX, punkt 2.2, litra a), b), d) og e).
6.3.   Bilag IX, punkt 2.3, første og andet afsnit, finder anvendelse.
Hvis kvalitetsstyringssystemet er et system, som sikrer, at udstyret er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet, og at det er i overensstemmelse med de relevante bestemmelser i denne forordning, skal det bemyndigede organ udstede et EU-kvalitetssikringscertifikat. Det bemyndigede organ underretter fabrikanten om sin afgørelse om at udstede certifikatet. Afgørelsen skal indeholde resultaterne af det bemyndigede organs audit og en begrundet vurdering.
6.4.   Bilag IX, punkt 2,4, finder anvendelse.
7.   Overvågning
Bilag IX, punkt 3.1, punkt 3.2, første, andet og fjerde led, og punkt 3.3, 3.4, 3.6 og 3.7, finder anvendelse.
For udstyr i klasse III skal tilsynet også omfatte en kontrol af, at mængden af fremstillede eller indkøbte råmaterialer eller væsentlige komponenter, der er godkendt for den pågældende type, svarer til mængden af færdige produkter.
8.   Batchverifikation i forbindelse med udstyr, der som en integreret del inkorporerer et lægemiddel, der anvendt alene betragtes som et lægemiddel fremstillet på basis af blod eller plasma fra mennesker, jf. artikel 1, stk. 8
Efter at have afsluttet fremstillingen af hver batch af udstyr, der som en integreret del inkorporerer et lægemiddel, der anvendt alene kan betragtes som et lægemiddel fremstillet på basis af humant blod eller plasma, jf. artikel 1, stk. 8, underretter fabrikanten det bemyndigede organ om frigivelsen af denne batch af udstyr og sender organet den officielle attest på frigivelsen af den batch, som det humane blod- eller plasmaderivat, der er anvendt i udstyret, stammer fra; attesten udstedes af en medlemsstats laboratorium eller et af en medlemsstat udpeget laboratorium, jf. artikel 114, stk. 2, i direktiv 2001/83/EF.
9.   Administrative bestemmelser
Fabrikanten, eller, hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, dennes autoriserede repræsentant skal i mindst 10 år, og for implantabelt udstyr i mindst 15 år, efter at det sidste udstyr er blevet bragt i omsætning, kunne forelægge de kompetente myndigheder:
—
EU-overensstemmelseserklæringen
—
den i bilag IX, punkt 2.1, femte led, omhandlede dokumentation
—
den i bilag IX, punkt 2.1, ottende led, omhandlede dokumentation, herunder EU-typeafprøvningscertifikatet, jf. bilag X
—
oplysninger om de i bilag IX, punkt 2.4, omhandlede ændringer og
—
de i bilag IX, punkt 2.3, 3.3 og 3.4, omhandlede afgørelser og rapporter fra det bemyndigede organ.
Bilag IX, punkt 8, finder anvendelse.
10.   Gældende for udstyr i klasse IIa
10.1.   Uanset punkt 5 anses fabrikanten i kraft af EU-overensstemmelseserklæringen for at sørge for og for at erklære, at det pågældende udstyr i klasse IIa er fremstillet i overensstemmelse med den i bilag II og III omhandlede tekniske dokumentation og opfylder de relevante krav i denne forordning.
10.2.   For udstyr i klasse IIa vurderer det bemyndigede organ som en del af auditten i punkt 6.3, om den i bilag II og III omhandlede tekniske dokumentation for udstyr, der er udvalgt på et repræsentativt grundlag, er i overensstemmelse med denne forordning.
Ved udvælgelse af en eller flere repræsentative stikprøver af udstyret skal det bemyndigede organ tage hensyn til, hvor nyskabende teknologien er, ligheder, hvad angår design, teknologi, fremstilling og steriliseringsmetoder, den tilsigtede brug og resultaterne af tidligere relevante audit (f.eks. hvad angår fysiske, kemiske, biologiske eller kliniske egenskaber), der er gennemført i overensstemmelse med denne forordning. Det bemyndigede organ skal dokumentere rationalet for den eller de udtagne stikprøver af udstyret.
10.3.   Hvis vurderingen i punkt 10.2 bekræfter, at det pågældende udstyr i klasse IIa er i overensstemmelse med den i bilag II og III omhandlede tekniske dokumentation og opfylder kravene i denne forordning, udsteder det bemyndigede organ et certifikat i henhold til denne del i nærværende bilag.
10.4.   Yderligere stikprøver, foruden dem, der blev udtaget med henblik på den indledende overensstemmelsesvurdering af udstyret, vurderes af det bemyndigede organ som en del af den i punkt 7 omhandlede tilsynsvurdering.
10.5.   Uanset punkt 6 skal fabrikanten eller dennes autoriserede repræsentant i et tidsrum, der ophører mindst 10 år efter, at det sidste udstyr er blevet bragt i omsætning, kunne forelægge de kompetente myndigheder:
—
EU-overensstemmelseserklæringen
—
den i bilag II og III omhandlede tekniske dokumentation, og
—
det i punkt 10.3 omhandlede certifikat.
Bilag IX, punkt 8, finder anvendelse.
DEL B
PRODUKTVERIFIKATION
11.   Ved produktverifikation forstås en procedure, hvorved fabrikanten, efter at have undersøgt alt fremstillet udstyr, ved at udfærdige en EU-overensstemmelseserklæring i overensstemmelse med artikel 19 og bilag IV anses for at sørge for og for at erklære, at det udstyr, der er omfattet af den procedure, der er fastlagt i punkt 14 og 15, er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet, og overholder de relevante bestemmelser i denne forordning.
12.   Fabrikanten træffer alle nødvendige foranstaltninger til at sikre, at fremstillingsprocessen garanterer, at udstyret er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet, samt med de relevante krav i denne forordning. Fabrikanten skal, inden fremstillingen påbegyndes, fremlægge dokumentation, som beskriver fremstillingsprocessen, navnlig vedrørende eventuel sterilisering, og samtlige forud fastsatte rutinemæssige procedurer, der vil blive iværksat for at sikre, at produktionen er ensartet, og i givet fald at udstyret er i overensstemmelse med den type, der er beskrevet i EU-typeafprøvningscertifikatet, samt med de relevante krav i denne forordning.
Desuden skal fabrikanten med hensyn til udstyr, der bringes i omsætning i steril tilstand, følge bestemmelserne i punkt 6 og 7, dog kun for så vidt angår de aspekter af fremstillingen, der tjener til at tilvejebringe den sterile tilstand og til at opretholde den.
13.   Fabrikanten forpligter sig til at indføre og opdatere en plan for overvågning, efter at udstyret er bragt i omsætning, herunder en PMCF-plan, samt de procedurer, der skal sikre overholdelse af de af fabrikantens forpligtelser, som følger af de sikkerhedsovervågningsbestemmelser og det system til overvågning, efter at udstyret er bragt i omsætning, som er fastsat i kapitel VII.
14.   Det bemyndigede organ foretager de nødvendige undersøgelser og prøvninger for at verificere, at udstyret er i overensstemmelse med kravene i denne forordning, ved undersøgelse og prøvning af hvert enkelt produkt som specificeret i punkt 15.
Undersøgelserne og prøvningerne i dette punkts første afsnit finder ikke anvendelse på de aspekter af fremstillingen, der tjener til at tilvejebringe den sterile tilstand.
15.   Verifikation ved undersøgelse og prøvning af hvert enkelt produkt
15.1.   Alt udstyr undersøges enkeltvis, og der gennemføres de fysiske prøvninger eller laboratorieprøvninger som omhandlet i den eller de relevante standarder, jf. artikel 8, eller tilsvarende prøvninger og vurderinger for i givet fald at verificere, at alt udstyr er i overensstemmelse med den type, som er beskrevet på EU-typeafprøvningscertifikatet samt med de relevante krav i denne forordning.
15.2.   Det bemyndigede organ anbringer sit identifikationsnummer eller lader det anbringe på hvert godkendt udstyr og udsteder et EU-produktverifikationscertifikat for de gennemførte prøvninger og vurderinger.
16.   Batchverifikation i forbindelse med udstyr, der som en integreret del inkorporerer et lægemiddel, der anvendt alene betragtes som et lægemiddel fremstillet på basis af blod eller plasma fra mennesker, jf. artikel 1, stk. 8
Efter at have afsluttet fremstillingen af hver batch af udstyr, der som en integreret del inkorporerer et lægemiddel, der anvendt alene kan betragtes som et lægemiddel fremstillet på basis af humant blod eller plasma, jf. artikel 1, stk. 8, underretter fabrikanten det bemyndigede organ om frigivelsen af denne batch af udstyr og sender organet den officielle attest på frigivelsen af den batch, som det humane blod- eller plasmaderivat, der er anvendt i udstyret, stammer fra; attesten udstedes af en medlemsstats laboratorium eller et af en medlemsstat udpeget laboratorium, jf. artikel 114, stk. 2, i direktiv 2001/83/EF.
17.   Administrative bestemmelser
Fabrikanten eller dennes autoriserede repræsentant skal i mindst 10 år, og for implantabelt udstyr i mindst 15 år, efter at det sidste udstyr er blevet bragt i omsætning, kunne forelægge de kompetente myndigheder:
—
EU-overensstemmelseserklæringen
—
den i punkt 12 omhandlede dokumentation
—
det i punkt 15.2 omhandlede certifikat, og
—
det i bilag X omhandlede EU-typeafprøvningscertifikat.
Bilag IX, punkt 8, finder anvendelse.
18.   Gældende for udstyr i klasse IIa
18.1.   Uanset punkt 11 anses fabrikanten i kraft af EU-overensstemmelseserklæringen for at sørge for og for at erklære, at det pågældende udstyr i klasse IIa er fremstillet i overensstemmelse med den i bilag II og III omhandlede tekniske dokumentation og opfylder de relevante krav i denne forordning.
18.2.   Den verifikation, der udføres af et bemyndiget organ i overensstemmelse med punkt 14, har til formål at fastslå, at det pågældende udstyr i klasse IIa er i overensstemmelse med den tekniske dokumentation, der er omhandlet i bilag II og III, og med de relevante krav i denne forordning.
18.3.   Hvis verifikationen i punkt 18.2 bekræfter, at det pågældende udstyr i klasse IIa er i overensstemmelse med den i bilag II og III omhandlede tekniske dokumentation og opfylder de relevante bestemmelser i denne forordning, udsteder det bemyndigede organ et certifikat i henhold til denne del i nærværende bilag.
18.4.   Uanset punkt 17 skal fabrikanten eller dennes autoriserede repræsentant i et tidsrum, der ophører mindst 10 år efter, at det sidste udstyr er blevet bragt i omsætning, kunne forelægge de kompetente myndigheder:
—
EU-overensstemmelseserklæringen
—
den i bilag II og III omhandlede tekniske dokumentation, og
—
det i punkt 18.3 omhandlede certifikat.
Bilag IX, punkt 8, finder anvendelse.
BILAG XII
CERTIFIKATER, DER UDSTEDES AF ET BEMYNDIGET ORGAN
KAPITEL I
GENERELLE KRAV
1.
Certifikater skal udfærdiges på et af EU's officielle sprog.
2.
Hvert certifikat må kun vedrøre én overensstemmelsesvurderingsprocedure.
3.
Et certifikat udstedes kun til én fabrikant. Fabrikantens navn og adresse på certifikatet skal være det navn og den adresse, som er registreret i det elektroniske system, der er omhandlet i artikel 30.
4.
Certifikaternes indhold skal utvetydigt identificere det omfattede udstyr:
a)
EU-certifikater for vurdering af teknisk dokumentation, EU-typeafprøvningscertifikater og EU-produktverifikationscertifikater skal indeholde en klar identifikation, herunder af udstyrets navn, model og type, det erklærede formål som opført af fabrikanten i brugsanvisningen og i forbindelse med hvilket udstyret er blevet vurderet i overensstemmelsesvurderingsproceduren, risikoklassificering og den grundlæggende UDI-DI, jf. artikel 27, stk. 6
b)
EU-kvalitetsstyringssystemcertifikater og EU-kvalitetssikringscertifikater skal indeholde identifikationsoplysninger om udstyr og grupper af udstyr, risikoklassificering og, for udstyr i klasse IIb, det erklærede formål.
5.
Det bemyndigede organ skal på anmodning kunne godtgøre, hvilket (individuelt) udstyr der er omfattet af certifikatet. Det bemyndigede organ opretter et system, der gør det muligt at identificere det udstyr, som er omfattet af certifikatet, herunder dets klassificering.
6.
Certifikater skal i påkommende tilfælde indeholde en note om, at med henblik på at bringe det udstyr, som den omfatter, i omsætning kræves der et andet certifikat i henhold til denne forordning.
7.
EU-kvalitetsstyringssystemcertifikater og EU-kvalitetssikringscertifikater for udstyr i klasse I, i forbindelse med hvilket et bemyndiget organ skal inddrages i overensstemmelse med artikel 52, stk. 7, skal indeholde en erklæring om, at det bemyndigede organs audit af kvalitetsstyringssystemet var begrænset til de aspekter, der er omhandlet i det nævnte stykke.
8.
Når et certifikat suppleres, ændres eller genudstedes, skal det nye certifikat indeholde en henvisning til det forrige certifikat og dets udstedelsesdato med angivelse af ændringerne.
KAPITEL II
CERTIFIKATET SKAL MINDST INDEHOLDE
1.
det bemyndigede organs navn, adresse og identifikationsnummer
2.
fabrikantens navn og adresse og, hvis det er relevant, den autoriserede repræsentants navn og adresse
3.
unikt nummer, der identificerer certifikatet
4.
fabrikantens SRN, hvis det allerede er udstedt, jf. artikel 31, stk. 2
5.
udstedelsesdato
6.
udløbsdato
7.
data, der er nødvendige for utvetydigt at kunne identificere udstyret, hvis det er relevant, jf. del I, punkt 4
8.
hvis det er relevant, en henvisning til et tidligere certifikat, jf. kapitel I, punkt 8
9.
en henvisning til denne forordning og til det relevante bilag, i henhold til hvilket overensstemmelsesvurderingen er foretaget
10.
gennemførte undersøgelser og prøvninger, f.eks. en henvisning til relevante fælles specifikationer, harmoniserede standarder, prøvningsrapporter og auditrapport(er)
11.
hvis det er relevant, en henvisning til de relevante dele af den tekniske dokumentation eller andre certifikater, der kræves for at bringe det omfattede udstyr i omsætning
12.
hvis det er relevant, oplysninger om det bemyndigede organs tilsyn
13.
konklusionen af det bemyndigede organs overensstemmelsesvurdering for så vidt angår det pågældende bilag
14.
betingelser for eller begrænsninger af certifikatets gyldighed
15.
det bemyndigede organs retligt bindende underskrift i henhold til gældende national ret.
BILAG XIII
PROCEDURE FOR UDSTYR EFTER MÅL
1.
Fabrikanten eller dennes autoriserede repræsentant afgiver for udstyr efter mål en erklæring, der skal indeholde alle de følgende oplysninger:
—
fabrikantens navn og adresse og angivelse af alle fremstillingssteder
—
hvis det er relevant, den autoriserede repræsentants navn og adresse
—
oplysninger, der gør det muligt at identificere det pågældende udstyr
—
en bekræftelse på, at udstyret er beregnet til udelukkende at blive anvendt af en bestemt patient eller bruger, der er identificeret ved navn, et akronym eller en talkode
—
navnet på den person, der har udfærdiget anvisningen, og som i henhold til national ret er autoriseret hertil i kraft af sine faglige kvalifikationer, og eventuelt navnet på den berørte sundhedsinstitution
—
udstyrets særlige karakteristika som anført i anvisningen
—
en bekræftelse på, at det pågældende udstyr er i overensstemmelse med de generelle krav til sikkerhed og ydeevne i bilag I, og i givet fald en angivelse af, hvilke generelle krav til sikkerhed og ydeevne der ikke er fuldstændigt opfyldt og hvorfor
—
hvis det er relevant, en angivelse af, at udstyret indeholder eller inkorporerer et lægemiddel, herunder et humant blod- eller plasmaderivat, eller væv eller celler af human oprindelse eller af animalsk oprindelse som omhandlet i forordning (EU) nr. 722/2012.
2.
Fabrikanten forpligter sig til at give de kompetente nationale myndigheder adgang til dokumentation, som angiver fremstillingsstedet eller -stederne, og som gør det muligt at opnå en forståelse af udstyrets design, fremstilling og ydeevne, herunder den forventede ydeevne, således at det er muligt at vurdere, om udstyret er i overensstemmelse med kravene i denne forordning.
3.
Fabrikanten træffer alle nødvendige foranstaltninger til at sikre, at det ved fremstillingsprocessen garanteres, at det fremstillede udstyr er i overensstemmelse med den dokumentation, der er omhandlet i punkt 2.
4.
Den erklæring, der er omhandlet i punkt 1, indledningen, skal opbevares i mindst 10 år efter, at udstyret er bragt i omsætning. For så vidt angår implantabelt udstyr skal oplysningerne opbevares i mindst 15 år.
Bilag IX, punkt 8, finder anvendelse.
5.
Fabrikanten behandler og dokumenterer de erfaringer, der gøres med udstyret efter fremstillingsfasen, herunder fra PMCF, jf. bilag XIV, del B, og bringer egnede midler i anvendelse for at iværksætte eventuelle nødvendige korrigerende handlinger. I denne forbindelse indberetter fabrikanten i overensstemmelse med artikel 87, stk. 1, alle alvorlige hændelser eller sikkerhedsrelaterede korrigerende handlinger eller begge til de kompetente myndigheder, så snart han får kendskab dertil.
BILAG XIV
KLINISK EVALUERING OG KLINISK OPFØLGNING, EFTER AT UDSTYRET ER BRAGT I OMSÆTNING
DEL A
KLINISK EVALUERING
1.   For at planlægge, løbende udføre og dokumentere en klinisk evaluering skal fabrikanter:
a)
oprette og opdatere en klinisk evalueringsplan, der mindst skal omfatte:
—
en identifikation af de generelle krav til sikkerhed og ydeevne, der kræver støtte fra relevante kliniske data
—
en specifikation af udstyrets erklærede formål
—
en klar specifikation af tilsigtede målgrupper med klare indikationer og kontraindikationer
—
en detaljeret beskrivelse af tilsigtede kliniske fordele for patienter med relevante og specificerede kliniske resultatparametre
—
en specifikation af, hvilke metoder der skal bruges til at undersøge de kvalitative og kvantitative aspekter af klinisk sikkerhed med klar henvisning til fastsættelse af tilbageværende risici og bivirkninger
—
en vejledende liste over og specifikation af de parametre, der bruges til på grundlag af den aktuelle tekniske viden inden for medicin at fastslå, om forholdet mellem fordele og risici er acceptabelt for de forskellige indikationer og for udstyrets erklærede formål
—
en angivelse af, hvordan spørgsmål forbundet med fordele og risici vedrørende specifikke komponenter såsom brug af farmaceutiske ikkelevedygtige animalske eller humane væv skal behandles, og
—
en klinisk udviklingsplan, der angiver udviklingen fra de indledende afprøvninger såsom first in human-forsøg, feasibilityundersøgelser og pilotundersøgelser til bekræftende afprøvninger såsom centrale kliniske afprøvninger og en PMCF som omhandlet i dette bilags del B med angivelse af milepæle og en beskrivelse af potentielle acceptkriterier
b)
identificere de tilgængelige kliniske data, der er relevante for udstyret og dets erklærede formål, og eventuelle mangler i den kliniske dokumentation via en systematisk gennemgang af videnskabelig litteratur
c)
bedømme alle relevante kliniske data ved at evaluere deres egnethed for fastlæggelsen af udstyrets sikkerhed og ydeevne
d)
gennem korrekt designede kliniske afprøvninger i overensstemmelse med den kliniske udviklingsplan generere eventuelle nye eller supplerende kliniske data, der er nødvendige for at behandle udestående problemstillinger, og
e)
analysere alle relevante kliniske data for at drage konklusioner med hensyn til udstyrets sikkerhed og kliniske ydeevne, herunder dets kliniske fordele.
2.   Den kliniske evaluering skal være grundig og objektiv og tage hensyn til både positive og negative data. Grundigheden og omfanget skal være passende og stå i rimeligt forhold til det pågældende udstyrs art, klassificering, erklærede formål og risici samt til fabrikantens angivelser i forbindelse med udstyret.
3.   En klinisk evaluering kan kun være baseret på kliniske data vedrørende et udstyr, hvis ækvivalensen med det pågældende udstyr kan godtgøres. Følgende tekniske, biologiske og kliniske karakteristika skal tages i betragtning ved påvisning af ækvivalens:
—
tekniske: udstyret har et tilsvarende design; anvendes under tilsvarende brugsbetingelser; har tilsvarende specifikationer og egenskaber, herunder fysisk-kemiske egenskaber såsom energiintensitet, trækstyrke, viskositet, overfladeegenskaber, bølgelængde og softwarealgoritmer; bruger tilsvarende anvendelsesmetode, hvis det er relevant; har tilsvarende funktionsprincipper og kritiske krav til ydeevnen
—
biologiske: udstyret bruger de samme materialer eller stoffer, der er i kontakt med de samme menneskelige væv eller legemsvæsker for så vidt angår en tilsvarende form for kontakt og varighed heraf og tilsvarende frigørelseskarakteristika for stoffer, herunder nedbrydningsprodukter og stoffer, der kan udvaskes
—
kliniske: udstyret bruges til samme kliniske tilstand eller formål, herunder tilsvarende sygdomsomfang og -fase, på samme sted i legemet, i en tilsvarende population, herunder med hensyn til alder, anatomi og fysiologi; har samme slags bruger; har en tilsvarende relevant kritisk ydeevne i betragtning af den forventede kliniske virkning med henblik på et specifikt erklæret formål.
De karakteristika, der er anført i første afsnit, skal være tilsvarende i et sådant omfang, at der ikke er nogen væsentlig klinisk forskel med hensyn til udstyrets sikkerhed og kliniske ydeevne. Betragtninger om ækvivalens skal være baseret på en behørig videnskabelig begrundelse. For at fabrikanter kan begrunde deres angivelser af ækvivalens, skal det tydeligt påvises, at de har tilstrækkelig adgang til dataene vedrørende det udstyr, som de angiver er ækvivalent.
4.   Resultaterne af den kliniske evaluering og den kliniske dokumentation, som den er baseret på, skal dokumenteres i en klinisk evalueringsrapport, som understøtter vurderingen af udstyrets overensstemmelse.
Den kliniske dokumentation skal sammen med ikkekliniske data genereret fra ikkekliniske testmetoder og anden relevant dokumentation gøre det muligt for fabrikanten at påvise overensstemmelse med de generelle krav til sikkerhed og ydeevne og skal indgå i den tekniske dokumentation for det pågældende udstyr.
Både positive og negative data betragtet i forbindelse med den kliniske evaluering skal fremgå af den tekniske dokumentation.
DEL B
KLINISK OPFØLGNING, EFTER AT UDSTYRET ER BRAGT I OMSÆTNING
5.   Ved PMCF forstås en kontinuerlig proces, der opdaterer den kliniske evaluering, jf. artikel 61 og del A i dette bilag, og PMCF skal behandles i fabrikantens plan for overvågning, efter at udstyret er bragt i omsætning. Ved gennemførelsen af PMCF skal fabrikanten proaktivt indsamle og evaluere kliniske data fra anvendelsen i eller på mennesker af udstyr, der er forsynet med CE-mærkning, og bringes i omsætning eller ibrugtages som tilsigtet i overensstemmelse med i den relevante overensstemmelsesvurderingsprocedure, med det erklærede formål at få bekræftet udstyrets sikkerhed og ydeevne i hele dets forventede levetid, sikre at konstaterede risici fortsat er acceptable og påvise nye risici på grundlag af faktuel evidens.
6.   PMCF skal udføres i henhold til en dokumenteret metode, der er fastlagt i en PMCF-plan.
6.1.   PMCF-planen skal specificere metoderne og procedurerne til proaktivt at indsamle og evaluere de kliniske data med det formål at:
a)
bekræfte udstyrets sikkerhed og ydeevne i hele dets forventede levetid
b)
identificere hidtil ukendte bivirkninger og monitorere konstaterede bivirkninger og kontraindikationer
c)
identificere og analysere nye risici på grundlag af faktuelle oplysninger
d)
sikre at forholdet mellem fordele og risici fortsat er acceptabelt, jf. bilag I, punkt 1 og 9, og
e)
identificere mulig systematisk forkert brug eller brug af udstyret uden for det erklærede formål med henblik på at verificere, om det erklærede formål er korrekt.
6.2.   PMCF-planen skal mindst indeholde:
a)
de generelle metoder og procedurer i forbindelse med PMCF, der skal anvendes, som f.eks. indsamling af kliniske erfaringer, feedback fra brugere, gennemgang af videnskabelig litteratur og af andre kilder til kliniske data
b)
de særlige metoder og procedurer i forbindelse med PMCF, der skal anvendes, som f.eks. evaluering af egnede registre eller PMCF-undersøgelser
c)
et rationale for valget af de metoder og procedurer, som er nævnt i litra a) og b)
d)
en henvisning til de relevante dele af den kliniske evalueringsrapport, der er nævnt i punkt 4, og den risikostyring, der er omhandlet i bilag I, punkt 3
e)
de specifikke formål, som PMCF skal fokusere på
f)
en evaluering af de kliniske data vedrørende tilsvarende eller lignende udstyr
g)
en henvisning til eventuelle relevante fælles specifikationer, harmoniserede standarder, når de anvendes af fabrikanten, og relevante retningslinjer vedrørende PMCF, og
h)
en detaljeret og behørigt begrundet tidsplan for PMCF-aktiviteter (f.eks. analyse af PMCF-data og -afrapportering), der skal gennemføres af fabrikanten.
7.   Fabrikanten skal analysere resultaterne af PMCF og dokumentere dem i en PMCF-evalueringsrapport, som skal indgå i den kliniske evalueringsrapport og den tekniske dokumentation.
8.   Konklusionerne i PMCF-evalueringsrapporten tages i betragtning ved den kliniske evaluering, jf. artikel 61 og del A i dette bilag, og i forbindelse med risikostyringen, jf. bilag I, punkt 3. Hvis der i forbindelse med PMCF konstateres et behov for forebyggende og/eller korrigerende handlinger, skal disse iværksættes af fabrikanten.
BILAG XV
KLINISKE AFPRØVNINGER
KAPITEL I
GENERELLE KRAV
1.   Etiske principper
Hver fase i den kliniske afprøvning fra de indledende overvejelser om behovet for undersøgelsen og dens berettigelse til offentliggørelsen af resultaterne foretages i overensstemmelse med anerkendte etiske principper.
2.   Metoder
2.1.   De kliniske afprøvninger udføres efter en relevant afprøvningsplan, der er videnskabeligt og teknisk tidssvarende, og som er designet således, at den bekræfter eller afkræfter fabrikantens angivelser vedrørende sikkerhed, ydeevne og aspekter vedrørende fordele og risici ved udstyret, jf. artikel 62, stk. 1; De kliniske afprøvninger omfatter et tilstrækkeligt antal observationer til at sikre, at konklusionerne er videnskabeligt gyldige. Rationalet for designet og den valgte statistiske metode præsenteres som nærmere beskrevet i dette bilags kapitel II, punkt 3.6.
2.2.   Det udstyr, der skal afprøves, er bestemmende for, hvilke kliniske afprøvningsprocedurer der skal anvendes.
2.3.   Det udstyr, der skal afprøves, er bestemmende for, hvilke kliniske forskningsmetoder der skal anvendes til at udføre afprøvningen.
2.4.   De kliniske afprøvninger skal udføres i henhold til den kliniske afprøvningsplan af et tilstrækkeligt antal tilsigtede brugere og i et klinisk miljø, der er repræsentativt for de tilsigtede normale forhold for udstyrets anvendelse i målpopulationen af patienter. De kliniske afprøvninger skal være i overensstemmelse med den kliniske evalueringsplan, jf. bilag XIV, del A.
2.5.   Der skal i afprøvningens design tages behørigt hensyn til alle udstyrets relevante tekniske og funktionelle forhold, især forhold vedrørende sikkerhed og ydeevne og deres forventede kliniske resultater. Der skal forelægges en liste over udstyrets tekniske og funktionelle forhold og de relaterede forventede kliniske resultater.
2.6.   Endepunkterne for den kliniske afprøvning skal omhandle udstyrets erklærede formål, kliniske fordele, ydeevne og sikkerhed. Endepunkterne skal fastlægges og vurderes ved hjælp af videnskabeligt anerkendte metoder. Det primære endepunkt skal være tilpasset til udstyret og være klinisk relevant.
2.7.   Investigatorer skal have adgang til de tekniske og kliniske data om udstyret. Personale, der deltager i gennemførelsen af en afprøvning, skal have modtaget tilstrækkelig instruktion og uddannelse i korrekt brug af udstyret bestemt til afprøvning og med hensyn til den kliniske afprøvningsplan og god klinisk praksis. Uddannelsen skal verificeres og om nødvendigt arrangeres af sponsor og dokumenteres behørigt.
2.8.   Den kliniske afprøvningsrapport, der skal underskrives af investigator, skal indeholde en kritisk evaluering af alle de data, der er indsamlet under den kliniske afprøvning, og skal omfatte eventuelle negative resultater.
KAPITEL II
DOKUMENTATION VEDRØRENDE ANSØGNINGEN OM KLINISK AFPRØVNING
For udstyr bestemt til afprøvning, som er omfattet af artikel 62, skal sponsor udarbejde og indsende en ansøgning i overensstemmelse med artikel 70 ledsaget af følgende dokumenter:
1.   Ansøgningsskema
Ansøgningsskemaet skal være behørigt udfyldt og indeholde følgende oplysninger:
1.1.
navn, adresse og kontaktoplysninger på sponsor og, hvis det er relevant, på dennes kontaktperson eller retlige repræsentant i overensstemmelse med artikel 62, stk. 2, i Unionen
1.2.
hvis forskelligt fra punkt 1.1, navn, adresse og kontaktoplysninger på fabrikanten af udstyret bestemt til klinisk afprøvning og, hvis det er relevant, på dennes autoriserede repræsentant
1.3.
titel på den kliniske afprøvning
1.4.
status for ansøgningen om den kliniske afprøvning (dvs. første indsendelse af en ansøgning, genindsendelse, væsentlig ændring)
1.5.
nærmere oplysninger om og/eller en henvisning til den kliniske evalueringsplan
1.6.
hvis der er tale om en genindsendelse af en ansøgning med hensyn til udstyr, for hvilket der allerede er indsendt en ansøgning, datoen eller datoerne og referencenummer eller -numre for den tidligere ansøgning, eller i tilfælde af en væsentlig ændring, en henvisning til den oprindelige ansøgning. Sponsor skal identificere alle ændringer i forhold til den tidligere ansøgning samt angive et rationale for disse ændringer, især om der er foretaget nogen ændringer for at følge konklusionerne fra tidligere gennemgange fra kompetente myndigheders eller etiske komitéers side
1.7.
hvis ansøgningen indsendes parallelt med en ansøgning om et klinisk forsøg i overensstemmelse med forordning (EU) nr. 536/2014, en henvisning til det officielle registreringsnummer for det kliniske forsøg
1.8.
identifikation af de medlemsstater og tredjelande, hvor den kliniske afprøvning på ansøgningstidspunktet skal gennemføres som led i en multicenterundersøgelse eller en multinational undersøgelse
1.9.
en kort beskrivelse af udstyret bestemt til afprøvning, dets klassificering og andre oplysninger, der er nødvendige for at kunne identificere udstyret og udstyrstypen
1.10.
oplysninger om, hvorvidt udstyret inkorporerer et lægemiddel, herunder et humant blod- eller plasmaderivat, eller om det er fremstillet ved anvendelse af ikkelevedygtige væv eller celler af human eller animalsk oprindelse eller af derivater heraf
1.11.
et sammendrag af den kliniske afprøvningsplan, herunder formålet eller formålene med den kliniske afprøvning, antallet af forsøgspersoner og deres køn, kriterier for udvælgelse af forsøgspersoner, om der er forsøgspersoner under 18 år, afprøvningens design, f.eks. kontrollerede og/eller randomiserede undersøgelser, planlagte datoer for påbegyndelse og afslutning af den kliniske afprøvning
1.12.
hvis det er relevant, oplysninger vedrørende komparatorudstyr, dets klassificering og andre oplysninger, der er nødvendige til identifikation af komparatorudstyret
1.13.
dokumentation fra sponsor for, at den kliniske investigator og afprøvningsstedet er i stand til at gennemføre den kliniske afprøvning i overensstemmelse med den kliniske afprøvningsplan
1.14.
nærmere oplysninger om den forventede startdato og varigheden af afprøvningen
1.15.
nærmere oplysninger til identifikation af det bemyndigede organ, hvis et sådant allerede er involveret på det tidspunkt, hvor ansøgningen om klinisk afprøvning indsendes
1.16.
bekræftelse på, at sponsor er klar over, at den kompetente myndighed kan kontakte den etiske komité, der vurderer eller har vurderet ansøgningen, og
1.17.
den i punkt 4.1 omhandlede erklæring.
2.   Investigators brochure
Investigators brochuren (IB) skal indeholde kliniske og ikkekliniske oplysninger om det pågældende udstyr bestemt til afprøvning, der er relevante for afprøvningen, og som er til rådighed på ansøgningstidspunktet. Eventuelle opdateringer af IB eller andre relevante oplysninger, der netop er blevet tilgængelige, skal meddeles investigatorerne rettidigt. IB skal klart kunne identificeres og især indeholde følgende oplysninger:
2.1.
identifikation og beskrivelse af udstyret, herunder oplysninger om det erklærede formål, risikoklasse og gældende klassificering i henhold til bilag VIII, udstyrets design og fremstilling og henvisning til tidligere og lignende generationer af udstyret
2.2.
fabrikantens anvisninger vedrørende installering, vedligeholdelse, opretholdelse af hygiejnestandarder og brug, herunder krav til opbevaring og håndtering, samt i hvilket omfang sådanne oplysninger er tilgængelige, oplysninger, der skal anføres på mærkningen, og brugsanvisning, der skal leveres med udstyret, når det bringes i omsætning. Desuden oplysninger om enhver relevant påkrævet uddannelse
2.3.
præklinisk evaluering på grundlag af relevant præklinisk afprøvning og forsøgsdata, især vedrørende designberegninger, in vitro-test, ex vivo-test, dyreforsøg, mekaniske eller elektriske test, pålidelighedstest, validering af sterilisering, softwareverifikation og -validering, test af ydeevne, evaluering af bioforligelighed og biologisk sikkerhed, hvis det er relevant
2.4.
eksisterende kliniske data, især:
—
fra relevant foreliggende videnskabelig litteratur, som beskriver udstyrets og/eller tilsvarende eller lignende udstyrs sikkerhed, ydeevne, kliniske fordele for patienterne, designkarakteristika og erklærede formål
—
andre relevante tilgængelige kliniske data, som beskriver sikkerhed, ydeevne, kliniske fordele for patienterne, designkarakteristika og erklærede formål for tilsvarende eller lignende udstyr fra samme fabrikant, herunder hvor længe det har været på markedet, og en gennemgang af forhold vedrørende ydeevne, kliniske fordele og sikkerhed og eventuelle korrigerende handlinger
2.5.
et resumé af analysen af forholdet mellem fordele og risici, herunder oplysninger om kendte eller forudsigelige risici, eventuelle bivirkninger, kontraindikationer og advarsler
2.6.
for udstyr, der inkorporerer et lægemiddel, herunder et humant blod- eller plasmaderivat, eller udstyr, der er fremstillet ved anvendelse af ikkelevedygtige væv eller celler af human eller animalsk oprindelse eller af derivater heraf, detaljerede oplysninger om lægemidlet eller om vævene, cellerne eller derivaterne heraf og om overholdelse af de relevante generelle krav til sikkerhed og ydeevne og særlige risikohåndteringsforanstaltninger i forhold til stoffet eller vævene, cellerne eller derivaterne heraf, samt dokumentation for merværdien af inkorporeringen af sådanne bestanddele i forbindelse med udstyrets kliniske fordele og/eller sikkerhed
2.7.
en liste, hvor det angives, at de relevante generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I, herunder de anvendte standarder og fælles specifikationer, er helt eller delvist overholdt, samt en beskrivelse af de løsninger, der er anvendt med henblik på at opfylde de relevante generelle krav til sikkerhed og ydeevne, for så vidt som disse standarder og fælles specifikationer ikke er eller kun delvist er blevet opfyldt eller mangler
2.8.
en detaljeret beskrivelse af de kliniske procedurer og diagnostiske prøvninger, der er brugt i løbet af den kliniske afprøvning, navnlig oplysninger om enhver afvigelse fra normal klinisk praksis.
3.   Klinisk afprøvningsplan
Den kliniske afprøvningsplan fastsætter rationale, formål, designmetode, monitorering, gennemførelse, registrering og analysemetode i forbindelse med den kliniske afprøvning. Den skal navnlig indeholde de oplysninger, som er anført i dette bilag. Hvis en del af disse oplysninger indsendes i et særskilt dokument, skal det oplyses i den kliniske afprøvningsplan.
3.1.   Generelt
3.1.1.   individuelt identifikationsnummer for den kliniske afprøvning, jf. artikel 70, stk. 1
3.1.2.   identifikation af sponsor — sponsors navn, adresse og kontaktoplysninger og, hvis det er relevant, navn, adresse og kontaktoplysninger på sponsors kontaktperson eller retlige repræsentant i overensstemmelse med artikel 62, stk. 2, i Unionen
3.1.3.   oplysninger om den primære investigator på hvert afprøvningssted, den koordinerende investigator for afprøvningen, adresseoplysninger på hvert afprøvningssted og kontaktoplysninger i nødstilfælde for den primære investigator på hvert afprøvningssted. De forskellige investigatortypers roller, ansvarsområder og kvalifikationer skal angives i den kliniske afprøvningsplan
3.1.4.   en kort beskrivelse af, hvordan den kliniske afprøvning er finansieret, og en kort beskrivelse af aftalen mellem sponsor og afprøvningsstedet
3.1.5.   en generel synopsis for den kliniske afprøvning på et officielt EU-sprog, der bestemmes af den berørte medlemsstat
3.2.   identifikation og beskrivelse af udstyret, herunder dets erklærede formål, fabrikant og sporbarhed, målpopulationen, materialer, der kommer i kontakt med det menneskelige legeme, medicinske eller kirurgiske procedurer, der er nødvendige for dets anvendelse, og den nødvendige uddannelse og erfaring for at kunne anvende det, gennemgang af baggrundslitteratur, den aktuelle tekniske viden inden for klinisk behandling på det relevante anvendelsesområde og det nye udstyrs foreslåede fordele
3.3.   risici og kliniske fordele ved det udstyr, der skal undersøges, med begrundelse for de tilsvarende forventede kliniske resultater i den kliniske afprøvningsplan
3.4.   en beskrivelse af relevansen af den kliniske afprøvning i forbindelse med den tekniske viden inden for klinisk praksis
3.5.   mål og hypoteser vedrørende den kliniske afprøvning
3.6.   den kliniske afprøvnings design med dokumentation for dens videnskabelige robusthed og gyldighed
3.6.1.   generelle oplysninger som f.eks. afprøvningstype med rationale for valg heraf, for dens endepunkter og for dens variabler som fastsat i den kliniske evalueringsplan
3.6.2.   oplysninger om udstyret bestemt til afprøvning, om komparatorer og om andet udstyr eller anden medicin, der skal anvendes til den kliniske afprøvning
3.6.3.   oplysninger om forsøgspersoner, udvælgelseskriterier, størrelsen af forsøgspopulationen, forsøgspopulationens repræsentativitet i forhold til målpopulationen og evt. oplysninger om sårbare deltagende forsøgspersoner såsom børn, gravide kvinder, immunsvækkede eller ældre forsøgspersoner
3.6.4.   nærmere oplysninger om de foranstaltninger, der skal træffes for at minimere skævvridninger, f.eks. randomisering, og håndtere potentielle confoundere
3.6.5.   beskrivelse af de kliniske procedurer og diagnostiske metoder vedrørende den kliniske afprøvning og især fremhævelse af enhver afvigelse fra normal klinisk praksis
3.6.6.   monitoreringsplan
3.7.   statistiske overvejelser med begrundelse, herunder en beregning af stikprøvestørrelsens statistiske værdi, hvis det er relevant
3.8.   datahåndtering
3.9.   oplysninger om eventuelle ændringer af den kliniske afprøvningsplan
3.10.   retningslinjer vedrørende opfølgning og håndtering af eventuelle afvigelser fra den kliniske afprøvningsplan på afprøvningsstedet og et klart forbud mod anvendelse af dispensationer fra den kliniske afprøvningsplan
3.11.   ansvarlighed i forbindelse med udstyret, navnlig kontrol af adgang til udstyret, opfølgning i forhold til udstyr anvendt i den kliniske afprøvning og tilbagesendelse af udstyr, der er ubrugt eller udløbet, eller som ikke fungerer
3.12.   erklæring om overensstemmelse med anerkendte etiske principper for medicinsk forskning med mennesker og principper for god klinisk praksis i forbindelse med kliniske afprøvninger af udstyr samt med de gældende reguleringskrav
3.13.   beskrivelse af informeret samtykke
3.14.   sikkerhedsindberetning, herunder definitioner af uønskede hændelser og alvorlige uønskede hændelser, mangler ved udstyret, procedurer og frister for indberetning
3.15.   kriterier og procedurer for opfølgning af forsøgspersoner efter afslutning, midlertidig standsning eller afbrydelse af en afprøvning samt for opfølgning af forsøgspersoner, der har trukket deres samtykke tilbage, og procedurer for forsøgspersoner, der ikke længere kan deltage i opfølgning. Sådanne procedurer skal for implantabelt udstyr som minimum omfatte sporbarhed
3.16.   en beskrivelse af ordningerne for pleje af forsøgspersonerne efter deres deltagelse i den kliniske afprøvning, hvis en sådan supplerende pleje er nødvendig på grund af forsøgspersonernes deltagelse i den kliniske afprøvning, og hvis denne adskiller sig fra, hvad der normalt forventes i henhold til forsøgspersonens sygdomstilstand
3.17.   retningslinjer vedrørende udarbejdelsen af den kliniske afprøvningsrapport og offentliggørelse af resultaterne i overensstemmelse med lovkravene og de etiske principper, der er omhandlet i kapitel I, punkt 1
3.18.   en liste over udstyrets tekniske og funktionelle kendetegn med specifik angivelse af forhold, der er omfattet af afprøvningen
3.19.   en bibliografi.
4.   Andre oplysninger
4.1.   en erklæring underskrevet af den fysiske eller juridiske person, der er ansvarlig for fremstillingen af udstyret bestemt til afprøvning, om, at det pågældende udstyr er i overensstemmelse med de generelle krav til sikkerhed og ydeevne, undtagen for så vidt angår de aspekter, der er omfattet af den kliniske afprøvning, og at der med hensyn til disse aspekter er truffet alle nødvendige forholdsregler for at beskytte forsøgspersonens sundhed og sikkerhed
4.2.   hvor det er relevant i henhold til national ret, en kopi af udtalelsen eller udtalelserne fra den eller de berørte etiske komitéer. Hvis der i henhold til national ret ikke kræves udtalelse eller udtalelser fra den eller de etiske komitéer, når ansøgningen indsendes, fremsendes en kopi af udtalelsen eller udtalelserne, så snart de(n) foreligger
4.3.   dokumentation for forsikringsdækning eller erstatning til forsøgspersoner i tilfælde af skader i henhold til artikel 69 og den tilsvarende nationale ret
4.4.   dokumenter, der skal anvendes for at indhente informeret samtykke, herunder patientoplysningsskemaet og det dokument, ved hvilket der er givet informeret samtykke
4.5.   en beskrivelse af de foranstaltninger, der træffes for at opfylde de gældende regler om beskyttelse og fortrolighed af personoplysninger, herunder:
—
organisatoriske og tekniske foranstaltninger, der vil blive iværksat for at forhindre uautoriseret adgang, videregivelse, udbredelse, ændring eller tab af behandlede informationer og personoplysninger
—
en beskrivelse af de foranstaltninger, der vil blive iværksat for at sikre fortroligheden af optegnelser og personoplysninger for forsøgspersoner, og
—
en beskrivelse af de foranstaltninger, der vil blive iværksat i tilfælde af et brud på datasikkerheden for at afbøde mulige negative virkninger.
4.6.   Alle oplysninger om den tilgængelige tekniske dokumentation, f.eks. detaljerede risikoanalyser/dokumentation om styring eller specifikke prøvningsrapporter, forelægges efter anmodning for den kompetente myndighed, der behandler en ansøgning.
KAPITEL III
ANDRE FORPLIGTELSER, DER PÅHVILER SPONSOR
1.   Sponsor forpligter sig til at stille sådanne dokumenter til rådighed for de kompetente nationale myndigheder, som er nødvendige for at kontrollere den dokumentation, der er omhandlet i kapitel II. Hvis sponsor ikke er den fysiske eller juridiske person, der er ansvarlig for fremstillingen af udstyret bestemt til afprøvning, kan den pågældende forpligtelse opfyldes af denne person på vegne af sponsor.
2.   Sponsor skal have en aftale, der sikrer, at enhver alvorlig uønsket hændelse eller enhver anden hændelse, der er omhandlet i artikel 80, stk. 2, indberettes rettidigt af investigator eller investigatorer til sponsor.
3.   Den dokumentation, der er omhandlet i dette bilag, skal opbevares i mindst 10 år efter, at den kliniske afprøvning af det pågældende udstyr er afsluttet, eller, hvis udstyret efterfølgende bringes i omsætning, i mindst 10 år efter, at det sidste udstyr blev bragt i omsætning. For så vidt angår implantabelt udstyr skal oplysningerne opbevares i mindst 15 år.
Hver medlemsstat skal kræve, at denne dokumentation kan stilles til rådighed for de kompetente myndigheder i den periode, der er omhandlet i første afsnit, hvis sponsor eller dennes kontaktperson eller retlige repræsentant, jf. artikel 62, stk. 2, som er etableret på dens område, går konkurs eller indstiller sine aktiviteter inden udgangen af denne periode.
4.   Sponsor udpeger en monitor, der er uafhængig af afprøvningsstedet, til sikring af, at afprøvningen gennemføres i overensstemmelse med den kliniske afprøvningsplan, principperne for god klinisk praksis og denne forordning.
5.   Sponsor skal gennemføre opfølgningen af afprøvningens forsøgspersoner.
6.   Sponsor skal forelægge dokumentation for, at afprøvningen gennemføres i overensstemmelse med god klinisk praksis, f.eks. gennem intern eller ekstern inspektion.
7.   Sponsor skal udarbejde en klinisk afprøvningsrapport, der mindst omfatter følgende:
—
forside/indledende side eller sider med angivelse af titlen på afprøvningen, udstyret bestemt til afprøvning, det individuelle identifikationsnummer, nummeret på den kliniske afprøvningsplan og nærmere oplysninger med underskrifter fra de koordinerende investigatorer og de primære investigatorer fra hvert afprøvningssted
—
nærmere oplysninger om ophavsmanden og datoen for rapporten
—
et sammendrag af afprøvningen, der indeholder titlen, formålet med afprøvningen, en beskrivelse af afprøvningen, afprøvningens design og de anvendte metoder, resultaterne af afprøvningen og en konklusion om afprøvningen. Datoen for afprøvningens afslutning og især nærmere oplysninger om afbrydelse, midlertidig standsning eller suspension af afprøvninger
—
en beskrivelse af udstyret bestemt til afprøvning, især et klart defineret erklæret formål
—
et sammendrag af den kliniske afprøvningsplan, der indeholder formål, design, etiske aspekter, monitorerings- og kvalitetsforanstaltninger, udvælgelseskriterier, målpopulationen af patienter, stikprøvestørrelse, behandlingsplaner, varighed af opfølgning, samtidige behandlinger, statistiske planer, herunder hypoteser/beregning af stikprøvestørrelse og analysemetoder samt en begrundelse
—
resultater af den kliniske afprøvning, der, med rationale og begrundelse, indeholder forsøgspersonernes demografi, analyser af resultater vedrørende udvalgte endepunkter, nærmere oplysninger om analyser af undergrupper samt overholdelse af den kliniske afprøvningsplan, og indeholder opfølgning af manglende data og af patienter, der har trukket sig fra den kliniske afprøvning eller er ikke længere kan deltage i opfølgning
—
en sammenfatning af alvorlige uønskede hændelser, hændelser, der kan forårsages af udstyret, mangler ved udstyret og eventuelle relevante korrigerende handlinger
—
drøftelser og overordnede konklusioner, der indeholder resultater vedrørende sikkerhed og ydeevne, vurdering af risici og kliniske fordele, drøftelse af klinisk relevans i overensstemmelse med den kliniske tekniske viden, eventuelle specifikke forholdsregler for specifikke patientpopulationer, virkninger for udstyret bestemt til afprøvning og begrænsninger for afprøvningen.
BILAG XVI
LISTE OVER GRUPPER AF PRODUKTER UDEN ET MEDICINSK FORMÅL SOM OMHANDLET I ARTIKEL 1, STK. 2
1.
kontaktlinser eller andre dele, der er bestemt til at blive indført i eller anbragt på øjet
2.
produkter, der er bestemt til at blive indført helt eller delvist i det menneskelige legeme ved hjælp af kirurgisk invasive midler med henblik på ændring af anatomien eller fastgørelse af legemsdele med undtagelse af tatoveringsprodukter og piercinger
3.
stoffer, en kombination af stoffer eller dele, der er bestemt til at blive brugt til ansigts- eller anden hud- eller slimhindefyldning ved hjælp af subkutan, submukøs eller intradermal injektion eller anden indføring, bortset fra dem, som er bestemt til tatovering
4.
udstyr, der er bestemt til at mindske, fjerne eller ødelægge fedtvæv, såsom udstyr til fedtsugning, fedtspaltning eller lipoplasty
5.
udstyr, der udsender elektromagnetisk stråling med høj intensitet (f.eks. infrarødt, synligt lys og ultraviolet) bestemt til brug på det menneskelige legeme, herunder sammenhængende og ikkesammenhængende kilder, monokromatiske og bredspektrede kilder, såsom lasere og intenst pulserende lysudstyr til skin resurfacing, fjernelse af tatoveringer eller hår eller anden hudbehandling
6.
udstyr bestemt til hjernestimulering med anvendelse af elektrisk strøm eller magnetiske og elektromagnetiske felter, der trænger ind i kraniet for at ændre neuronal aktivitet i hjernen.
BILAG XVII
SAMMENLIGNINGSTABEL
Rådets direktiv 90/385/EØF
Rådets direktiv 93/42/EØF
Denne forordning
Artikel 1, stk. 1
Artikel 1, stk. 1
Artikel 1, stk. 1
Artikel 1, stk. 2
Artikel 1, stk. 2
Artikel 2
Artikel 1, stk. 3
Artikel 1, stk. 3, første afsnit
Artikel 1, stk. 9, første afsnit
—
Artikel 1, stk. 3, andet afsnit
Artikel 1, stk. 9, andet afsnit
Artikel 1, stk. 4 og 4a
Artikel 1, stk. 4 og 4a
Artikel 1, stk. 8, første afsnit
Artikel 1, stk. 5
Artikel 1, stk. 7
Artikel 1, stk. 11
Artikel 1, stk. 6
Artikel 1, stk. 5
Artikel 1, stk. 6
—
Artikel 1, stk. 6
—
—
Artikel 1, stk. 8
Artikel 1, stk. 13
Artikel 2
Artikel 2
Artikel 5, stk. 1
Artikel 3, stk. 1
Artikel 3, stk. 1
Artikel 5, stk. 2
Artikel 3, stk. 2
Artikel 3, stk. 2
Artikel 1, stk. 12
Artikel 4, stk. 1
Artikel 4, stk. 1
Artikel 24
Artikel 4, stk. 2
Artikel 4, stk. 2
Artikel 21, stk. 1 og 2
Artikel 4, stk. 3
Artikel 4, stk. 3
Artikel 21, stk. 3
Artikel 4, stk. 4
Artikel 4, stk. 4
Artikel 10, stk. 11
Artikel 4, stk. 5, litra a)
Artikel 4, stk. 5, første afsnit
Artikel 20, stk. 6
Artikel 4, stk. 5, litra b)
Artikel 4, stk. 5, andet afsnit
—
Artikel 5, stk. 1
Artikel 5, stk. 1
Artikel 8, stk. 1
Artikel 5, stk. 2
Artikel 5, stk. 2
Artikel 8, stk. 2
Artikel 6, stk. 1
Artikel 5, stk. 3, og artikel 6
—
Artikel 6, stk. 2
Artikel 7, stk. 1
Artikel 114
Artikel 7
Artikel 8
Artikel 94-97
—
Artikel 9
Artikel 51
Artikel 8, stk. 1
Artikel 10, stk. 1
Artikel 87, stk. 1, og artikel 89, stk. 2
Artikel 8, stk. 2
Artikel 10, stk. 2
Artikel 87, stk. 10, og stk. 11, første afsnit
Artikel 8, stk. 3
Artikel 10, stk. 3
Artikel 89, stk. 7
Artikel 8, stk. 4
Artikel 10, stk. 4
Artikel 91
Artikel 9, stk. 1
Artikel 11, stk. 1
Artikel 52, stk. 3
—
Artikel 11, stk. 2
Artikel 52, stk. 6
—
Artikel 11, stk. 3
Artikel 52, stk. 4 og 5
—
Artikel 11, stk. 4
—
—
Artikel 11, stk. 5
Artikel 52, stk. 7
Artikel 9, stk. 2
Artikel 11, stk. 6
Artikel 52, stk. 8
Artikel 9, stk. 3
Artikel 11, stk. 8
Artikel 11, stk. 3
Artikel 9, stk. 4
Artikel 11, stk. 12
Artikel 52, stk. 12
Artikel 9, stk. 5
Artikel 11, stk. 7
—
Artikel 9, stk. 6
Artikel 11, stk. 9
Artikel 53, stk. 1
Artikel 9, stk. 7
Artikel 11, stk. 10
Artikel 53, stk. 4
Artikel 9, stk. 8
Artikel 11, stk. 11
Artikel 53, stk. 2
Artikel 9, stk. 9
Artikel 11, stk. 13
Artikel 59
Artikel 9, stk. 10
Artikel 11, stk. 14
Artikel 4, stk. 5, og artikel 122, stk. 3
—
Artikel 12
Artikel 22
—
Artikel 12a
Artikel 17
Artikel 9a, stk. 1, første led
Artikel 13, stk. 1, litra c)
—
Artikel 9a, stk. 1, andet led
Artikel 13, stk. 1, litra d)
Artikel 4, stk. 1
—
Artikel 13, stk. 1, litra a)
Artikel 51, stk. 3, litra a), og stk. 6
—
Artikel 13, stk. 1, litra b)
Artikel 51, stk. 3, litra b), og stk. 6
Artikel 10
Artikel 15
Artikel 62-82
Artikel 10a, stk. 1, stk. 2, andet punktum, og stk. 3
Artikel 14, stk. 1, stk. 2, andet punktum, og stk. 3
Artikel 29, stk. 4, og artikel 30 og 31
Artikel 10a, stk. 2, første punktum
Artikel 14, stk. 2, første punktum
Artikel 11, stk. 1
Artikel 10b
Artikel 14a
Artikel 33 og 34
Artikel 10c
Artikel 14b
Artikel 98
Artikel 11, stk. 1
Artikel 16, stk. 1
Artikel 42 og 43
Artikel 11, stk. 2
Artikel 16, stk. 2
Artikel 36
Artikel 11, stk. 3
Artikel 16, stk. 3
Artikel 46, stk. 4
Artikel 11, stk. 4
Artikel 16, stk. 4
—
Artikel 11, stk. 5
Artikel 16, stk. 5
Artikel 56, stk. 5
Artikel 11, stk. 6
Artikel 16, stk. 6
Artikel 56, stk. 4
Artikel 11, stk. 7
Artikel 16, stk. 7
Artikel 38, stk. 2, og artikel 44, stk. 2
Artikel 12
Artikel 17
Artikel 20
Artikel 13
Artikel 18
Artikel 94-97
Artikel 14
Artikel 19
Artikel 99
Artikel 15
Artikel 20
Artikel 109
Artikel 15a
Artikel 20a
Artikel 102
Artikel 16
Artikel 22
—
Artikel 17
Artikel 23
—
—
Artikel 21
—

Summary:
Sikring af medicinsk udstyrs sikkerhed og ydeevne
RESUMÉ AF:
Forordning (EU) 2017/745 om medicinsk udstyr
HVAD ER FORMÅLET MED FORORDNINGEN?
Den opdaterer reglerne for omsætning, tilgængelighed og ibrugtagning af 
medicinsk udstyr
1
 til 
human brug
 og tilbehør til dette på markedet i 
Den Europæiske Union
 (EU).
Den indeholder også bestemmelser om, hvordan 
kliniske afprøvninger
2
 af sådant udstyr og tilbehør foretages i EU.
Den har til formål at forbedre 
patientsikkerheden
 ved at indføre mere strenge procedurer for 
overensstemmelsesvurdering
 (for at sikre, at farligt udstyr eller udstyr, der ikke er i overensstemmelse med kravene, ikke bringes i omsætning) og 
overvågning efter at udstyret er bragt i omsætning
.
Ændringsforordning (EU) 
2020/561
 blev vedtaget for at gøre det muligt for EU’s 
medlemsstater
 og disses myndigheder og institutioner at prioritere bekæmpelsen af covid-19-pandemien. Den udskyder anvendelsen af visse bestemmelser i forordning (EU) 2017/745 med ét år for at sikre et velfungerende 
indre marked
 i EU, opretholde et højt beskyttelsesniveau for 
folkesundheden
 og patientsikkerheden, sikre retssikkerhed og undgå potentielle markedsforstyrrelser under pandemien.
HOVEDPUNKTER
Anvendelsesområde
Udover medicinsk udstyr omfatter forordningen også bestemte grupper af produkter uden medicinsk formål. Det er for eksempel farvede kontaktlinser (dvs. linser, som ikke korrigerer synet) og udstyr til fedtsugning. En liste over disse produkter findes i forordningens bilag XVI.
Klassificering
Medicinsk udstyr klassificeres i henhold til deres erklærede formål og de dermed forbundne risici (klasse I, IIa, IIb og III, som fastsat i forordningens bilag VIII).
Bemyndigede organer
Forordningen strammer reglerne om, hvordan uafhængige 
bemyndigede organer
 — som vurderer middel- og højrisikoudstyrs overensstemmelse, før det bringes i omsætning på markedet — udpeges, organiseres og overvåges.
Disse organer skal leve op til de samme højkvalitetsstandarder i hele EU og skal have de fornødne kompetencer, ressourcer og personale til at kunne udføre deres opgaver i forbindelse med overensstemmelsesvurderinger.
Der skal foretages inspektioner på stedet hos fabrikanter, hvoraf nogle skal være uanmeldte.
Vurderinger af bestemte typer af højrisikoudstyr (for eksempel implantater) kan også involvere paneler af uafhængige eksperter (
ekspertpaneler
).
Kliniske data
Forordningen fastsætter krav i forbindelse med dataindsamling ved kliniske afprøvninger af medicinsk udstyr. Disse krav er i vid udstrækning afstemt med de krav, der gælder for kliniske forsøg med humanmedicinske lægemidler. De omhandler blandt andet regler vedrørende informeret samtykke og beskyttelse af sårbare personer (for eksempel unge under 18 år, gravide kvinder eller personer med funktionsnedsættelse).
Kliniske afprøvninger, der gennemføres i mere end én medlemsstat, skal undergå en 
samlet koordineret vurdering
.
Fabrikanters og andre erhvervsdrivendes forpligtelser
Fabrikanterne pålægges klarere og strengere forpligtelser til at overvåge kvalitet, ydeevne og sikkerhed for de producerede enheder.
De skal sikre tilstrækkelig finansiel dækning for så vidt angår deres mulige erstatningsansvar i henhold til direktiv 
85/374/EØF
 om produktansvar (se 
resumé
), og de relaterede foranstaltninger skal stå i rimeligt forhold til risikoklassen, typen af udstyr og virksomhedens størrelse.
Fabrikanter skal etablere 
kvalitetsstyringssystemer og systemer til overvågning, efter at udstyret er bragt i omsætning
, der står i rimeligt forhold til risikoklassen og typen af det pågældende udstyr.
I tilfælde af skade som følge af defekt udstyr hæfter fabrikantens autoriserede repræsentant solidarisk.
Brugen af 
farlige stoffer
, som er kræftfremkaldende, mutagene, reproduktionstoksiske eller hormonforstyrrende, i 
invasivt medicinsk udstyr
3
 over en 
bestemt grænse
, skal begrundes af fabrikanten over for det bemyndigede organ.
Der fastsættes også specifikke betingelser for de relaterede erhvervsdrivende: autoriserede repræsentanter, importører, distributører og dem, der beskæftiger sig med systemer og behandlingspakker.
Sporbarhed
Forordningen indfører et system for registrering af enheder og fabrikanter, importører og autoriserede repræsentanter for at sikre, at enhederne kan spores gennem hele forsyningskæden ved hjælp af en 
unik udstyrsidentifikationskode
. Dette vil sikre, at der hurtigt kan iværksættes foranstaltninger, hvis der opstår problemer.
Engangsudstyr
Engangsudstyr må kun 
oparbejdes
 (rengøres, desinficeres, afprøves, genoprettes med henblik på teknisk og funktionel sikkerhed og steriliseres), hvis det er tilladt ifølge national ret og overholder bestemte krav, der er anført i denne forordning. Enhver fysisk eller juridisk person, som oparbejder engangsudstyr for at gøre det egnet til videre anvendelse, skal påtage sig de forpligtelser, som påhviler en fabrikant. I visse tilfælde kan medlemsstaterne tillade undtagelser fra de generelle regler, hvis engangsudstyret oparbejdes og bruges inden for en sundhedsinstitution, såfremt bestemte krav i forordningen er opfyldt.
Indberetning af hændelser
Udover fabrikanternes pligt til at indberette alvorlige hændelser og tendenser inden for hændelser, der ikke er alvorlige, indfører forordningen en forpligtelse gældende for medlemsstaterne til at tilskynde og sætte sundhedsfaglige personer, brugere og patienter i stand til at indberette formodede hændelser på nationalt niveau i et standardiseret format.
Markedsovervågning
De kompetente EU-myndigheder har ansvar for at sikre, at farligt udstyr eller udstyr, der ikke er i overensstemmelse med kravene, ikke bringes i omsætning, eller at det trækkes tilbage fra markedet, hvis det opdages, at det er farligt, efter at det er blevet bragt i omsætning.
Eudamed
Et centralt system, 
den europæiske database for medicinsk udstyr
 (Eudamed), etableres med det formål at tilvejebringe oplysninger om medicinsk udstyr, der er tilgængeligt i EU, for medlemsstaterne, erhvervsdrivende, patienter, sundhedsfaglige personer og offentligheden.
Implantatkort
For så vidt angår 
implantabelt udstyr
 skal fabrikanterne give patienterne vigtige oplysninger på et 
implantatkort
, som leveres sammen med udstyret. Dette omfatter:
identifikation af udstyret, dets navn, serienummer, lotnummer, unikke udstyrsidentifikationskode samt oplysninger om fabrikanten
oplysninger om negative indvirkninger på udstyret forårsaget af instrumenter, som forelå på tidspunktet for afprøvningen eller behandlingen
udstyrets forventede levetid og al nødvendig opfølgning.
Gennemførelsesretsakter
Den komplette liste over 
gennemførelsesretsakter
 til forordning (EU) 2017/745 findes 
her
.
Ophævelse af eksisterende lovgivning — direktiv 90/385/EØF og 93/42/EØF
Forordningen, som ændret ved forordning (EU) 2020/561, ophæver direktiv 
90/385/EØF
 og 
93/42/EØF
 fra den 
26. maj 2021
, idet der er fastsat specifikke overgangsbestemmelser og visse undtagelser i artikel 120 og 122.
HVORNÅR GÆLDER FORORDNINGEN FRA?
Den trådte i kraft den 
25. maj 2017
. Med ændringsforordning (EU) 2020/561 har den været gældende siden den 
26. maj 2021
, et år senere end det oprindeligt var hensigten. Nogle af bestemmelserne i forordningen har dog andre ikrafttrædelsesdatoer; dette fremgår af artikel 120, 122 og 123 med ændringer.
BAGGRUND
Denne forordning er en af to, som EU har vedtaget for at give sin lovgivning om medicinsk udstyr et eftersyn. Den anden forordning (forordning (EU) 
2017/746
, se 
resumé
) omhandler medicinsk udstyr til 
in vitro
-diagnostik.
For yderligere oplysninger henvises til:
Medicinsk udstyr
 (Europa-Kommissionen).
VIGTIGE BEGREBER
Medicinsk udstyr.
 Et udtryk, der dækker en lang række produkter, som for eksempel anvendes til: Den forventede hovedvirkning fremkaldes ikke ad farmakologisk, immunologisk eller metabolisk vej, men sidstnævnte kan bidrage til dens funktion. Eksempler på medicinsk udstyr er bandager, kunstige hofteled og pacemakere. Den fuldstændige definition af begrebet medicinsk udstyr er fastlagt i artikel 2, stk. 1, i forordning (EU) 2017/745.
Klinisk afprøvning.
 En systematisk afprøvning, der involverer et eller flere mennesker, og som har til formål at vurdere udstyrs sikkerhed eller ydeevne.
Invasivt medicinsk udstyr.
 Udstyr, som helt eller delvis trænger ind i legemet enten gennem en legemsåbning eller gennem legemets overflade.
HOVEDDOKUMENT
Europa-Parlamentets og Rådets forordning (EU) 
2017/745
 af 
5. april 2017
 om medicinsk udstyr, om ændring af direktiv 2001/83/EF, forordning (EF) 
nr. 178/2002
 og forordning (EF) 
nr. 1223/2009
 og om ophævelse af Rådets direktiv 90/385/EØF og 93/42/EØF (EUT L 117 af 
5.5.2017
, 
s. 1-175
).
Efterfølgende ændringer af forordning (EU) 2017/745 er blevet indarbejdet i grundteksten. Denne 
konsoliderede udgave
 har ingen retsvirkning.
TILHØRENDE DOKUMENTER
Europa-Parlamentets og Rådets forordning (EU) 
2017/746
 af 
5. april 2017
 om medicinsk udstyr til in vitro-diagnostik og om ophævelse af direktiv 98/79/EF og Kommissionens afgørelse 2010/227/EU (EUT L 117 af 
5.5.2017
, 
s. 176-332
).
Se den 
konsoliderede udgave
.
seneste ajourføring 
27.1.2022