CELEX ID: 32017R0746

--- ENGLISH ---

Document:
5.5.2017
EN
Official Journal of the European Union
L 117/176
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
(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)
Directive 98/79/EC of the European Parliament and of the Council 
(
3
)
 constitutes the Union regulatory framework for 
in vitro
 diagnostic medical devices. However, a fundamental revision of that Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for 
in vitro
 diagnostic 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 
in vitro
 diagnostic 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 
in vitro
 diagnostic 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 
in vitro
 diagnostic 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 
in vitro
 diagnostic medical devices by ensuring, among other things, that data generated in performance studies are reliable and robust and that the safety of subjects participating in performance studies is protected.
(3)
This Regulation does not seek to harmonise rules relating to the further making available on the market of 
in vitro
 diagnostic 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, risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding 
in vitro
 diagnostic medical devices should be introduced, to improve health and safety.
(5)
To the extent possible, guidance developed for 
in vitro
 diagnostic medical devices at international level, in particular in the context of the Global Harmonization Task Force and its follow-up initiative, the International Medical Devices Regulators Forum, 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 evidence.
(6)
There are specific features of 
in vitro
 diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the 
in vitro
 diagnostic medical device sector which require the adoption of specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned.
(7)
The scope of application of this Regulation should be clearly delimited from other legislation concerning products, such as medical devices, general laboratory products and products for research use only.
(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, the European Chemicals Agency and the European Food Safety Authority, as relevant.
(9)
It appears that it is possible that divergent national rules regarding the provision of information and counselling in relation to genetic testing might only have an impact on the smooth functioning of the internal market to a limited extent. Therefore, it is appropriate to lay down only limited requirements in this regard in this Regulation, having regard to the need to ensure constant respect of the principles of proportionality and subsidiarity.
(10)
It should be made clear that all tests that provide information on the predisposition to a medical condition or a disease, such as genetic tests, and tests that provide information to predict treatment response or reactions, such as companion diagnostics, are 
in vitro
 diagnostic medical devices.
(11)
Companion diagnostics are essential for defining patients' eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at a higher risk of developing an adverse reaction to the medicinal product in question or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective. Such biomarker or biomarkers can be present in healthy subjects and/or in patients.
(12)
Devices that are used with a view to monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be companion diagnostics.
(13)
The requirement to reduce risks as far as possible should be fulfilled taking into account the generally acknowledged state of the art in the field of medicine.
(14)
Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council 
(
4
)
 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.
(15)
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 
(
5
)
 which pursues other objectives.
(16)
This Regulation should include requirements for devices' safety and performance characteristics which are developed in such a way as to prevent occupational injuries, including protection from radiation.
(17)
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 an 
in vitro
 diagnostic medical device, qualifies as an 
in vitro
 diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being purposes is not an 
in vitro
 diagnostic 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.
(18)
The definitions in this Regulation regarding the devices themselves, the making available of devices, economic operators, users and specific processes, the conformity assessment, clinical evidence, 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.
(19)
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 
(
6
)
 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.
(20)
To recognise the important role of standardisation in the field of 
in vitro
 diagnostic medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council 
(
7
)
 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.
(21)
Directive 98/79/EC 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 performance studies and performance evaluation and/or post-market follow-up, laid down in this Regulation.
(22)
Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and taking account of the European and international standards.
(23)
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 
(
8
)
 and Decision No 768/2008/EC of the European Parliament and of the Council 
(
9
)
.
(24)
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.
(25)
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.
(26)
For the purpose of this Regulation, the activities of distributors should be deemed to include acquisition, holding and supplying of devices.
(27)
Several of the obligations on manufacturers, such as performance evaluation or vigilance reporting, that were set out only in the Annexes to Directive 98/79/EC, should be incorporated into the enacting provisions of this Regulation to facilitate its application.
(28)
To ensure the highest level of health protection, the rules governing 
in vitro
 diagnostic medical devices, manufactured and used within a single health institution only, should be clarified and strengthened. That use should be understood to include measurement and delivery of results.
(29)
Health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby addressing, 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 devices manufactured and used only within health institutions, including hospitals as well as institutions, such as laboratories and public health institutes that support the health care 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.
(30)
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 
(
10
)
. 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.
(31)
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 incidents and field safety corrective actions.
(32)
The risk management system should be carefully aligned with and reflected in the performance evaluation process for the device, including the clinical risks to be addressed as part of performance studies, performance evaluation and post-market performance follow-up. The risk management and performance evaluation processes should be inter-dependent and should be regularly updated.
(33)
It should be ensured that supervision and control of the manufacture of devices, as well as 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.
(34)
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.
(35)
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.
(36)
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 
(
11
)
 in other relevant sectors and existing good practice in the field of 
in vitro
 diagnostic medical devices.
(37)
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.
(38)
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.
(39)
The UDI system should apply to all devices placed on the market except devices for performance studies, 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 and in Regulation (EU) 2017/745 of the European Parliament and of the Council 
(
12
)
.
(40)
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.
(41)
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, performance studies, 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 
(
13
)
.
(42)
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.
(43)
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 performance studies 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.
(44)
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 
(
14
)
 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 
(
15
)
 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.
(45)
For class C and D devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the performance evaluation in a document that should be publicly available.
(46)
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.
(47)
Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on performance 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.
(48)
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.
(49)
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.
(50)
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.
(51)
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.
(52)
For class D devices, competent authorities should be informed about certificates granted by notified bodies and be given the right to scrutinise the assessment conducted by notified bodies.
(53)
For class D devices for which no CS exist it is appropriate to provide that where it is the first certification for that specific type of device and there is no similar device on the market having the same intended purpose and based on similar technology, notified bodies should, in addition to the laboratory testing of the performance claimed by the manufacturer and the compliance of the device by the EU reference laboratories, be obliged to request expert panels to scrutinise their performance evaluation assessment reports. The consultation of expert panels in relation to the performance evaluation should lead to a harmonised evaluation of high-risk 
in vitro
 diagnostic medical devices by sharing expertise on performance aspects and developing CS on categories of devices that have undergone that consultation process.
(54)
To enhance patient safety and to take due account of technological progress, the current classification system for devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the corresponding conformity assessment procedures should be accordingly adapted.
(55)
It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in four risk classes and to establish a set of robust risk-based classification rules, in line with international practice.
(56)
The conformity assessment procedure for class A devices should be carried out, as a general rule, under the sole responsibility of manufacturers, since such devices pose a low risk to patients. For class B, class C and class D devices, an appropriate level of involvement of a notified body should be compulsory.
(57)
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.
(58)
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.
(59)
It is necessary to clarify the requirements regarding batch release verification for the highest risk devices.
(60)
EU reference laboratories should be enabled to verify by laboratory testing the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
(61)
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 evidence. It is necessary to clarify the requirements for the demonstration of the clinical evidence, that is based on data on scientific validity, and the analytical performance and clinical performance of the device. To allow for a structured and transparent process, generating reliable and robust data, sourcing and assessment of available scientific information and data generated in performance studies should be based on a performance evaluation plan.
(62)
As a general rule, clinical evidence should be sourced from performance studies 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 performance study.
(63)
It is necessary to ensure that the clinical evidence of devices is updated throughout their lifecycle. Such updating entails the planned monitoring of scientific developments and changes in medical practice by the manufacturer. Relevant new information should then trigger a reassessment of the clinical evidence of the device thus ensuring safety and performance through a continuous process of performance evaluation.
(64)
It should be recognised that the concept of clinical benefit for 
in vitro
 diagnostic medical devices is fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical devices, since the benefit of 
in vitro
 diagnostic medical devices lies in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available.
(65)
Where specific devices have no analytical or clinical performance or specific performance requirements are not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions relating to such requirements.
(66)
The rules on performance studies 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 performance studies conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies 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.
(67)
It should be left to the Member State where a performance study is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a performance study and to organise the involvement of ethics committees within the timelines for the authorisation of that performance study 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.
(68)
An electronic system should be set up at Union level to ensure that every interventional clinical performance study and other performance study involving risks for the subjects of the studies is recorded and reported in a publicly accessible database. To protect the right to 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 performance study should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use.
(69)
Where an interventional clinical performance study or another performance study involving risks for the subjects 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 device for performance study and of the scientific design of that performance study, 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 performance study, 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.
(70)
Sponsors should report certain adverse events and device deficiencies that occur during interventional clinical performance studies and other performance studies involving risks for the subjects to the Member States in which those studies are being conducted. Member States should have the possibility of terminating or suspending the studies or revoking the authorisation for those studies, if considered necessary to ensure a high level of protection of the subjects participating in such studies. Such information should be communicated to the other Member States.
(71)
The sponsor of a performance study should submit a summary of results of the performance study that is easily understandable for the intended user together with the performance study 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.
(72)
With exemption of some general requirements, this Regulation should only cover performance studies intended to gather scientific data for the purpose of demonstrating conformity of devices.
(73)
It is necessary to clarify that performance studies using left-over specimens need not be authorised. Nevertheless, the general requirements and other additional requirements with regard to data protection and the requirements applicable to procedures that are performed in accordance with national law such as ethical review should continue to apply to all performance studies, including when using left-over specimens.
(74)
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 the Council 
(
16
)
 should be observed. In particular, the unnecessary duplication of tests and studies should be avoided.
(75)
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 that 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 performance evaluation, and should also serve the purposes of transparency.
(76)
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.
(77)
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 incident and, where a manufacturer confirms that such an incident might have occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents.
(78)
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.
(79)
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.
(80)
The reporting of serious adverse events or device deficiencies during interventional clinical performance studies and other performance studies involving risks for the subjects, and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.
(81)
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.
(82)
Any statistically significant increase in the number or severity of incidents that are not serious or in expected erroneous results 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.
(83)
An expert committee, the 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 in accordance with the conditions and modalities defined in Regulation (EU) 2017/745 to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/745, 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.
(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 uniform high level of health and safety protection within the internal market, in particular in the areas of performance studies 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 devices to facilitate the exchange of safety-related information regarding devices and 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 
(
17
)
. 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 
(
18
)
.
(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 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 and EU reference 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 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 Directive 98/79/EC and to their capacity to continue issuing valid certificates under that Directive 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 Directive 98/79/EC 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)
Directive 98/79/EC should be repealed to ensure that only one set of rules applies to the placing of 
in vitro
 diagnostic 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 that Directive 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 adverse incidents related to devices placed on the market pursuant to that Directive using the same tools as those for reporting on devices placed on the market pursuant to this Regulation. However, Decision 2010/227/EU adopted in implementation of that Directive and Council Directives 90/385/EEC 
(
19
)
 and 93/42/EEC 
(
20
)
 should also be repealed as from the date when Eudamed becomes fully functional.
(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 98/79/EC.
(100)
The European Data Protection Supervisor has given an opinion 
(
21
)
 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 
in vitro
 diagnostic 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
INTRODUCTORY PROVISIONS
Section 1
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 
in vitro
 diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such 
in vitro
 diagnostic medical devices and accessories conducted in the Union.
2.   For the purposes of this Regulation, 
in vitro
 diagnostic medical devices and accessories for 
in vitro
 diagnostic medical devices shall hereinafter be referred to as ‘devices’.
3.   This Regulation does not apply to:
(a)
products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for 
in vitro
 diagnostic examination;
(b)
invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;
(c)
internationally certified reference materials;
(d)
materials used for external quality assessment schemes.
4.   Any device which, when placed on the market or put into service, incorporates, as an integral part, a medical device as defined in point 1 of Article 2 of Regulation (EU) 2017/745 shall be governed by that Regulation. The requirements of this Regulation shall apply to the 
in vitro
 diagnostic medical device part.
5.   This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.
6.   Devices which 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 
(
22
)
 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.
7.   This Regulation shall not affect the application of Directive 2013/59/Euratom.
8.   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.
9.   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 health care institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling.
10.   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 ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745;
(2)
‘
in vitro
 diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used 
in vitro
 for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
(a)
concerning a physiological or pathological process or state;
(b)
concerning congenital physical or mental impairments;
(c)
concerning the predisposition to a medical condition or a disease;
(d)
to determine the safety and compatibility with potential recipients;
(e)
to predict treatment response or reactions;
(f)
to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be 
in vitro
 diagnostic medical devices;
(3)
‘specimen receptacle’ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of 
in vitro
 diagnostic examination;
(4)
‘accessory for an 
in vitro
 diagnostic medical device’ means an article which, whilst not being itself an 
in vitro
 diagnostic medical device, is intended by its manufacturer to be used together with one or several particular 
in vitro
 diagnostic medical device(s) to specifically enable the 
in vitro
 diagnostic 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 
in vitro
 diagnostic medical device(s) in terms of its/their intended purpose(s);
(5)
‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services;
(6)
‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional;
(7)
‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to:
(a)
identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
(b)
identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product;
(8)
‘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;
(9)
‘single-use device’ means a device that is intended to be used during a single procedure;
(10)
‘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;
(11)
‘kit’ means a set of components that are packaged together and intended to be used to perform a specific 
in vitro
 diagnostic examination, or a part thereof;
(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 or as specified by the manufacturer in the performance 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)
‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
(17)
‘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;
(18)
‘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;
(19)
‘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;
(20)
‘making available on the market’ means any supply of a device, other than a device for performance study, 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;
(21)
‘placing on the market’ means the first making available of a device, other than a device for performance study, on the Union market;
(22)
‘putting into service’ means the stage at which a device, other than a device for performance study, 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;
(23)
‘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 trade mark;
(24)
‘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;
(25)
‘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;
(26)
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
(27)
‘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;
(28)
‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
(29)
‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
(30)
‘user’ means any healthcare professional or lay person who uses a device;
(31)
‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
(32)
‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
(33)
‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;
(34)
‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
(35)
‘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;
(36)
‘clinical evidence’ means clinical data and performance 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;
(37)
‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;
(38)
‘scientific validity of an analyte’ means the association of an analyte with a clinical condition or a physiological state;
(39)
‘performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose;
(40)
‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte;
(41)
‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;
(42)
‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;
(43)
‘performance study plan’ means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study;
(44)
‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;
(45)
‘device for performance study’ means a device intended by the manufacturer to be used in a performance study.
A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study;
(46)
‘interventional clinical performance study’ means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment;
(47)
‘subject’ means an individual who participates in a performance study and whose specimen(s) undergo 
in vitro
 examination by a device for performance study and/or by a device used for control purposes;
(48)
‘investigator’ means an individual responsible for the conduct of a performance study at a performance study site;
(49)
‘diagnostic specificity’ means the ability of a device to recognise the absence of a target marker associated with a particular disease or condition;
(50)
‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker associated with a particular disease or condition;
(51)
‘predictive value’ means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition;
(52)
‘positive predictive value’ means the ability of a device to separate true positive results from false positive results for a given attribute in a given population;
(53)
‘negative predictive value’ means the ability of a device to separate true negative results from false negative results for a given attribute in a given population;
(54)
‘likelihood ratio’ means the likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state;
(55)
‘calibrator’ means a measurement reference material used in the calibration of a device;
(56)
‘control material’ means a substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device;
(57)
‘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 performance study;
(58)
‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study 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 performance study;
(59)
‘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;
(60)
‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision, 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 performance study, whether or not related to the device for performance study;
(61)
‘serious adverse event’ means any adverse event that led to any of the following:
(a)
a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring,
(b)
death,
(c)
serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, 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,
(d)
foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
(62)
‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer;
(63)
‘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;
(64)
‘market surveillance’ means the activities carried out and measures taken by public 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;
(65)
‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;
(66)
‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;
(67)
‘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 harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device;
(68)
‘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;
(69)
‘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;
(70)
‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;
(71)
‘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;
(72)
‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;
(73)
‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
(74)
‘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.
Section 2
Regulatory status of products and counselling
Article 3
Regulatory status of products
1.   Upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of Regulation (EU) 2017/745 (MDCG), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘
in vitro
 diagnostic medical device’ or ‘accessory for an 
in vitro
 diagnostic medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(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 107(3).
3.   The Commission shall ensure that Member States share expertise in the fields of 
in vitro
 diagnostic medical devices, 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 and the European Food Safety Authority, as relevant.
Article 4
Genetic information, counselling and informed consent
1.   Member States shall ensure that where a genetic test is used on individuals, in the context of healthcare as defined in point (a) of Article 3 of Directive 2011/24/EU of the European Parliament and of the Council 
(
23
)
 and for the medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing, the individual being tested or, where applicable, his or her legally designated representative is provided with relevant information on the nature, the significance and the implications of the genetic test, as appropriate.
2.   In the context of the obligations referred to in paragraph 1, Member States shall, in particular, ensure that there is appropriate access to counselling in the case of the use of genetic tests that provide information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable according to the state of science and technology.
3.   Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease which the individual being tested is already known to have is confirmed by a genetic test or in cases where a companion diagnostic is used.
4.   Nothing in this Article shall prevent Member States from adopting or maintaining measures at national level which are more protective of patients, more specific or which deal with informed consent.
CHAPTER II
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, 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 performance evaluation in accordance with Article 56.
4.   Devices that are manufactured and used within health institutions, with the exception of devices for performance studies, 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 laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation;
(d)
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;
(e)
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;
(f)
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;
(g)
as regards class D devices in accordance with the rules set out in Annex VIII, 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. Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;
(h)
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g); and
(i)
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 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 107(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, performance studies, clinical evidence or post-market performance follow-up (‘PMPF’).
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, provided that references to those monographs have been published in the 
Official Journal of the European Union
.
Article 9
Common specifications
1.   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 performance evaluation and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annex XIII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(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.
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 performance evaluation in accordance with the requirements set out in Article 56 and Annex XIII, including a PMPF.
4.   Manufacturers shall draw up and keep up to date the 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 108 amending, in the light of technical progress, the Annexes II and III.
5.   Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devices for performance study, shall draw up an EU declaration of conformity in accordance with Article 17, and affix the CE marking of conformity in accordance with Article 18.
6.   Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 24 and with the registration obligations referred to in Article 26 and 28.
7.   Manufacturers shall keep 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 51, 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.
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.
8.   Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a product is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than devices for performance study, 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 Section 3 of Annex I;
(f)
performance evaluation, in accordance with Article 56 and Annex XIII, including PMPF;
(g)
product realisation, including planning, design, development, production and service provision;
(h)
verification of the UDI assignments made in accordance with Article 24(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 26;
(i)
setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 78;
(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.
9.   Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 78.
10.   Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 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.
The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing shall be easily understandable and provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient.
11.   Manufacturers that 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 51, in particular, of the non-compliance and of any corrective action taken.
12.   Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 82 and 83.
13.   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.
14.   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 27(1).
15.   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 51, at the disposal of competent authorities for the period referred to in Article 10(7);
(c)
comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied with the registration obligations laid down in Article 26;
(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), (5), (6), (8), (9), (10) and (11).
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 grounds 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 24.
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 26. Importers shall add their details to the registration in accordance with Article 28.
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 51 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(7), keep a copy of the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51.
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 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(10);
(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 
in vitro
 diagnostic 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 
in vitro
 diagnostic medical devices;
(b)
four years of professional experience in regulatory affairs or in quality management systems relating to 
in vitro
 diagnostic medical devices.
2.   Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC 
(
24
)
 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(9);
(d)
the reporting obligations referred to in Articles 82 to 86 are fulfilled;
(e)
in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV 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 
in vitro
 diagnostic 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 
in vitro
 diagnostic medical devices;
(b)
four years of professional experience in regulatory affairs or in quality management systems relating to 
in vitro
 diagnostic 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 own 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 (23) 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 20 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 referred to 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 a 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
EU declaration of conformity
1.   The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled. 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 108 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
Article 18
CE marking of conformity
1.   Devices, other than devices for performance studies, 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 48. 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 19
Devices for special purposes
1.   Member States shall not create obstacles to devices for performance study being supplied for that purpose to laboratories or other institutions, if they meet the conditions laid down in Articles 57 to 76, and in the implementing acts adopted pursuant to Article 77.
2.   The devices referred to in paragraph 1 shall not bear the CE marking, with the exception of the devices referred to in Article 70.
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 that 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 20
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 21
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 22
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(7):
(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 23
Medical devices nomenclature
To facilitate the functioning of the European database on medical devices (Eudamed) as referred to in Article 33 of Regulation (EU) 2017/745, 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 24
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 devices for performance studies, 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 respectively;
(d)
establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28 of Regulation (EU) 2017/745.
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, health institutions and healthcare professionals.
3.   Before placing a device, other than a device for performance study, 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 device for performance study, is placed on the market the manufacturer must ensure that the information referred to in Part B of Annex V of the device in question are correctly submitted and transferred to the UDI database referred to in Article 25.
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 82.
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 17.
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 the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11.
9.   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, health care 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 108:
(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 107(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 102 and 103 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 health care systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders.
Article 25
UDI database
The Commission, after consulting the MDCG, shall set up and manage a UDI database in accordance with the conditions and detailed arrangements provided for in Article 28 of Regulation (EU) 2017/745.
Article 26
Registration of devices
1.   Before placing a device on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 24(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.   For devices that are the subject of a conformity assessment as referred to in Article 48(3) and (4), the second subparagraph of Article 48(7), Article 48(8) and the second subparagraph of Article 48(9), 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 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.
3.   Before placing a device on the market, 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 thereafter shall keep the information updated.
Article 27
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 28(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 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 28
Registration of manufacturers, authorised representatives and importers
1.   Before placing a 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 48, 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 27 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 26.
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 27.
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 27 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 104.
Article 29
Summary of safety and performance
1.   For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary of safety and performance.
The summary of safety and 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 performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48 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 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, contra-indications 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)
reference to any harmonised standards and CS applied;
(e)
the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF;
(f)
the metrological traceability of assigned values;
(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 performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2).
Article 30
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’) in accordance with the conditions and detailed arrangements established by Articles 33 and 34 of Regulation (EU) 2017/745.
2.   Eudamed shall include the following electronic systems:
(a)
the electronic system for registration of devices referred to in Article 26;
(b)
the UDI database referred to in Article 25;
(c)
the electronic system on registration of economic operators referred to in Article 27;
(d)
the electronic system on notified bodies and on certificates referred to in Article 52;
(e)
the electronic system on performance studies referred to in Article 69,
(f)
the electronic system on vigilance and post-market surveillance referred to in Article 87;
(g)
the electronic system on market surveillance referred to in Article 95.
CHAPTER IV
NOTIFIED BODIES
Article 31
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 (the ‘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 
in vitro
 diagnostic medical devices, it shall ensure that the national authority responsible for 
in vitro
 diagnostic 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 peer-review activities provided for in Article 44.
Article 32
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 107(3).
Article 33
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 34
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 35. 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 35
Assessment of the application
1.   The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 34 is complete and shall request the applicant to provide any missing information. Once the application is complete that national 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 36. 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 competent 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 43(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 34. 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 of 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 34 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 107(3).
Article 36
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 
in vitro
 diagnostic medical devices to participate in the activities referred to in Articles 35 and 44.
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 52.
Article 37
Language requirements
All documents required pursuant to Articles 34 and 35 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 34 and 35, 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 35(3).
Article 38
Designation and notification procedure
1.   Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 35 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 40, 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 35(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 40, 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 add to the electronic system referred to in Article 52 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 response 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 107(3). The Commission, after consulting the MDCG, may update this list based, inter alia, on information arising from the coordination activities described in Article 44.
Article 39
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 38(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 Directive 98/79/EC shall retain the identification number assigned to them pursuant to that Directive.
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 52. The Commission shall ensure that the list is kept up to date.
Article 40
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 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 performance evaluation documentation as further outlined in Article 41.
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 34 and 35.
11.   The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to amend paragraph 10 of this Article 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 52.
Article 41
Review of notified body assessment of technical documentation and performance 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 performance evaluation documentation 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 performance 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 40(10) and the joint assessment activities referred to in Article 43(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, or 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 performance 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 performance evaluation documentation, as referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Article 42
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 35 and in Article 38 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 52.
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 in the electronic system referred to in Article 52 information in relation to certificates of which it has required their suspension or withdrawal;
(e)
inform the competent authority for 
in vitro
 diagnostic medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 52 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 
in vitro
 diagnostic 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 
in vitro
 diagnostic 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 national competent authority for 
in vitro
 diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered 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 43
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 35(3) and (5) 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 35. 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 36 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 40 and as outlined in the annual assessment plan described in Article 40(4) therein.
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 107(3). It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 52.
5.   The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly.
Article 44
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 36;
(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 38(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 35. Alternatively, a national authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 40.
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 mechanisms 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 107(3).
Article 45
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 the coordination group of notified bodies, as referred to in Article 49 of Regulation (EU) 2017/745.
The bodies notified under this Regulation shall participate in the work of that group.
Article 46
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 47
Classification of devices
1.   Devices shall be divided into classes A, B, C and D, 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 107(3).
Section 2
Conformity assessment
Article 48
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, with the exception of in-house devices manufactured pursuant to Article 5(5), 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 D devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I, II except for Section 5, and in Chapter III of Annex IX.
In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX.
In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council 
(
25
)
 or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.
4.   Manufacturers of class D devices, other than devices for performance study, may, instead of the conformity assessment procedure applicable pursuant to paragraph 3, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.
For companion diagnostics, the notified body shall in particular consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
5.   In particular, and without prejudice to any of the obligations pursuant to the other procedures referred to in paragraphs 3 and 4, for devices for which one or more EU reference laboratories have been designated in accordance with Article 100, the notified body performing the conformity assessment shall request one of the EU reference laboratories to verify by laboratory testing the performance claimed by the manufacturer and the compliance of the device with the applicable CS, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 4.9 of Annex IX and in point (j) of Section 3 of Annex X. Laboratory tests performed by an EU reference laboratory shall in particular focus on analytical and diagnostic sensitivity using the best available reference materials.
6.   In addition to the procedure applicable pursuant to paragraphs 3 and 4, where no CS are available for class D devices and where it is also the first certification for that type of device, the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer. To that end, the notified body shall provide the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the manufacturer. The relevant experts shall, under the supervision of the Commission, provide their views, in accordance with Section 4.9 of Annex IX or point (j) of Section 3 of Annex X, as applicable, to the notified body within the deadline for delivery of the scientific opinion by the EU reference laboratory as specified therein.
7.   Manufacturers of class C devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex of at least one representative device per generic device group.
In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX.
In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.
8.   Manufacturers of class C devices, other than devices for performance study, may, instead of the conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5.
For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
9.   Manufacturers of class B devices, other than devices for performance study, 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 Sections 4.4 to 4.8 of that Annex for at least one representative device per category of devices.
In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out in Section 5.1 of Annex IX.
10.   Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III.
However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions.
11.   Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77.
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 10 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.   The Commission may, by means of implementing acts, specify the 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 third paragraph of Section 2.3. and in Section 3.5 of Annex IX, in the case of class C 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 frequency of samples of the manufactured devices or batches of class D devices to be sent to an EU reference laboratory designated under Article 100 in accordance with Section 4.12 of Annex IX and Section 5.1 of Annex XI; or
(d)
the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX and points (f) and (g) of Section 3. of Annex X.
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Article 49
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 52, 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 50
Mechanism for scrutiny of conformity assessments of class D devices
1.   A notified body shall notify the competent authority of certificates it has granted for class D devices, with the exception of applications to supplement or renew existing certificates. Such notification shall take place through the electronic system referred to in Article 52 and shall include the instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106 of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, 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 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in accordance with to Articles 90 and 92.
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 51
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 users or require manufacturers to undertake specific PMPF studies pursuant to Part B of Annex XIII.
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 52 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 108 amending the minimum content of the certificates set out in Annex XII.
Article 52
Electronic system on notified bodies and on certificates of conformity
For the purposes of this Regulation, the following information shall be collated and processed pursuant to Article 57 of Regulation (EU) 2017/745 in the electronic system set up in accordance with that Article:
(a)
the list of subsidiaries referred to in Article 33(2);
(b)
the list of experts referred to in Article 36(2);
(c)
the information relating to the notification referred to in Article 38(10) and the amended notifications referred to in Article 42(2);
(d)
the list of notified bodies referred to in Article 39(2);
(e)
the summary of the report referred to in Article 40(12);
(f)
the notifications for conformity assessments and certificates referred to in Article 50(1);
(g)
withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and Section 4.3 of Annex VII;
(h)
the information regarding certificates referred to in Article 51(5);
(i)
the summary of safety and performance referred to in Article 29.
Article 53
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 54
Derogation from the conformity assessment procedures
1.   By way of derogation from Article 48, 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 107(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 107(4).
Article 55
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 26. Where a notified body has issued a certificate pursuant to Article 51, 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 107(2).
CHAPTER VI
CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES
Article 56
Performance evaluation and clinical evidence
1.   Confirmation of conformity with relevant general safety and performance requirements set out in Annex I, in particular those concerning the performance characteristics referred to in Chapter I and Section 9 of Annex I, under the normal conditions of the intended use of the device, and the evaluation of the interference(s) and cross-reaction(s) and of the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I, shall be based on scientific validity, analytical and clinical performance 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 the 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 performance evaluation in accordance with this Article and with Part A of Annex XIII.
2.   The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.
3.   A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of the following, in accordance with this Article and with Part A of Annex XIII:
(a)
scientific validity;
(b)
analytical performance;
(c)
clinical performance.
The data and conclusions drawn from the assessment of those elements shall constitute the clinical evidence for the device. The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance, that the relevant general safety and performance requirements set out in Annex I, are fulfilled, under normal conditions of use.
4.   Clinical performance studies in accordance with Section 2 of Part A of Annex XIII shall be carried out unless it is duly justified to rely on other sources of clinical performance data.
5.   The scientific validity data, the analytical performance data and the clinical performance data, their assessment and the clinical evidence derived therefrom, shall be documented in the performance evaluation report referred to in Section 1.3.2 of Part A of Annex XIII. The performance evaluation report shall be part of the technical documentation, referred to in Annex II, relating to the device concerned.
6.   The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer's PMPF plan in accordance with Part B of Annex XIII and the post-market surveillance plan referred to in Article 79.
The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually, with the data referred to in the first subparagraph. The summary of safety and performance referred to in Article 29(1) shall be updated as soon as possible, where necessary.
7.   Where necessary to ensure the uniform application of Annex XIII, 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 107(3).
Article 57
General requirements regarding performance studies
1.   The manufacturer shall ensure that a device for performance study complies with the general safety and performance requirements set out in Annex I apart from the aspects covered by the performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons.
2.   Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device.
3.   Performance studies shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all other interests and the data generated are scientifically valid, reliable and robust.
Performance studies, including performance studies that use left-over samples, shall be conducted in accordance with applicable law on data protection.
Article 58
Additional requirements for certain performance studies
1.   Any performance study:
(a)
in which surgically invasive sample-taking is done only for the purpose of the performance study;
(b)
that is an interventional clinical performance study as defined in point (46) of Article 2; or
(c)
where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies,
shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised, conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV.
2.   Performance studies involving companion diagnostics shall be subject to the same requirements as the performance studies listed in paragraph 1. This does not apply to performance studies involving companion diagnostics using only left-over samples. Such studies shall however be notified to the competent authority.
3.   Performance studies 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 performance study. At least one lay person shall participate in the ethical review.
4.   Where the sponsor of a performance study 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 performance studies 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 performance study who shall be the addressee for all communications with the sponsor provided for in this Regulation.
5.   A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
(a)
the performance study is the subject of an authorisation by the Member State(s) in which the performance study 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 performance study, 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 4 is established in the Union;
(d)
vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64;
(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 59;
(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 performance study 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 performance study plan and constantly monitored;
(j)
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, any other person entitled by national law to provide the relevant patient care under performance study 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 performance study;
(l)
where appropriate, biological safety testing reflecting the latest scientific knowledge or any other test deemed necessary in the light of the device's intended purpose has been conducted;
(m)
in the case of clinical performance studies, the analytical performance has been demonstrated, taking into consideration the state of the art;
(n)
in the case of interventional clinical performance studies, the analytical performance and scientific validity has been demonstrated, taking into consideration the state of the art. Where, for companion diagnostics, the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided;
(o)
the technical safety of the device with regard to its use has been proven, taking into consideration the state of the art as well as provisions in the field of occupational safety and accident prevention;
(p)
the requirements of Annex XIV are fulfilled.
6.   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 performance study 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.
7.   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 or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.
8.   Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used.
Article 59
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 performance study.
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 performance study;
(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 performance study at any time without any resulting detriment and without having to provide any justification;
(iii)
the conditions under which the performance study is to be conducted, including the expected duration of the subject's participation in the performance study; and
(iv)
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the performance study 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; and
(d)
include information about the applicable damage compensation system referred to in Article 65;
(e)
include the Union-wide unique single identification number for the performance study referred to in Article 66(1) and information about the availability of the performance study 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 report of the performance study and a summary presented in terms understandable to the intended user will be made available pursuant to Article 73(5) in the electronic system on performance studies referred to in Article 69, irrespective of the outcome of the performance study, 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 performance study.
Article 60
Performance studies 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 performance study may be conducted only where, in addition to the conditions set out in Article 58(5), 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 59(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 59(2) to refuse participation in, or to withdraw from, the performance study 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 performance study;
(e)
the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods;
(f)
the performance study relates directly to a medical condition from which the subject suffers;
(g)
there are scientific grounds for expecting that participation in the performance study will produce:
(i)
a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
(ii)
some benefit for the population represented by the incapacitated subject concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition.
2.   The subject shall as far as possible take part in the informed consent procedure.
3.   Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved.
Article 61
Performance studies on minors
1.   A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58(5), 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 59(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 59(2) to refuse participation in, or to withdraw from, the performance study 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 performance study;
(e)
the performance study is intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods;
(f)
the performance study 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 performance study will produce:
(i)
a direct benefit to the minor subject outweighing the risks and burdens involved; or
(ii)
some benefit for the population represented by the minor concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor's condition;
(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 performance study the minor reaches the age of legal competence to give informed consent as defined in the national law, his or her express informed consent shall be obtained before that subject can continue to participate in the performance study.
2.   Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on minors, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved.
Article 62
Performance studies on pregnant or breastfeeding women
A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met:
(a)
the performance study 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)
if such a performance study has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if:
(i)
a performance study of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding;
(ii)
the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and
(iii)
the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth;
(c)
where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child;
(d)
no incentives or financial inducements are given to subjects, except for compensation for expenses and loss of earnings directly related to the participation in the performance study.
Article 63
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 performance studies, or persons in residential care institutions.
Article 64
Performance studies in emergency situations
1.   By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information on the performance studies may be given, after the decision to include the subject in the performance study, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical performance study plan for that performance study 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 performance study;
(b)
there are scientific grounds to expect that participation of the subject in the performance study 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 performance study previously expressed by the subject;
(e)
the performance study 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 performance study is of such a nature that it may be conducted exclusively in emergency situations;
(f)
the performance study 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 59 shall be sought to continue the participation of the subject in the performance study, and information on the performance study 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 59(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 59(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 performance study 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 performance study.
Article 65
Damage compensation
1.   Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a performance study 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 performance study is conducted.
Article 66
Application for performance studies
1.   The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an application to the Member State(s) in which the performance study is to be conducted (referred to for the purposes of this Article as ‘Member State concerned’) accompanied by the documentation referred to in Sections 2 and 3 of Annex XIII and in Annex XIV.
The application shall be submitted by means of the electronic system referred to in Article 69, which shall generate a Union-wide unique single identification number for the performance study which shall be used for all relevant communication in relation to that performance study. Within 10 days of receiving the application, the Member State concerned shall notify the sponsor as to whether the performance study falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I of Annex XIV.
2.   Within one week of any change occurring in relation to the documentation referred to in Chapter I of Annex XIV, the sponsor shall update the relevant data in the electronic system referred to in Article 69 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 performance study applied for does not fall within the scope of this Regulation or that the application 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 69. 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 that the application falls under the scope of this Regulation and/or is complete but the Member State concerned does not agree, 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 performance study 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 paragraphs 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 deadline pursuant to the 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 performance study in the following circumstances:
(a)
in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated by national law, immediately after the validation date of application described in paragraph 5 of this Article, 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 performance study;
(b)
in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, 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 performance study. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application 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 108 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV.
9.   In order to assure the uniform application of the requirements laid down in Chapter I of Annex XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Article 67
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 performance study, as well as free of any other undue influence.
2.   Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience.
3.   Member States shall assess whether the performance study 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 device(s) for performance study with the applicable general safety and performance requirements, apart from the aspects covered by the performance study, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, in case of performance studies, the evaluation of the analytical performance, and in case of interventional clinical performance studies, the evaluation of the analytical performance, clinical performance and scientific validity, taking into consideration the state of the art;
(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 device for performance study are adequate;
(d)
the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the performance study and methodological aspects, including sample size, comparator and endpoints;
(e)
whether the requirements of Annex XIV are met.
4.   Member States shall refuse the authorisation of the performance study if:
(a)
the application dossier submitted pursuant to Article 66(3) remains incomplete;
(b)
the device or the submitted documents, especially the performance study plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the performance study, 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 58 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 68
Conduct of a performance study
1.   The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study 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 performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. 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 performance study including the following:
(a)
the objective and methodology of the performance study; and
(b)
the degree of deviation of the intervention from normal clinical practice.
3.   All performance study 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, performance study site(s) to check that performance studies 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 study.
Article 69
Electronic system on performance studies
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 performance studies referred to in Article 66(1);
(b)
to be used as an entry point for the submission of all applications or notifications for performance studies referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context;
(c)
for the exchange of information relating to performance studies in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in to Articles 72 and 74;
(d)
for information to be provided by the sponsor in accordance with Article 73, including the performance study 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 76.
2.   When setting up the electronic system referred to 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 
(
26
)
 as concerns performance studies of companion diagnostics.
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 performance study 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 70
Performance studies regarding devices bearing the CE marking
1.   Where a performance study 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 18(1) (‘PMPF study’), and where the performance study 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 69. The sponsor shall include the documentation referred to in Section 2 of Part A of Annex XIII and in Annex XIV. Points (b) to (l) and (p) of Article 58(5), and Articles 71, 72 and 73 Article 76(5) and the relevant provisions of Annexes XIII and XIV shall apply to PMPF studies.
2.   Where a performance study 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 18(1), Articles 58 to 77 shall apply.
Article 71
Substantial modifications to performance studies
1.   If a sponsor intends to introduce modifications to a performance study 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 data generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article 69, the Member State(s) in which the performance study 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 Annex XIV 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 performance study in accordance with the procedure laid down in Article 67.
3.   The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in paragraph 1, unless:
(a)
the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or 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 performance study, 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 72
Corrective measures to be taken by Member States and information exchange between Member States on performance studies
1.   Where a Member State in which a performance study 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 performance study;
(b)
suspend or terminate the performance study;
(c)
require the sponsor to modify any aspect of the performance study.
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 performance study, or has been notified by the sponsor of the early termination of a performance study 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 69.
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 69 to all Member States and the Commission.
Article 73
Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
1.   If the sponsor has temporarily halted a performance study or has terminated a performance study early, it shall inform within 15 days the Member States in which that performance study has been temporarily halted or terminated early, through the electronic system referred to in Article 69, of the temporary halt or early termination. In the event that the sponsor has temporarily halted or terminated early the performance study on safety grounds, it shall inform all Member States in which that performance study is being conducted thereof within 24 hours.
2.   The end of a performance study 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 performance study plan.
3.   The sponsor shall notify each Member State in which that performance study was being conducted of the end of that performance study in that Member State. That notification shall be made within 15 days of the end of the performance study in relation to that Member State.
4.   If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member States. That notification shall be made within 15 days of that end of the performance study.
5.   Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII.
The performance study 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 69.
Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available. In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study 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 performance study 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 performance studies.
7.   The summary and the performance study report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 69, at the latest when the device is registered in accordance with Article 26 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 26 within one year of the summary and the performance study 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 74
Coordinated assessment procedure for performance studies
1.   By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted in more than one Member State may submit, for the purpose of Article 66, a single application that, upon receipt, is transmitted electronically to all Member States in which the performance study 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 performance study is to be conducted acts as coordinating Member State. The Member States in which the performance study 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 I of Annex XIV.
However, the completeness of the documentation referred to in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of Section 2.3.2. of Part A of Annex XIII shall be assessed separately by each Member State concerned in accordance with Article 66(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 performance study falls within the scope of this Regulation and whether the application is complete and shall notify the sponsor accordingly. Article 66(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 66(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 C and D 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 and in the case of reporting of adverse events pursuant to Article 76(4) and in the case of performance studies involving companion diagnostics, where the medicinal products 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 107(3).
8.   Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the conduct of the performance study is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member State(s) 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 performance study 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 (d) 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 69 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 performance study 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 performance study 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, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV are not complied with, or where an ethics committee has issued a negative opinion in relation to that performance study 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 69 as to whether the performance study 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 of this Article, by the coordinating Member State of the final assessment report. Where an authorisation of a performance study 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 71 shall be notified to the Member States concerned by means of the electronic system referred to in Article 69. 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, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of Section 2.3.2 of Part A of Annex XIII, 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 2029, be applied only by those of the Member States in which the performance studies are to be conducted which have agreed to apply it. After 27 May 2029, all Member States shall be required to apply that procedure.
Article 75
Review of the coordinated assessment procedure
By 27 May 2028, the Commission shall submit to the European Parliament and to the Council a report on the experience gained from the application of Article 74 and, if necessary, propose a review of Article 74(14) and point (g) of Article 113(3).
Article 76
Recording and reporting of adverse events that occur during performance studies
1.   The sponsor shall fully record all of the following:
(a)
any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study;
(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 a performance study is being conducted all of the following by means of the electronic system referred to in Article 69:
(a)
any serious adverse event that has a causal relationship with the device, the comparator or the study 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 performance study 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 performance study is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a performance study is performed under the same clinical performance study plan as the one applying to a performance study covered by this Regulation by means of the electronic system referred to in Article 69.
4.   In the case of a performance study for which the sponsor has used the single application referred to in Article 74, 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 69. Upon receipt, this report shall be transmitted electronically to all Member States in which the performance study is being conducted.
Under the direction of the coordinating Member State referred to in Article 74(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate the performance study or whether to revoke the authorisation for that performance study.
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 PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 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 performance study has been established.
Article 77
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 performance studies and their assessment as referred to in Articles 66 and 74, taking into account specific categories or groups of devices;
(b)
the functioning of the electronic system referred to in Article 69;
(c)
harmonised electronic forms for the notification of PMPF studies as referred to in Article 70(1), and of substantial modifications as referred to in Article 71;
(d)
the exchange of information between Member States as referred to in Article 72;
(e)
harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 76;
(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 76;
(g)
uniform application of the requirements regarding the clinical evidence/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 107(3).
CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
Section 1
Post-market surveillance
Article 78
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(8).
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 performance evaluation;
(d)
to update the summary of safety and performance referred to in Article 29;
(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 83.
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 82.
Article 79
Post-market surveillance plan
The post-market surveillance system referred to in Article 78 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III. The post-market surveillance plan shall be part of the technical documentation specified in Annex II.
Article 80
Post-market surveillance report
Manufacturers of class A and B 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 79 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 notified body and the competent authority upon request.
Article 81
Periodic safety update report
1.   Manufacturers of class C and class D 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 79 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 PMPF; and
(c)
the volume of sales of the device and an estimate of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the technical documentation as specified in Annexes II and III.
2.   Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
3.   For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
Section 2
Vigilance
Article 82
Reporting of serious incidents and field safety corrective actions
1.   Manufacturers of devices, made available on the Union market, other than devices for performance study, shall report, to the relevant competent authorities, in accordance with Articles 87(5) and (7), the following:
(a)
any serious incident involving devices made available on the Union market, except expected erroneous results which are clearly documented and quantified in the product information and in the technical documentation and are subject to trend reporting pursuant to Article 83;
(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 87.
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) immediately after they have established a 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 84(9), in consultation with the competent authorities referred to in points (a) and (b) of Article 87(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 87(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 84.
Where the manufacturer of the device concerned considers that the incident is not a serious incident or is to be treated as an increase in expected erroneous results, which will be covered by trend reporting in accordance with to Article 83, 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 84.
Article 83
Trend reporting
1.   Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically significant increase in the frequency or severity of incidents that are not serious incidents 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 unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I and 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 events or change in performance, as well as the observation period, in the post-market surveillance plan referred to in Article 79.
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 84
Analysis of serious incidents and field safety corrective actions
1.   Following the reporting of a serious incident pursuant to Article 82(1), the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned. This shall include risk assessment of the incident and field safety corrective action taking into account the 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 82 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 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 the 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 for 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 87. The report shall set out conclusions and where relevant indicate corrective actions to be taken.
6.   In the case of companion diagnostic, the evaluating competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall, depending on whether the relevant competent authority of the Member State that authorised the medicinal products or the EMA was consulted by the notified body in accordance with the procedures set out in Section 5.2 of Annex IX and Section 3.11 of Annex X, inform that national competent authority or the EMA, as appropriate.
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 87, 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 serious incidents 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 them 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 87 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 87, 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 85
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 87, 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 86
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 80 to 85 and 87 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 80, 81, 82, 83 and 84 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 82;
(e)
harmonised forms for the exchange of information between competent authorities as referred to in Article 84;
(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 107(3).
Article 87
Electronic system on vigilance and 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)
reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 82(1) and Article 84(5);
(b)
the periodic summary reports by manufacturers referred to in Article 82(9);
(c)
the reports by manufacturers on trends referred to in Article 83;
(d)
the PSURs referred to in Article 81;
(e)
the field safety notices by manufacturers referred to in Article 84(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 84(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 49.
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 82(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 83(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 States in which the incidents occurred.
7.   The reports on field safety corrective actions referred to in point (b) of Article 82(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 State 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 82(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 84(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 51.
Section 3
Market surveillance
Article 88
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 99 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 95.
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 95.
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 95.
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 89
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 90
Procedure for dealing with devices presenting an unacceptable risk to health and safety
1.   Where, having performed an evaluation pursuant to Article 89, 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 51 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 95.
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 95.
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 95, 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 95.
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 91
Procedure for evaluating national measures at Union level
1.   Where, within two months of receipt of the notification referred to in Article 90(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 107(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 90(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 90(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 107(3).
Article 92
Other non-compliance
1.   Where, having performed an evaluation pursuant to Article 89, 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 95.
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 107(3).
Article 93
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 95.
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 107(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 107(3).
Article 94
Good administrative practice
1.   Any measure adopted by the competent authorities of the Member States pursuant to Articles 90 to 93 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 90 to 93 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 95 inform the relevant notified body and the authority responsible for the notified body of the measure taken.
Article 95
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 88(4);
(b)
the final inspection report as referred to in Article 88(7);
(c)
information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 90(2), (4) and (6);
(d)
information in relation to non-compliance of products as referred to in Article 92(2);
(e)
information in relation to the preventive health protection measures referred to in Article 93(2);
(f)
summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in Article 88(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 51 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, EU REFERENCE LABORATORIES AND DEVICE REGISTERS
Article 96
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 97
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 98
Medical Device Coordination Group
The Medical Device Coordination Group (MDCG) established in accordance with the conditions and detailed arrangements referred to in Article 103 and 107 of Regulation (EU) 2017/745 shall carry out, with the support of the Commission as provided in Article 104 of Regulation (EU) 2017/745, the tasks conferred on it under this Regulation as well as those under Regulation (EU) 2017/745.
Article 99
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 45;
(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 performance evaluations 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) 2017/745 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 and of CS;
(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, performance studies, 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 88;
(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 100
The European Union reference laboratories
1.   For specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices, the Commission may designate, by means of implementing acts, one or more European Union reference laboratories (the ‘EU reference laboratories’), that satisfy the criteria set out in paragraph 4. The Commission shall only designate the EU reference laboratories for which a Member State or the Commission's Joint Research Centre have submitted an application for designation.
2.   Within the scope of their designation, the EU reference laboratories shall, where appropriate, have the following tasks:
(a)
to verify the performance claimed by the manufacturer and the compliance of class D devices with the applicable CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3);
(b)
to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 4.12 of Annex IX and in Section 5.1 of Annex XI;
(c)
to provide scientific and technical assistance to the Commission, the MDCG, the Member States and notified bodies in relation to the implementation of this Regulation;
(d)
to provide scientific advice regarding the state of the art in relation to specific devices, or a category or group of devices;
(e)
to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks;
(f)
to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance;
(g)
to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures;
(h)
to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order;
(i)
to contribute to the development of CS and of international standards;
(j)
to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation and publish them by electronic means having considered national provisions on confidentiality.
3.   At the request of a Member State, the Commission may also designate the EU reference laboratories where that Member State wishes to have recourse to such laboratories to ensure the verification of the performance claimed by the manufacturer and the compliance of class C devices with the applicable CS when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
4.   The EU reference laboratories shall satisfy the following criteria:
(a)
have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the 
in vitro
 diagnostic medical devices for which they are designated;
(b)
possess the necessary equipment and reference material 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;
(f)
act in the public interest and in an independent manner;
(g)
ensure that their staff do not have financial or other interests in the 
in vitro
 diagnostic medical device industry which could affect their impartiality, declare any other direct and indirect interests they may have in the 
in vitro
 diagnostic medical device industry and update this declaration whenever a relevant change occurs.
5.   The EU reference laboratories shall form a network in order to coordinate and harmonise their working methods as regards testing and assessment. That coordination and harmonisation shall involve:
(a)
applying coordinated methods, procedures and processes;
(b)
agreeing on the use of same reference materials and common test samples and seroconversion panels;
(c)
establishing common assessment and interpretation criteria;
(d)
using common testing protocols and assessing the test results using standardised and coordinated evaluation methods;
(e)
using standardised and coordinated test reports;
(f)
developing, applying and maintaining a peer review system;
(g)
organizing regular quality assessment tests (including mutual checks on the quality and comparability of test results);
(h)
agreeing on joint guidelines, instructions, procedural instructions or standard operational procedures;
(i)
coordinating the introduction of testing methods for new technologies and according to new or amended CS;
(j)
reassessing the state of the art on the basis of comparative test results or by further studies, as requested by a Member State or by the Commission.
6.   The EU reference laboratories may be granted a Union financial contribution.
The Commission may adopt, by means of implementing acts, the detailed arrangements and the amount of a Union financial contribution to the EU reference laboratories, taking into account the objectives of health and safety protection, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
7.   Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to predetermined and transparent terms and conditions.
8.   The Commission shall specify by means of implementing acts:
(a)
detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure compliance with the criteria referred to in paragraph 4 of this Article.
(b)
the structure and the level of the fees referred to in paragraph 7 of this Article which may be levied by an EU reference laboratory for providing scientific opinions in response to consultations by notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human health and safety protection, support of innovation and cost-effectiveness.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
9.   The EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation. If those controls find that an EU reference laboratory is not complying with the requirements for which it has been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the designation.
10.   The provisions in Article 107(1) of Regulation (EU) 2017/745 shall apply to the staff of the EU reference laboratories.
Article 101
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.
CHAPTER IX
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
Article 102
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 103;
(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 103
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 104
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 105
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 107(3).
Article 106
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 2022 and shall notify it without delay of any subsequent amendment affecting them.
CHAPTER X
FINAL PROVISIONS
Article 107
Committee procedure
1.   The Commission shall be assisted by the Committee on Medical Devices established by Article 114 of Regulation (EU) 2017/745. 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 108
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 10(4), 17(4), 24(10), 51(6) and 66(8) 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 10(4), 17(4), 24(10), 51(6) and 66(8) 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 10(4), 17(4), 24(10), 51(6) and 66(8) 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 109
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 110
Transitional provisions
1.   From 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void.
2.   Certificates issued by notified bodies in accordance with Directive 98/79/EC 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 VI to Directive 98/79/EC which shall become void at the latest on 27 May 2024.
Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 shall become void by 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 98/79/EC 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 that Directive, 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 and replace the corresponding requirements in that Directive.
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 applicable requirements relating to the devices it has certified.
4.   Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 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 Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before 26 May 2022.
6.   By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2022. 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 2022.
7.   As regards devices subject to the procedures laid down in Article 48(3) and (4), paragraph 5 of this Article applies provided that the necessary appointments to the MDCG and expert panels and of EU reference laboratories have been made.
8.   By way of derogation from Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Article 27(3) and Article 28(1) and Article 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC as specified in Decision 2010/227/EU.
9.   Authorisations granted by the competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation.
10.   Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.
Article 111
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 devices through the storage, pursuant to Article 24, of the UDI by economic operators, health institutions and health professionals. The evaluation shall also include a review on the functioning of Article 4.
Article 112
Repeal
Without prejudice to Articles 110 (3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and the obligations of manufacturers as regards the making available of documentation, under Directive 98/79/EC, that Directive is repealed with effect from 26 May 2022 with the exception of:
(a)
Article 11, point (c) of Article 12(1) and Article 12(2) and (3) of Directive 98/79/EC, and the obligations relating to vigilance and performance studies provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation; and
(b)
Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, and the obligations relating to registration of devices and economic operators, and 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 Article 113(2) and point (f) of Article 113(3) of this Regulation.
As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs.
Decision 2010/227/EU adopted in implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC shall be repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation.
References to the repealed Directive shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XV.
Article 113
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 2022.
3.   By way of derogation from paragraph 2:
(a)
Article 27(3) and Article 51(5) shall apply from 27 November 2023;
(b)
Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34;
(c)
Article 97 shall apply from 26 May 2018;
(d)
Article 100 shall apply from 25 November 2020;
(e)
for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027;
(f)
without prejudice to the obligations on the Commission pursuant to Article 34 of Regulation (EU) 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, 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) of that Regulation. The provisions referred to in the preceding sentence are:
—
Article 26,
—
Article 28,
—
Article 29,
—
the second sentence of Article 36(2),
—
Article 38(10),
—
Article 39(2),
—
the second subparagraph of Article 40(12),
—
points (d) and (e) of Article 42(7),
—
Article 49(2),
—
Article 50(1),
—
Articles 66 to 73,
—
paragraphs 1 to 13 of Article 74,
—
Articles 75 to 77,
—
Article 81(2),
—
Articles 82 and 83,
—
Article 84(5) and (7) and the third subparagraph of Article 84(8),
—
Article 85,
—
Article 88(4), (7) and (8),
—
Article 90(2) and (4),
—
the last sentence of Article 92(2),
—
Article 94(4),
—
the second sentence of the first subparagraph of Article 110(3).
Until Eudamed is fully functional the corresponding provisions of Directive 98/79/EC 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 performance studies, vigilance reporting, registration of devices and economic operators, and certificate notifications.
(g)
The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14).
(h)
Article 110(10) 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
)
  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
).
(
4
)
  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
).
(
5
)
  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
).
(
6
)
  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
).
(
7
)
  Regulation (EU) No 1025/2012 of 25 October 2012 of the European Parliament and of the Council 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
).
(
8
)
  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
).
(
9
)
  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
).
(
10
)
  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
).
(
11
)
  Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C-400/09 and C-207/10, ECLI:EU:C:2011:519.
(
12
)
  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 (see page 1 of this Official Journal).
(
13
)
  Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (
OJ L 102, 23.4.2010, p. 45
).
(
14
)
  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
).
(
15
)
  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
).
(
16
)
  Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes (
OJ L 276, 20.10.2010. p. 33
).
(
17
)
  
            
OJ L 123, 12.5.2016, p. 1
.
(
18
)
  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
).
(
19
)
  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
)
(
20
)
  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (
OJ L 169, 12.7.1993, p. 1
)
(
21
)
  
            
OJ C 358, 7.12.2013, p. 10
.
(
22
)
  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (
OJ L 157, 9.6.2006, p. 24
).
(
23
)
  Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (
OJ L 88, 4.4.2011, p. 45
).
(
24
)
  Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (
OJ L 124, 20.5.2003, p. 36
).
(
25
)
  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
).
(
26
)
  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 26(3) and 28, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 25 and 26 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 on assessment of technical documentation
X
Conformity assessment based on type examination
XI
Conformity assessment based on production quality assurance
XII
Certificates issued by a notified body
XIII
Performance evaluation, performance studies and post-market performance follow-up
XIV
Interventional clinical performance studies and certain other performance studies
XV
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, the 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, the 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 effects shall be minimised and be acceptable when weighed against the evaluated potential benefits to the patients and/or the user arising from the intended performance of the device during normal conditions of use.
CHAPTER II
REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE
9.   Performance characteristics
9.1.   Devices shall be designed and manufactured in such a way that they are suitable for the purposes referred to in point (2) of Article 2, as specified by the manufacturer, and suitable with regard to the performance they are intended to achieve, taking account of the generally acknowledged state of the art. They shall achieve the performances, as stated by the manufacturer and in particular, where applicable:
(a)
the analytical performance, such as, analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, cross-reactions; and
(b)
the clinical performance, such as diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations.
9.2.   The performance characteristics of the device shall be maintained during the lifetime of the device as indicated by the manufacturer.
9.3.   Where the performance of devices depends on the use of calibrators and/or control materials, the metrological traceability of values assigned to calibrators and/or control materials shall be assured through suitable reference measurement procedures and/or suitable reference materials of a higher metrological order. Where available, metrological traceability of values assigned to calibrators and control materials shall be assured to certified reference materials or reference measurement procedures.
9.4.   The characteristics and performances of the device shall be specifically checked in the event that they may be affected when the device is used for the intended use under normal conditions:
(a)
for devices for self-testing, performances obtained by laypersons;
(b)
for devices for near-patient testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances).
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 the possibility of impairment of analytical performance due to physical and/or chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device.
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 as to reduce to a level as low as reasonably practicable the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council 
(
1
)
, and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified 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
)
.
10.4.   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.
11.   Infection and microbial contamination
11.1.   Devices and their manufacturing processes shall be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or, where applicable, other persons. The design shall:
(a)
allow easy and safe handling;
(b)
reduce as far as possible any microbial leakage from the device and/or microbial exposure during use;
and, where necessary
(c)
prevent microbial contamination of the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen.
11.2.   Devices labelled either as sterile or as having a specific microbial state shall be designed, manufactured and packaged to ensure that their sterile condition or microbial state is maintained under the transport and storage conditions specified by the manufacturer until that packaging is opened at the point of use, unless the packaging which maintains their sterile condition or microbial state is damaged.
11.3.   Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods.
11.4.   Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities.
11.5.   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.
11.6.   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 materials of biological origin
Where devices include tissues, cells and substances of animal, human or microbial origin, the selection of sources, the processing, preservation, testing and handling of tissues, cells and substances of such origin and control procedures shall be carried out so as to provide safety for user or other person.
In particular, safety with regard to microbial and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This might not apply to certain devices if the activity of the microbial and other transmissible agent are integral to the intended purpose of the device or when such elimination or inactivation process would compromise the performance of the device.
13.   Construction of devices and interaction with their environment
13.1.   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 performances of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use.
13.2.   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 risk of incorrect identification of specimens and the risk of erroneous results due to, for example, confusing colour and/or numeric and/or character codings on specimen receptacles, removable parts and/or accessories used with devices in order to perform the test or assay as intended;
(g)
the risks of any foreseeable interference with other devices.
13.3.   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.
13.4.   Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.
13.5.   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.
13.6.   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 users, 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.
13.7   The measuring, monitoring or display scale (including colour change and other visual indicators) 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.   Devices with a measuring function
14.1.   Devices having a primary analytical measuring function shall be designed and manufactured in such a way as to provide appropriate analytical performance in accordance with point (a) of Section 9.1 of Annex I, taking into account the intended purpose of the device.
14.2.   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 
(
3
)
.
15.   Protection against radiation
15.1.   Devices shall be designed, manufactured and packaged in such a way that exposure of users or other persons to radiation (intended, unintended, stray or scattered) 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 diagnostic purposes.
15.2.   When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall as far as possible be:
(a)
designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation emitted can be controlled and/or adjusted; and
(b)
fitted with visual displays and/or audible warnings of such emissions.
15.3.   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 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.   Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
16.1.   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.
16.2.   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.
16.3.   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).
16.4.   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.
17.   Devices connected to or equipped with an energy source
17.1.   For devices connected to or equipped with an energy source, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
17.2.   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.
17.3.   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.
17.4.   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.
17.5.   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 user, or 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.   Protection against mechanical and thermal risks
18.1.   Devices shall be designed and manufactured in such a way as to protect users and other persons against mechanical risks.
18.2.   Devices shall be sufficiently stable under the foreseen operating conditions. They shall be suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer.
18.3.   Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means shall be incorporated.
Any guards or other means included with the device to provide protection, in particular against moving parts, shall be secure and shall not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer.
18.4.   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.
18.5.   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.
18.6.   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.
18.7.   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.
18.8.   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.
19.   Protection against the risks posed by devices intended for self-testing or near-patient testing
19.1.   Devices intended for self-testing or near-patient testing 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 the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user's technique and environment. The information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result provided by the device and to avoid misleading information. In the case of near-patient testing, the information and the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience required by the user.
19.2.   Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way as to:
(a)
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; and
(b)
reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, the specimen, and also in the interpretation of the results.
19.3.   Devices intended for self-testing and near-patient testing shall, where feasible, include a procedure by which the intended user:
(a)
can verify that, at the time of use, the device will perform as intended by the manufacturer; and
(b)
be warned if the device has failed to provide a valid result.
CHAPTER III
REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE
20.   Label and instructions for use
20.1.   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. If individual full labelling of each unit is not practicable, the information shall be set out 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 or bar codes.
(d)
Instructions for use shall be provided together with devices. However, in duly justified and exceptional cases instructions for use shall not be required or may be abbreviated if the device can be used safely and as intended by the manufacturer without any such instructions for use.
(e)
Where multiple devices, with the exception of devices intended for self-testing or near-patient testing, 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)
When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.
(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, taking into account the intended users. 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.
(i)
In the case of devices containing a substance or a mixture which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given in the instructions for use.
(j)
The provisions of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all relevant information, as appropriate, is already made available in the instructions for use.
20.2.   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 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 its authorised representative and the address of the registered place of business of the authorised representative;
(e)
an indication that the device is an 
in vitro
 diagnostic medical device, or if the device is a ‘device for performance study’, an indication of that fact;
(f)
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;
(g)
the UDI carrier as referred to in Article 24 and Part C of Annex VI;
(h)
an unambiguous indication of the time limit for using the device safely, without degradation of performance, expressed at least in terms of year and month and, where relevant, the day, in that order;
(i)
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;
(j)
where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of thereof, or other terms which accurately reflect the contents of the package;
(k)
an indication of any special storage and/or handling condition that applies;
(l)
where appropriate, an indication of the sterile state of the device and the sterilisation method, or a statement indicating any special microbial state or state of cleanliness;
(m)
warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device or 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 instructions for use are not provided in paper form in accordance with point (f) of Section 20.1, a reference to their accessibility (or availability), and where applicable the website address where they can be consulted;
(o)
where applicable, any particular operating instructions;
(p)
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;
(q)
if the device is intended for self-testing or near-patient testing, an indication of that fact;
(r)
where rapid assays are not intended for self-testing or near-patient testing, the explicit exclusion hereof;
(s)
where device kits include individual reagents and articles that are made available as separate devices, each of those devices shall comply with the labelling requirements contained in this Section and with the requirements of this Regulation;
(t)
the devices and separate components shall be identified, where applicable in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. As far as practicable and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales packaging;
(u)
the label for devices for self-testing shall bear the following particulars:
(i)
the type of specimen(s) required to perform the test (e.g. blood, urine or saliva);
(ii)
the need for additional materials for the test to function properly;
(iii)
contact details for further advice and assistance.
The name of devices for self-testing shall not reflect an intended purpose other than that specified by the manufacturer.
20.3.   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)
the month and year of manufacture,
(g)
an unambiguous indication of the time limit for using the device safely, expressed at least in terms of year and month and, where relevant, the day, in that order,
(h)
an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.
20.4.   Information in the instructions for use
20.4.1.   The instructions for use shall contain all of the following particulars:
(a)
the name or trade name of the device;
(b)
the details strictly necessary for the user to uniquely identify the device;
(c)
the device's intended purpose:
(i)
what is detected and/or measured;
(ii)
its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic);
(iii)
the specific information that is intended to be provided in the context of:
—
a physiological or pathological state;
—
congenital physical or mental impairments;
—
the predisposition to a medical condition or a disease;
—
the determination of the safety and compatibility with potential recipients;
—
the prediction of treatment response or reactions;
—
the definition or monitoring of therapeutic measures;
(iv)
whether it is automated or not;
(v)
whether it is qualitative, semi-quantitative or quantitative;
(vi)
the type of specimen(s) required;
(vii)
where applicable, the testing population; and
(viii)
for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test.
(d)
an indication that the device is an 
in vitro
 diagnostic medical device, or, if the device is a ‘device for performance study’, an indication of that fact;
(e)
the intended user, as appropriate (e.g. self-testing, near patient and laboratory professional use, healthcare professionals);
(f)
the test principle;
(g)
a description of the calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated instrument only);
(h)
a description of the reagents and any limitation upon their use (e.g. suitable for a dedicated instrument only) and the composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device contains other ingredients which might influence the measurement;
(i)
a list of materials provided and a list of special materials required but not provided;
(j)
for devices intended for use in combination with or installed with or connected to other devices and/or general purpose equipment:
—
information to identify such devices or equipment, in order to obtain a validated and safe combination, including key performance characteristics, and/or
—
information on any known restrictions to combinations of devices and equipment.
(k)
an indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling conditions which apply;
(l)
in-use stability which may include the storage conditions, and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions, where this is relevant;
(m)
if the device is supplied as sterile, an indication of its sterile state, the sterilisation method and instructions in the event of the sterile packaging being damaged before use;
(n)
information that allows the user to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device. That information shall cover, where appropriate:
(i)
warnings, precautions and/or measures to be taken in the event of malfunction of the device or its degradation as suggested by changes in its appearance that may affect performance,
(ii)
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,
(iii)
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, therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment,
(iv)
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,
(v)
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,
(vi)
if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, decontamination, packaging and, where appropriate, the validated method of re-sterilisation. Information shall be provided to identify when the device should no longer be reused, such as signs of material degradation or the maximum number of allowable reuses;
(o)
any warnings and/or precautions related to potentially infectious material that is included in the device;
(p)
where relevant, requirements for special facilities, such as a clean room environment, or special training, such as on radiation safety, or particular qualifications of the intended user;
(q)
conditions for collection, handling, and preparation of the specimen;
(r)
details of any preparatory treatment or handling of the device before it is ready for use, such as sterilisation, final assembly, calibration, etc., for the device to be used as intended by the manufacturer;
(s)
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, including cleaning and 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;
—
methods for mitigating the risks encountered by persons involved in installing, calibrating or servicing devices.
(t)
where applicable, recommendations for quality control procedures;
(u)
the metrological traceability of values assigned to calibrators and control materials, including identification of applied reference materials and/or reference measurement procedures of higher order and information regarding maximum (self-allowed) batch to batch variation provided with relevant figures and units of measure;
(v)
assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding batch to batch variation provided with relevant figures and units of measure;
(w)
analytical performance characteristics, such as analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and measurement range, (information needed for the control of known relevant interferences, cross-reactions and limitations of the method), measuring range, linearity and information about the use of available reference measurement procedures and materials by the user;
(x)
clinical performance characteristics as defined in Section 9.1 of this Annex;
(y)
the mathematical approach upon which the calculation of the analytical result is made;
(z)
where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity and diagnostic specificity, positive and negative predictive value;
(aa)
where relevant, reference intervals in normal and affected populations;
(ab)
information on interfering substances or limitations (
e.g.
 visual evidence of hyperlipidaemia or haemolysis, age of specimen) that may affect the performance of the device;
(ac)
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:
(i)
infection or microbial hazards, such as consumables contaminated with potentially infectious substances of human origin;
(ii)
environmental hazards such as batteries or materials that emit potentially hazardous levels of radiation);
(iii)
physical hazards such as explosion.
(ad)
the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business at which he can be contacted and its location be established, together with a telephone number and/or fax number and/or website address to obtain technical assistance;
(ae)
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, with a clear indication of the introduced modifications;
(af)
a notice to the user that any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority of the Member State in which the user and/or the patient is established;
(ag)
where device kits include individual reagents and articles that may be made available as separate devices, each of these devices shall comply with the instructions for use requirements contained in this Section and with the requirements of this Regulation;
(ah)
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.
20.4.2   In addition, the instructions for use for devices intended for self-testing shall comply with all of the following principles:
(a)
details of the test procedure shall be given, including any reagent preparation, specimen collection and/or preparation and information on how to run the test and interpret the results;
(b)
specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to use the device and to understand the result(s) produced by the device;
(c)
the device's intended purpose shall provide sufficient information to enable the user to understand the medical context and to allow the intended user to make a correct interpretation of the results;
(d)
the results shall be expressed and presented in a way that is readily understood by the intended user;
(e)
information shall be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result), on the test limitations and on the possibility of false positive or false negative result. Information shall also be provided as to any factors that can affect the test result such as age, gender, menstruation, infection, exercise, fasting, diet or medication;
(f)
the information provided shall include a statement clearly directing that the user should not take any decision of medical relevance without first consulting the appropriate healthcare professional, information on disease effects and prevalence, and, where available, information specific to the Member State(s) where the device is placed on the market on where a user can obtain further advice such as national helplines, websites;
(g)
for devices intended for self-testing used for the monitoring of a previously diagnosed existing disease or condition, the information shall specify that the patient should only adapt the treatment if he has received the appropriate training to do so.
(
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 136, 29.5.2007, p. 3
).
(
3
)
  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 purpose of the device which may include information on:
(i)
what is to be detected and/or measured;
(ii)
its function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic;
(iii)
the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate;
(iv)
whether it is automated or not;
(v)
whether it is qualitative, semi-quantitative or quantitative;
(vi)
the type of specimen(s) required;
(vii)
where applicable, the testing population;
(viii)
the intended user;
(ix)
in addition, for companion diagnostics, the relevant target population and the associated medicinal product(s).
(d)
the description of the principle of the assay method or the principles of operation of the instrument;
(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)
the description of the components and where appropriate, the description of the reactive ingredients of relevant components such as antibodies, antigens, nucleic acid primers;
and where applicable:
(h)
the description of the specimen collection and transport materials provided with the device or descriptions of specifications recommended for use;
(i)
for instruments of automated assays: the description of the appropriate assay characteristics or dedicated assays;
(j)
for automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation;
(k)
a description of any software to be used with the device;
(l)
a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;
(m)
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 the device.
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
(a)
the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in the case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold;
(b)
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
3.1.   Design information
Information to allow the design stages applied to the device to be understood shall include:
(a)
a description of the critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use with the device;
(b)
for instruments, a description of major subsystems, analytical technology such as operating principles and control mechanisms, dedicated computer hardware and software;
(c)
for instruments and software, an overview of the entire system;
(d)
for software, a description of the data interpretation methodology, namely the algorithm;
(e)
for devices intended for self-testing or near-patient testing, a description of the design aspects that make them suitable for self-testing or near-patient testing.
3.2.   Manufacturing information
(a)
information to allow the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device to be understood. More detailed information shall be provided for the audit of the quality management system or other applicable conformity assessment procedures;
(b)
identification of all sites, including suppliers and sub-contractors, where 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 also 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;
(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.   BENFIT-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.
This includes:
6.1.   Information on analytical performance of the device
6.1.1.   Specimen type
This Section shall describe the different specimen types that can be analysed, including their stability such as storage, where applicable specimen transport conditions and, with a view to time-critical analysis methods, information on the timeframe between taking the specimen and its analysis and storage conditions such 
as
 duration, temperature limits and freeze/thaw cycles.
6.1.2.   Analytical performance characteristics
6.1.2.1.   Accuracy of measurement
(a)
Trueness of measurement
This Section shall provide information on the trueness of the measurement procedure and summarise the data in sufficient detail to allow an assessment of the adequacy of the means selected to establish the trueness. Trueness measures apply to both quantitative and qualitative assays only when a certified reference material or certified reference method is available.
(b)
Precision of measurement
This Section shall describe repeatability and reproducibility studies.
6.1.2.2.   Analytical sensitivity
This Section shall include information about the study design and results. It shall provide a description of specimen type and preparation including matrix, analyte levels, and how levels were established. The number of replicates tested at each concentration shall also be provided as well as a description of the calculation used to determine assay sensitivity.
6.1.2.3.   Analytical specificity
This Section shall describe interference and cross reactivity studies performed to determine the analytical specificity in the presence of other substances/agents in the specimen.
Information shall be provided on the evaluation of potentially interfering and cross-reacting substances or agents on the assay, on the tested substance or agent type and its concentration, specimen type, analyte test concentration, and results.
Interferents and cross-reacting substances or agents, which vary greatly depending on the assay type and design, could derive from exogenous or endogenous sources such as:
(a)
substances used for patient treatment such as medicinal products;
(b)
substances ingested by the patient such as alcohol, foods;
(c)
substances added during specimen preparation such as preservatives, stabilisers;
(d)
substances encountered in specific specimen types such as haemoglobin, lipids, bilirubin, proteins;
(e)
analytes of similar structure such as precursors, metabolites or medical conditions unrelated to the test condition including specimens negative for the assay but positive for a condition that can mimic the test condition.
6.1.2.4.   Metrological traceability of calibrator and control material values
6.1.2.5.   Measuring range of the assay
This Section shall include information on the measuring range regardless of whether the measuring systems are linear or non-linear, including the limit of detection and describe information on how the range and detection limit were established.
This information shall include a description of specimen type, number of specimens, number of replicates, and specimen preparation including information on the matrix, analyte levels and how levels were established. If applicable, a description of any high dose hook effect and the data supporting the mitigation such as dilution steps shall be added.
6.1.2.6.   Definition of assay cut-off
This Section shall provide a summary of analytical data with a description of the study design including methods for determining the assay cut-off, such as:
(a)
the population(s) studied: demographics, selection, inclusion and exclusion criteria, number of individuals included;
(b)
method or mode of characterisation of specimens; and
(c)
statistical methods such as Receiver Operator Characteristic (ROC) to generate results and if applicable, define grey-zone/equivocal zone.
6.1.3.   The analytical performance report referred to in Annex XIII.
6.2.   Information on clinical performance and clinical evidence. Performance Evaluation Report
The documentation shall contain the performance evaluation report, which includes the reports on the scientific validity, the analytical and the clinical performance, as referred to in Annex XIII, together with an assessment of those reports.
The clinical performance study documents referred to in Section 2 of Part A of Annex XIII shall be included and/or fully referenced in the technical documentation.
6.3.   Stability (excluding specimen stability)
This Section shall describe claimed shelf life, in use stability and shipping stability studies.
6.3.1.   Claimed shelf-life
This Section shall provide information on stability testing studies to support the shelf life that is claimed for the device. Testing shall be performed on at least three different lots manufactured under conditions that are essentially equivalent to routine production conditions. The three lots do not need to be consecutive. Accelerated studies or extrapolated data from real time data are acceptable for initial shelf life claims but shall be followed up with real time stability studies.
Such detailed information shall include:
(a)
the study report including the protocol, number of lots, acceptance criteria and testing intervals;
(b)
where accelerated studies have been performed in anticipation of the real time studies, the method used for accelerated studies shall be described;
(c)
the conclusions and claimed shelf life.
6.3.2.   In-use stability
This Section shall provide information on in-use stability studies for one lot reflecting actual routine use of the device, regardless of whether real or simulated. This may include open vial stability and/or, for automated instruments, on board stability.
In the case of automated instrumentation, if calibration stability is claimed, supporting data shall be included.
Such detailed information shall include:
(a)
the study report (including the protocol, acceptance criteria and testing intervals);
(b)
the conclusions and claimed in-use stability.
6.3.3.   Shipping stability
This Section shall provide information on shipping stability studies for one lot of devices to evaluate the tolerance of devices to the anticipated shipping conditions.
Shipping studies may be done under real and/or simulated conditions and shall include variable shipping conditions such as extreme heat and/or cold.
Such information shall describe:
(a)
the study report (including the protocol, acceptance criteria);
(b)
the method used for simulated conditions;
(c)
the conclusion and recommended shipping conditions.
6.4.   Software verification and validation
The documentation shall contain evidence of the validation of the software, as it is used in the finished device. Such information shall typically include the summary results of all verification, validation and testing performed in-house and applicable in an 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 labelling.
6.5.   Additional information required in specific cases
(a)
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 regard to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.
(b)
In the case of devices containing tissues, cells and substances of animal, human or microbial origin, information on the origin of such material and on the conditions in which it was collected.
(c)
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.
(d)
If the device is to be connected to other equipment in order to operate as intended, a description of the resulting combination including proof that it conforms to the general safety and performance requirements set out in Annex I when connected to any such equipment having regard to the characteristics specified by the manufacturer.
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 78 to 81 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.
1.   The post-market surveillance plan drawn up in accordance with Article 79.
The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 78.
(a)
The post-market surveillance plan shall address the collection and utilisation 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 83, 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 78, 79 and 81;
—
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 PMPF plan as referred to in Part B of Annex XIII, or a justification as to why a PMPF is not applicable.
2.   The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.
ANNEX IV
EU DECLARATION OF CONFORMITY
The EU declaration of conformity shall contain the following information:
1.
Name, registered trade name or registered trade mark and, if already issued, SRN referred to in Article 28 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 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM
PART A
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28
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 shall or has been placed on the market in the Union,
2.4.
in the case of class B, class C or class D devices: Member States where the device is or is to be made available,
2.5.
presence of tissues, cells, or, their derivatives, of human origin (y/n),
2.6.
presence of tissues, cells or their derivatives of animal origin as referred to in Regulation (EU) No 722/2012(y/n),
2.7.
presence of cells or substances of microbial origin (y/n),
2.8.
risk class of the device,
2.9.
where applicable, the single identification number of the performance study,
2.10.
in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(14), the name, address and contact details of that legal or natural person,
2.11.
in the case of class C or D devices, the summary of safety and performance,
2.12.
status of the device (on the market, no longer placed on the market, recalled, field safety corrective Action initiated),
2.13.
indication as to whether the device is a ‘new’ device.
A device shall be considered to be ‘new’ if:
(a)
there has been no such device continuously available on the Union market during the previous three years for the relevant analyte or other parameter;
(b)
the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three years.
2.14.
indication as to whether the device is intended for self-testing or near-patient testing.
PART B
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26
The manufacturer shall provide to the UDI database the UDI-DI and 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 24(6) 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’ UDI-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 28(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 23,
9.
risk class of the device,
10.
if applicable, name or trade name,
11.
if applicable, device model, reference, or catalogue number,
12.
additional product description (optional),
13.
if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
14.
if applicable, additional trade names of the device,
15.
labelled as a single use device (y/n),
16.
if applicable, the maximum number of reuses,
17.
device labelled sterile (y/n),
18.
need for sterilisation before use (y/n),
19.
URL for additional information, such as electronic instructions for use (optional),
20.
if applicable, critical warnings or contra-indications,
21.
status of the device (on the market, no longer placed on the market, recalled, field safety 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.
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 customised to meet specific needs.
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 fixed quantity of devices, such as a carton or case.
Production Identifier (UDI-PI)
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
The different types of UDI-PI(s) 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 24(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.   Kits 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.
3.10.   Manufacturers that repackage 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 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 class A and class B devices 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 packages. 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.
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 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.
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 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 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 minimised 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.   Reusable devices that are part of kits and that require cleaning, disinfection, sterilisation or refurbishing between uses
6.1.1.   The UDI of such devices shall be placed on the device and shall be readable after each procedure to make the device ready for the next use;
6.1.2.   The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
6.2.   Device software
6.2.1.   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.
6.2.2.   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.
6.2.3.   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.
6.2.4.   UDI placement criteria for software
(a)
where the software is delivered on a physical medium, for example via 
a
 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 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:
(a)
provision of adequate resources for conformity assessment activities;
(b)
development of procedures and policies for the operation of the notified body;
(c)
supervision of implementation of the procedures, policies and quality management systems of the notified body;
(d)
supervision of the notified body's finances;
(e)
activities and decisions taken by the notified body, including contractual agreements;
(f)
delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities;
(g)
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 the devices or processes under assessment; and
(e)
be linked to any organisation which itself provides consultancy services as referred to in the point (d). Such restriction shall not preclude general training activities that are not client specific and that relate to regulation of devices s 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 interests 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 interests 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 shall 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 the 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 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 requirement 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 their 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 of Regulation (EU) 2017/745 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:
(a)
management system structure and documentation, including policies and objectives for its activities;
(b)
policies for assignment of activities and responsibilities to personnel;
(c)
assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management;
(d)
the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
(e)
control of documents;
(f)
control of records;
(g)
management reviews;
(h)
internal audits;
(i)
corrective and preventive actions;
(j)
complaints and appeals;
(k)
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 the notified body itself or on its behalf and under its 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, performance 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 their assignment of their duties and 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 to 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, decision-making, and batch release, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics and performance 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 the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 38(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:
—
biological safety,
—
performance evaluation,
—
devices for self and near patient testing,
—
companion diagnostics,
—
functional safety,
—
software,
—
packaging, 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 performance 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 performance evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment of the performance evaluation presented by the manufacturer;
—
be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's performance evaluation;
—
be able to ascertain the comparability and consistency of the assessments of performance evaluation conducted by clinical experts;
—
be able to make an assessment of the manufacturer's performance 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 performance evaluation, biological safety, sterilisation and software validation, shall have all the following proven qualifications:
—
successful completion of a university or a technical college degree or an 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 design, manufacture, testing or use of devices 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 performance 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 l devices 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, as a group, shall have proven knowledge and comprehensive experience of all of the following:
—
devices legislation and relevant guidance documents;
—
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 the conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
—
the notified body's quality 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;
—
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;
—
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;
—
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 devices or technologies, the notified body in question shall have adequate 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 as a minimum, verify that personnel:
—
are aware of the 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;
—
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 its 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;
(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 52 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 the following requirements:
—
to appropriately plan the conduct of each individual project,
—
to 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,
—
to specify the rationale for fixing time limits for completion of conformity assessment activities,
—
to assess the manufacturer's technical documentation and the solutions adopted to meet the requirements laid down in Annex I,
—
to review the manufacturer's procedures and documentation relating to performance evaluation,
—
to address the interface between the manufacturer's risk management process and its appraisal and analysis of the performance evaluation and to evaluate their relevance for the demonstration of conformity with the relevant requirements in Annex I,
—
to carry out the ‘specific procedures’ referred to in Section 5 of Annex IX,
—
in the case of class B or C devices, to assess the technical documentation of devices selected on a representative basis,
—
to plan and periodically carry out appropriate surveillance audits and assessments, to 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,
—
to 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, 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 B and class C 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,
—
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
—
PMPF,
—
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 as 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 Section 4.5.4. for performance evaluation,
—
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, performance evaluation, risk management and sterilisation, and
—
the assessment of conformity of the design with this Regulation, and taking account of Sections 4.5.4. and 4.5.5. This assessment shall include the 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. and 4.5.5, 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;
—
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 batch
The notified body shall:
(a)
have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product batch in accordance with Annexes IX and 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 C 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 B 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 batch as specified in Section 5 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;
(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.   Performance evaluation assessment
The assessment by notified bodies of 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 have been deviations from procedures, the notified body in question shall critically examine the justification presented by the manufacturer.
The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to performance evaluation both for initial conformity assessment and on an ongoing basis. The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address:
(a)
the planning, conduct, assessment, reporting and updating of the performance evaluation as referred to in Annex XIII,
(b)
post-market surveillance and post-market performance follow up,
(c)
the interface with the risk management process,
(d)
the appraisal and analysis of the available data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I,
(e)
the conclusions drawn with regard to the clinical evidence and drawing up of the performance evaluation report.
The procedures referred to in the second paragraph shall take into consideration available CS, guidance and best practice documents.
The notified body's assessment of performance evaluations as referred to in Annex XIII shall cover:
—
the intended use specified by the manufacturer and claims for the device defined by it,
—
the planning of the performance evaluation,
—
the methodology for the literature search,
—
relevant documentation from the literature search,
—
the performance studies,
—
post-market surveillance and post-market performance follow up,
—
validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability and conclusions data from equivalent and similar devices,
—
the performance evaluation report,
—
justifications in relation to non-performance of performance studies or PMPF.
In relation to data from performance studies included within the performance evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved performance study plan.
The notified body shall ensure that the performance evaluation adequately addresses the relevant safety and performance requirements provided for in Annex I, that it is appropriately aligned with the risk management requirements and that it is conducted in accordance with Annex XIII and that it is appropriately reflected in the information provided relating to the device.
4.5.5.   Specific Procedures
The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to in Section 5 of Annex IX, for which they are designated.
In the case of companion diagnostics, the notified body shall have documented procedures in place that aim to fulfil the requirements of this Regulation in relation to consultation of the EMA or a medicinal products competent authority during its assessment of such types of device.
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 performance evaluation in a performance evaluation assessment report,
—
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,
—
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 performance evaluation and risk management whether the post-market surveillance plan, including the PMPF plan, is adequate,
—
decide on specific milestones for further review by the notified body of the up to date performance evaluation,
—
decide whether specific conditions or provisions need to be defined for the certification,
—
decide, based on the novelty, risk classification, performance 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,
—
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 52.
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 approved type of a device,
—
any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.5.
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,
—
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,
—
to review vigilance data to which they have access under to Article 87 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 on 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 authorities' 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 that it adequately assesses the manufacturer's documentation on, and application of, the provisions on vigilance, the post-market surveillance and PMPF,
—
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 performance evaluation as most recently updated by the manufacturer based on the manufacturer's post-market surveillance, on its PMPF 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,
—
ensure that the performance 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 performance evaluation, including the results of any performance studies and PMPF,
(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 performance studies 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 PMPF activities undertaken since the previous certification or re-certification, including appropriate updates to manufacturers' performance evaluation reports.
For the decision on the 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 to be taken for certification, such as application and application review.
ANNEX VIII
CLASSIFICATION RULES
1.   IMPLEMENTING RULES
1.1.   Application of the classification rules shall be governed by the intended purpose of the devices.
1.2.   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.
1.3.   Accessories for an 
in vitro
 diagnostic medical device shall be classified in their own right separately from the device with which they are used.
1.4.   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.
1.5.   Calibrators intended to be used with a device shall be classified in the same class as the device.
1.6.   Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes shall be classified in the same class as the device.
1.7.   The manufacturer shall take into consideration all classification and implementation rules in order to establish the proper classification for the device.
1.8.   Where a manufacturer states multiple intended purposes for a device, and as a result the device falls into more than one class, it shall be classified in the higher class.
1.9.   If several classification rules apply to the same device, the rule resulting in the higher classification shall apply.
1.10.   Each of the classification rules shall apply to first line assays, confirmatory assays and supplemental assays.
2.   CLASSIFICATION RULES
2.1.   Rule 1
Devices intended to be used for the following purposes are classified as class D:
—
detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration;
—
detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation;
—
determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.
2.2.   Rule 2
Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers:
—
ABO system [A (ABO1), B (ABO2), AB (ABO3)];
—
Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
—
Kell system [Kel1 (K)];
—
Kidd system [JK1 (Jka), JK2 (Jkb)];
—
Duffy system [FY1 (Fya), FY2 (Fyb)];
in which case they are classified as class D.
2.3.   Rule 3
Devices are classified as class C if they are intended:
(a)
for detecting the presence of, or exposure to, a sexually transmitted agent;
(b)
for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation;
(c)
for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual's offspring;
(d)
for pre-natal screening of women in order to determine their immune status towards transmissible agents;
(e)
for determining infective disease status or immune status, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;
(f)
to be used as companion diagnostics;
(g)
to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;
(h)
to be used in screening, diagnosis, or staging of cancer;
(i)
for human genetic testing;
(j)
for monitoring of levels of medicinal products, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;
(k)
for management of patients suffering from a life-threatening disease or condition;
(l)
for screening for congenital disorders in the embryo or foetus;
(m)
for screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities.
2.4.   Rule 4
(a)
Devices intended for self-testing are classified as class C, except for devices for the detection of pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of glucose, 
erythrocytes
, 
leucocytes
 and bacteria in urine, which are classified as class B.
(b)
Devices intended for near-patient testing are classified in their own right.
2.5.   Rule 5
The following devices are classified as class A:
(a)
products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for 
in vitro
 diagnostic procedures relating to a specific examination;
(b)
instruments intended by the manufacturer specifically to be used for 
in vitro
 diagnostic procedures;
(c)
specimen receptacles.
2.6.   Rule 6
Devices not covered by the above-mentioned classification rules are classified as class B.
2.7.   Rule 7
Devices which are controls without a quantitative or qualitative assigned value are classified as class B.
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(8), 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 17 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 by the quality management system and required under this Regulation and of 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 PMPF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87,
—
a description of the procedures in place to keep up to date the post-market surveillance system and, where applicable, the PMPF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87, as well as the undertaking by the manufacturer to apply those procedures,
—
documentation on the performance evaluation plan, and
—
a description of the procedures in place to keep up to date the performance 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,
—
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 into account and, where opted for, harmonised standards,
—
risk management as referred to in Section 3 of Annex I,
—
the performance evaluation, pursuant to Article 56 and Annex XIII, including PMPF,
—
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;
(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 substantiate 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 C devices, the quality management system assessment shall be accompanied by the assessment of the technical documentation for devices selected on a representative basis in accordance with provisions in 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 99 and in particular, the novelty of the technology, the potential impact on the patient and standard medical practice, similarities in design, technology, manufacturing and, where applicable, sterilisation methods, the intended purpose and the results of any previous relevant assessments 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 tits 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 C and class D 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,
—
the documentation on any findings and conclusions resulting from the application of the post-market surveillance plan, including the PMPF plan, for a representative sample of devices, and of the provisions on vigilance set out in Articles 82 to 87,
—
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,
—
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, the site 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. 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, notified bodies shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation. 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 C devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 of 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 third paragraph of Section 2.3.
3.6.   Notified bodies 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 of class B, C and D devices and batch verification applicable to class D devices
4.1.   In addition to the obligation laid down in Section 2, the manufacturer of devices shall lodge with the notified body an application for the 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.
In the case of devices for self-testing or near-patient testing, the application shall also include the aspects referred to in point (b) of Section 5.1.
4.3.   The notified body shall examine the application by using staff, employed by it, with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence. 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.
4.4.   The notified body shall review the clinical evidence presented by the manufacturer in the performance evaluation report and the related performance evaluation that was conducted. The notified body shall use employed device reviewers with sufficient clinical expertise and including external clinical experts with direct and current experience relating to the clinical application of the device in question 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.
4.6.   The notified body shall verify that the clinical evidence and the performance 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 PMPF plan proposed, where applicable.
4.7.   Based on its assessment of the clinical evidence, the notified body shall consider the performance 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 PMPF data.
4.8.   The notified body shall clearly document the outcome of its assessment in the performance evaluation assessment report.
4.9.   Before issuing an EU technical documentation assessment certificate, the notified body shall request an EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The verification shall include laboratory tests by the EU reference laboratory as referred to in Article 48(5).
In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation, consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 in accordance with the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
The EU reference laboratory shall provide a scientific opinion within 60 days.
The scientific opinion of the EU reference laboratory and, where applicable, the views of the experts consulted, pursuant to the procedure laid down in Article 48(6), and any possible updates shall be included in the documentation of the notified body concerning the device. The notified body shall, when making its decision, give due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views expressed by the experts consulted pursuant to Article 48(6). The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable.
4.10.   The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a performance 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 device, and, where appropriate, a description of the intended purpose of the device.
4.11.   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 48 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.
Where the changes could affect compliance with the CS or with other solutions chosen by the manufacturer which were approved through the EU technical documentation assessment certificate, the notified body shall consult the EU reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CS or with other solutions chosen by the manufacturer, to ensure a level of safety and performance that is at least equivalent, is maintained.
The EU reference laboratory shall provide a scientific opinion within 60 days.
4.12.   To verify conformity of manufactured class D devices, the manufacturer shall carry out tests on each manufactured batch of devices. After the conclusion of the controls and tests, it shall forward to the notified body, without delay, the relevant reports on those tests. Furthermore, the manufacturer shall make the samples of manufactured batches of devices available to the notified body in accordance with pre-agreed conditions and detailed arrangements which shall include that the notified body or the manufacturer shall send samples of the manufactured batches of devices to the EU reference laboratory, where such a laboratory has been designated in accordance with Article 100, to carry out appropriate tests. The EU reference laboratory shall inform the notified body about its findings.
4.13.   The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates.
5.   Assessment of the technical documentation of specific types of devices
5.1.   Assessment of the technical documentation of class B, C and D devices for self-testing and near-patient testing
(a)
The manufacturer of class B, C and D devices for self-testing and near-patient testing shall lodge with the notified body an application for the assessment of the technical documentation.
(b)
The application shall enable the design of the device characteristics and performance(s) to be understood and shall enable conformity with the design-related requirements of this Regulation to be assessed. It shall include:
(i)
test reports, including results of studies carried out with intended users;
(ii)
where practicable, an example of the device; if required, the device shall be returned on completion of the technical documentation assessment;
(iii)
data showing the suitability of the device in view of its intended purpose for self-testing or near patient-testing;
(iv)
the information to be provided with the device on its label and its instructions for use.
The notified body may require the application to be completed by carrying out further tests or by providing further proof to allow assessment of conformity with the requirements of this Regulation.
(c)
The notified body shall verify the compliance of the device with the relevant requirements set out in Annex I of this Regulation.
(d)
The notified body shall assess the application, by using staff, employed by it, with proven knowledge and experience regarding the technology concerned and the intended purpose of the device and provide the manufacturer with a technical documentation assessment report.
(e)
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 assessment, the conditions of its validity, the data needed for the identification of the approved devices and, where appropriate, a description of the intended purpose of the device.
(f)
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 48 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.
5.2.   Assessment of the technical documentation of companion diagnostics
(a)
The manufacturer of a companion diagnostic shall lodge with the notified body an application for the assessment of the technical documentation. The notified body shall assess that application in accordance with the procedure laid down in Sections 4.1 to 4.8 of this Annex.
(b)
The application shall enable the characteristics and performance of the device to be understood, and shall enable conformity with the design-related requirements of this Regulation to be assessed, in particular, with regard to the suitability of the device in relation to the medicinal product concerned.
(c)
The notified body shall, before issuing an EU technical documentation assessment certificate for the companion diagnostic and on the basis of the draft summary of safety and performance and the draft instructions for use, 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, regarding the suitability of the device in relation to the medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex to Regulation (EC) No 726/2004 of the European Parliament and of the Council 
(
1
)
, the notified body shall seek the opinion of the EMA. If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products authority, or the EMA, that is responsible for the authorisation.
(d)
The medicinal products authority consulted shall provide its opinion, within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a further 60 days on justified grounds. The opinion and any possible update shall be included in the documentation of the notified body concerning the device.
(e)
The notified body shall give due consideration to the scientific opinion referred to in point (d) when making its decision. The notified body shall convey its final decision to the medicinal products authority consulted. The EU technical documentation assessment certificate shall be delivered in accordance with point (e) of Section 5.1.
(f)
Before changes affecting the performance and/or the intended use and/or the suitability of the device in relation to the medicinal product concerned are made, the manufacturer shall inform the notified body of the changes. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 48 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 and seek the opinion of the medicinal products authority consulted. The medicinal products authority consulted shall give its opinion within 30 days of receipt of the all the necessary documentation regarding the changes. A supplement to the EU technical documentation assessment certificate shall be issued in accordance with point (f) of Section 5.1.
CHAPTER III
ADMINISTRATIVE PROVISIONS
6.   The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, it's 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 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 Sections 4.2. and point (b) of Section 5.1., and
—
the decisions and reports from the notified body as referred to in this Annex.
7.   Each Member State shall require that the documentation referred to in Section 6 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.
(
1
)
  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
).
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 the address of its registered place of business 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,
—
in the case of devices for self-testing or near-patient testing, test reports, including results of studies carried out with intended users, and data showing the handling suitability of the device in relation to its intended purpose for self-testing or near patient-testing,
—
where practicable, an example of the device. If required, the device shall be returned on completion of the technical documentation assessment;
—
data showing the suitability of the device in relation to its intended purpose for self-testing or near-patient testing,
—
the information to be provided with the device on its label and its instructions for use, 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 in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence. 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 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 performance evaluation report in accordance with Section 1.3.2 of Annex XIII. 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 clinical application of the device in question for the purposes of that review;
(d)
in circumstances in which the clinical evidence is partly or totally based 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 the performance evaluation assessment report referred to in Section 4.8 of Annex IX;
(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;
(i)
draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to (g);
(j)
in the case of class D devices, request the EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The verification shall include laboratory tests by the EU reference laboratory in accordance with Article 48(5).
In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation, consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 following the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
The EU reference laboratory shall provide a scientific opinion within 60 days.
The scientific opinion of the EU reference laboratory and, where the procedure laid down in Article 48(6) is applicable, the views of the experts consulted, and any possible updates 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 EU reference laboratory, and, where applicable, to the views expressed by the experts consulted in accordance with Article 48(6), when making its decision. The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable;
(k)
for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use, of one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as ‘the medicinal products authority consulted’ depending on which has been consulted under this point) on the suitability of the device in relation to the medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMA. If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the EMA, that is responsible for the authorisation. The medicinal products authority consulted shall deliver its opinion within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a further 60 days on justified grounds. The 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 opinion expressed by the medicinal products authority consulted when making its decision. It shall convey its final decision to the medicinal products authority consulted; and
(l)
draw up an EU type-examination report on the results of the assessments and tests carried out, and scientific opinions provided under, points (a) to (k), including a performance evaluation assessment report for class C or class D devices or covered by the third indent of Section 2.
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 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 further 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.
5.4.   Where the changes could affect the performance claimed by the manufacturer or compliance with the CS or with other solutions chosen by the manufacturer which were approved through the EU type-examination certificate, the notified body shall consult the EU reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained.
The EU reference laboratory shall provide a scientific opinion within 60 days.
5.5.   Where the changes affect the performance or the intended use of a companion diagnostic approved through the EU type-examination certificate or its suitability in relation to a medicinal product, the notified body shall consult the medicinal products competent authority that was involved in the initial consultation or the EMA. The medicinal products authority consulted shall give its opinion, if any, within 30 days after receipt of the valid documentation regarding the changes. The approval of any change to the approved type shall take the form of a supplement to the initial EU type-examination certificate.
6.   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, 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,
—
copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements.
Section 7 of Annex IX shall apply.
ANNEX XI
CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
1.   The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and shall be subject to the surveillance referred to in Section 4.
2.   When the manufacturer fulfils the obligations laid down in Section 1, it shall draw up and keep an EU declaration of conformity in accordance with Article 17 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 meets the requirements of this Regulation which apply to the device, and in the case of class C and class D devices that undergo a type examination, conforms to the type described in the EU type-examination certificate.
3.   Quality management system
3.1.   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,
—
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.
3.2.   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.
3.3.   The first and second paragraphs 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 conform to the relevant provisions of this Regulation, the notified body shall issue an EU production 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.
3.4.   Section 2.4 of Annex IX shall apply.
4.   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.
5.   Verification of manufactured class D devices
5.1.   In the case of class D devices, the manufacturer shall carry out tests on each manufactured batch of devices. After the conclusion of the controls and tests, it shall forward to the notified body without delay the relevant reports on those tests. Furthermore, the manufacturer shall make samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and detailed arrangements which shall include that the notified body or the manufacturer, shall send samples of the manufactured devices or batches of devices to an EU reference laboratory, where such a laboratory has been designated in accordance with Article 100, to carry out appropriate laboratory tests. The EU reference laboratory shall inform the notified body about its findings.
5.2.   The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates.
6.   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 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 7 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 27.
4.
The scope of the certificates shall unambiguously describe the device or devices covered:
(a)
EU technical documentation assessment certificates and EU type-examination certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose as indicated 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 24(6).
(b)
EU quality management system certificates and EU production quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification and 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 production quality assurance certificates for class A sterile devices shall include a statement that the audit by the notified body was limited to the aspects of manufacture concerned with securing and maintaining sterile conditions.
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 Article 28(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 this Annex;
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
PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP
PART A
PERFORMANCE EVALUATION AND PERFORMANCE STUDIES
1.   PERFORMANCE EVALUATION
Performance evaluation of a device is a continuous process by which data are assessed and analysed to demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended purpose as stated by the manufacturer. To plan, continuously conduct and document a performance evaluation, the manufacturer shall establish and update a performance evaluation plan. The performance evaluation plan shall specify the characteristics and the performance of the device and the process and criteria applied to generate the necessary clinical evidence.
The performance evaluation shall be thorough and objective, considering both favourable and unfavourable data.
Its depth and extent shall be proportionate and appropriate to the characteristics of the device including the risks, risk class, performance and its intended purpose.
1.1.   Performance evaluation plan
As a general rule, the performance evaluation plan shall include at least:
—
a specification of the intended purpose of the device;
—
a specification of the characteristics of the device as described in Section 9 of Chapter II of Annex I and in point (c) of Section 20.4.1. of Chapter III of Annex I;
—
a specification of the analyte or marker to be determined by the device;
—
a specification of the intended use of the device;
—
identification of certified reference materials or reference measurement procedures to allow for metrological traceability;
—
a clear identification of specified target patient groups with clear indications, limitations and contra-indications;
—
an identification of the general safety and performance requirements as laid down in Sections 1 to 9 of Annex I that require support from relevant scientific validity and analytical and clinical performance data;
—
a specification of methods, including the appropriate statistical tools, used for the examination of the analytical and clinical performance of the device and of the limitations of the device and information provided by it;
—
a description of the state of the art, including an identification of existing relevant standards, CS, guidance or best practices documents;
—
an indication 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 intended purpose or purposes and for the analytical and clinical performance of the device;
—
for software qualified as a device, an identification and specification of reference databases and other sources of data used as the basis for its decision making;
—
an outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria;
—
the PMPF planning as referred to in Part B of this Annex.
Where any of the above mentioned elements are not deemed appropriate in the Performance Evaluation Plan due to the specific device characteristics a justification shall be provided in the plan.
1.2.   Demonstration of the scientific validity and the analytical and clinical performance:
As a general methodological principle the manufacturer shall:
—
identify through a systematic scientific literature review the available data relevant to the device and its intended purpose and identify any remaining unaddressed issues or gaps in the data;
—
appraise all relevant data by evaluating their suitability for establishing the safety and performance of the device;
—
generate any new or additional data necessary to address outstanding issues.
1.2.1.   Demonstration of the scientific validity
The manufacturer shall demonstrate the scientific validity based on one or a combination of the following sources:
—
relevant information on the scientific validity of devices measuring the same analyte or marker;
—
scientific (peer-reviewed) literature;
—
consensus expert opinions/positions from relevant professional associations;
—
results from proof of concept studies;
—
results from clinical performance studies.
The scientific validity of the analyte or marker shall be demonstrated and documented in the scientific validity report.
1.2.2.   Demonstration of the analytical performance
The manufacturer shall demonstrate the analytical performance of the device in relation to all the parameters described in point (a) of Section 9.1 of Annex I, unless any omission can be justified as not applicable.
As a general rule, the analytical performance shall always be demonstrated on the basis of analytical performance studies.
For novel markers or other markers without available certified reference materials or reference measurement procedures, it may not be possible to demonstrate trueness. If there are no comparative methods, different approaches may be used if demonstrated to be appropriate, such as comparison to some other well-documented methods or the composite reference standard. In the absence of such approaches, a clinical performance study comparing performance of the novel device to the current clinical standard practice is required.
Analytical performance shall be demonstrated and documented in the analytical performance report.
1.2.3.   Demonstration of the clinical performance
The manufacturer shall demonstrate the clinical performance of the device in relation to all the parameters described in point (b) of Section 9.1. of Annex I, unless any omission can be justified as not applicable.
Demonstration of the clinical performance of a device shall be based on one or a combination of the following sources:
—
clinical performance studies;
—
scientific peer-reviewed literature;
—
published experience gained by routine diagnostic testing.
Clinical performance studies shall be performed unless due justification is provided for relying on other sources of clinical performance data.
Clinical performance shall be demonstrated and documented in the clinical performance report.
1.3.   Clinical evidence and performance evaluation report
1.3.1.   The manufacturer shall assess all relevant scientific validity, analytical and clinical performance data to verify the conformity of its device with the general safety and performance requirements as referred to in Annex I. The amount and quality of that data shall allow the manufacturer to make a qualified assessment whether the device will achieve the intended clinical benefit or benefits and safety, when used as intended by the manufacturer. The data and conclusions drawn from this assessment shall constitute the clinical evidence for the device. The clinical evidence shall scientifically demonstrate that the intended clinical benefit or benefits and safety will be achieved according to the state of the art in medicine.
1.3.2.   Performance evaluation report
The clinical evidence shall be documented in a performance evaluation report. This report shall include the scientific validity report, the analytical performance report, the clinical performance report and an assessment of those reports allowing demonstration of the clinical evidence.
The performance evaluation report shall in particular include:
—
the justification for the approach taken to gather the clinical evidence;
—
the literature search methodology and the literature search protocol and literature search report of a literature review;
—
the technology on which the device is based, the intended purpose of the device and any claims made about the device's performance or safety;
—
the nature and extent of the scientific validity and the analytical and clinical performance data that has been evaluated;
—
the clinical evidence as the acceptable performances against the state of the art in medicine;
—
any new conclusions derived from PMPF reports in accordance with Part B of this Annex.
1.3.3.   The clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's PMPF plan in accordance with Part B of this Annex, as part of the performance evaluation and the post-market surveillance system referred to in Article 10(9). The performance evaluation report shall be part of the technical documentation. Both favourable and unfavourable data considered in the performance evaluation shall be included in the technical documentation.
2.   CLINICAL PERFORMANCE STUDIES
2.1.   Purpose of clinical performance studies
The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. This information is used to demonstrate compliance with the relevant general safety and performance requirements with respect to clinical performance. When clinical performance studies are conducted, the data obtained shall be used in the performance evaluation process and be part of the clinical evidence for the device.
2.2.   Ethical considerations for clinical performance studies
Each step in the clinical performance study, 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.
2.3.   Methods for clinical performance studies
2.3.1.   Clinical performance study design type
Clinical performance studies shall be designed in such a way as to maximize the relevance of the data while minimising potential bias.
2.3.2.   Clinical performance study plan
Clinical performance studies shall be performed on the basis of a clinical performance study plan (CPSP).
The CPSP shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study. It shall contain in particular the following information:
(a)
the single identification number of the clinical performance study, as referred to in Article 66(1);
(b)
identification of the sponsor, including the name, address of the registered place of business and contact details of the sponsor and, if applicable, the name, address of the registered place of business and contact details of its contact person or legal representative pursuant to Article 58(4) established in the Union;
(c)
information on the investigator or investigators, namely principal, coordinating or other investigator; qualifications; contact details, and investigation site or sites, such as number, qualification, contact details and, in the case of devices for self-testing, the location and number of lay persons involved;
(d)
the starting date and scheduled duration for the clinical performance study;
(e)
identification and description of the device, its intended purpose, the analyte or analytes or marker or markers, the metrological traceability, and the manufacturer;
(f)
information about the type of specimens under investigation;
(g)
overall synopsis of the clinical performance study, its design type, such as observational, interventional, together with the objectives and hypotheses of the study, reference to the current state of the art in diagnosis and/or medicine;
(h)
a description of the expected risks and benefits of the device and of the clinical performance study in the context of the state of the art in clinical practice, and with the exception of studies using left-over samples, the medical procedures involved and patient management;
(i)
the instructions for use of the device or test protocol, the necessary training and experience of the user, the appropriate calibration procedures and means of control, the indication of any other devices, medical devices, medicinal product or other articles to be included or excluded and the specifications on any comparator or comparative method used as reference;
(j)
description of and justification for the design of the clinical performance study, its scientific robustness and validity, including the statistical design, and details of measures to be taken to minimise bias, such as randomisation, and management of potential confounding factors;
(k)
the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justification for any omission;
(l)
parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined, with justification for any omission; and with the exception of studies using left-over samples the specified clinical outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health and/or public health management decisions;
(m)
information on the performance study population: specifications of the subjects, selection criteria, size of performance study population, representativity of target population and, if applicable, information on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
(n)
information on use of data out of left over specimens banks, genetic or tissue banks, patient or disease registries etc. with description of reliability and representativity and statistical analysis approach; assurance of relevant method for determining the true clinical status of patient specimens;
(o)
monitoring plan;
(p)
data management;
(q)
decision algorithms;
(r)
policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP, with a clear prohibition of use of waivers from the CPSP;
(s)
accountability regarding the device, in particular control of access to the device, follow-up in relation to the device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
(t)
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 performance studies as well as with the applicable regulatory requirements;
(u)
description of the informed consent process, including a copy of the patient information sheet and consent forms;
(v)
procedures for safety recording and reporting, including definitions of recordable and reportable events, and procedures and timelines for reporting;
(w)
criteria and procedures for suspension or early termination of the clinical performance study;
(x)
criteria and procedures for follow up of subjects following completion of a performance study, procedures for follow up of subjects in the case of suspension or early termination, procedures for follow up of subjects who have withdrawn their consent and procedures for subjects lost to follow up;
(y)
procedures for communication of test results outside the study, including communication of test results to the performance study subjects;
(z)
policy as regards the establishment of the clinical performance study report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 2.2;
(aa)
list of the technical and functional features of the device indicating those that are covered by the performance study;
(ab)
bibliography.
If part of the information referred to in the second paragraph is submitted in a separate document, it shall be referenced in the CPSP. For studies using left-over samples, points (u), (x), (y) and (z) shall not apply.
Where any of the elements referred to in the second paragraph are not deemed appropriate for inclusion in the CPSP due to the specific study design chosen, such as use of left-over samples versus interventional clinical performance studies, a justification shall be provided.
2.3.3.   Clinical performance study report
A clinical performance study report, signed by a medical practitioner or any other authorised person responsible, shall contain documented information on the clinical performance study protocol plan, results and conclusions of the clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias and clinically relevant. The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents. The report shall also include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale.
3.   OTHER PERFORMANCE STUDIES
By analogy, the performance study plan referred to in Section 2.3.2, and the performance study report, referred to in Section 2.3.3, shall be documented for other performance studies than clinical performance studies.
PART B
POST-MARKET PERFORMANCE FOLLOW-UP
4.   PMPF shall be understood to be a continuous process that updates the performance evaluation referred to in Article 56 and Part A of this Annex and shall be specifically addressed in the manufacturer's post-market surveillance plan. When conducting PMPF, the manufacturer shall proactively collect and evaluate performance and relevant scientific data from the use 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, performance and scientific validity throughout the expected lifetime of the device, of ensuring the continued acceptability of the benefit-risk ratio and of detecting emerging risks on the basis of factual evidence.
5.   PMPF shall be performed pursuant to a documented method laid down in a PMPF plan.
5.1.   The PMPF plan shall specify the methods and procedures for proactively collecting and evaluating safety, performance and scientific data with the aim of:
(a)
confirming the safety and performance of the device throughout its expected lifetime,
(b)
identifying previously unknown risks or limits to performance and contra-indications,
(c)
identifying and analysing emergent risks on the basis of factual evidence,
(d)
ensuring the continued acceptability of the clinical evidence and of the benefit-risk ratio referred to in Sections 1 and 8 of Chapter I of Annex I, and
(e)
identifying possible systematic misuse.
5.2.   The PMPF plan shall include at least:
(a)
the general methods and procedures of the PMPF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of performance or scientific data;
(b)
the specific methods and procedures of PMPF to be applied, such as ring trials and other quality assurance activities, epidemiological studies, evaluation of suitable patient or disease registers, genetic databanks or post-market clinical performance 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 performance evaluation report referred to in Section 1.3 of this Annex and to the risk management referred to in Section 3 of Annex I;
(e)
the specific objectives to be addressed by the PMPF;
(f)
an evaluation of the performance data relating to equivalent or similar devices, and the current state of the art;
(g)
reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMPF, and;
(h)
a detailed and adequately justified time schedule for PMPF activities, such as analysis of PMPF data and reporting, to be undertaken by the manufacturer.
6.   The manufacturer shall analyse the findings of the PMPF and document the results in a PMPF evaluation report that shall update the performance evaluation report and be part of the technical documentation.
7.   The conclusions of the PMPF evaluation report shall be taken into account for the performance evaluation referred to in Article 56 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMPF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
8.   If PMPF is not deemed appropriate for a specific device then a justification shall be provided and documented within the performance evaluation report.
ANNEX XIV
INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
CHAPTER I
DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES
For devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies, the sponsor shall draw up and submit the application in accordance with Article 58 accompanied by the following documents:
1.
Application form
The application form shall be duly filled in, containing the following information:
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 58(4) 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 performance evaluation and, if applicable, of its authorised representative;
1.3.
title of the performance study;
1.4.
single identification number in accordance with Article 66(1);
1.5.
status of the performance study, such as. the first submission, resubmission, significant amendment;
1.6.
details and/ or reference to the performance study plan, such as including details of the design phase of the performance study;
1.7.
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;
1.8.
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;
1.9.
identification of the Member States and third countries in which the clinical performance study is to be conducted as part of a multicentre or multinational study at the time of application;
1.10.
brief description of the device for performance study, its classification and other information necessary for the identification of the device and device type;
1.11.
summary of the performance study plan;
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 performance study in accordance with the performance study plan;
1.14.
details of the anticipated start date and duration of the performance study;
1.15.
details to identify the notified body, if already involved at the stage of application for the performance study;
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;
1.17.
the statement referred to in Section 4.1.
2.
Investigator's brochure
The investigator's brochure (IB) shall contain the information on the device for performance study that is relevant for the study 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 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.
Analytical performance.
2.4.
Existing clinical data, in particular:
—
from relevant peer-reviewed scientific literature and available consensus expert opinions or positions from relevant professional associations relating to the safety, performance, clinical benefits to patients, design characteristics, scientific validity, clinical performance and intended purpose of the device and/or of equivalent or similar devices;
—
other relevant clinical data available relating to the safety, scientific validity, clinical performance, clinical benefits to patients, design characteristics and intended purpose of similar devices, including details of their similarities and differences with the device in question.
2.5.
Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks and warnings.
2.6.
In the case of devices that include tissues, cells and substances of human, animal or microbial origins detailed information on the tissues, cells and substances, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to those tissues, cells and substances.
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 performance study and in particular information on any deviation from normal clinical practice.
3.
Performance study plan as referred to in Sections 2 and 3 of Annex XIII.
4.
Other information
4.1.
A signed statement by the natural or legal person responsible for the manufacture of the device for performance study that the device in question conforms to the general safety and performance requirements laid down in Annex I apart from the aspects covered by the clinical performance study 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, a copy of the opinion or opinions of the ethics committee or committees concerned. Where under 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 65 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;
—
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 be submitted to the competent authority reviewing an application upon request.
CHAPTER II
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 I of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance study, 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 76(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 time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market.
Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the competent authorities for the period indicated in the first subparagraph in case the sponsor, or his contact person, 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 of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation.
5.
The sponsor shall complete the follow-up of investigation subjects.
ANNEX XV
CORRELATION TABLE
Directive 98/79/EC
This Regulation
Article 1(1)
Article 1(1)
Article 1(2)
Article 2
Article 1(3)
points (54) and (55) of Article 2
Article 1(4)
—
Article 1(5)
Article 5(4) and (5)
Article 1(6)
Article 1(9)
Article 1(7)
Article 1(5)
Article 2
Article 5(1)
Article 3
Article 5(2)
Article 4(1)
Article 21
Article 4(2)
Article 19(1) and (2)
Article 4(3)
Article 19(3)
Article 4(4)
Article 10(10)
Article 4(5)
Article 18(6)
Article 5(1)
Article 8(1)
Article 5(2)
—
Article 5(3)
Article 9
Article 6
—
Article 7
Article 107
Article 8
Articles 89 and 92
Article 9(1) first subparagraph
Article 48(10) first subparagraph
Article 9(1) second subparagraph
Article 48(3) second subparagraph, Article 48(7) second subparagraph and Article 48(9) second subparagraph
Article 9(2)
Article 48(3) to (6)
Article 9(3)
Article 48(3) to (9)
Article 9(4)
Article 5(6)
Article 9(5)
—
Article 9(6)
Article 11(3) and (4)
Article 9(7)
Article 10(7)
Article 9(8)
Article 49(1)
Article 9(9)
Article 49(4)
Article 9(10)
Article 51(2)
Article 9(11)
Article 48(12)
Article 9(12)
Article 54(1)
Article 9(13)
Article 48(2)
Article 10(1) and (2), second sentence of Article 10(3) and Article 10(4)
Articles 26(3), 27 and 28
Article 10(3), first sentence
Article 11(1)
Article 11(1)
Articles 82(1) and 84(2)
Article 11(2)
Article 82(10) and Article 82(11) first subparagraph
Article 11(3)
Article 84(7)
Article 11(4)
—
Article 11(5)
Article 86
Article 12
Article 30
Article 13
Article 93
Article 14(1)(a)
—
Article 14(1)(b)
Article 47(3) and (6)
Article 14(2)
—
Article 14(3)
—
Article 15(1)
Article 38 and Article 39
Article 15(2)
Article 32
Article 15(3)
Article 40(2) and (4)
Article 15(4)
—
Article 15(5)
Article 51(5)
Article 15(6)
Article 51(4)
Article 15(7)
Article 34(2) and Article 40(2)
Article 16
Article 18
Article 17
Articles 89 to 92
Article 18
Article 94
Article 19
Article 102
Article 20
Article 97
Article 21
—
Article 22
—
Article 23
—
Article 24
—

Summary:
Ensuring the safety and performance of in vitro diagnostic medical devices
SUMMARY OF:
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
WHAT IS THE AIM OF THE REGULATION?
It updates the rules on placing on the 
European Union
 (EU) market, making available and putting into service 
in vitro
 diagnostic (IVD) medical devices
1
 
for human use
 and their accessories.
It also contains rules on the conduct of 
performance studies
2
 for IVD medical devices or accessories.
It aims to improve 
patient safety
 by introducing stricter procedures for 
conformity assessment
 (to ensure that unsafe or non-compliant devices do not end up on the market)and 
post-market surveillance
.
KEY POINTS
Scope
The regulation covers IVD medical devices for human use and their accessories (hereafter referred to as devices). However, devices manufactured and used in the same healthcare institution are exempted from the rules, other than those relating to the relevant general safety and performance requirements, so long as a number of conditions are fulfilled.
Classification system
The classification system for the devices has been adapted to the rapid scientific progress in the field and to the international guidance. They are classified according to their intended purpose and their inherent risks (classes A, B, C and D – for more details, see Annex VIII to the regulation).
Harmonised standards and common specifications
An 
implementing act
 adopted by the 
European Commission
 – Implementing Decision (EU) 
2021/1195
, as amended – lists the harmonised standards drafted in support of Regulation (EU) 2017/746.
Commission Implementing Regulation (EU) 
2022/1107
 lays down common specifications on the performance of certain class D devices. The manufacturers must follow the specifications or show that their alternative solution is at least equivalent in terms of the safety and performance of the device.
Notified bodies
The regulation tightens the rules concerning how the independent 
notified bodies
, which assess the conformity of medium- and high-risk 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 staff to successfully perform their conformity assessment tasks.
On-site inspections of manufacturers, of which some are unannounced, must be carried out.
Implementing Regulation (EU) 
2017/2185
 sets out the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of IVDs.
Performance studies
The manufacturer must support its claims on the performance of the device with rigorous evidence, including scientific validity and analytical and clinical performance data.
The regulation specifies what is required in the data collection of high-risk performance studies on devices.
Performance studies conducted in more than one EU 
Member State
 will be subject to a 
coordinated assessment
.
The regulation also applies to performance studies carried out in non-EU countries if they use specimens from EU patients.
Manufacturers’ obligations
Manufacturers: 
have clearer and more stringent obligations to monitor the quality, performance and safety of devices;
are required to have measures in place that correspond to the level of risk, type of device and size of the company;
must ensure they have sufficient financial coverage with respect to their potential liability under the 
product liability directive
 (see 
summary
), along with 
quality management and post-market surveillance systems
.
In the event of damages due to defective devices, a manufacturer’s authorised representative is jointly and severally liable.
Traceability
A system of 
unique device identifiers (UDIs)
 for registering devices and manufacturers, importers and authorised representatives ensures the traceability of devices throughout the supply chain and that, should problems arise, measures can be taken rapidly.
Implementing Decision (EU) 
2019/939
 lists the issuing entities designated to operate a system for the assignment of UDIs in the field of medical devices.
High-risk devices
In the event of the 
first certification for a new class D device
, for which common specifications are not available, an 
expert panel
 will provide its views on the performance of the device. Although the notified body is not bound by the panel’s opinion, it has to provide a justification for not following it.
The Commission may designate 
EU reference laboratories
 that will test whether class D devices perform as claimed by the manufacturer. The notified body may not deliver the certificate for the device if the scientific opinion of the EU reference laboratory is negative.
The tasks of and criteria for the EU reference laboratories in the field of IVDs are set out in Implementing Regulation (EU) 
2022/944
.
Implementing Regulation (EU) 
2022/945
 sets out the rules on fees that may be levied by the EU reference laboratories in the field of IVDs.
Genetic counselling
Patients tested with a genetic test must be provided with all relevant information on its nature, significance and implications. They must be given appropriate access to counselling in cases where a test provides information on the genetic predisposition for medical conditions and/or diseases that are generally considered to be untreatable.
Incident reporting
In addition to the obligation for manufacturers to report serious incidents (resulting in death or a serious deterioration in a person’s health) and trends in non-serious incidents (e.g. side effects from the use of a device), the regulation introduces the obligation for Member States to encourage and enable healthcare professionals, users and patients to report suspected incidents at the national level.
Market surveillance
The relevant authorities in the Member States are responsible for checking that devices on their market comply with the regulation and do not endanger health or safety of patients, users or other people.
Eudamed
A centralised database, called the 
European database on medical devices (Eudamed)
 is being developed to provide Member States, businesses, patients, healthcare professionals and the public with information on medical devices available in the EU.
Implementing Regulation (EU) 
2021/2078
 sets out the arrangements necessary for Eudamed’s set-up and maintenance.
Transition periods
Due to the challenges to ensuring proper implementation and application presented by the 
COVID-19
 pandemic, Regulation (EU) 2017/746 was amended by Regulation (EU) 
2022/112
, which extended some transition periods for already marketed devices in accordance with their risk class, as follows: 
for higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), the transition period ends on 
26 May 2025
 and 
26 May 2026
 respectively;
for lower risk devices such as class B devices and class A sterile devices, the transition period ends on 
26 May 2027
.
The transition period for most requirements applicable to devices manufactured and used within the same health institutions (in-house devices) was extended until May 2024. The requirement to justify that the needs of the patients cannot be met by an equivalent device on the market applies from May 2028.
Repeal of legislation
The regulation repeals Directive 
98/79/EC
 and 
Decision 2010/227/EU
 from 
26 May 2022
, with some exceptions laid down in Article 112.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 
26 May 2022
. Dates of application for some of the regulation’s articles vary and are detailed in Articles 110 and 113.
BACKGROUND
This regulation is one of two adopted by the EU to overhaul its laws on medical devices. The second regulation (Regulation (EU) 
2017/745
) concerns medical devices.
During the 
COVID-19
 pandemic, given the need to test for the presence of or past exposure to the virus, the Commission adopted 
guidelines on 
COVID-19
 
in vitro
 diagnostic tests and their performance
 in April 2020.
For further information, see: 
Medical devices
 (European Commission)
In vitro
 diagnostics
 – press release (European Commission)
Progressive roll-out of the 
in vitro
 diagnostic medical devices regulation
 – press release (European Commission).
KEY TERMS
In vitro diagnostic medical devices.
 Term covering a wide variety of devices used to provide information on: (a) a physiological or pathological process or state; (b) a congenital physical or mental impairment; (c) the predisposition to a medical condition or disease; (d) the safety and compatibility between the materials used and the specimens of the body intended to be used; (e) treatment response or reactions; (f) defining or monitoring therapeutic measures. Examples range from self-tests for pregnancy to tests for highly transmissible agents using specimens taken from the human body.
Performance studies.
 Studies that establish or confirm the analytical or clinical performances of a device.
MAIN 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
).
Successive amendments to Regulation (EU) 2017/746 have been incorporated in the original text. This 
consolidated version
 is of documentary value only.
Communication
 from the Commission – Guidelines on 
COVID-19
 in vitro diagnostic tests and their performance (OJ C 122I, 
15.4.2020
, 
pp. 1–7
).
RELATED DOCUMENTS
Commission Implementing Regulation (EU) 
2022/1107
 of 
4 July 2022
 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council (OJ L 178, 
5.7.2022
, 
pp. 3–56
).
Commission Implementing Regulation (EU) 
2022/944
 of 
17 June 2022
 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (OJ L 164, 
20.6.2022
, 
pp. 7–19
).
Commission Implementing Regulation (EU) 
2022/945
 of 
17 June 2022
 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices (OJ L 164, 
20.6.2022
, 
pp. 20–22
).
Commission Implementing Regulation (EU) 
2021/2078
 of 
26 November 2021
 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed) (OJ L 426, 
29.11.2021
, 
pp. 9–15
).
Commission Implementing Decision (EU) 
2021/1195
 of 
19 July 2021
 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council (OJ L 258, 
20.7.2021
, 
pp. 50–52
).
Successive amendments to Implementing Decision (EU) 2021/1195 have been incorporated into the original text. This 
consolidated version
 is of documentary value only.
Commission Implementing Decision (EU) 
2019/939
 of 
6 June 2019
 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (OJ L 149, 
7.6.2019
, 
pp. 73–75
).
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
).
See 
consolidated version
.
Commission Decision 
2010/227/EU
 of 
19 April 2010
 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 
23.4.2010
, 
pp. 45–48
).
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
, 
pp. 1–37
).
See 
consolidated version
.
last update 
24.8.2022

--- DANISH ---

Document:
5.5.2017
DA
Den Europæiske Unions Tidende
L 117/176
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
(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)
Europa-Parlamentets og Rådets direktiv 98/79/EF 
(
3
)
 udgør Unionens regelsæt for medicinsk udstyr til in vitro-diagnostik. Det er imidlertid nødvendigt med en grundlæggende revision af nævnte direktiv for at indføre et robust, gennemsigtigt, forudsigeligt og bæredygtigt regelsæt for medicinsk udstyr til in vitro-diagnostik, 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 til in vitro-diagnostik 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 kvaliteten og sikkerheden af medicinsk udstyr til in vitro-diagnostik 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 (TEUF) 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 kvaliteten og sikkerheden af medicinsk udstyr til in vitro-diagnostik bl.a. ved at sikre, at oplysninger, der er genereret ved undersøgelser af ydeevne, er pålidelige og robuste, og at sikkerheden for de forsøgspersoner, der deltager i en undersøgelse af ydeevne, er beskyttet.
(3)
Denne forordning søger ikke at harmonisere reglerne vedrørende den videre tilgængeliggørelse på markedet af medicinsk udstyr til in vitro-diagnostik, 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, risikoklassificering, overensstemmelsesvurderingsprocedurer, ydeevneevaluering og undersøgelser af ydeevne, 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 til in vitro-diagnostik.
(5)
Der bør så vidt muligt tages hensyn til de retningslinjer, der på internationalt plan er fastlagt for medicinsk udstyr til in vitro-diagnostik, navnlig inden for rammerne af Global Harmonization Task Force og dens opfølgende initiativ International Medical Devices Regulators Forum, 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 den kliniske dokumentation.
(6)
Der er specifikke forhold ved medicinsk udstyr til in vitro-diagnostik, navnlig hvad angår risikoklassificering, overensstemmelsesvurderingsprocedurer og klinisk dokumentation, og ved sektoren for medicinsk udstyr til in vitro-diagnostik, som kræver vedtagelse af specifik lovgivning, som klart adskiller sig fra lovgivningen om andet medicinsk udstyr, hvorimod de horisontale aspekter, der er fælles for begge sektorer, bør ensrettes.
(7)
Denne forordnings anvendelsesområde bør være klart afgrænset fra anden lovgivning vedrørende produkter, f.eks. medicinsk udstyr, produkter til almindelig laboratoriebrug og produkter, der udelukkende er beregnet til forskning.
(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, Det Europæiske Kemikalieagentur og Den Europæiske Fødevaresikkerhedsautoritet høres i et passende omfang, hvis det er relevant.
(9)
Det lader til, at det er muligt, at forskellige nationale regler med hensyn til at give oplysninger og yde rådgivning i forbindelse med genetiske test muligvis kun i begrænset omfang har indvirkning på et velfungerende indre marked. Der bør derfor kun fastsættes begrænsede krav hertil i denne forordning under hensyntagen til behovet for til stadighed at sikre, at proportionalitetsprincippet og nærhedsprincippet overholdes.
(10)
Det bør gøres klart, at alle test, der giver oplysninger om disposition for en medicinsk tilstand eller sygdom, f.eks. genetiske test, og test, der giver oplysninger, der kan anvendes til forudsigelse af virkningen af eller reaktioner på behandlinger, f.eks. ledsagende diagnosticering, er medicinsk udstyr til in vitro-diagnostik.
(11)
Ledsagende diagnosticering er afgørende for at definere patienters egnethed til en specifik behandling med et lægemiddel gennem kvantitativ eller kvalitativ fastsættelse af markører, der identificerer forsøgspersoner med en højere risiko for at udvikle en bivirkning ved det pågældende lægemiddel eller identificerer patienter i den population, for hvem det terapeutiske produkt på passende vis er blevet undersøgt og fundet sikkert og effektivt. En eller flere sådanne biomarkører kan forekomme i sunde forsøgspersoner og/eller i patienter.
(12)
Udstyr, der anvendes med henblik på monitorering af behandling med et lægemiddel for at sikre, at koncentrationen af relevante stoffer i det menneskelige legeme er inden for det terapeutiske vindue, betragtes ikke som udstyr til ledsagende diagnostik.
(13)
Kravet om at mindske risici mest muligt bør være opfyldt under hensyntagen til det alment anerkendte tekniske niveau på medicinområdet.
(14)
Sikkerhedsaspekter, der er omhandlet i Europa-Parlamentets og Rådets direktiv 2014/30/EU 
(
4
)
, udgør en integreret del af de generelle krav til sikkerhed og ydeevne fastlagt i denne forordning udstyr. Derfor bør denne forordning betragtes som en lex specialis i forhold til nævnte direktiv.
(15)
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 
(
5
)
, som forfølger andre mål.
(16)
Denne forordning bør omfatte krav til udstyrs sikkerhed og ydeevnekarakteristika, som skal udformes med henblik på at forebygge arbejdsskader, herunder beskytte mod stråling.
(17)
Det er nødvendigt at præcisere, at selvstændigt software, 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 til in vitro-diagnostik, er medicinsk udstyr til in vitro-diagnostik, hvorimod software til generelle formål, selv når det benyttes i forbindelse med sundhedspleje, eller software til velværeformål, ikke er medicinsk udstyr til in vitro-diagnostik. Bestemmelsen af software som enten udstyr eller tilbehør bør være uafhængig af softwarens placering eller typen af sammenkobling mellem softwaren og udstyret.
(18)
For at forbedre retssikkerheden bør definitionerne i denne forordning vedrørende selve udstyret, tilgængeliggørelsen af udstyret, erhvervsdrivende, brugere og specifikke processer, overensstemmelsesvurderingen, klinisk dokumentation, 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.
(19)
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 
(
6
)
, 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.
(20)
For at anerkende den vigtige rolle, som standardisering spiller på området for medicinsk udstyr til in vitro-diagnostik, bør overholdelsen af harmoniserede standarder som defineret i Europa-Parlamentets og Rådets forordning (EU) nr. 1025/2012 
(
7
)
 være et middel, som fabrikanterne kan bruge til at påvise overensstemmelse med de generelle krav til sikkerhed og ydeevne og andre juridiske krav, såsom krav vedrørende kvalitets- og risikostyring, fastsat i denne forordnings.
(21)
Direktiv 98/79/EF 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 undersøgelser af ydeevne og ydeevneevaluering og/eller opfølgning, efter at udstyret er bragt i omsætning.
(22)
Der bør udvikles fælles specifikationer efter høring af de relevante interessenter og under hensyntagen til de europæiske og internationale standarder.
(23)
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 
(
8
)
 og Europa-Parlamentets og Rådets afgørelse nr. 768/2008/EF 
(
9
)
.
(24)
Bestemmelserne om EU-markedsovervågning og kontrol af produkter, der indføres på EU-markedet, som er fastlagt 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.
(25)
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.
(26)
I denne forordning bør distributørers aktiviteter anses for at omfatte erhvervelse, opbevaring og levering af udstyr.
(27)
Flere af de forpligtelser, der påhviler fabrikanterne, såsom ydeevneevaluering eller indberetning i forbindelse med sikkerhedsovervågning, og som kun blev fastsat i bilagene til direktiv 98/79/EF, bør indarbejdes i de dispositive bestemmelser i denne forordning for at lette dens anvendelse.
(28)
For at sikre det højeste sundhedsbeskyttelsesniveau bør reglerne for medicinsk udstyr til in vitro-diagnostik, der både fremstilles og anvendes i én enkelt sundhedsinstitution præciseres og styrkes. Denne anvendelse bør anses for at omfatte målinger og resultater heraf.
(29)
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. I forbindelse med denne forordning bør det 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.
(30)
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 
(
10
)
. 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.
(31)
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.
(32)
Risikostyringssystemet bør være nøje afstemt med og afspejlet i processen for ydeevneevaluering for udstyret, herunder de kliniske risici, som der skal tages hensyn til som led i undersøgelserne af ydeevne, ydeevneevalueringen og opfølgningen, efter at udstyret er bragt i omsætning. Risikostyringsprocessen og processen for ydeevneevaluering bør være indbyrdes afhængige og opdateres regelmæssigt.
(33)
Det bør sikres, at overvågning af og kontrol med fremstilling af udstyr samt overvågningsaktiviteter, 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.
(34)
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.
(35)
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.
(36)
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 
(
11
)
 i andre relevante sektorer og eksisterende god praksis på området for medicinsk udstyr til in vitro-diagnostik.
(37)
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.
(38)
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.
(39)
UDI-systemet bør finde anvendelse på alt udstyr, der bringes i omsætning, bortset fra udstyr beregnet til undersøgelse af ydeevne, 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 og i Europa-Parlamentets og Rådets forordning (EU) 2017/745 
(
12
)
 fastsættes nærmere regler til sikring af, at UDI-systemet bliver funktionsdygtigt inden anvendelsen af denne forordning.
(40)
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.
(41)
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, undersøgelser af ydeevne, 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 
(
13
)
.
(42)
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.
(43)
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 undersøgelser af ydeevne 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.
(44)
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 
(
15
)
 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.
(45)
For udstyr i klasse C og D bør fabrikanterne sammenfatte de vigtigste aspekter af udstyrets sikkerhed og ydeevne og resultatet af ydeevneevalueringen i et dokument, som bør være offentligt tilgængeligt.
(46)
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 af og tilsyn med bemyndigede organer i overensstemmelse med detaljerede og strenge kriterier bør derfor være underlagt kontrol på EU-plan.
(47)
Bemyndigede organers vurderinger af fabrikanters tekniske dokumentation, navnlig dokumentation af vurderingen af ydeevne, bør evalueres kritisk af myndigheden med ansvar for bemyndigede organer. Denne evaluering bør være et led i den risikobaserede tilgang til bemyndigede organers kontrol- og tilsynsaktiviteter og bør baseres på stikprøver af den relevante dokumentation.
(48)
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.
(49)
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 den 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.
(50)
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.
(51)
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.
(52)
For så vidt angår udstyr i klasse D bør de kompetente myndigheder underrettes om certifikater udstedt af bemyndigede organer, og de bør have ret til at foretage en grundig gennemgang af den vurdering, som de bemyndigede organer foretager.
(53)
For så vidt angår udstyr i klasse D, for hvilket der ikke findes fælles specifikationer, bør det fastsættes, at hvis der er tale om den første certificering af denne specifikke type udstyr, og der ikke findes tilsvarende udstyr på markedet med samme erklærede formål og baseret på tilsvarende teknologi, bør de bemyndigede organer ud over laboratorietestning ved EU-referencelaboratorier af den ydeevne, der er angivet af fabrikanten, og af udstyrets overensstemmelse være forpligtet til at anmode eksperter om at foretage en grundig gennemgang af deres vurderingsrapport om ydeevneevaluering. Høringen af ekspertpaneler i forbindelse med ydeevneevalueringen bør føre til en harmoniseret evaluering af medicinsk højrisikoudstyr til in vitro-diagnostik ved at udveksle ekspertise om aspekter vedrørende ydeevne og udvikle fælles specifikationer for kategorier af udstyr, der har været underkastet denne høringsproces.
(54)
For at forbedre patientsikkerheden og tage passende hensyn til den teknologiske udvikling bør det nuværende klassificeringssystem for udstyr fastsat i direktiv 98/79/EF ændres grundlæggende i overensstemmelse med international praksis, og de tilsvarende overensstemmelsesvurderingsprocedurer bør tilpasses i overensstemmelse hermed.
(55)
Navnlig med henblik på overensstemmelsesvurderingsprocedurerne er det nødvendigt at klassificere udstyr i fire risikoklasser og at fastlægge et sæt robuste, risikobaserede klassificeringsregler i overensstemmelse med international praksis.
(56)
Overensstemmelsesvurderingsproceduren for udstyr i klasse A bør som hovedregel gennemføres på fabrikanters eneansvar, da sådant udstyr indebærer en lav risiko for patienterne. For udstyr i klasse B, C og D bør det være obligatorisk at inddrage et bemyndiget organ i passende omfang.
(57)
Overensstemmelsesvurderingsprocedurerne for udstyr bør styrkes og strømlines yderligere, mens kravene til de vurderinger, som de bemyndigede organer skal foretage, bør være klart defineret for at sikre lige vilkår.
(58)
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.
(59)
Det er nødvendigt at præcisere kravene vedrørende batchfrigivelsesverifikation for udstyr i højeste risikoklasse.
(60)
EU-referencelaboratorier bør ved laboratorietestning kunne verificere udstyr i højeste risikoklasse for så vidt angår den ydeevne, der er angivet af fabrikanten, og overensstemmelse med de relevante fælles specifikationer, hvis der foreligger sådanne fælles specifikationer, eller på grundlag af andre løsninger, som vælges af fabrikanten for at sikre et niveau for sikkerhed og ydeevne, som mindst svarer hertil.
(61)
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 klinisk dokumentation. Det er nødvendigt at præcisere kravene til påvisning af den kliniske dokumentation, som er baseret på oplysninger om videnskabelig validitet, og udstyrets analytiske ydeevne og kliniske ydeevne. For at sikre en struktureret og gennemsigtig proces, der genererer pålidelige og robuste data, bør tilvejebringelsen og vurderingen af tilgængelige videnskabelige oplysninger og data, der genereres i undersøgelser af ydeevne, baseres på en plan for ydeevneevaluering.
(62)
Som hovedregel bør den kliniske dokumentation stamme fra undersøgelser af ydeevne, 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 undersøgelsen af ydeevne.
(63)
Det er nødvendigt at sikre, at den kliniske dokumentation for udstyr opdateres i hele udstyrets livscyklus. En sådan opdatering indebærer, at fabrikanten som planlagt overvåger den videnskabelige udvikling og ændringer i medicinsk praksis. Relevante nye oplysninger bør efterfølgende afstedkomme en revurdering af den kliniske dokumentation for udstyret og dermed garantere sikkerhed og ydeevne via en løbende proces med ydeevneevaluering.
(64)
Det bør anerkendes, at begrebet kliniske fordele i forbindelse med medicinsk udstyr til in vitro-diagnostik er grundlæggende anderledes end det, der gælder i forbindelse med lægemidler eller terapeutisk medicinsk udstyr, eftersom fordelene ved medicinsk udstyr til in vitro-diagnostik består i at give nøjagtige medicinske oplysninger om patienter, eventuelt vurderet i forhold til medicinske oplysninger, der er opnået ved brug af andre diagnostiske metoder og teknologier, hvis det endelige kliniske resultat for patienten er afhængigt af yderligere diagnostiske og/eller terapeutiske metoder, som kan være til rådighed.
(65)
Hvis specifikt udstyr ikke har nogen analytisk eller klinisk ydeevne, eller hvis specifikke krav til ydeevne ikke finder anvendelse, bør udeladelser med tilknytning til sådanne krav begrundes i planen for ydeevneevaluering og i relaterede rapporter.
(66)
Bestemmelserne om undersøgelser af ydeevne bør være i overensstemmelse med veletablerede internationale retningslinjer på dette område, f.eks. den internationale ISO-standard 14155:2011 om god klinisk praksis for klinisk afprøvning af medicinsk udstyr til brug på mennesker, for at resultaterne af undersøgelser af ydeevne, der foretages i Unionen, lettere kan anerkendes som dokumentation uden for Unionen, og for at resultaterne af undersøgelser af ydeevne, 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.
(67)
Det bør overlades til den medlemsstat, hvor en undersøgelse af ydeevne skal foretages, at afgøre, hvilken relevant myndighed der skal inddrages i vurderingen af ansøgningen om at gennemføre en undersøgelse af ydeevne, og at organisere inddragelsen af etiske komitéer inden for de frister tilladelse til undersøgelsen af ydeevne, 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.
(68)
Der bør oprettes et elektronisk system på EU-plan for at sikre, at alle interventionsundersøgelser af klinisk ydeevne og andre undersøgelser af ydeevne, der omfatter risici for de personer, der er genstand for undersøgelserne, 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 undersøgelse af ydeevne, i det elektroniske system. For at sikre synergier med området for kliniske forsøg med lægemidler bør det elektroniske system for undersøgelser af ydeevne være interoperabelt med den EU-database, der skal oprettes for kliniske forsøg med humanmedicinske lægemidler.
(69)
Hvis en interventionsundersøgelse af klinisk ydeevne eller en anden undersøgelse af ydeevne, der omfatter risici for de personer, der er genstand, 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, hvis ydeevne skal undersøges, og af det videnskabelige design af den undersøgelse af ydeevne 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 undersøgelse af ydeevne, 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 interventionsundersøgelser af klinisk ydeevne og andre undersøgelser af ydeevne, der omfatter risici for de personer, der er genstand for undersøgelserne, til de medlemsstater, hvori undersøgelserne gennemføres. Medlemsstaterne bør have mulighed for at afbryde eller suspendere undersøgelserne 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 undersøgelserne. Denne information bør sendes til de øvrige medlemsstater.
(71)
Sponsoren i en undersøgelse af ydeevne bør inden for fristerne i denne forordning forelægge et sammendrag af resultaterne af undersøgelsen af ydeevne, der er letforståeligt for den tilsigtede bruger, sammen med rapporten om undersøgelsen af ydeevne, 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.
(72)
Med undtagelse af visse generelle krav bør denne forordning udelukkende omfatte undersøgelser af ydeevne, der har til formål at indsamle videnskabelige oplysninger med henblik på at påvise udstyrets overensstemmelse.
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Det er nødvendigt at præcisere, at undersøgelser af ydeevne ved brug af overskydende prøvemateriale ikke kræver tilladelse. De generelle krav og andre yderligere krav vedrørende databeskyttelse og krav vedrørende procedurer, der udføres i medfør af national ret, såsom etisk gennemgang, bør fortsat finde anvendelse på alle undersøgelser af ydeevne, herunder ved brug af overskydende prøvemateriale.
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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.
(75)
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 ydeevneevaluering, og bør også tjene gennemsigtighedsformålet.
(76)
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.
(77)
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 og sættes i stand til at indberette formodede alvorlige hændelser på nationalt plan ved hjælp af harmoniserede formater. De nationale kompetente myndigheder bør underrette fabrikanterne om enhver formodet alvorlig hændelse, og bør, hvis en fabrikant bekræfter, at der kan være indtruffet en alvorlig hændelse, sikre at passende opfølgning foretages for at mindske risikoen for gentagelser af sådanne hændelser.
(78)
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.
(79)
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.
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Der bør sondres klart mellem indberetning af alvorlige uønskede hændelser eller mangler ved udstyr i forbindelse med interventionsundersøgelser af klinisk ydeevne og andre undersøgelser af ydeevne, der omfatter risici for de personer, der er genstand for undersøgelserne, og indberetning af alvorlige hændelser, efter at udstyret er bragt i omsætning, for at undgå dobbelt indberetning.
(81)
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.
(82)
Enhver statistisk signifikant stigning i antallet eller alvoren af hændelser, der ikke er alvorlige hændelser, eller forventede fejlagtige resultater, som kan have væsentlig indvirkning på analysen 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.
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Der bør i overensstemmelse med betingelserne og reglerne i forordning (EU) 2017/745 nedsættes en ekspertgruppe, 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 forordning (EU) 2017/745 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.
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For at sikre et ensartet, højt beskyttelsesniveau for sundhed og sikkerhed i det indre marked, navnlig på områderne for undersøgelser af ydeevne 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.
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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.
(86)
Unionen og, når det er relevant, medlemsstaterne bør aktivt deltage i internationalt reguleringssamarbejde om udstyr for at lette udvekslingen af sikkerhedsrelevante oplysninger om 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 udføres 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.
(91)
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 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.
(93)
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.
(94)
Kommissionen bør tillægges gennemførelsesbeføjelser, således at den kan udpege udstedende enheder og EU-referencelaboratorier.
(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 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 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 98/79/EF og deres kompetence til fortsat at udstede gyldige certifikater i henhold til nævnte direktiv indtil datoen for denne forordnings anvendelse.
(96)
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 98/79/EF 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.
(97)
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 98/79/EF bør ophæves for at sikre, at der kun gælder ét sæt regler for omsætning af medicinsk udstyr til in vitro-diagnostik 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 direktiv, 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 utilsigtede hændelser relateret til udstyr, der er bragt i omsætning i henhold til direktivet, ved hjælp af de samme værktøjer som dem for indberetning vedrørende udstyr, som er bragt i omsætning i henhold til denne forordning. Afgørelse 2010/227/EU, der er vedtaget til gennemførelse af nævnte direktiv og Rådets direktiv 90/385/EØF 
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 og 93/42/EØF 
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, bør dog også ophæves med virkning fra den dato, hvor Eudamed bliver fuldt funktionsdygtig.
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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 98/79/EF.
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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.
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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 til in vitro-diagnostik, 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
INDLEDENDE BESTEMMELSER
Afdeling 1
Anvendelsesområde og definitioner
Artikel 1
Genstand og anvendelsesområde
1.   Denne forordning fastlægger regler for at bringe medicinsk udstyr til in vitro-diagnostik 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 undersøgelser vedrørende ydeevne for medicinsk udstyr til in vitro-diagnostik og tilbehør, som gennemføres i Unionen.
2.   Med henblik på denne forordning benævnes medicinsk udstyr til in vitro-diagnostik og tilbehør til medicinsk udstyr til in vitro-diagnostik i det følgende »udstyr«.
3.   Denne forordning finder ikke anvendelse på:
a)
produkter til almindelig laboratoriebrug eller produkter, der udelukkende er beregnet til forskning, medmindre fabrikanten af sådanne produkter på baggrund af deres karakteristika specifikt har bestemt, at de skal anvendes til in vitro-diagnostiske undersøgelser
b)
invasive produkter, der er beregnet til udtagning af prøvemateriale, samt produkter, som er anbragt i direkte kontakt med det menneskelige legeme med henblik på udtagning af en prøve
c)
internationalt certificeret referencemateriale
d)
materiale, der anvendes i eksterne kvalitetsvurderingsordninger.
4.   Ethvert udstyr, der, når det bringes i omsætning eller ibrugtages, som en integreret bestanddel indeholder medicinsk udstyr som defineret i artikel 2, nr. 1), i forordning (EU) 2017/745 er omfattet af den pågældende forordning. Kravene i denne forordning finder anvendelse på den del af udstyret, der omfatter medicinsk udstyr til in vitro-diagnostik.
5.   Denne forordning er specifik EU-lovgivning som omhandlet i artikel 2, stk. 3, i direktiv 2014/30/EU.
6.   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.
7.   Denne forordning berører ikke anvendelsen af direktiv 2013/59/Euratom.
8.   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.
9.   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.
10.   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 følgende:
1)   
»medicinsk udstyr«
: medicinsk udstyr som defineret i artikel 2, nr. 1), i forordning (EU) 2017/745
2)   
»medicinsk udstyr til in vitro-diagnostik«
: ethvert medicinsk udstyr, som er et reagens, et reagensprodukt, en kalibrator, et kontrolmateriale, et prøvesæt, et instrument, et apparat, en anordning, software eller et system, anvendt alene eller i kombination, og som ifølge fabrikanten er bestemt til anvendelse in vitro til undersøgelse af prøvemateriale fra det menneskelige legeme, herunder blod- og vævsdonationer, udelukkende eller hovedsagelig med henblik på at tilvejebringe oplysninger om en eller flere af følgende:
a)
om en fysiologisk eller patologisk proces eller tilstand
b)
om medfødte fysiske eller mentale handicap
c)
om disposition for en medicinsk tilstand eller sygdom
d)
til fastlæggelse af sikkerhed for og kompatibilitet med potentielle recipienter
e)
til forudsigelse af reaktioner på behandlinger
f)
til definition eller monitorering af terapeutiske foranstaltninger.
Prøvebeholdere anses også for at være medicinsk udstyr til in vitro-diagnostik
3)   
»prøvebeholder«
: udstyr, uanset om det er lufttomt, som ifølge fabrikanten specifikt er bestemt til direkte at skulle indeholde og opbevare prøvemateriale fra det menneskelige legeme med henblik på en in vitro-diagnostisk undersøgelse
4)   
»tilbehør til medicinsk udstyr til in vitro-diagnostik«
: ethvert produkt, der, selv om det ikke i sig selv er medicinsk udstyr til in vitro-diagnostik, ifølge fabrikanten er bestemt til at blive anvendt sammen med en eller flere slags bestemt medicinsk udstyr til in vitro-diagnostik for specifikt at muliggøre, at dette kan anvendes i overensstemmelse med sit erklærede formål, eller for specifikt og direkte at hjælpe den medicinske funktion af det medicinske udstyr til in vitro-diagnostik i henhold til dets erklærede formål
5)   
»udstyr til selvtestning«
: ethvert udstyr, som ifølge fabrikanten er bestemt til at anvendes af lægmand, herunder udstyr, der anvendes til testningstjenester, der tilbydes lægmand via informationssamfundstjenester
6)   
»udstyr til patientnær testning«
: ethvert udstyr, som ikke er bestemt til selvtestning, men som er bestemt til gennemførelse af test uden for et laboratoriemiljø, almindeligvis tæt på eller hos patienten af en sundhedsperson
7)   
»udstyr til ledsagende diagnosticering«
: udstyr, som er afgørende for sikker og effektiv brug af et tilknyttet lægemiddel med henblik på:
a)
før og/eller under behandling at identificere de patienter, som har størst sandsynlighed for at få gavn af det tilknyttede lægemiddel, eller
b)
før og/eller under behandling at identificere de patienter, der sandsynligvis vil have en øget risiko for alvorlige bivirkninger som følge af behandling med det tilknyttede lægemiddel
8)   
»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
9)   
»engangsudstyr«
: udstyr, der er beregnet til at blive brugt i forbindelse med en enkelt procedure
10)   
»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
11)   
»prøvesæt« (kit)
: et sæt komponenter, der er samlet i en pakke og bestemt til at blive brugt til at udføre en bestemt in vitro-diagnostisk undersøgelse eller en del heraf
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 salgserklæringerne eller som specificeret af fabrikanten i ydeevneevalueringen
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 brugeren 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)   
»risiko«
: kombination af sandsynligheden for skade og den pågældende skades alvor
17)   
»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
18)   
»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 konflikter/interferens eller bivirkninger
19)   
»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
20)   
»gøre tilgængelig på markedet«
: enhver levering af udstyr, bortset fra udstyr, hvis ydeevne skal undersøges, med henblik på distribution, forbrug eller anvendelse på EU-markedet som led i erhvervsvirksomhed mod eller uden vederlag
21)   
»bringe i omsætning«
: første tilgængeliggørelse af udstyr, bortset fra udstyr, hvis ydeevne skal undersøges, på EU-markedet
22)   
»ibrugtagning«
: det stadium, hvor udstyr, bortset fra udstyr, hvis ydeevne skal undersøges, stilles til rådighed for slutbrugeren og er klar til for første gang at blive anvendt i overensstemmelse med sit erklærede formål på EU-markedet
23)   
»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
24)   
»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
25)   
»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
26)   
»importør«
: enhver fysisk eller juridisk person, der er etableret i Unionen, og som bringer udstyr fra et tredjeland i omsætning på EU-markedet
27)   
»distributør«
: enhver fysisk eller juridisk person i forsyningskæden, bortset fra fabrikanten eller importøren, som gør udstyr tilgængeligt på markedet indtil ibrugtagningen
28)   
»erhvervsdrivende«
: en fabrikant, en autoriseret repræsentant, en importør eller en distributør
29)   
»sundhedsinstitution«
: en organisation, hvis hovedformål er pleje eller behandling af patienter eller fremme af folkesundheden
30)   
»bruger«
: enhver sundhedsperson eller lægmand, der bruger et udstyr
31)   
»lægmand«
: en person, som ikke har en formel uddannelse inden for et relevant sundhedsområde eller medicinsk fagområde
32)   
»overensstemmelsesvurdering«
: en proces til påvisning af, om denne forordnings krav vedrørende et udstyr er blevet opfyldt
33)   
»overensstemmelsesvurderingsorgan«
: et organ, der som tredjepart udfører overensstemmelsesvurderingsopgaver, herunder kalibrering, testning, certificering og inspektion
34)   
»bemyndiget organ«
: et overensstemmelsesvurderingsorgan, der er udpeget i overensstemmelse med denne forordning
35)   
»CE-overensstemmelsesmærkning« eller »CE-mærkning«
: en 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
36)   
»klinisk dokumentation«
: de kliniske data og resultaterne af ydeevneevalueringen 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
37)   
»klinisk fordel«
: udstyrs positive virkning med hensyn til dets funktion, f.eks. den positive virkning af screening, monitorering, diagnosticering eller hjælp til diagnosticering af patienter, eller en positiv virkning på patientbehandlingen eller folkesundheden
38)   
»videnskabelig validitet af en analyt«
: en analyts sammenhæng med en klinisk tilstand eller en fysiologisk tilstand
39)   
»udstyrs ydeevne«
: udstyrs evne til at opfylde det af fabrikanten angivne erklærede formål. Det omfatter den analytiske og, hvor relevant, den kliniske ydeevne, som støtter det pågældende erklærede formål
40)   
»analytisk ydeevne«
: udstyrets evne til på korrekt vis at påvise eller måle en bestemt analyt
41)   
»klinisk ydeevne«
: udstyrets evne til at give resultater, som er forbundet med en bestemt klinisk tilstand eller en fysiologisk eller patologisk proces eller tilstand, alt efter målpopulationen og den tilsigtede bruger
42)   
»undersøgelse af ydeevne«
: undersøgelse, som foretages for at fastslå eller bekræfte udstyrs analytiske eller kliniske ydeevne
43)   
»plan for undersøgelse af ydeevne«
: dokument, som beskriver rationale, formål, design, metodologi, monitorering, statistiske overvejelser, tilrettelæggelse og gennemførelse i forbindelse med en undersøgelse af ydeevne
44)   
»ydeevneevaluering«
: vurdering og analyse af data for at fastslå eller verificere udstyrets videnskabelige validitet og analytiske og eventuelt kliniske ydeevne
45)   
»udstyr, hvis ydeevne skal undersøges«
: ethvert udstyr, der af fabrikanten er bestemt til at blive anvendt i en undersøgelse af ydeevne.
Udstyr, der er beregnet til anvendelse til forskningsformål, men som ikke har noget medicinsk sigte, anses ikke for at være udstyr, hvis ydeevne skal undersøges
46)   
»interventionsundersøgelser af klinisk ydeevne«
: en undersøgelse af klinisk ydeevne, hvis testresultater kan påvirke beslutninger om patientbehandling og/eller blive anvendt i forbindelse med behandlingsvejledning
47)   
»forsøgsperson«
: en person, der deltager i en undersøgelse af ydeevne, og hvis prøve(r) udtages til in vitro-undersøgelse foretaget ved hjælp af udstyr, hvis ydeevne skal undersøges, og/eller ved hjælp af udstyr, der anvendes til kontrolformål
48)   
»investigator«
: en person, der er ansvarlig for gennemførelsen af en undersøgelse af ydeevne på et undersøgelsessted
49)   
»diagnostisk specificitet«
: udstyrs evne til at påvise fravær af en målmarkør, der er forbundet med en bestemt sygdom eller tilstand
50)   
»diagnostisk sensitivitet«
: udstyrs evne til at påvise tilstedeværelsen af en målmarkør, der er forbundet med en bestemt sygdom eller tilstand
51)   
»prognoseværdi«
: sandsynligheden for, at en person med et positivt testresultat har en bestemt sygdom, der er genstand for en undersøgelse, eller at en person med et negativt testresultat ikke har en bestemt sygdom
52)   
»positiv prognoseværdi«
: udstyrets evne til at skelne mellem »sande« positive resultater og »falske« positive resultater for et givet karaktertræk i en given population
53)   
»negativ prognoseværdi«
: udstyrets evne til at skelne mellem »sande« negative resultater og »falske« negative resultater for et givet karaktertræk i en given population
54)   
»sandsynlighedskvotient«
: sandsynligheden for, at et givent resultat viser sig hos en person med den undersøgte kliniske eller fysiologiske tilstand i forhold til sandsynligheden for, at samme resultat viser sig hos en person uden den kliniske eller fysiologiske tilstand
55)   
»kalibrator«
: et målereferencemateriale, der anvendes ved kalibrering af udstyr
56)   
»kontrolmateriale«
: et stof, et materiale eller et produkt, som ifølge fabrikanten er bestemt til at blive anvendt til verifikation af ydeevnekarakteristika for udstyr
57)   
»sponsor«
: en person, et firma, en institution eller en organisation, der påtager sig ansvaret for igangsætningen, for ledelsen og organiseringen af finansieringen af undersøgelsen af ydeevnen
58)   
»informeret samtykke«
: en forsøgspersons utvungne og frivillige tilkendegivelse af sin vilje til at deltage i en bestemt undersøgelse af ydeevne efter at være blevet informeret om alle de aspekter af undersøgelsen af ydeevne, 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 undersøgelsen af ydeevne
59)   
»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
60)   
»uønsket hændelse«
: enhver utilsigtet medicinsk hændelse, uhensigtsmæssig patientbehandlingsbeslutning, utilsigtet sygdom eller utilsigtede skader eller ethvert utilsigtet klinisk tegn, herunder unormale laboratorieresultater, hos forsøgspersoner, brugere eller andre personer i forbindelse med en undersøgelse af ydeevne, uanset om dette er relateret til udstyr, hvis ydeevne skal undersøges
61)   
»alvorlig uønsket hændelse«
: enhver uønsket hændelse med et af følgende udfald:
a)
en patientbehandlingsbeslutning, der medfører døden eller indebærer en umiddelbart livstruende situation for den person, der testes, eller medfører døden for den pågældende persons afkom
b)
dødsfald
c)
alvorlig forringelse af helbredet for den person, der testes, eller modtageren af testede donationer eller materialer, i form af:
i)
livstruende sygdom eller skader
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 skader eller varig forringelse af en legemsstruktur eller en legemsfunktion
v)
kronisk sygdom
d)
fosterskade, fosterdød eller et medfødt fysisk eller mentalt handicap eller fødselsskade
62)   
»mangel ved udstyret«
: enhver utilstrækkelighed i identiteten, kvaliteten, holdbarheden, pålideligheden, sikkerheden eller ydeevnen af udstyr, hvis ydeevne skal undersøges, herunder funktionsfejl, brugerfejl eller unøjagtigheder i fabrikantens oplysninger
63)   
»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
64)   
»markedsovervågning«
: aktiviteter, der gennemføres, og foranstaltninger, der træffes af offentlige 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
65)   
»tilbagetrækning«
: enhver foranstaltning, der har til formål at opnå, at udstyr, der allerede er gjort tilgængeligt for slutbrugeren, returneres
66)   
»tilbagekaldelse«
: enhver foranstaltning, der har til formål at forhindre, at udstyr i forsyningskæden gøres yderligere tilgængeligt på markedet
67)   
»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 skade som følge af en lægelig beslutning og handlinger, der foretages eller undlades på grundlag af oplysninger eller et eller flere resultater, som udstyret har givet
68)   
»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 svækkelse af en patients, brugers eller anden persons sundhedstilstand
c)
en alvorlig trussel mod folkesundheden
69)   
»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
70)   
»korrigerende handling«
: enhver handling, der foretages for at fjerne årsagen til en potentiel eller faktisk afvigelse eller anden uønsket situation
71)   
»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
72)   
»sikkerhedsmeddelelse«
: en meddelelse udsendt af en fabrikant til brugere eller kunder i forbindelse med en sikkerhedsrelateret korrigerende handling
73)   
»harmoniseret standard«
: en europæisk standard som defineret i artikel 2, nr. 1), litra c), i forordning (EU) nr. 1025/2012
74)   
»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 udstyr, processer eller systemer.
Afdeling 2
Produkters reguleringsmæssige status og rådgivning
Artikel 3
Produkters reguleringsmæssige status
1.   Kommissionen fastlægger efter en behørigt begrundet anmodning fra en medlemsstat og efter høring af Koordinationsgruppen for Medicinsk Udstyr (MDCG) nedsat i henhold til artikel 103 i forordning (EU) 2017/745 ved hjælp af gennemførelsesretsakter, hvorvidt et specifikt produkt eller en specifik kategori eller gruppe af produkter falder ind under definitionerne af »medicinsk udstyr til in vitro-diagnostik« eller »tilbehør til medicinsk udstyr til in vitro-diagnostik«. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 107, stk. 3, i nærværende 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 107, stk. 3.
3.   Kommissionen sørger for, at medlemsstaterne udveksler ekspertise på områderne medicinsk udstyr til in vitro-diagnostik, medicinsk udstyr, 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 og Den Europæiske Fødevaresikkerhedsautoritet høres i et passende omfang, hvis det er relevant.
Artikel 4
Genetisk information, rådgivning og informeret samtykke
1.   Hvis en genetisk test anvendes på personer i forbindelse med sundhedsydelser som defineret i artikel 3, litra a), i Europa-Parlamentets og Rådets direktiv 2011/24/EU 
(
23
)
 og med det medicinske formål at foretage diagnosticering, forbedre behandlingen eller gennemføre prædiktive eller prænatale test, skal medlemsstaterne sikre, at den person, som testes, eller, hvor det er relevant, dennes retligt udpegede repræsentant i passende omfang modtager relevante oplysninger om den genetiske tests karakter, betydning og implikationer.
2.   I forbindelse med de i stk. 1 omhandlede forpligtelser skal medlemsstaterne navnlig sikre, at der er passende adgang til rådgivning, hvis der anvendes genetiske test, som giver oplysninger om genetisk disposition for medicinske tilstande og/eller sygdomme, som generelt anses for at være uhelbredelige på grundlag af det videnskabelige og teknologiske niveau.
3.   Stk. 2 finder ikke anvendelse i tilfælde, hvor en genetisk test bekræfter diagnosticeringen af en medicinsk tilstand og/eller sygdom, som den person, der testes, i forvejen har, eller i tilfælde, hvor der anvendes ledsagende diagnosticering.
4.   Intet i denne artikel er til hinder for, at medlemsstaterne vedtager eller opretholder foranstaltninger på nationalt plan, som beskytter patienter bedre, er mere specifikke eller vedrører informeret samtykke.
KAPITEL II
TILGÆNGELIGGØRELSE PÅ MARKEDET OG IBRUGTAGNING AF UDSTYR, ERHVERVSDRIVENDES FORPLIGTELSER, CE-MÆRKNING OG FRI BEVÆGELIGHED
Artikel 5
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 ydeevneevaluering i overensstemmelse med artikel 56.
4.   Udstyr, der fremstilles og anvendes i sundhedsinstitutioner, bortset fra udstyr beregnet til undersøgelse af ydeevne, 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)
sundhedsinstitutionens laboratorium opfylder standard EN ISO 15189 eller, hvis det er relevant, nationale bestemmelser, herunder nationale bestemmelser om akkreditering
d)
sundhedsinstitutionen begrunder i sin dokumentation, at patientmålgruppens specifikke behov ikke kan opfyldes eller ikke kan opfyldes på et passende ydeevneniveau af tilsvarende udstyr, der allerede er tilgængeligt på markedet
e)
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
f)
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
g)
for så vidt angår udstyr i klasse D i overensstemmelse med reglerne i bilag VIII, udarbejder sundhedsinstitutionen 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, så den kompetente myndighed kan konstatere, om de generelle krav til sikkerhed og ydeevne som fastsat i denne forordnings bilag I er opfyldt. Medlemsstaterne kan også anvende denne bestemmelse på udstyr i klasse A, B eller C i overensstemmelse med reglerne i bilag VIII
h)
sundhedsinstitutionen træffer alle nødvendige foranstaltninger til sikring af, at alt udstyr er fremstillet i overensstemmelse med dokumentationen, jf. litra g), og
i)
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 107, 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, undersøgelser af ydeevne, klinisk dokumentation eller opfølgning af ydeevne, efter at udstyret er bragt i omsætning (»PMPF«).
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, såfremt referencer til disse monografier er offentliggjort i 
Den Europæiske Unions Tidende
.
Artikel 9
Fælles specifikationer
1.   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, ydeevneevalueringen og PMPF, som fastsat i bilag XIII eller kravene vedrørende undersøgelser af ydeevne som fastsat i bilag XIII. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 107, 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.
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 ydeevneevaluering i overensstemmelse med kravene i artikel 56 og bilag XIII, herunder en PMPF.
4.   Fabrikanterne udarbejder og opdaterer den tekniske 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 108 for på baggrund af den tekniske udvikling at ændre bilag II og III.
5.   Hvis overensstemmelsen med de gældende krav er blevet dokumenteret efter den relevante overensstemmelsesvurderingsprocedure, udarbejder fabrikanter af udstyr, bortset fra udstyr, hvis ydeevne skal undersøges, en EU-overensstemmelseserklæring i overensstemmelse med artikel 17 og anbringer CE-overensstemmelsesmærkningen i overensstemmelse med artikel 18.
6.   Fabrikanterne skal overholde de forpligtelser, der er forbundet med UDI-systemet, jf. artikel 24, og registreringsforpligtelserne, jf. artikel 26 og 28.
7.   Fabrikanterne stiller 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 51, 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.
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.
8.   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 produktets design eller egenskaber og til ændringer i de harmoniserede standarder eller de fælles specifikationer, som der er henvist til for at dokumentere produktets overensstemmelse med de gældende krav. Fabrikanter af udstyr, bortset fra udstyr, hvis ydeevne skal undersøges, 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)
ydeevneevaluering i overensstemmelse med artikel 56 og bilag XIII, herunder PMPF
g)
produktrealisering, herunder planlægning, design, udvikling, produktion og levering af tjenesteydelser
h)
verifikation af UDI-tildelinger efter artikel 24, stk. 3, til alt relevant udstyr og for at sikre overensstemmelse med og validitet af de oplysninger, der er forelagt i henhold til artikel 26
i)
etablering, implementering og opretholdelse af et system til overvågning, efter at udstyret er bragt i omsætning, i overensstemmelse med artikel 78
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.
9.   Fabrikanter af udstyr implementerer og opdaterer systemet til overvågning, efter at udstyret er bragt i omsætning, i overensstemmelse med artikel 78.
10.   Fabrikanterne sikrer, at udstyret ledsages af de oplysninger, der er omhandlet i overensstemmelse med bilag I, punkt 20, 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.
De oplysninger, der afgives i medfør af bilag I, punkt 20, for så vidt angår udstyr til selvtestning eller patientnær testning skal være letforståelige og forelægges på det eller de officielle EU-sprog, som er fastsat af den medlemsstat, hvor udstyret gøres tilgængeligt for brugeren eller patienten.
11.   Fabrikanter, der 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 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 51, om navnlig den manglende overensstemmelse og korrigerende handlinger.
12.   Fabrikanterne skal have et system til registrering og indberetning af hændelser og sikkerhedsrelaterede korrigerende handlinger som beskrevet i artikel 82 og 83.
13.   Efter anmodning fra en kompetent national myndighed forelægger fabrikanterne den al den information og dokumentation, der er nødvendig for at påvise produktets overensstemmelse med lovgivningen, 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.
14.   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 27, stk. 1.
15.   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 51, til rådighed for de kompetente myndigheder i den periode, der er nævnt i artikel 10, stk. 7
c)
opfylder registreringsforpligtelserne i artikel 28 og verificerer, at fabrikanten har opfyldt registreringsforpligtelserne i artikel 26
d)
forelægger som svar på en kompetent myndigheds anmodning al den information og dokumentation, der er nødvendig for at påvise udstyrets overensstemmelse med lovgivningen, 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 nærværende artikels stk. 3 omhandlede fuldmagt må ikke uddelegere fabrikantens forpligtelser som fastsat i artikel 10, stk. 1, 2, 3, 4, 5, 6, 8, 9, 10 og 11.
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 de grunde, 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 de krævede brugsanvisninger
d)
fabrikanten, hvis det er relevant, har tildelt udstyret en UDI i overensstemmelse med artikel 24.
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 26. Importørerne tilføjer deres oplysninger til registreringen i henhold til artikel 28.
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 51 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. 7, en kopi af 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 51.
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. 10
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 lovgivningen.
Distributørerne anses for at have opfyldt forpligtelsen i første afsnit, når fabrikanten 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 til in vitro-diagnostik. 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 til in vitro-diagnostik
b)
fire års erhvervserfaring med reguleringsmæssige spørgsmål eller kvalitetsstyringssystemer vedrørende medicinsk udstyr til in vitro-diagnostik.
2.   Mikrovirksomheder og små virksomheder i den i Kommissionens henstilling 2003/361/EF 
(
24
)
 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. 9
d)
indberetningsforpligtelserne i artikel 82-86 er opfyldt
e)
for så vidt angår udstyr beregnet til undersøgelse af ydeevne, der er beregnet til anvendelse som led i interventionsundersøgelser af klinisk ydeevne eller andre undersøgelser af ydeevne, der omfatter risici for de personer, der er genstand for undersøgelsen, den erklæring, der er nævnt i bilag XIV, punkt 4.1, er udstedt.
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 til in vitro-diagnostik 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 de pågældende medlemsstater har anerkendt som svarende hertil, inden for jura, medicin, farmaci, ingeniørvidenskab eller anden relevant videnskabelig disciplin og mindst et års erhvervserfaring med reguleringsmæssige spørgsmål eller kvalitetsstyringssystemer vedrørende medicinsk udstyr til in vitro-diagnostik
b)
fire års erhvervserfaring med reguleringsmæssige spørgsmål eller kvalitetsstyringssystemer vedrørende medicinsk udstyr til in vitro-diagnostik
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. 23), 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 20, 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
EU-overensstemmelseserklæring
1.   Det skal af EU-overensstemmelseserklæringen fremgå, at kravene i denne forordning er opfyldt. 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 de 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 108 for at ændre mindstekravet til indholdet af EU-overensstemmelseserklæringen, jf. bilag IV, på baggrund af den tekniske udvikling.
Artikel 18
CE-overensstemmelsesmærkning
1.   Udstyr, der anses for at opfylde kravene i denne forordning, bortset fra udstyr beregnet til undersøgelse af ydeevne, 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 48. 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 19
Udstyr til særlige formål
1.   Medlemsstaterne må ikke skabe hindringer for udstyr beregnet til undersøgelse af ydeevne, som leveres til laboratorier eller andre institutioner med dette formål, hvis det opfylder betingelserne i artikel 57-76 og i gennemførelsesretsakterne vedtaget i henhold til artikel 77.
2.   Udstyr, der er omhandlet i stk. 1, forsynes ikke med CE-mærkning, med undtagelse af det udstyr, der er omhandlet i artikel 70.
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 20
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 dets 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 21
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 22
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. 7:
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 23
Nomenklatur for medicinsk udstyr
For at lette anvendelsen af den europæiske database for medicinsk udstyr (Eudamed), jf. artikel 33 i forordning (EU) 2017/745 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 24
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 beregnet til undersøgelse af ydeevne, 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 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 stk. 8 og 9
d)
etablering af et elektronisk system for unik udstyrsidentifikation (»UDI-database«) i overensstemmelse med artikel 28 i forordning (EU) 2017/745
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, sundhedsinstitutioner og sundhedspersoner.
3.   Før udstyr, bortset fra udstyr, hvis ydeevne skal undersøges, 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 udstyr, hvis ydeevne skal undersøges, bringes i omsætning skal fabrikanten sikre, at de i bilag V, del B, omhandlede oplysninger vedrørende det pågældende udstyr er korrekt indsendt og overført til den i artikel 25 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 82.
6.   Den grundlæggende UDI-DI som defineret i bilag VI, del C, skal fremgå af EU-overensstemmelseserklæringen, jf. artikel 17.
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 udstyr, kategorier eller grupper af udstyr, der fastlægges ved en foranstaltning, der er omhandlet i stk. 11, litra a).
9.   Medlemsstaterne tilskynder til og kan 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 108 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 107, 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 102 og 103
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 25
UDI-database
Kommissionen opretter og forvalter efter høring af MDCG en UDI-database i overensstemmelse med betingelserne og de nærmere bestemmelser i artikel 28 i forordning (EU) 2017/745
Artikel 26
Registrering af udstyr
1.   Inden udstyr bringes i omsætning tildeler fabrikanten i overensstemmelse med reglerne fra den udstedende enhed, jf. artikel 24, 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.   For så vidt angår udstyr, der er omfattet af overensstemmelsesvurdering som omhandlet i artikel 48, stk. 3 og 4, artikel 48, stk. 7, andet afsnit, artikel 48, stk. 8 og artikel 48, stk. 9, andet 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, punkt 4, litra a), og i Eudamed bekræfte, at de i bilag VI, 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.
3.   Inden udstyr 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. deri, i Eudamed og herefter løbende opdatere disse oplysninger.
Artikel 27
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 28, 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 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 sine nærmere oplysninger til den eller de relevante registreringer.
Artikel 28
Registrering af fabrikanter, autoriserede repræsentanter og importører
1.   Inden udstyr 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 48, 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 27, 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 26.
4.   Senest en uge efter enhver ændring i forbindelse med de i denne artikels stk. 1 omhandlede oplysninger opdaterer den erhvervsdrivende dataene i det elektroniske system, jf. artikel 27.
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 27, 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 104.
Artikel 29
Sammenfatning af sikkerhed og ydeevne
1.   For udstyr i klasse C og D, bortset fra udstyr beregnet til undersøgelse af ydeevne, udarbejder fabrikanten en sammenfatning af sikkerhed og ydeevne.
Sammenfatningen 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 ydeevne skal indgå i den dokumentation, der skal forelægges det bemyndigede organ, der deltager i overensstemmelsesvurderingen i henhold til artikel 48, 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 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)
henvisning til eventuelle harmoniserede standarder og fælles specifikationer, der er anvendt
e)
sammenfatningen af rapporten om ydeevneevaluering, jf. bilag XIII, og relevante oplysninger om PMPF
f)
den metrologiske sporbarhed af fastsatte værdier
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 ydeevne. Disse gennemførelsesretsakter vedtages efter rådgivningsproceduren i artikel 107, stk. 2.
Artikel 30
Europæisk database for medicinsk udstyr
1.   Kommissionen opretter, opretholder og vedligeholder efter høring af MDCG en europæisk database for medicinsk udstyr (»Eudamed«) i overensstemmelse med betingelserne og de nærmere bestemmelser i artikel 33 og 34 i forordning (EU) 2017/745
2.   Eudamed skal omfatte følgende elektroniske systemer:
a)
det elektroniske system for registrering af udstyr, jf. artikel 26
b)
UDI-databasen, jf. artikel 25
c)
det elektroniske system for registrering af erhvervsdrivende, jf. artikel 27
d)
det elektroniske system for bemyndigede organer og certifikater, jf. artikel 52
e)
det elektroniske system for undersøgelser af ydeevne, jf. artikel 69
f)
det elektroniske system til sikkerhedsovervågning og overvågning, efter at udstyret er bragt i omsætning, jf. artikel 87
g)
det elektroniske system for markedsovervågning, jf. artikel 95.
KAPITEL IV
BEMYNDIGEDE ORGANER
Artikel 31
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 til in vitro-diagnostik, sikrer den, at den nationale myndighed med ansvar for medicinsk udstyr til in vitro-diagnostik høres om relevante forhold.
7.   Medlemsstaterne offentliggør generelle oplysninger om deres foranstaltninger, der gælder 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 44.
Artikel 32
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 107, stk. 3.
Artikel 33
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 34
Ansøgning om udpegelse fra overensstemmelsesvurderingsorganer
1.   Overensstemmelsesvurderingsorganer skal indsende 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 35. 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 den nationale myndighed med ansvar for bemyndigede organer har mulighed for at føre tilsyn med og verificere, at alle kravene i bilag VII fortsat opfyldes.
Artikel 35
Vurdering af ansøgningen
1.   Myndigheden med ansvar for bemyndigede organer kontrollerer inden for 30 dage, at den i artikel 34 omhandlede ansøgning er fuldstændig, og anmoder ansøgeren om at indsende eventuelle manglende oplysninger. Når ansøgningen er fuldstændig, sender denne nationale 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 36 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 kompetente eksperter, som er kvalificerede til at vurdere de overensstemmelsesvurderingsaktiviteter og de typer af udstyr, som ansøgningen vedrører, eller, navnlig hvis vurderingsproceduren iværksættes i henhold til artikel 43, 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 34. 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 tilfældene af den manglende opfyldelse af kravene.
6.   Det fælles vurderingshold dokumenterer eventuelle udestående afvigende opfattelser vedrørende 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 34, og vurderingen af ansøgningen, der er fastsat i denne artikel. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 107, stk. 3.
Artikel 36
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 in vitro-diagnostik, til at deltage i de aktiviteter, der er omhandlet i artikel 35 og 44.
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 52.
Artikel 37
Sprogkrav
Alle de dokumenter, der kræves i henhold til artikel 34 og 35, 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 34 og 35, 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 35, stk. 3.
Artikel 38
Udpegelses- og notifikationsprocedure
1.   Medlemsstaterne må kun udpege overensstemmelsesvurderingsorganer, for hvilke vurderingen i henhold til artikel 35 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 40.
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 35, 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 40, 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 oplysningerne vedrørende notifikation af det bemyndigede organ i det elektroniske system, der er omhandlet i artikel 52, sammen med de dokumenter, der er nævnt i nærværende artikels stk. 4, og udtalelsen og svaret, 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 den 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 107, 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 44.
Artikel 39
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 38, 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 98/79/EF, det identifikationsnummer, som de har fået tildelt i henhold til det direktiv.
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 52. Kommissionen holder listen opdateret.
Artikel 40
Tilsyn med og revurdering 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 i den medlemsstat, hvori organet er etableret, skal sørge for, at det bemyndigede organ følger 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.
Myndigheden 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 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 dokumentation vedrørende evaluering af ydeevne som nærmere beskrevet i artikel 41.
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 efter proceduren i artikel 34 og 35.
11.   Kommissionen tillægges beføjelse til at vedtage delegerede retsakter i overensstemmelse med artikel 108 for at ændre nærværende artikels stk. 10 med henblik på at ændre den hyppighed, hvormed de fuldstændige fornyede vurderinger, der er omhandlet i nævnte stykke, 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 52.
Artikel 41
Gennemgang af det bemyndigede organs vurdering af den tekniske dokumentation og dokumentationen for ydeevneevalueringen
1.   Myndigheden med ansvar for bemyndigede organer skal som led i sit løbende tilsyn af bemyndigede organer evaluere et passende antal af det bemyndigede organs vurderinger af fabrikanternes tekniske dokumentation, navnlig dokumentation vedrørende evaluering af ydeevne, for at verificere konklusionerne fra det bemyndigede organ på grundlag af de oplysninger, som fabrikanten har forelagt. De evalueringer, som nationale myndighed med ansvar for bemyndigede organer foretager, skal udføres både eksternt og på stedet.
2.   De stikprøver, der 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 evaluerer, om det bemyndigede organs vurdering 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 evaluering af ydeevne, 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 40, stk. 10, og de fælles vurderingsaktiviteter i artikel 43, stk. 3. Evalueringerne skal udføres ved at benytte passende ekspertise.
5.   MDCG kan på grundlag af de rapporter og evalueringer, som udføres 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 evalueringer af ydeevne, 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 vurderinger af teknisk dokumentation og dokumentation vedrørende ydeevneevaluering, jf. denne artikel. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 107, stk. 3.
Artikel 42
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 35 og artikel 38 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 52.
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 organet 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 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 52, indføre oplysninger vedrørende certifikater, som den har krævet suspenderet eller tilbagekaldt
e)
underrette den kompetente myndighed for medicinsk udstyr til in vitro-diagnostik i den medlemsstat, hvor fabrikanten har sit registrerede forretningssted, gennem det elektroniske system, der er omhandlet i artikel 52 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 til in vitro-diagnostik i den medlemsstat, hvor fabrikanten af det udstyr, der er omfattet af certifikaterne, 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 følgende tilfælde:
a)
Hvis den kompetente myndighed for medicinsk udstyr til in vitro-diagnostik 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 tilbagekaldelsen af udpegelsen.
Under de omstændigheder, der er omhandlet i stk. 1, kan den nationale kompetente myndighed for medicinsk udstyr til in vitro-diagnostik 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.
Myndigheden eller det bemyndigede organ, der har påtaget sig funktionerne for det bemyndigede organ, der er berørt af ændringen af udpegelsen, underretter straks Kommissionen, de øvrige medlemsstater og de øvrige bemyndigede organer herom.
Artikel 43
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 35, stk. 3 og 5, 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 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 35. 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 36, tilladelse til at deltage i en vurdering på stedet som led i de planlagte tilsyns- og vurderingsaktiviteter i overensstemmelse med artikel 40 og som angivet i den årlige vurderingsplan, der er beskrevet i artikel 40, 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 107, stk. 3. Den underretter den pågældende medlemsstat om sin afgørelse og opdaterer NANDO og det elektroniske system, der er omhandlet i artikel 52.
5.   Kommissionen sikrer, at alle fortrolige oplysninger, som den indhenter som led i sine undersøgelser, behandles i overensstemmelse hermed.
Artikel 44
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 de myndigheder med ansvar for bemyndigede organer. En sådan udveksling skal omfatte elementer som bl.a.:
a)
udarbejdelse af dokumenter om bedste praksis vedrørende aktiviteterne i myndigheder 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 36
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 38, stk. 13
f)
udvikling af en mekanisme til peer reviews 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 35. Alternativt kan en national myndighed vælge, at sådanne peer reviews skal finde sted som en del af dens tilsynsaktiviteter, jf. artikel 40.
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-mekanismerne og uddannelse og kvalifikationer, jf. denne artikels stk. 1. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 107, stk. 3.
Artikel 45
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 koordineringsgruppen af bemyndigede organer, jf. artikel 49 i forordning (EU) 2017/745
De organer, der er bemyndiget i henhold til denne forordning, deltager i denne gruppes arbejde.
Artikel 46
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 47
Klassificering af udstyr
1.   Udstyr inddeles i klasse A, B, C og D 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 for udstyr 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 markedsovervågningsaktiviteterne, 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 107, stk. 3.
Afdeling 2
Overensstemmelsesvurdering
Artikel 48
Overensstemmelsesvurderingsprocedurer
1.   Inden udstyr bringes i omsætning, foretager fabrikanten en overensstemmelsesvurdering af udstyret i overensstemmelse med de gældende overensstemmelsesvurderingsprocedurer, jf. bilag IX-XI.
2.   Inden ibrugtagning af udstyr, som ikke bringes i omsætning, bortset fra internt udstyr fremstillet i henhold til artikel 5, stk. 5, foretager fabrikanten en vurdering af udstyrets overensstemmelse med kravene i overensstemmelse med de gældende overensstemmelsesvurderingsprocedurer, jf. bilag IX-XI.
3.   Fabrikanter af udstyr i klasse D, bortset fra udstyr, hvis ydeevne skal undersøges, skal følge en overensstemmelsesvurdering som omhandlet i kapital I, kapitel II, undtagen punkt 5, og kapitel III i bilag IX
For udstyr til selvtestning og patientnær testning skal fabrikanten i tillæg til procedurerne i første afsnit følge proceduren for vurdering af teknisk dokumentation i bilag IX, punkt 5.1.
For udstyr til ledsagende diagnosticering skal det bemyndigede organ i tillæg til procedurerne i første og andet afsnit høre en kompetent myndighed, der er udpeget af medlemsstaterne i overensstemmelse med Europa-Parlamentets og Rådets direktiv 2001/83/EF 
(
25
)
, eller, hvis det er relevant, EMA i overensstemmelse med proceduren i bilag IX, punkt 5.2.
4.   Fabrikanter af udstyr i klasse D, bortset fra udstyr, hvis ydeevne skal undersøges, kan i stedet for den overensstemmelsesvurderingsprocedure, der findes anvendelse i henhold til stk. 3, vælge at anvende en overensstemmelsesvurdering som omhandlet i bilag X, kombineret med en overensstemmelsesvurdering som omhandlet i bilag XI.
For ledsagende diagnosticering skal det bemyndigede organ navnlig høre en kompetent myndighed, der er udpeget af medlemsstaterne i overensstemmelse med direktiv 2001/83/EF, eller, hvis det er relevant, EMA i overensstemmelse med proceduren i bilag X, punkt 3, litra k).
5.   Uden at det berører nogen af forpligtelserne i henhold til de andre procedurer, der er omhandlet i stk. 3 og 4, anmoder det bemyndigede organ, som udfører overensstemmelsesvurderingen, navnlig for udstyr, for hvilket der er blevet udpeget et eller flere EU-referencelaboratorier i overensstemmelse med artikel 100, et af disse EU-referencelaboratorier om ved hjælp af laboratorietestning at verificere den ydeevne, der er angivet af fabrikanten, og udstyrets overensstemmelse med de relevante fælles specifikationer, eller med andre løsninger, som vælges af fabrikanten, for at sikre et niveau med hensyn til sikkerhed og ydeevne, som mindst svarer hertil, jf. bilag IX, punkt 4.9, og bilag X, punkt 3, litra j). Laboratorieprøvninger, der udføres af et EU-referencelaboratorium, skal især fokusere på analytisk og diagnostisk sensitivitet ved brug af de bedste foreliggende referencematerialer.
6.   Hvis der ikke foreligger fælles specifikationer for udstyr i klasse D, og hvis det også er den første certificering af den pågældende type udstyr, skal det bemyndigede organ i tillæg til de gældende procedurer i henhold til stk. 3 og 4 høre det relevante ekspertpanel, der er omhandlet i artikel 106 i forordning (EU) 2017/745 om fabrikantens rapport om ydeevneevaluering. Med henblik herpå forelægger det bemyndigede organ fabrikantens rapport om ydeevneevaluering for ekspertpanelet senest fem dage efter modtagelsen fra fabrikanten. De relevante eksperter forelægger under Kommissionens tilsyn deres synspunkter i overensstemmelse med bilag IX, punkt 4.9, eller bilag X, punkt 3, litra j), alt efter hvad der er relevant, for det bemyndigede organ inden for fristen for EU-referencelaboratoriets afgivelse af den videnskabelige udtalelse som specificeret deri.
7.   Fabrikanter af udstyr i klasse C, bortset fra udstyr, hvis ydeevne skal undersøges, skal følge en overensstemmelsesvurderingsprocedure som omhandlet i kapitel I og III i bilag IX, herunder en vurdering af den tekniske dokumentation som omhandlet i nævnte bilags punkt 4.4-4.8 af mindst et repræsentativt udstyr pr. generisk gruppe af udstyr.
For udstyr til selvtestning og patientnær testning skal fabrikanten i tillæg til procedurerne i første afsnit følge proceduren for vurdering af teknisk dokumentation omhandlet i bilag IX, punkt 5.1.
For ledsagende diagnosticering skal det bemyndigede organ for hvert udstyr i tillæg til de i første og andet afsnit omhandlede procedurer følge proceduren for vurdering af teknisk dokumentation i bilag IX, punkt 5.2, og skal anvende proceduren for vurdering af teknisk dokumentation i bilag IX, punkt 4.1-4.8 samt skal høre den kompetente myndighed, der er udpeget af medlemsstaterne i overensstemmelse med direktiv 2001/83/EF, eller, hvis det er relevant, EMA i overensstemmelse med proceduren i bilag IX, punkt 5.2.
8.   Fabrikanter af udstyr i klasse C, bortset fra udstyr, hvis ydeevne skal undersøges, kan i stedet for overensstemmelsesvurderingsproceduren i henhold til stk. 7, vælge at anvende en overensstemmelsesvurdering som omhandlet i bilag X, kombineret med en overensstemmelsesvurdering som omhandlet i bilag XI, bortset fra punkt 5 heraf.
For ledsagende diagnosticering skal det bemyndigede organ navnlig for hvert udstyr høre den kompetente myndighed, der er udpeget af medlemsstaterne i overensstemmelse med direktiv 2001/83/EF, eller, hvis det er relevant, EMA i overensstemmelse med proceduren i bilag X, punkt 3, litra k).
9.   Fabrikanter af udstyr i klasse B, bortset fra udstyr, hvis ydeevne skal undersøges, 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 nævnte bilags punkt 4.4-4.8 for mindst ét repræsentativt udstyr pr. gruppe af udstyr.
For udstyr til selvtestning og patientnær testning skal fabrikanten i tillæg til procedurerne i første afsnit følge proceduren for vurdering af teknisk dokumentation omhandlet i bilag IX, punkt 5.1.
10.   Fabrikanter af udstyr i klasse A, bortset fra udstyr, hvis ydeevne skal undersøges, skal erklære, at deres produkter er i overensstemmelse med de relevante krav ved at udstede EU-overensstemmelseserklæringen, jf. artikel 17, når de har udarbejdet den tekniske dokumentation, der er anført i bilag II og III.
Hvis disse udstyr imidlertid markedsføres i steril tilstand, skal fabrikanten anvende procedurerne i bilag IX eller i bilag XI. Det bemyndigede organs inddragelse skal begrænses til aspekterne i forbindelse med at opnå, sikre og opretholde den sterile tilstand.
11.   Udstyr beregnet til undersøgelse af ydeevne er omfattet af kravene i artikel 57-77.
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. 1-10, 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.   Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte de 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 C
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)
hyppigheden for prøveudtagningen af det fremstillede udstyr eller partier af det fremstillede udstyr i klasse D, som sendes til et EU-referencelaboratorium, som er udpeget i medfør af artikel 100 i henhold til bilag IX, punkt 4.12, og bilag XI, punkt 5.1, eller
d)
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, og bilag X, punkt 3, litra f) og g).
De gennemførelsesretsakter, der er omhandlet i første afsnit, vedtages efter undersøgelsesproceduren i artikel 107, stk. 3.
Artikel 49
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 at udføre 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 52, 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 50
Mekanisme til kontrol af overensstemmelsesvurderinger af udstyr i klasse D
1.   Et bemyndiget organ underetter den kompetente myndighed om certifikater, som det har udstedt for udstyr, der er klassificeret i klasse D, bortset fra ansøgninger om at supplere eller forlænge eksisterende certifikater. En sådan underretning skal ske via det elektroniske system, der er omhandlet i artikel 52, og indeholde de brugsanvisninger, der er omhandlet i bilag I, punkt 20.4, sammenfatningen af sikkerhed og ydeevne, der er omhandlet i artikel 29, vurderingsrapporten fra det bemyndigede organ og, hvis det er relevant, laboratorieprøvninger og den videnskabelige udtalelse fra EU-referencelaboratoriet i medfør af artikel 48, stk. 3, andet afsnit, og, hvis det er relevant, de synspunkter, som de i artikel 106 i forordning (EU) 2017/745 omhandlede eksperter har givet udtryk for i overensstemmelse med artikel 48, stk. 4. I tilfælde af divergerende synspunkter mellem det bemyndigede organ og de hørte eksperter 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 40, 41, 42, 43 eller 89 og, hvis det skønnes nødvendigt, træffe passende foranstaltninger i henhold til artikel 90 og 92.
3.   MDCG og eventuelt Kommissionen kan i tilfælde af rimelig tvivl anmode om videnskabelig rådgivning fra ekspertpanelerne for så vidt angår udstyrs sikkerhed og ydeevne.
Artikel 51
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 brugere eller kræve, at fabrikanterne foretager PMPF-undersøgelser, efter at udstyret er bragt i omsætning, i henhold til bilag XIII, 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 52, 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 108 for at ændre mindstekravet til indholdet af de certifikater, der er fastlagt i bilag XII, på baggrund af den tekniske udvikling.
Artikel 52
Elektronisk system for bemyndigede organer og overensstemmelsescertifikater
Med henblik på denne forordning indsamles og behandles følgende oplysninger, jf. artikel 57 i forordning (EU) 2017/745 i det elektroniske system, der oprettes i overensstemmelse med nævnte artikel:
a)
listen over dattervirksomheder, jf. artikel 33, stk. 2
b)
listen over eksperter, jf. artikel 36, stk. 2
c)
oplysninger om notifikationen, jf. artikel 38, stk. 10, og de ændrede notifikationer, jf. artikel 42, stk. 2
d)
listen over bemyndigede organer, jf. artikel 39, stk. 2
e)
resuméet af rapporten, jf. artikel 40, stk. 12
f)
underretninger om overensstemmelsesvurderinger og -certifikater, jf. artikel 50, stk. 1
g)
tilbagetrækning af eller afslag på ansøgninger om certifikater, jf. artikel 49, stk. 2, og bilag VII, punkt 4.3
h)
oplysningerne vedrørende certifikater, jf. artikel 51, stk. 5
i)
sammenfatningen af sikkerhed og ydeevne, jf. artikel 29.
Artikel 53
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 54
Undtagelse fra overensstemmelsesvurderingsprocedurerne
1.   Uanset artikel 48 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 107, stk. 3.
I behørigt begrundede særligt hastende tilfælde vedrørende menneskers sikkerhed og sundhed vedtager Kommissionen efter proceduren i artikel 107, stk. 4, gennemførelsesretsakter, der finder anvendelse straks.
Artikel 55
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 26. Hvis et bemyndiget organ har udstedt et certifikat i henhold til artikel 51, 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 107, stk. 2.
KAPITEL VI
KLINISK DOKUMENTATION, YDEEVNEEVALUERING OG UNDERSØGELSER AF YDEEVNE
Artikel 56
Ydeevneevaluering og klinisk dokumentation
1.   Bekræftelse af, at udstyr under de normale påtænkte anvendelsesforhold er i overensstemmelse med de i bilag 1 fastsatte relevante generelle krav til sikkerhed og ydeevne, der er fastlagt i bilag I, navnlig med hensyn til ydeevneegenskaber, jf. bilag I, kapitel I, og punkt 9, samt vurderingen af interferens(er) og krydsreaktion(er) og af, om forholdet mellem fordele og risici er acceptabelt, jf. bilag I, punkt 1 og 8, baseres på videnskabelig validitet, analytiske og kliniske ydeevnedata med tilstrækkelig klinisk dokumentation, herunder eventuelt relevante oplysninger 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 den kliniske dokumentation skal stå i rimeligt forhold til udstyrets egenskaber og erklærede formål.
Med henblik herpå planlægger, udfører og dokumenterer fabrikanterne en ydeevneevaluering i overensstemmelse med denne artikel og bilag XIII, del A.
2.   Den kliniske dokumentation skal understøtte udstyrets erklærede formål som angivet af fabrikanten og være baseret på en løbende proces med ydeevneevaluering i henhold til en plan om ydeevneevaluering.
3.   En ydeevneevaluering skal følge en defineret og metodologisk forsvarlig fremgangsmåde til påvisning af følgende i overensstemmelse med denne artikel og bilag XIII, del A:
a)
videnskabelig validitet
b)
analytisk ydeevne
c)
klinisk ydeevne.
Dataene og konklusionerne fra vurderingen af de pågældende elementer udgør udstyrets kliniske dokumentation. Den kliniske dokumentation skal være af en sådan art, at den med henvisning til det aktuelle tekniske niveau inden for medicin videnskabeligt påviser, at den tilsigtede kliniske fordel/de tilsigtede kliniske fordele og sikkerhed vil blive opnået, og at udstyret er sikkert. Den kliniske dokumentation, der udledes af ydeevneevalueringen, skal sikre videnskabeligt underbygget sikkerhed for, at de relevante generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I, er opfyldt ved forskriftsmæssig brug.
4.   Der skal i overensstemmelse med bilag XIII, del A, punkt 2, foretages undersøgelser af klinisk ydeevne, medmindre det er behørigt begrundet at anvende andre kilder til data for klinisk ydeevne.
5.   Data for videnskabelig validitet, analytisk ydeevne og klinisk ydeevne, vurdering heraf og klinisk dokumentation afledt heraf dokumenteres i rapporten om ydeevneevaluering, jf. bilag XIII, del A, punkt 1.3.2. Rapporten om ydeevneevaluering skal være en del af det pågældende udstyrs tekniske dokumentation, jf. bilag II.
6.   Ydeevneevalueringen og den tilhørende dokumentation skal opdateres i hele det pågældende udstyrs livscyklus med data fra gennemførelsen af fabrikantens PMPF-plan, efter at udstyret er bragt i omsætning i overensstemmelse med bilag XIII, del B, og planen for overvågning, efter at udstyret er bragt i omsætning, jf. artikel 79.
Rapporten om ydeevneevaluering opdateres for så vidt angår udstyr i klasse C og D, når det er nødvendigt, men mindst én gang om året, med data omhandlet i første afsnit. Sammenfatningen af sikkerhed og ydeevne, der er omhandlet i artikel 29, stk. 1, opdateres hurtigst muligt, når det er nødvendigt.
7.   For at sikre en ensartet anvendelse af bilag XIII kan Kommissionen om nødvendigt under behørigt hensyn 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 107, stk. 3.
Artikel 57
Generelle krav vedrørende undersøgelser af ydeevne
1.   Fabrikanten sikrer, at udstyr, hvis ydeevne skal undersøges, opfylder de i bilag I fastsatte generelle krav til sikkerhed og ydeevne, undtagen for så vidt angår de aspekter, der er omfattet af undersøgelsen af ydeevne, og, for så vidt angår disse aspekter, at alle nødvendige forholdsregler er truffet for at beskytte patientens, brugerens eller andre personers helbred og sikkerhed.
2.   Når det er hensigtsmæssigt, udføres undersøgelserne af ydeevne under forhold, der svarer til udstyrets normale anvendelsesforhold.
3.   Undersøgelser af ydeevne skal designes og gennemføres på en sådan måde, at de forsøgspersoner, der deltager i sådanne undersøgelser af ydeevne, er beskyttet med hensyn til deres rettigheder, sikkerhed, værdighed og velfærd, som skal komme før alle andre interesser, og at de data, der genereres, er videnskabeligt underbyggede, pålidelige og robuste.
Undersøgelser af ydeevne, herunder undersøgelser af ydeevne ved brug af overskydende prøver, skal gennemføres i overensstemmelse med gældende ret om databeskyttelse.
Artikel 58
Yderligere krav til visse undersøgelser af ydeevne
1.   Enhver undersøgelse af ydeevne,
a)
hvor kirurgisk invasive prøver kun udtages med henblik på undersøgelsen af ydeevne
b)
der er en interventionsundersøgelse af klinisk ydeevne som defineret i artikel 2, nr. 46), eller
c)
hvor undersøgelsernes gennemførelse omfatter yderligere invasive indgreb eller andre risici for de personer, der er genstand for undersøgelserne,
skal ud over at opfylde kravene i artikel 57 og bilag XIII designes, tillades, gennemføres, registreres og rapporteres i overensstemmelse med nærværende artikel og artikel 59-77 og bilag XIV.
2.   Undersøgelser af ydeevne, der omfatter udstyr til ledsagende diagnosticering, skal underkastes de samme krav som de undersøgelser af ydeevne, der er nævnt i stk. 1. Dette gælder ikke for undersøgelser af ydeevne, der omfatter udstyr til ledsagende diagnosticering, som udelukkende anvender overskydende prøver. Sådanne undersøgelser skal dog underrettes til den kompetente myndighed.
3.   Undersøgelser af ydeevne 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 undersøgelse af ydeevne. Mindst én lægmand skal deltage i den etiske gennemgang.
4.   Hvis sponsor af en undersøgelse af ydeevne 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 for så vidt angår undersøgelser af ydeevne, 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 undersøgelse af ydeevne, som skal være adressat for al kommunikation med sponsor i henhold til denne forordning.
5.   En undersøgelse af ydeevne i henhold til stk. 1 må kun gennemføres, hvis alle de følgende betingelser er opfyldt:
a)
undersøgelsen af ydeevne er omfattet af en tilladelse fra den eller de medlemsstater, hvor undersøgelsen af ydeevne 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 undersøgelse af ydeevne, 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. 4 er etableret i Unionen
d)
sårbare populationer og forsøgspersoner beskyttes på passende vis i overensstemmelse med artikel 59-64
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 59
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)
undersøgelsen af ydeevne 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 planen for undersøgelse af ydeevne og til stadighed kontrolleres
j)
ansvaret for behandlingen på sundhedsområdet, der gives forsøgspersonerne, påhviler en behørigt kvalificeret læge eller, hvor det er relevant, enhver anden, der i henhold til national ret har beføjelse til at udføre den relevante patientpleje på betingelserne for undersøgelsen af ydeevne
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 undersøgelsen af ydeevne
l)
hvis det er relevant, gennemført testning af den biologiske sikkerhed, der afspejler den nyeste videnskabelige viden, eller enhver anden test, der anses for nødvendig i lyset af udstyrets erklærede formål
m)
den analytiske ydeevne er blevet dokumenteret i tilfælde af undersøgelser af klinisk ydeevne under hensyntagen til det aktuelle tekniske niveau
n)
den analytiske ydeevne og videnskabelige gyldighed er blevet dokumenteret i tilfælde af interventionsundersøgelser af klinisk ydeevne under hensyntagen til det aktuelle tekniske niveau Hvis den videnskabelige validitet ikke er fastslået for udstyr til ledsagende diagnosticering, leveres det videnskabelige rationale for brug af biomarkøren
o)
udstyrets tekniske sikkerhed med hensyn til dets anvendelse er blevet påvist under hensyntagen til det aktuelle tekniske niveau samt bestemmelser inden for arbejdssikkerhed og forebyggelse af ulykker
p)
kravene i bilag XIV er opfyldt.
6.   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 undersøgelsen af ydeevne 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.
7.   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 eller laboratoriemedicin. Andet personale, der er involveret i gennemførelse af en undersøgelse af ydeevne, 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.
8.   De faciliteter, hvor undersøgelsen af ydeevne, der omfatter forsøgspersoner, gennemføres, skal i givet fald være egnede til undersøgelsen af ydeevne og skal svare til faciliteterne, hvor udstyret er bestemt til at skulle anvendes.
Artikel 59
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 undersøgelsen af ydeevne.
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)
art, formål, fordele, implikationer, risici og ulemper ved undersøgelsen af ydeevne
ii)
forsøgspersonens rettigheder og garantier for så vidt angår dennes beskyttelse, navnlig retten til at nægte at deltage i undersøgelsen af ydeevne samt retten til når som helst at udgå af undersøgelsen af ydeevne, uden at det er til skade for vedkommende og uden at skulle give en begrundelse herfor
iii)
betingelserne for, hvorledes undersøgelsen af ydeevne skal gennemføres, herunder den forventede varighed af forsøgspersonens deltagelse i undersøgelsen af ydeevne, og
iv)
mulige behandlingsalternativer, herunder opfølgningsforanstaltninger, såfremt forsøgspersonens deltagelse i undersøgelsen af ydeevne 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, og
d)
indeholde information om den gældende skadeserstatningsordning, jf. artikel 65
e)
indeholde det EU-dækkende unikke individuelle identifikationsnummer for undersøgelsen af ydeevne som omhandlet i artikel 66, stk. 1, og information om tilgængeligheden af resultaterne af undersøgelsen af ydeevne i overensstemmelse med nærværende 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 rapport om undersøgelsen af ydeevne og et resumé, som er forståeligt for den tilsigtede bruger, gøres tilgængelige i henhold til artikel 73, stk. 5, i det elektroniske system om undersøgelser af ydeevne som omhandlet i artikel 69, uanset udfaldet af undersøgelsen af ydeevne 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 undersøgelse af ydeevne oven i det informerede samtykke, der gives af den retligt udpegede repræsentant.
Artikel 60
Undersøgelser af ydeevne 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 undersøgelsen af ydeevne kun gennemføres, hvis alle de følgende betingelser, ud over betingelserne i artikel 58, stk. 5, er opfyldt:
a)
der er indhentet et informeret samtykke fra deres retligt udpegede repræsentant
b)
forsøgspersoner uden handleevne har modtaget den i artikel 59, 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 59, stk. 2, omhandlede information, om ikke at deltage i eller om når som helst at udgå af undersøgelsen af ydeevne
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 undersøgelsen af ydeevne
e)
undersøgelsen af ydeevne er afgørende i forbindelse med forsøgspersoner uden handleevne, og data af sammenlignelig validitet kan ikke indhentes ved undersøgelser af ydeevne på personer, der er i stand til at give et informeret samtykke, eller ved andre forskningsmetoder
f)
undersøgelsen af ydeevne direkte vedrører en sygdomstilstand, som forsøgspersonen befinder sig i
g)
der er videnskabeligt belæg for at antage, at deltagelse i undersøgelsen af ydeevne vil give:
i)
en direkte fordel for forsøgspersonen uden handleevne, der opvejer de risici og byrder, der er forbundet med den, eller
ii)
visse fordele for den population, der repræsenteres af den berørte forsøgsperson uden handleevne, når undersøgelsen af ydeevne kun vil medføre minimal risiko og minimale byrder for den berørte forsøgsperson uden handleevne sammenlignet med standardbehandlingen af den tilstand, som forsøgspersonen uden handleevne befinder sig i.
2.   Forsøgspersonen skal så vidt muligt deltage i proceduren for informeret samtykke.
3.   Stk. 1, litra g), nr. ii), berører ikke strengere nationale bestemmelser, som forbyder gennemførelsen af disse undersøgelser af ydeevne på forsøgspersoner uden handleevne, når der ikke er videnskabeligt belæg for at antage, at deltagelse i undersøgelsen af ydeevne vil give forsøgspersonen en direkte fordel, som opvejer de risici og byrder, der er forbundet med den.
Artikel 61
Undersøgelse af ydeevne på mindreårige
1.   En undersøgelse af ydeevne på mindreårige må kun gennemføres, hvis alle de følgende betingelser, ud over betingelserne i artikel 58, stk. 5, er opfyldt:
a)
der er indhentet et informeret samtykke fra deres retligt udpegede repræsentant
b)
de mindreårige har fra investigator eller medlemmer af forsøgsholdet, der er uddannet i eller har erfaring med at arbejde med børn, modtaget den information, der er omhandlet i artikel 59, 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 59, stk. 2, omhandlede information, om ikke at deltage i eller om når som helst at udgå af undersøgelsen af ydeevne
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 undersøgelsen af ydeevne
e)
undersøgelsen af ydeevne har til formål at undersøge behandlinger af en sygdomstilstand, som kun forekommer hos mindreårige, eller undersøgelsen af ydeevne er afgørende i forbindelse med mindreårige for at validere data indhentet ved undersøgelser af ydeevne på personer, der er i stand til at give informeret samtykke, eller ved andre forskningsmetoder
f)
undersøgelsen af ydeevne 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 undersøgelsen af ydeevne vil give:
i)
en direkte fordel for den mindreårige forsøgsperson, som opvejer de risici og byrder, der er forbundet med den, eller
ii)
visse fordele for den population, der repræsenteres af den berørte mindreårige, når undersøgelsen af ydeevne kun vil medføre minimal risiko og minimale byrder for den berørte mindreårige sammenlignet med standardbehandlingen af den tilstand, som den mindreårige befinder sig i
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 undersøgelsen af ydeevne 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 undersøgelsen af ydeevne.
2.   Stk. 1, litra g), nr. ii), berører ikke strengere nationale bestemmelser, som forbyder gennemførelsen af disse undersøgelser af ydeevne på mindreårige, når der ikke er videnskabeligt belæg for at antage, at deltagelse i undersøgelsen af ydeevne vil give forsøgspersonen en direkte fordel, som opvejer de risici og byrder, der er forbundet med den.
Artikel 62
Undersøgelse af ydeevne på gravide eller ammende kvinder
En undersøgelse af ydeevne på gravide eller ammende kvinder må kun gennemføres, hvis alle de følgende betingelser, ud over betingelserne i artikel 58, stk. 5, er opfyldt:
a)
undersøgelsen af ydeevne 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)
undersøgelsen af ydeevne må, såfremt den ikke har nogen direkte fordele for den berørte gravide eller ammende kvinde eller hendes embryo, foster eller barn efter fødslen, kun gennemføres, hvis:
i)
en undersøgelse af ydeevne med sammenlignelig effektivitet ikke kan udføres på kvinder, der ikke er gravide eller ammende
ii)
undersøgelsen af ydeevne bidrager til at opnå resultater, der kan være til fordel for gravide eller ammende kvinder eller andre kvinder i forbindelse med reproduktion eller andre embryoer, fostre eller børn, og
iii)
undersøgelsen af ydeevne medfører en minimal risiko og en minimal byrde for den berørte gravide eller ammende kvinde eller hendes embryo, foster eller barn efter fødslen
c)
ved forskning, der gennemføres på ammende kvinder, udvises der særlig omhu for at undgå enhver negativ indvirkning på barnets sundhed
d)
der gives ingen tilskyndelse eller økonomisk begunstigelse til forsøgspersonerne, bortset fra en kompensation for udgifter og tab af indkomst, der er direkte forbundet med deltagelsen i undersøgelsen af ydeevne.
Artikel 63
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 undersøgelser af ydeevne, eller personer, der bor på plejeinstitutioner.
Artikel 64
Undersøgelser af ydeevne i akutte situationer
1.   Uanset artikel 58, stk. 5, litra f), artikel 60, stk. 1, litra a) og b), og artikel 61, stk. 1, litra a) og b), kan der indhentes informeret samtykke til at deltage i en undersøgelse af ydeevne, og information om undersøgelserne af ydeevne kan gives, efter at beslutningen om at inkludere forsøgspersonen i undersøgelsen af ydeevne træffes, forudsat at denne beslutning træffes på tidspunktet for den første intervention på en forsøgsperson i overensstemmelse med planen for undersøgelse af klinisk ydeevne i forbindelse med denne undersøgelse af ydeevne, 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 undersøgelsen af ydeevne
b)
der er videnskabeligt belæg for at antage, at forsøgspersonens deltagelse i undersøgelsen af ydeevne 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 undersøgelsen af ydeevne
e)
undersøgelsen af ydeevne 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 undersøgelsen af ydeevne er af en sådan art, at den udelukkende kan udføres i akutte situationer
f)
undersøgelsen af ydeevne medfører en minimal risiko og en minimal byrde for forsøgspersonen i forhold til standardbehandlingen af forsøgspersonens tilstand.
2.   Efter en intervention i henhold til denne artikels stk. 1 skal der i overensstemmelse med artikel 59 indhentes informeret samtykke, for at forsøgspersonen fortsat kan deltage i undersøgelsen af ydeevne, og informationen om undersøgelsen af ydeevne 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 59, 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 59, 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 undersøgelsen af ydeevne, 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 undersøgelsen af ydeevne, anvendes.
Artikel 65
Skadeserstatning
1.   Medlemsstaterne sikrer, at der findes erstatningsordninger for skader påført en forsøgsperson som følge af deltagelse i en undersøgelse af ydeevne, 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, hvor undersøgelsen af ydeevne gennemføres.
Artikel 66
Ansøgning om undersøgelser af ydeevne
1.   Sponsor af en undersøgelse af ydeevne, der er omhandlet i artikel 58, stk. 1 og 2, indfører og indsender en ansøgning til den eller de medlemsstater, hvor undersøgelsen af ydeevne skal gennemføres (med henblik på denne artikel benævnt »den berørte medlemsstat«), ledsaget af den dokumentation, der er omhandlet i bilag XIII, punkt 2 og 3, og bilag XIV.
Ansøgningen indsendes ved hjælp af det elektroniske system, der er omhandlet i artikel 69, og som genererer et EU-dækkende unikt individuelt identifikationsnummer for den undersøgelse af ydeevne, der skal anvendes i al relevant kommunikation i forbindelse med denne undersøgelse af ydeevne. Senest 10 dage efter modtagelsen af ansøgningen underretter den berørte medlemsstat sponsor om, hvorvidt undersøgelsen af ydeevne falder ind under denne forordnings anvendelsesområde, og hvorvidt ansøgningen er fuldstændig, jf. bilag XIV, kapitel I.
2.   Senest en uge efter enhver ændring i forbindelse med den dokumentation, der er omhandlet i bilag XIV, kapitel I, opdaterer sponsor de relevante data i det elektroniske system, der er omhandlet i artikel 69, 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 undersøgelsen af ydeevne, som der er ansøgt om, ikke falder ind under denne forordnings anvendelsesområde, eller at ansøgningen ikke er fuldstændig, 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 69. 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 undersøgelsen af ydeevne anses for at falde ind under denne forordnings anvendelsesområde, og hvorvidt ansøgningen er fuldstændig.
4.   Den berørte medlemsstat kan også forlænge hver frist, 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 fristen i henhold til stk. 7, litra b), suspenderes fra datoen for den første anmodning indtil det tidspunkt, hvor de supplerende oplysninger modtages.
7.   Sponsor kan påbegynde undersøgelsen af ydeevne i følgende tilfælde:
a)
for undersøgelser af ydeevne udført i henhold til artikel 58, stk. 1, litra a), og hvis indsamlingen af prøver ikke udgør en væsentlig klinisk risiko for den person, der er genstand for undersøgelsen, medmindre andet er anført i national ret, umiddelbart efter ansøgningens valideringsdato, der er beskrevet i nærværende artikels stk. 5, og forudsat at der ikke er afgivet en negativ udtalelse, der gælder for hele den pågældende medlemsstat i henhold til dens nationale ret, af en etisk komité i den berørte medlemsstat i forbindelse med undersøgelsen af ydeevne
b)
for undersøgelser af ydeevne udført i henhold til artikel 58, stk. 1, litra b) og c), og artikel 58, stk. 2, eller andre undersøgelser af ydeevne end dem, der er omhandlet i nærværende stykkes litra a), så snart den berørte medlemsstat har underrettet sponsor om sin tilladelse, og forudsat at der ikke er afgivet en negativ udtalelse, der gælder for hele den pågældende medlemsstat i henhold til dens nationale ret, af en etisk komité i den berørte medlemsstat i forbindelse med undersøgelsen af ydeevne. Medlemsstaten underretter sponsor om tilladelsen senest 45 dage efter ansøgningens 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 108 for på baggrund af den tekniske udvikling og den internationale reguleringsmæssige udvikling at ændre kravene, jf. bilag XIV, kapitel I.
9.   For at sikre en ensartet anvendelse af kravene i bilag XIV, kapitel 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 107, stk. 3.
Artikel 67
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 undersøgelsen af ydeevne, 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 undersøgelsen af ydeevne 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, hvis ydeevne skal undersøges, overholder de gældende generelle krav til sikkerhed og ydeevne, undtagen for så vidt angår de aspekter, der er omfattet af undersøgelsen af ydeevne, og at der med hensyn til de pågældende aspekter er truffet alle nødvendige forholdsregler for at beskytte forsøgspersonernes sundhed og sikkerhed. Dette omfatter, for så vidt angår undersøgelser af ydeevne, evaluering af analytisk ydeevne og, for så vidt angår interventionsundersøgelser af klinisk ydeevne, evaluering af analytisk ydeevne, klinisk ydeevne og videnskabelig validitet under hensyntagen til det aktuelle tekniske niveau
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, hvis ydeevne skal undersøges, er tilstrækkelig
d)
pålideligheden og robustheden af de data, der genereres i undersøgelsen af ydeevne, under hensyntagen til statistiske metoder, design af undersøgelsen af ydeevne og metodologiske aspekter, herunder prøvestørrelse, komparator og endepunkter
e)
om kravene i bilag XIV er opfyldt.
4.   Medlemsstaterne afslår at give tilladelse til undersøgelsen af ydeevne, hvis:
a)
den ansøgning, som er indsendt i henhold til artikel 66, stk. 3, fortsat er ufuldstændig
b)
udstyret eller de forelagte dokumenter, især planen for undersøgelse af ydeevne og investigators brochure, ikke svarer til niveauet af videnskabelig viden, og navnlig hvis undersøgelsen af ydeevne ikke er egnet til at dokumentere udstyrets sikkerhed, ydeevneegenskaber eller fordele for forsøgspersoner eller patienter, eller
c)
kravene i artikel 58 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 68
Gennemførelse af undersøgelse af ydeevne
1.   Sponsor og investigator sikrer, at undersøgelsen af ydeevne gennemføres i overensstemmelse med den godkendte plan for undersøgelsen af ydeevne.
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 undersøgelsen af ydeevne er i overensstemmelse med denne forordnings krav, sikrer sponsor passende monitorering af gennemførelsen af en undersøgelse af ydeevne. Omfanget og arten af monitoreringen fastlægges af sponsor på grundlag af en vurdering, der tager højde for alle karakteristika for undersøgelsen af ydeevne, herunder følgende:
a)
formål og metodologi for undersøgelsen af ydeevne, og
b)
graden af interventionens afvigelse fra normal klinisk praksis.
3.   Alle oplysninger om undersøgelsen af ydeevne 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, udbredelse, formidling, ændring eller tilintetgørelse eller mod hændeligt tab, navnlig når behandlingen indebærer overførsel via et netværk.
5.   Medlemsstaterne inspicerer undersøgelsesstedet/undersøgelsesstederne i en passende grad for at sikre, at undersøgelsen af ydeevne 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 undersøgelsen.
Artikel 69
Elektronisk system for undersøgelser af ydeevne
1.   Kommissionen skal i samarbejde med medlemsstaterne oprette, forvalte og vedligeholde et elektronisk system:
a)
til oprettelse af individuelle identifikationsnumre for undersøgelser af ydeevne som omhandlet i artikel 66, stk. 1
b)
til brug som indgang for indsendelse af alle ansøgninger eller underretninger om undersøgelser af ydeevne som omhandlet i artikel 66, 70, 71 og 74 samt for alle andre indsendelser af data eller behandling af data i denne sammenhæng
c)
til udveksling af oplysninger vedrørende undersøgelser af ydeevne i overensstemmelse med nærværende forordning mellem medlemsstaterne og mellem disse og Kommissionen, herunder udveksling af oplysninger som omhandlet i artikel 72 og 74
d)
til oplysninger, som sponsor skal give i overensstemmelse med artikel 73, herunder rapporten om undersøgelsen af ydeevne og dens resumé som krævet i nævnte artikels stk. 5
e)
til indberetning af de alvorlige uønskede hændelser og de mangler ved udstyret og opdateringerne heraf, der er omhandlet i artikel 76.
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 
(
26
)
, for så vidt angår undersøgelser ydeevneevaluering i forbindelse med udstyr til ledsagende diagnosticering.
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 investigators brochure, 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 undersøgelsen af ydeevne 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 70
Undersøgelser af ydeevne vedrørende udstyr, der er forsynet med CE-mærkning
1.   Hvis der skal gennemføres en undersøgelse af ydeevne ved anvendelse i henhold til udstyrets erklærede formål for yderligere at vurdere udstyr, der allerede er forsynet med CE-mærkning i overensstemmelse med artikel 18, stk. 1, (PMPF-undersøgelse), og hvis undersøgelsen af ydeevne indebærer, at forsøgspersoner udsættes for yderligere procedurer end dem, der udføres ved normal anvendelse af udstyret, og disse yderligere procedurer er invasive eller belastende, underretter sponsor de berørte medlemsstater mindst 30 dage inden undersøgelsens påbegyndelse ved hjælp af det elektroniske system, som er omhandlet i artikel 69. Sponsor skal vedlægge den dokumentation, der er omhandlet i bilag XIII, del A, punkt 2, og bilag XIV. Artikel 58, stk. 5, litra b)-l) og p), artikel 71, 72 og 73, artikel 76, stk. 5, og de relevante bestemmelser i bilag XIII og XIV finder anvendelse på PMPF-undersøgelser.
2.   Hvis der skal gennemføres en undersøgelse af ydeevne ved anvendelse, der ligger uden for udstyrets erklærede formål, for at vurdere udstyr, der allerede er forsynet med CE-mærkning i overensstemmelse med artikel 18, stk. 1, finder artikel 58-77, anvendelse.
Artikel 71
Væsentlige ændringer af undersøgelser af ydeevne
1.   Hvis sponsor har til hensigt at indføre ændringer i en undersøgelse af ydeevne, der kan have en væsentlig indflydelse på forsøgspersonernes sikkerhed, sundhed eller rettigheder eller på robustheden eller pålideligheden af de data, der er genereret i forbindelse med undersøgelsen, underretter sponsor ved hjælp af det elektroniske system, der er omhandlet i artikel 69, inden for en uge den eller de medlemsstater, hvor undersøgelsen af ydeevne gennemføres eller skal gennemføres, om begrundelsen for disse ændringer og deres art. Sponsor skal vedlægge en opdateret version af den relevante dokumentation, jf. bilag XIV, som en del af underretningen. Ændringer af den relevante dokumentation skal klart kunne identificeres.
2.   Medlemsstaterne vurderer alle væsentlige ændringer af undersøgelsen af ydeevne i overensstemmelse med proceduren i artikel 67.
3.   Sponsor må tidligst gennemføre de ændringer, der er omhandlet i stk. 1, 38 dage efter den underretning, der er omhandlet i stk. 1, medmindre:
a)
den medlemsstat, hvor undersøgelsen af ydeevne gennemføres eller skal gennemføres, har givet sponsor afslag af de grunde, der er omhandlet i artikel 67, 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 undersøgelsen af ydeevne, 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 72
Korrigerende foranstaltninger, der træffes af medlemsstaterne, og udveksling af oplysninger mellem medlemsstaterne om undersøgelser af ydeevne
1.   Har den medlemsstat, hvor undersøgelsen af ydeevne gennemføres eller skal gennemføres, grunde til at mene, at kravene i denne forordning ikke længere er opfyldt, kan den som minimum træffe enhver af de følgende foranstaltninger på sit område:
a)
tilbagekalde tilladelsen til en undersøgelse af ydeevne
b)
suspendere eller afbryde undersøgelsen af ydeevne
c)
kræve, at sponsor ændrer et hvilket som helst aspekt af en undersøgelse af ydeevne.
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 undersøgelse af ydeevne eller af sponsoren er blevet underrettet om, at en undersøgelse af ydeevne 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 69.
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 69.
Artikel 73
Oplysninger, som sponsor skal give ved afslutningen af en undersøgelse af ydeevne eller ved en midlertidig standsning eller afbrydelse
1.   Hvis sponsor midlertidigt har standset en undersøgelse af ydeevne eller har afbrudt en undersøgelse af ydeevne, informerer sponsor senest inden for 15 dage de medlemsstater, hvor undersøgelsen af ydeevne er blevet midlertidigt standset eller afbrudt, om den midlertidige standsning eller afbrydelse via det elektroniske system, som er omhandlet i artikel 69. Hvis sponsor af sikkerhedsgrunde midlertidigt har standset eller afbrudt undersøgelsen af ydeevne, informerer sponsor inden for 24 timer alle de medlemsstater, hvor undersøgelsen af ydeevne gennemføres.
2.   Afslutningen af en undersøgelse af ydeevne anses for at falde sammen med den sidste forsøgspersons sidste besøg, medmindre der i planen for undersøgelse af ydeevne er fastsat et andet tidspunkt for afslutningen.
3.   Sponsor underretter hver medlemsstat, hvor undersøgelsen af ydeevne blev gennemført, om afslutningen af undersøgelsen af ydeevne i den pågældende medlemsstat. Denne underretning foretages senest 15 dage efter afslutningen af undersøgelsen af ydeevne i den pågældende medlemsstat.
4.   Hvis en undersøgelse gennemføres i mere end én medlemsstat, underretter sponsor alle de medlemsstater, hvor undersøgelsen af ydeevne blev gennemført, om afslutningen af undersøgelsen af ydeevne i alle medlemsstater. Denne underretning foretages senest 15 dage efter den pågældende afslutning af undersøgelsen af ydeevne.
5.   Uanset resultatet af undersøgelsen af ydeevne forelægger sponsor senest et år efter afslutningen af undersøgelsen af ydeevne eller senest tre måneder efter afbrydelsen eller den midlertidige standsning for de medlemsstater, hvor der blev gennemført en undersøgelse af ydeevne, en rapport om undersøgelsen af ydeevne, jf. bilag XIII, del A, punkt 2.3.3.
Rapporten om undersøgelsen af ydeevne 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 69.
Hvis det af videnskabelige grunde ikke er muligt at forelægge rapporten om undersøgelsen af ydeevne inden for et år efter afslutningen af undersøgelsen, skal den forelægges, så snart den foreligger. I så fald angives det i planen for undersøgelse af klinisk ydeevne, jf. bilag XIII, del A, punkt 2.3.2, hvornår resultaterne af undersøgelsen af ydeevne vil foreligge, sammen med en begrundelse.
6.   Kommissionen udsteder retningslinjer vedrørende indholdet og strukturen af resuméet af rapporten om undersøgelsen af ydeevne.
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 undersøgelser af ydeevne.
7.   Resuméet og rapporten om undersøgelsen af ydeevne, jf. denne artikels stk. 5, skal gøres offentligt tilgængelige via det elektroniske system, som er omhandlet i artikel 69, senest når udstyret er blevet registreret i henhold til artikel 26, 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 26 inden for et år efter indførelsen af resuméet og rapporten om undersøgelsen af ydeevne i det elektroniske system i henhold til denne artikels stk. 5, skal de gøres offentligt tilgængelige på dette tidspunkt.
Artikel 74
Koordineret vurderingsprocedure for undersøgelser af ydeevne
1.   Ved hjælp af det elektroniske system, som er omhandlet i artikel 69, kan sponsor af en undersøgelse af ydeevne, der skal gennemføres i mere end én medlemsstat, med henblik på artikel 66 indsende en enkelt ansøgning, som efter modtagelsen sendes elektronisk til alle medlemsstater, hvor undersøgelsen af ydeevne skal gennemføres.
2.   I den enkelte ansøgning som omhandlet i stk. 1 foreslår sponsor, at en af de medlemsstater, hvor undersøgelsen af ydeevne skal gennemføres, fungerer som koordinerende medlemsstat. De medlemsstater, hvor undersøgelsen af ydeevne 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 XIV, kapitel I.
Fuldstændigheden af den dokumentation, der er omhandlet i bilag XIV, kapitel I, punkt 1.13, 4.2, 4.3 og 4.4, og bilag XIII, del A, punkt 2.3.2, litra c), skal dog vurderes særskilt af hver enkelt berørt medlemsstat i henhold til artikel 66, 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, hvorvidt undersøgelsen af ydeevne er omfattet af denne forordning, og hvorvidt ansøgningen er fuldstændig, samt underrette sponsor herom. Artikel 66, 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 66, 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 C og D 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 og i tilfælde af indberetning af uønskede hændelser i henhold til artikel 76, stk. 4, og i tilfælde af undersøgelser af ydeevne, der omfatter udstyr beregnet til ledsagende diagnosticering, hvor lægemidlerne 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 107, stk. 3.
8.   Er den koordinerende medlemsstats konklusion vedrørende området for koordineret vurdering, at gennemførelsen af undersøgelsen af ydeevne 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 undersøgelsen af ydeevne 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 d).
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 69, 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 undersøgelsen af ydeevne ikke kan accepteres, anses den pågældende konklusion for at være alle de berørte medlemsstaters konklusion.
10.   En berørt medlemsstat afslår at tillade en undersøgelse af ydeevne, 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 XIV, kapitel I, punkt 1.13, 4.2, 4.3 og 4.4, ikke er overholdt, eller hvis en etisk komité har afgivet negativ udtalelse vedrørende den pågældende undersøgelse af ydeevne, 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 69, sponsor om, hvorvidt undersøgelsen af ydeevne tillades, om den tillades på visse betingelser, eller om der er givet afslag på tilladelse. Underretningen sker ved hjælp af en enkelt afgørelse senest fem dage efter den koordinerende medlemsstats fremsendelse i henhold til nærværende artikels stk. 4, litra d), af den endelige vurderingsrapport. Hvis en tilladelse til en undersøgelse af ydeevne 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 71, ved hjælp af det elektroniske system, som er omhandlet i artikel 69. 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 XIV, kapitel I, punkt 1.13, 4.2, 4.3 og 4.4, og bilag XIII, del A, punkt 2.3.2, litra c), 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 2029 kun anvendes i de medlemsstater, hvori den kliniske afprøvning skal gennemføres, og som har godkendt procedurens anvendelse. Efter den 27. maj 2029 skal alle medlemsstater anvende den nævnte procedure.
Artikel 75
Gennemgang af den koordinerede vurderingsprocedure
Senest den 27. maj 2028 forelægger Kommissionen en rapport for Europa-Parlamentet og Rådet om erfaringerne med anvendelsen af artikel 74 og foreslår om nødvendigt en gennemgang af artikel 74, stk. 14, og artikel 113, stk. 3, litra g).
Artikel 76
Registrering og indberetning af uønskede hændelser i forbindelse med undersøgelser af ydeevne
1.   Sponsor foretager en fuldstændig registrering af alle følgende punkter:
a)
enhver uønsket hændelse af den type, der i planen for undersøgelse af ydeevne er identificeret som kritisk for evalueringen af resultaterne af undersøgelsen af ydeevne
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), b) og c).
2.   Sponsor indberetter straks alle følgende punkter til alle de medlemsstater, hvor undersøgelsen af ydeevne gennemføres, ved hjælp af det elektroniske system, der er omhandlet i artikel 69:
a)
enhver alvorlig uønsket hændelse, som har en kausal sammenhæng med udstyret, komparatoren eller undersøgelsesproceduren, 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 en hvilken som helst medlemsstat, hvor undersøgelsen af ydeevne 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 undersøgelse af ydeevne i henhold til en plan for undersøgelse af klinisk ydeevne, der er den samme som den, der gælder for en undersøgelse af ydeevne, der er omfattet af denne forordning, til de medlemsstater, hvor undersøgelsen af ydeevne gennemføres, ved hjælp af det elektroniske system, der er omhandlet i artikel 69.
4.   For så vidt angår en undersøgelse af ydeevne, i forbindelse med hvilken sponsor har indsendt én enkelt ansøgning, jf. artikel 74, indberetter sponsor enhver hændelse, der er omhandlet i denne artikels stk. 2, ved hjælp af det elektroniske system, der er omhandlet i artikel 69. Efter modtagelsen sendes denne indberetning elektronisk til alle de medlemsstater, hvor undersøgelsen af ydeevne gennemføres.
Under ledelse af den koordinerende medlemsstat, jf. artikel 74, stk. 2, koordinerer medlemsstaterne deres vurdering af alvorlige uønskede hændelser og mangler ved udstyret for at afgøre, om en undersøgelse af ydeevne skal ændres, suspenderes eller afbrydes eller om tilladelsen til undersøgelsen af ydeevne 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 PMPF-undersøgelser, jf. artikel 70, stk. 1, finder sikkerhedsovervågningsbestemmelserne i artikel 82-85 og i de gennemførelsesretsakter, der er vedtaget i henhold til artikel 86, 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 undersøgelse af ydeevne.
Artikel 77
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 undersøgelser af ydeevne og vurderingen heraf, jf. artikel 66 og 74, idet der tages hensyn til specifikke kategorier eller grupper af udstyr
b)
det elektroniske systems funktion, jf. artikel 69
c)
harmoniserede elektroniske formularer til indberetning af PMPF-undersøgelser, jf. artikel 70, stk. 1, og væsentlige ændringer, jf. artikel 71
d)
udveksling af oplysninger mellem medlemsstaterne, jf. artikel 72
e)
harmoniserede elektroniske formularer til indberetning af alvorlige uønskede hændelser og mangler ved udstyret, jf. artikel 76
f)
fristerne for indberetning af alvorlige uønskede hændelser og mangler ved udstyret under hensyn til alvoren af den hændelse, der skal indberettes, jf. artikel 76
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 107, stk. 3.
KAPITEL VII
OVERVÅGNING, EFTER AT UDSTYRET ER BRAGT I OMSÆTNING, SIKKERHEDSOVERVÅGNING OG MARKEDSOVERVÅGNING
Afdeling 1
Overvågning, efter at udstyret er bragt i omsætning
Artikel 78
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. 8.
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 ydeevneevalueringen
d)
at opdatere sammenfatningen af sikkerhed og ydeevne, jf. artikel 29
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 83.
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 82.
Artikel 79
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 78, 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. Planen for overvågning, efter at udstyret er bragt i omsætning, skal være en del af den tekniske dokumentation, jf. bilag II.
Artikel 80
Rapport om overvågning, efter at udstyret er bragt i omsætning
Fabrikanter af udstyr i klasse A og B 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 79 sammen med et rationale for og en beskrivelse af eventuelle forebyggende og korrigerende handlinger. Rapporten opdateres efter behov og stilles til rådighed for det bemyndigede organ og den kompetente myndighed efter anmodning.
Artikel 81
Periodisk opdateret sikkerhedsindberetning
1.   Fabrikanter af udstyr i klasse C og D udarbejder en periodisk opdateret sikkerhedsindberetning (»PSUR«) 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 79 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)
PMPF'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 C og D skal opdatere den periodiske opdaterede sikkerhedsindberetning mindst én gang årligt. Denne periodiske opdaterede sikkerhedsindberetning skal være en del af den tekniske dokumentation, jf. bilag II og III.
2.   Fabrikanter af udstyr i klasse D fremlægger periodiske opdaterede sikkerhedsindberetninger via det elektroniske system, der er omhandlet i artikel 87, for det bemyndigede organ, der deltager i overensstemmelsesvurderingen af sådant udstyr i overensstemmelse med artikel 48. 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 udstyr i klasse C 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 82
Indberetning af alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger
1.   Fabrikanter af udstyr, der er gjort tilgængeligt på EU-markedet, bortset fra udstyr, hvis ydeevne skal undersøges, skal til de relevante kompetente myndigheder, indberette følgende, jf. artikel 87, stk. 5 og 7:
a)
enhver alvorlig hændelse vedrørende udstyr, der er gjort tilgængeligt på EU-markedet, bortset fra forventede fejlagtige resultater, som er klart dokumenteret og kvantificeret i produktinformationen og i den tekniske dokumentation og er genstand for indberetning af tendenser i henhold til artikel 83
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 87 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 en kausal 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 84, stk. 9, i samråd med de kompetente myndigheder, der er omhandlet i artikel 87, stk. 8, litra a) og b), er blevet enig med fabrikanten om form, indhold og hyppighed af den periodiske sammenfattende indberetning. Hvis artikel 87, 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 det formodede alvorlige hændelser.
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 denne artikels stk. 1-5 og foretage passende opfølgning i overensstemmelse med artikel 84.
Hvis fabrikanten af det pågældende udstyr mener, at hændelsen ikke er en alvorlig hændelse eller skal behandles som en stigning i forventede fejlagtige resultater, der vil være omfattet af indberetning af tendenser i henhold til artikel 83, 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 nærværende artikels stk. 1-5 og anmode fabrikanten om at sikre, at der foretages en passende opfølgning i overensstemmelse med artikel 84.
Artikel 83
Indberetning af tendenser
1.   Fabrikanter skal via det elektroniske system, der er omhandlet i artikel 87, indberette enhver statistisk signifikant stigning i hyppigheden eller alvoren af hændelser, der ikke er alvorlige hændelser, som kunne 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 uacceptable risici for patienters, brugeres eller andre personers sundhed og sikkerhed eller enhver betydelig stigning i forventede fejlagtige resultater fastsat i forhold til udstyrets angivne ydeevne som omhandlet i bilag I, punkt 9.1, litra a) og b), og som fastsat i den tekniske dokumentation og produktinformationen.
Fabrikanten skal i planen for overvågning, efter at udstyret er bragt i omsætning, jf. artikel 79, 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 eller ændringer af ydeevnen, 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 84
Analyse af alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger
1.   Efter indberetning af en alvorlig hændelse i henhold til artikel 82, 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 de 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 82, evalueres centralt 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 det indberettede alvorlige hændelser, 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, den kliniske fordel 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 87. Rapporten skal indeholde konklusioner og, når det er relevant, angive de korrigerende handlinger, der skal foretages.
6.   For så vidt angår udstyr til ledsagende diagnosticering underretter den evaluerende kompetente myndighed eller den koordinerende kompetente myndighed, jf. denne artikels stk. 9, alt efter om det var den relevante kompetente myndighed i den medlemsstat, der godkendte lægemidlerne, eller EMA, der blev hørt af det bemyndigede organ i overensstemmelse med procedurerne i bilag IX, punkt 5.2, og bilag X, punkt 3.11, denne nationale kompetente myndighed eller i givet fald EMA.
7.   Efter at have foretaget evalueringen i overensstemmelse med denne artikels stk. 3 underretter den evaluerende kompetente myndighed via det elektroniske system, jf. artikel 87, 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 alvorlige 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 dem 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 87, 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 87, 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 85
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 87, 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 86
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 80-85 og 87 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 80, 81, 82, 83 og 84
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 82
e)
harmoniserede formularer til udveksling af oplysninger mellem de kompetente myndigheder, jf. artikel 84
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 107, stk. 3.
Artikel 87
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 82, stk. 1, og artikel 84, stk. 5
b)
fabrikanternes periodiske sammenfattende indberetninger, jf. artikel 82, stk. 9
c)
fabrikanternes indberetninger af tendenser, jf. artikel 83
d)
periodiske opdaterede sikkerhedsindberetninger, jf. artikel 81
e)
fabrikanternes sikkerhedsmeddelelser, jf. artikel 84, stk. 8
f)
de oplysninger, som udveksles mellem medlemsstaternes kompetente myndigheder og mellem disse og Kommissionen, jf. artikel 84, 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 49.
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.   Indberetningerne af alvorlige hændelser, jf. artikel 82, 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 hændelsen indtraf.
6.   Indberetningerne af tendenser, jf. artikel 83, 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, hvori de pågældende hændelser indtraf.
7.   Indberetningerne af sikkerhedsrelaterede korrigerende handlinger, jf. artikel 82, 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)
den medlemsstat, hvor den sikkerhedsrelaterede korrigerende handling foretages eller skal foretages
b)
den medlemsstat, hvor fabrikanten har sit registrerede forretningssted.
8.   De periodiske sammenfattende indberetninger, jf. artikel 82, stk. 9, overføres efter modtagelsen automatisk via det elektroniske system, der er omhandlet i nærværende artikels stk. 1 i denne artikel, til den kompetente myndighed i:
a)
den eller de medlemsstater, som deltager i koordineringsproceduren i overensstemmelse med artikel 84, 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 nærværende artikels stk. 1, til det bemyndigede organ, der udstedte certifikatet for det pågældende udstyr i overensstemmelse med artikel 51.
Afdeling 3
Markedsovervågning
Artikel 88
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 99, 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 95.
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 95.
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 95.
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 89
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 udstyrets enhver anden manglende overensstemmelse med kravene.
De relevante erhvervsdrivende skal samarbejde med de kompetente myndigheder.
Artikel 90
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 89 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 på en måde, som står i passende forhold til risikoens art, for at bringe udstyret i overensstemmelse med de krav i denne forordning, der vedrører den risiko, som udstyret udgør, begrænse tilgængeliggørelsen af udstyret på markedet på en måde, som står i passende forhold til risikoens art, 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 51 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 95.
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 95.
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 95, 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 95.
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 91
Procedure for evaluering af nationale foranstaltninger på EU-plan
1.   Hvis en medlemsstat inden for to måneder efter modtagelsen af den i artikel 90, 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 107, stk. 3.
2.   Hvis Kommissionen anser den nationale foranstaltning for at være berettiget, jf. denne artikels stk. 1, finder artikel 90, 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 træffer en afgørelse i henhold til denne artikels stk. 1 senest otte måneder efter modtagelsen af den underretning, der er omhandlet i artikel 90, 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 107, stk. 3.
Artikel 92
Anden manglende overensstemmelse med kravene
1.   Hvis en medlemsstats kompetente myndigheder efter at have foretaget en evaluering i henhold til artikel 89 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 95.
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 107, stk. 3.
Artikel 93
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 95.
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 107, 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 107, stk. 3.
Artikel 94
God administrativ praksis
1.   Enhver foranstaltning, der træffes af medlemsstaternes kompetente myndigheder i henhold til artikel 90-93, 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 90-93 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 95, det relevante bemyndigede organ og myndigheden med ansvar for det bemyndigede organ om den trufne foranstaltning.
Artikel 95
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 88, stk. 4
b)
den endelige inspektionsrapport, jf. artikel 88, stk. 7
c)
oplysninger vedrørende udstyr, som udgør en uacceptabel risiko for sundheden og sikkerheden, jf. artikel 90, stk. 2, 4 og 6
d)
oplysninger om produkters manglende overensstemmelse, jf. artikel 92, stk. 2
e)
oplysninger om forebyggende sundhedsmæssige foranstaltninger, jf. artikel 93, stk. 2
f)
sammendrag af resultaterne af evalueringerne og vurderingerne af medlemsstaternes markedsovervågningsaktiviteter, jf. artikel 88, stk. 8.
2.   De oplysninger, der er omhandlet 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 51 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, EU-REFERENCELABORATORIER OG REGISTRE OVER UDSTYR
Artikel 96
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 97
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 98
Koordinationsgruppen for Medicinsk Udstyr
Koordinationsgruppen for Medicinsk Udstyr (MDCG), som er oprettet i overensstemmelse med betingelserne og de nærmere bestemmelser i artikel 103 og 107 i forordning (EU) 2017/745 varetager med Kommissionens støtte, jf. artikel 104 i forordning (EU) 2017/745 de opgaver, som den pålægges ved denne forordning og ved forordning (EU) 2017/745
Artikel 99
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 45
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 evalueringer af ydeevne, de 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 fastlagt i denne forordning og forordning (EU) 2017/745 er tilstrækkelige til at sikre sikkerheden og ydeevnen af udstyr, og dermed bidrage til at identificere, hvorvidt der er behov for at ændre bilag I til nærværende forordning
e)
at bidrage til udviklingen af udstyrsstandarder og fælles specifikationer
f)
bistå medlemsstaternes kompetente myndigheder i deres koordineringsaktiviteter, navnlig på områderne for klassificering og fastlæggelse af den reguleringsmæssige status for udstyr, undersøgelser af ydeevne, 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 88
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 100
EU-referencelaboratorier
1.   For specifikt udstyr eller en kategori eller gruppe af udstyr eller for specifikke farer, der er forbundet med en kategori eller gruppe af udstyr, kan Kommissionen ved hjælp af gennemførelsesretsakter udpege et eller flere EU-referencelaboratorier, som opfylder de kriterier, der er anført i stk. 4. Kommissionen udpeger kun EU-referencelaboratorier, for hvilke en medlemsstat eller Kommissionens Fælles Forskningscenter har indgivet en ansøgning om udpegelse.
2.   Inden for rammerne af deres udpegelse skal EU-referencelaboratorier varetage følgende opgaver:
a)
at verificere den ydeevne, som fabrikanten har angivet for udstyr i klasse D, og dets overensstemmelse med de relevante fælles specifikationer, hvor der foreligger sådanne, eller med andre løsninger, som fabrikanten har valgt for at sikre et niveau med hensyn til sikkerhed og ydeevne, der mindst svarer hertil, jf. artikel 48, stk. 3, tredje afsnit
b)
at gennemføre de nødvendige prøvninger af prøver af udstyr i klasse D eller partier af udstyr i klasse D, jf. bilag IX, punkt 4.12, og bilag XI, punkt 5.1
c)
at yde videnskabelig og teknisk bistand til Kommissionen, MDCG, medlemsstaterne og bemyndigede organer i forbindelse med gennemførelsen af denne forordning
d)
at yde videnskabelig rådgivning om den nyeste udvikling i forbindelse med specifikt udstyr eller en kategori eller gruppe af udstyr
e)
at oprette og lede et netværk af nationale referencelaboratorier efter høring af de nationale myndigheder og offentliggøre en liste over de deltagende nationale referencelaboratorier og deres respektive opgaver
f)
at bidrage til udviklingen af passende prøvnings- og analysemetoder, der skal anvendes i forbindelse med overensstemmelsesvurderingsprocedurer og markedsovervågning
g)
at samarbejde med bemyndigede organer om udviklingen af bedste praksis for gennemførelsen af overensstemmelsesvurderingsprocedurer
h)
at give anbefalinger vedrørende relevant referencemateriale og referencemåleprocedurer af højere metrologisk niveau
i)
at bidrage til udviklingen af fælles specifikationer og internationale standarder
j)
at afgive videnskabelige udtalelser i forbindelse med bemyndigede organers høringer i overensstemmelse med denne forordning og offentliggøre dem elektronisk under hensyntagen til nationale bestemmelser om tavshedspligt.
3.   Kommissionen kan på anmodning af en medlemsstat også udpege EU-referencelaboratorier, hvis den pågældende medlemsstat ønsker at have adgang til sådanne laboratorier for at sikre verifikation af den ydeevne, som fabrikanten har angivet for udstyr i klasse C, og dets overensstemmelse med de relevante fælles specifikationer, hvor der foreligger sådanne, eller med andre løsninger, som fabrikanten har valgt for at sikre et niveau med hensyn til sikkerhed og ydeevne, der mindst svarer hertil.
4.   EU-referencelaboratorierne skal opfylde følgende kriterier:
a)
have passende og tilstrækkeligt kvalificeret personale med den nødvendige viden og erfaring inden for det medicinske udstyr til in vitro-diagnostik, de er udpeget for
b)
besidde det nødvendige udstyr og referencemateriale 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
f)
handle uafhængigt og i offentlighedens interesse
g)
sikre, at deres personale ikke har finansielle eller andre interesser i industrien for medicinsk udstyr til in vitro-diagnostik, som kan påvirke deres uvildighed, afgive en erklæring om eventuelle andre direkte eller indirekte interesser, de måtte have i industrien for medicinsk udstyr til in vitro-diagnostik, og opdatere denne erklæring, når der indtræder en relevant ændring.
5.   EU-referencelaboratorierne skal oprette et netværk med henblik på at koordinere og samordne deres arbejdsmetoder med hensyn til prøvning og vurdering. Denne koordinering og samordning skal omfatte:
a)
at anvende koordinerede metoder, procedurer og processer
b)
at opnå enighed om at anvende de samme referencematerialer og fælles prøver og serokonversionspaneler
c)
at etablere fælles vurderings- og fortolkningskriterier
d)
at anvende fælles prøvningsprotokoller og vurdere prøvningsresultaterne med standardiserede og koordinerede evalueringsmetoder
e)
at anvende standardiserede og koordinerede prøvningsrapporter
f)
at udvikle, anvende og vedligeholde et peer review-system
g)
at tilrettelægge regelmæssige vurderingskontroller (herunder gensidige kontroller af prøvningsresultaternes kvalitet og sammenlignelighed)
h)
at opnå enighed om fælles retningslinjer, anvisninger, proceduremæssige anvisninger eller operative standardprocedurer
i)
at koordinere indførelsen af prøvningsmetoder for nye teknologier og i henhold til nye eller ændrede fælles specifikationer
j)
at foretage fornyet vurdering af det tekniske niveau på grundlag af sammenlignelige prøvningsresultater eller gennem yderligere undersøgelser på anmodning fra en medlemsstat eller Kommissionen.
6.   Der kan ydes et EU-tilskud til EU-referencelaboratorierne.
Kommissionen kan ved hjælp af gennemførelsesretsakter vedtage de nærmere bestemmelser for og størrelsen af EU-tilskuddet til EU-referencelaboratorierne, idet der tages hensyn til målsætningerne om beskyttelse af sundheden og sikkerheden, støtte til innovation og omkostningseffektivitet. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 107, stk. 3.
7.   Hvis bemyndigede organer eller medlemsstater anmoder om videnskabelig eller teknisk bistand eller en videnskabelig udtalelse fra et EU-referencelaboratorium, kan de blive bedt om at betale gebyrer til helt eller delvis at dække de udgifter, der er afholdt af laboratoriet til at udføre de ønskede opgaver i henhold til forud fastlagte og gennemsigtige vilkår og betingelser.
8.   Kommissionen præciserer ved hjælp af gennemførelsesretsakter:
a)
detaljerede regler med henblik på at lette anvendelsen af denne artikels stk. 2 og detaljerede regler med henblik på at sikre overensstemmelse med de kriterier, der er omhandlet i denne artikels stk. 4
b)
strukturen og størrelsen af de gebyrer, der er omhandlet i denne artikels stk. 7, og som må opkræves af et EU-referencelaboratorium for at afgive videnskabelige udtalelser i forbindelse med bemyndigede organers og medlemsstaters høringer i overensstemmelse med denne forordning, idet der tages hensyn til målsætningerne om beskyttelse af menneskers sundhed og sikkerhed, støtte til innovation og omkostningseffektivitet.
Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren i artikel 107, stk. 3.
9.   EU-referencelaboratorierne er undergivet Kommissionens kontrol, herunder besøg og revision på stedet, for at verificere overholdelsen af kravene i denne forordning. Hvis det ved en sådan kontrol konstateres, at et EU-referencelaboratorium tilsidesætter de krav, det er blevet pålagt, træffer Kommissionen ved hjælp af gennemførelsesretsakter passende foranstaltninger, herunder begrænsning, suspendering eller tilbagekaldelse af udpegelsen.
10.   Bestemmelserne i artikel 107, stk. 1, i forordning (EU) 2017/745 finder anvendelse på EU-referencelaboratoriernes personale.
Artikel 101
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.
KAPITEL IX
TAVSHEDSPLIGT, DATABESKYTTELSE, FINANSIERING OG SANKTIONER
Artikel 102
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 103
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 straffelovgivningens rammer.
4.   Kommissionen og medlemsstaterne kan udveksle fortrolige oplysninger med reguleringsmyndigheder i tredjelande, med hvilke de har indgået bilaterale eller multilaterale aftaler om fortrolighed.
Artikel 103
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 104
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 105
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 107, stk. 3.
Artikel 106
Sanktioner
Medlemsstaterne fastsætter regler om sanktioner, der skal anvendes i tilfælde af overtrædelse af bestemmelserne i denne forordning, og træffer alle nødvendige foranstaltninger til 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 2022 Kommissionen meddelelse om disse regler og foranstaltninger og underretter den straks om senere ændringer, der berører dem.
KAPITEL X
AFSLUTTENDE BESTEMMELSER
Artikel 107
Udvalgsprocedure
1.   Kommissionen bistås af Udvalget for Medicinsk Udstyr, der er nedsat ved artikel 114 i forordning (EU) 2017/745. 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 108
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 5, stk. 7, artikel 10, stk. 4, artikel 17, stk. 4, artikel 24, stk. 10, artikel 51, stk. 6, og artikel 66, stk. 8, 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 5, stk. 7, artikel 10, stk. 4, artikel 17, stk. 4, artikel 24, stk. 10, artikel 51, stk. 6, og artikel 66, stk. 8, 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 10, stk. 4, artikel 17, stk. 4, artikel 24, stk. 10, artikel 51, stk. 6, og artikel 66, stk. 8, 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 109
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 110
Overgangsbestemmelser
1.   Fra den 26. maj 2022 er enhver offentliggørelse af en notifikation vedrørende et bemyndiget organ i overensstemmelse med direktiv 98/79/EF ugyldig.
2.   Certifikater, der er udstedt af bemyndigede organer i overensstemmelse med direktiv 98/79/EF 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 VI til direktiv 98/79/EF, der bliver ugyldige senest den 27. maj 2024.
Certifikater, der er udstedt af bemyndigede organer i henhold til direktiv 98/79/EF fra den 25. maj 2017, bliver ugyldige senest den 27. maj 2024.
3.   Uanset denne forordnings artikel 5 kan udstyr med et certifikat, der blev udstedt i overensstemmelse med direktiv 98/79/EF, 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 nævnte direktiv, 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 direktiv.
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 98/79/EF før den 26. maj 2022, og udstyr, der er bragt i omsætning fra den 26. maj 2022, 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 98/79/EF kan udstyr, der opfylder kravene i denne forordning, bringes i omsætning før den 26. maj 2022.
6.   Uanset direktiv 98/79/EF kan overensstemmelsesvurderingsorganer, som opfylder kravene i denne forordning, udpeges og notificeres inden den 26. maj 2022. 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, inden den 26. maj 2022.
7.   For så vidt angår udstyr, som er underlagt de procedurer, der er fastsat i artikel 48, stk. 3 og 4, finder stk. 5 i nærværende artikel anvendelse, forudsat at de nødvendige udpegelser til MDCG og ekspertpaneler og af EU-referencelaboratorier er foretaget.
8.   Uanset artikel 10 og artikel 12, stk. 1, litra a) og b), i direktiv 98/79/EF 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 113, stk. 3, litra f), og slutter 18 måneder senere, opfylder bestemmelserne i artikel 27, stk. 3, artikel 28, stk. 1, og artikel 51, stk. 5, i denne forordning, for at opfylde de love og bestemmelser, som medlemsstaterne har vedtaget i overensstemmelse med artikel 10 og artikel 12, stk. 1, litra a) og b), i direktiv 98/79/EF, jf. afgørelse 2010/227/EU.
9.   Tilladelser, der gives af medlemsstaternes kompetente myndigheder i overensstemmelse med artikel 9, stk. 12, i direktiv 98/79/EF fortsætter med at være gyldige som angivet i tilladelsen.
10.   Indtil Kommissionen i medfør af artikel 24, stk. 2, har udpeget udstedende enheder, anses GS1, HIBCC og ICCBBA som udpegede udstedende enheder.
Artikel 111
Evaluering
Senest den 27. maj 2027 vurderer Kommissionen anvendelsen af denne forordning og udarbejder en evalueringsrapport om fremskridt med hensyn til at nå forordningens mål, herunder en vurdering af de nødvendige ressourcer for at gennemføre denne forordning. Der skal især fokuseres på sporingen af udstyr, jf. artikel 24, gennem de erhvervsdrivendes, sundhedsinstitutionernes og sundhedspersonernes lagring af UDI'en. Evalueringen skal også omfatte en gennemgang af anvendelsen af artikel 4.
Artikel 112
Ophævelse
Uden at dette berører denne forordnings artikel 110, 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 98/79/EF, ophæves nævnte direktiv med virkning fra den 26. maj 2022 med undtagelse af
a)
artikel 11, artikel 12, stk. 1, litra c), og artikel 12, stk. 2 og 3, i direktiv 98/79/EF og forpligtelserne vedrørende sikkerhedsovervågning og undersøgelser af ydeevne i de tilhørende bilag, som ophæves med virkning fra den seneste af de datoer, der er omhandlet i denne forordnings artikel 113, stk. 2, og artikel 113, stk. 3, litra f), og
b)
artikel 10 og artikel 12, stk. 1, litra a) og b), i direktiv 98/79/EF 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 113, stk. 2, og artikel 113, stk. 3, litra f).
For så vidt angår udstyr omhandlet i artikel 110, stk. 3 og 4, finder direktiv 98/79/EF fortsat anvendelse indtil den 27. maj 2025 i det omfang, det er nødvendigt med henblik på anvendelsen af de nævnte stykker.
Afgørelse 2010/227/EU, der er vedtaget i medfør af direktiv 90/385/EØF, 93/42/EØF og 98/79/EF, ophæves med virkning fra den seneste af de datoer, der er omhandlet i artikel 113, stk. 2, og artikel 113, stk. 3, litra f), i denne forordning.
Henvisninger til det ophævede direktiv gælder som henvisninger til nærværende forordning og læses efter sammenligningstabellen i bilag XV.
Artikel 113
Ikrafttræden og anvendelsesdato
1.   Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i 
Den Europæiske Unions Tidende
.
2.   Den anvendes den 26. maj 2022.
3.   Uanset stk. 2 anvendes:
a)
artikel 27, stk. 3, og artikel 51, stk. 5, fra den 27. november 2023
b)
artikel 31-46 og artikel 96 fra den 26. november 2017. Imidlertid finder de forpligtelser, der påhviler de bemyndigede organer i medfør af artikel 31-46, kun anvendelse på de organer, som indsender en ansøgning om udpegelse i overensstemmelse med artikel 34 fra den nævnte dato og indtil den 26. maj 2022
c)
artikel 97 fra den 26. maj 2018
d)
artikel 100 fra den 25. november 2020
e)
for udstyr i klasse D, artikel 24, stk. 4, fra den 26. maj 2023. For udstyr i klasse B og C anvendes artikel 24, stk. 4, fra den 26. maj 2025. For udstyr i klasse A anvendes artikel 24, stk. 4, fra den 26. maj 2027
f)
uden at det berører forpligtelserne for Kommissionen i henhold til artikel 34 i forordning (EU) 2017/745 hvor 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, i nævnte forordning, ikke er fuldt funktionsdygtig den 26. maj 2022, de forpligtelser og krav, som vedrører Eudamed, fra den dato, der svarer til seks måneder efter datoen for meddelelsens offentliggørelse, jf. artikel 34, stk. 3, i nævnte forordning. De i forrige punktum omhandlede bestemmelser er:
—
artikel 26
—
artikel 28
—
artikel 29
—
artikel 36, stk. 2, andet punktum
—
artikel 38, stk. 10
—
artikel 39, stk. 2
—
artikel 40, stk. 12, andet afsnit
—
artikel 42, stk. 7, litra d) og e)
—
artikel 49, stk. 2
—
artikel 50, stk. 1
—
artikel 66-73
—
artikel 74, stk. 1-13
—
artikel 75-77
—
artikel 81, stk. 2
—
artikel 82 og 83
—
artikel 84, stk. 5 og 7, og artikel 84, stk. 8, tredje afsnit
—
artikel 85
—
artikel 88, stk. 4, 7 og 8
—
artikel 90, stk. 2 og 4
—
artikel 92, stk. 2, sidste punktum
—
artikel 94, stk. 4
—
artikel 110, stk. 3, første afsnit, sidste punktum.
Indtil Eudamed er fuldt funktionsdygtig finder de tilsvarende bestemmelser i direktiv 98/79/EF 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 undersøgelser af ydeevne, indberetning i forbindelse med sikkerhedsovervågning, registrering af udstyr og erhvervsdrivende samt certifikatmeddelelser.
g)
den procedure, der er fastsat i artikel 74, fra den 26. maj 2027, jf. dog artikel 74, stk. 14
h)
artikel 110, stk. 10, fra den 26. maj 2019.
Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver medlemsstat.
Udfærdiget i Strasbourg, den 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
)
  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
).
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4
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  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
).
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5
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  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
).
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  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
).
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  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
).
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  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
).
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  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
).
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10
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  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
).
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  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 (se side 1 i denne EUT).
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  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
).
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14
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  Europa-Parlamentets 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
).
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15
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  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
).
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  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
).
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EUT L 123 af 12.5.2016, s. 1
.
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  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
).
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  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
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  Rådets direktiv 93/42/EØF af 14. juni 1993 om medicinsk udstyr (
EFT L 169 af 12.7.1993, s. 1
).
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EUT C 358 af 7.12.2013, s. 10
.
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  Europa-Parlamentets og Rådets direktiv 2006/42/EF af 17. maj 2006 om maskiner (
EUT L 157 af 9.6.2006, s. 24
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  Europa-Parlamentets og Rådets direktiv 2011/24/EU af 9. marts 2011 om patientrettigheder i forbindelse med grænseoverskridende sundhedsydelser (
EUT L 88 af 4.4.2011, s. 45
).
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  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
).
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25
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  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
).
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  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 26, stk. 3, og artikel 28, centrale dataelementer, der sammen med UDI-DI skal indsendes til UDI-databasen, jf. artikel 25 og 26, og UDI-systemet
VII
Krav, som skal være opfyldt af de bemyndigede organer
VIII
Klassificeringskriterier
IX
Overensstemmelsesvurdering baseret på et fuldt kvalitetsstyringssystem og på en vurdering af den tekniske dokumentation
X
Overensstemmelsesvurdering på grundlag af typeafprøvning
XI
Overensstemmelsesvurdering baseret på kvalitetssikring af produktionen
XII
Certifikater udstedt af bemyndigede organer
XIII
Ydeevneevaluering, undersøgelser af ydeevne og opfølgning af ydeevne, efter at udstyret er bragt i omsætning
XIV
Interventionsundersøgelser af klinisk ydeevne og visse andre undersøgelser af ydeevne
XV
Sammenligningstabel
BILAG I
GENERELLE KRAV TIL SIKKERHED OG YDEEVNE
KAPITEL I
GENERELLE KRAV
1.   Udstyr 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 det er muligt, forstås begrænsning af risici så meget, som det er 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 et udstyrs livscyklus, som kræver regelmæssig systematisk opdatering. Når fabrikanter foretager 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 sikkerhedsprincipperne 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 det er 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 virkninger skal minimeres og være acceptable, når de sammenlignes med de vurderede potentielle fordele for patienten og/eller brugeren som følge af udstyrets tilsigtede ydeevne under normale anvendelsesvilkår.
KAPITEL II
KRAV VEDRØRENDE YDEEVNE, DESIGN OG FREMSTILLING
9.   Ydeevnekarakteristika
9.1.   Udstyr skal designes og fremstilles således, at det er egnet til de i artikel 2, nr. 2), nævnte formål som angivet af fabrikanten og egnet for så vidt angår ydeevnen under hensyntagen til det almindeligt anerkendte tekniske niveau. Det skal have den af fabrikanten anførte ydeevne, og, hvor det er relevant, navnlig:
a)
analytisk ydeevne, herunder analytisk sensitivitet, analytisk specificitet, korrekthed (bias), præcision (repeterbarhed og reproducerbarhed), nøjagtighed (som følge af korrekthed og præcision), detektions- og bestemmelsesgrænser, måleskala, linearitet, afgrænsning, herunder fastlæggelse af passende kriterier for indsamling af prøver og håndtering og kontrol af kendt relevant endogen og exogen interferens, krydsreaktioner, og
b)
klinisk ydeevne, herunder diagnostisk sensitivitet, diagnostisk specificitet, positiv prognoseværdi, negativ prognoseværdi, sandsynlighedskvotient og forventede værdier i normale og berørte populationer.
9.2.   Udstyrets ydeevnekarakteristika skal opretholdes i den af fabrikanten angivne levetid.
9.3.   Hvis udstyrets ydeevne afhænger af anvendelsen af kalibratorer og/eller kontrolmateriale, skal den metrologiske sporbarhed af værdier, der er fastsat for kalibratorer og/eller kontrolmateriale, sikres via relevante referencemåleprocedurer og/eller relevant referencemateriale af højere metrologisk orden. Den metrologiske sporbarhed af værdier, der er fastsat for kalibratorer og kontrolmateriale, skal, hvis den foreligger, sikres i forhold til certificeret referencemateriale eller referencemåleprocedurer.
9.4.   Udstyrets karakteristika og ydeevne skal specifikt kontrolleres, hvis disse kan påvirkes, når udstyret anvendes som tilsigtet under normale betingelser:
a)
for udstyr til selvtestning, ydeevne, der opnås af lægmand
b)
for udstyr til patientnær testning, ydeevne, der opnås i relevante miljøer (f.eks. patienters hjem, skadestuer og ambulancer).
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.
Opmærksomheden skal navnlig rettes mod muligheden for, at den analytiske ydeevne forringes som følge af fysisk og/eller kemisk inkompatibilitet mellem de anvendte materialer og det prøvemateriale, den analyt eller markør, der skal påvises (f.eks. biologisk væv, celler, legemsvæsker og mikroorganismer), under hensyntagen til udstyrets erklærede formål.
10.2.   Udstyr skal designes, fremstilles og emballeres på en sådan måde, at den risiko, som kontaminerende stoffer og reststoffer udgør for det personale, der deltager i transporten, opbevaringen og anvendelsen af udstyret, samt for patienterne, mindskes mest muligt under hensyntagen til udstyrets erklærede formål. Der skal især tages hensyn til udsat væv for disse kontaminerende stoffer og reststoffer samt til udsættelsens varighed og hyppighed.
10.3.   Udstyr skal designes og fremstilles på en sådan måde, at de risici, som skyldes stoffer eller partikler, herunder slidaffald, nedbrydningsprodukter og restprodukter, der kan frigøres af udstyret, begrænses til et niveau, der er så lavt, som det med rimelighed er praktisk muligt. Der skal især fokuseres på stoffer, 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 
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1
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, og stoffer med hormonforstyrrende egenskaber, for hvilke der foreligger videnskabelig dokumentation for mulige alvorlige konsekvenser for menneskers sundhed, og som fastlægges i overensstemmelse med den procedure, der er omhandlet i artikel 59 i Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 
(
2
)
.
10.4.   Udstyr skal designes og fremstilles på en sådan måde, at de risici, som opstår ved utilsigtet indtrængen af stoffer i udstyret begrænses så meget, som det er muligt, idet der tages hensyn til udstyret og de omgivelser, hvori det skal anvendes.
11.   Infektion og mikrobiel kontaminering
11.1.   Udstyr og fremstillingsprocesser skal designes på en sådan måde, at infektionsfaren fjernes eller begrænses så meget, som det er muligt, for brugere og eventuelt andre personer. Designet skal:
a)
gøre det let og sikkert at håndtere udstyret
b)
så vidt det er muligt, mindske mikrobiel lækage fra udstyret og/eller mikrobiel eksponering under brugen
og om nødvendigt
c)
forhindre mikrobiel kontaminering af udstyret under brug og, for så vidt angår prøvebeholdere, risikoen for kontaminering af prøven.
11.2.   Udstyr, der er mærket som sterilt eller som værende i en bestemt mikrobiel tilstand, skal designes, fremstilles og emballeres på en sådan måde, at dets sterile eller mikrobielle tilstand opretholder, under de af fabrikanten fastsatte transport- og opbevaringsbetingelser, indtil emballagen åbnes på brugsstedet, medmindre den emballage, som opretholder deres sterile eller mikrobielle tilstand, er beskadiget.
11.3.   Udstyr, der er mærket som sterilt, skal behandles, fremstilles, emballeres og steriliseres under anvendelse af hensigtsmæssige validerede metoder.
11.4.   Udstyr, der skal steriliseres, skal fremstilles og emballeres under passende og kontrollerede betingelser og i passende og kontrollerede faciliteter.
11.5.   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.
11.6.   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 materialer af biologisk oprindelse
Hvis udstyret omfatter væv, celler og stoffer af animalsk, human eller mikrobiel oprindelse, skal udvælgelsen af kilder, behandlingen, præserveringen, testningen og håndteringen af væv, celler og stoffer af sådan oprindelse og kontrolprocedurer foregå på en sådan måde, at der opnås sikkerhed for brugere eller eventuelt andre personer.
Navnlig skal sikkerheden tilgodeses i forbindelse med mikrobielle agenser og andre overførbare agenser gennem anvendelse af validerede metoder til eliminering eller inaktivering under fremstillingsprocessen. Dette gælder ikke for visse typer udstyr, hvor mikrobielle agenser og andre overførbare agensers aktivitet er en integreret del af udstyrets erklærede formål, eller hvor en sådan eliminerings- eller inaktiveringsproces ville forringe udstyrets ydeevne.
13.   Konstruktion af udstyr og interaktion med dets omgivelser
13.1.   Når udstyr er beregnet til at skulle anvendes sammen med andet udstyr eller andre anordninger, skal hele kombinationen, herunder sammenkoblingssystemet, være sikker og udformet 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.
13.2.   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 ukorrekt identifikation af prøver og risikoen for fejlagtige resultater på grund af f.eks. forvirrende farvekoder og/eller talkoder og/eller tegnkoder på prøvebeholdere, aftagelige dele og/eller tilbehør til udstyr med henblik på at udføre prøvningen eller testen efter hensigten
g)
risikoen for forudsigelig interferens med andet udstyr.
13.3.   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 omfatter, at det udsættes for eller anvendes i forbindelse med brændbare eller eksplosive eller brandnærende stoffer.
13.4.   Udstyr skal designes og fremstilles på en sådan måde, at tilpasning, kalibrering og vedligeholdelse kan ske på en sikker og effektiv måde.
13.5.   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.
13.6.   Udstyr skal designes og fremstilles på en sådan måde, at det er let for brugeren eller en anden person at bortskaffe det og relateret affald på en sikker måde. Med henblik herpå fastlægger og tester fabrikanter procedurer og foranstaltninger, som følge af hvilke deres udstyr kan bortskaffes sikkert efter brug. Sådanne procedurer skal beskrives i brugsanvisningen.
13.7.   Måle-, monitorerings- og displayindretninger (herunder farveændringer og andre visuelle indikatorer) 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.   Udstyr med målefunktion
14.1.   Udstyr med en primær, analytisk målefunktion, skal designes og fremstilles på en sådan måde, at der sikres en passende analytisk ydeevne i overensstemmelse med bilag I, punkt 9.1, litra a) under hensyntagen til udstyrets erklærede formål.
14.2.   Målinger, der udføres ved hjælp af udstyr med målefunktion, skal udtrykkes i forskriftsmæssige enheder, der er i overensstemmelse med bestemmelserne i Rådets direktiv 80/181/EØF 
(
3
)
.
15.   Strålingsbeskyttelse
15.1.   Udstyr skal designes, fremstilles og emballeres på en sådan måde, at stråling (tilsigtet, utilsigtet eller spredt), som brugere eller 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 diagnosticeringsformål, dog ikke må begrænses.
15.2.   Når udstyr er beregnet til at udsende farlig eller potentielt farlig, ioniserende og/eller ikkeioniserende stråling, skal det så vidt muligt:
a)
designes og fremstilles på en sådan måde, at det sikres, at arten og mængden af den udsendte stråling kan kontrolleres og/eller justeres, og
b)
være udstyret med visuelle og/eller akustiske varslingssignaler, som markerer, at der udsendes stråling.
15.3.   Brugsanvisningen til udstyr, som udsender farlig eller potentielt farlig stråling, skal indeholde præcise oplysninger om, hvilken art stråling der udsendes, hvorledes brugeren kan beskyttes, og hvordan forkert brug og risici i forbindelse med installering kan begrænses så meget, som det er muligt og hensigtsmæssigt. Desuden angives oplysninger om modtagekontrol, testning af ydeevne og acceptkriterier samt vedligeholdelsesprocedure.
16.   Elektroniske programmerbare systemer — udstyr, der indeholder elektroniske programmerbare systemer, og software, der er udstyr i sig selv
16.1.   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 i overensstemmelse med den 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 det er muligt.
16.2.   For udstyr, der omfatter software, eller for software, der er udstyr i sig selv, skal softwaren udvikles og fremstilles på grundlag af det aktuelle tekniske niveau, idet der tages hensyn til principperne om udviklingslivscyklus, risikostyring, herunder informationssikkerhed, verifikation og validering.
16.3.   Software, der er nævnt i dette punkt, og som er bestemt til at skulle anvendes sammen med mobile databehandlingsplatforme, skal designes 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).
16.4.   Fabrikanter skal angive mindstekrav til hardware, IT-netværksegenskaber og IT-sikkerhedsforanstaltninger, herunder beskyttelse mod uautoriseret adgang, der er nødvendige for at køre softwaren som tilsigtet.
17.   Udstyr, som er tilsluttet en energikilde eller forsynet med en sådan
17.1.   Hvis der for udstyr, som er tilsluttet en energikilde eller udstyret med en sådan, opstår en første fejlforekomst, skal der træffes passende forholdsregler til at fjerne de dermed forbundne risici eller begrænse dem så meget, som det er muligt.
17.2.   Udstyr, hvor en intern energiforsyning 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.
17.3.   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.
17.4.   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.
17.5.   Udstyr skal designes og fremstilles på en sådan måde, at det i videst muligt omfang undgås, at brugere eller andre personer udsættes for risiko for utilsigtede elektriske stød ved normal anvendelse og ved første fejlforekomst, når udstyret installeres og vedligeholdes som angivet af fabrikanten.
18.   Beskyttelse mod mekaniske og termiske risici
18.1.   Udstyr skal designes og fremstilles på en sådan måde, at brugere og andre personer beskyttes mod mekaniske risici.
18.2.   Udstyr skal under normal anvendelse være tilstrækkelig stabilt. Det skal kunne modstå påvirkninger, der forekommer i det pågældende arbejdsmiljø, og bevare denne modstandsdygtighed i sin forventede levetid, når eftersyn og vedligeholdelse foretages efter fabrikantens forskrifter.
18.3.   Består der fare i forbindelse med bevægelige dele eller risiko for sammenbrud eller løsrivelse eller for lækning af stoffer, skal passende beskyttelsesanordninger være indbygget.
Eventuelle afskærmninger eller andre anordninger, der skal give beskyttelse i forbindelse med udstyret, særlig mod bevægelige dele, skal være sikre og må ikke besværliggøre adgangen til normal anvendelse af udstyret eller begrænse rutinemæssig vedligeholdelse af det efter fabrikantens forskrifter.
18.4.   Udstyr skal designes og fremstilles på en sådan måde, at risici som følge af vibrationer fra udstyret reduceres mest muligt under hensyn til den tekniske udvikling og eksisterende midler til at reducere vibrationerne, navnlig ved kilden, medmindre vibrationerne udgør en del af den angivne ydeevne.
18.5.   Udstyr skal designes og fremstilles på en sådan måde, at risici som følge af støjemissioner reduceres mest muligt under hensyn til den tekniske udvikling og eksisterende midler til at reducere støjen, navnlig ved kilden, medmindre støjemissionerne udgør en del af den angivne ydeevne.
18.6.   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.
18.7.   Sandsynlige fejl ved montering eller genmontering af visse dele, som kan medføre risici, skal umuliggøres ved designet og konstruktionen af disse dele, og hvis dette ikke lader sig gøre, ved oplysninger, der anføres på selve delene og/eller deres afdækning.
De samme oplysninger anføres på de bevægelige dele og/eller deres afdækning, når det er nødvendigt at kende bevægelsesretningen for at undgå en risiko.
18.8.   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.
19.   Beskyttelse mod risici i forbindelse med udstyr, der er bestemt til selvtestning eller patientnær testning
19.1.   Udstyr til selvtestning eller patientnær testning 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, de tilsigtede brugere har, og til de påvirkninger, der skyldes den variation, som med rimelighed kan forventes i den tilsigtede brugers teknik og omgivelser. Fabrikantens oplysninger og instruktioner skal være lette at forstå og anvende af den tilsigtede bruger for at sikre en korrekt fortolkning af det resultat, som udstyret giver, og for at undgå vildledende oplysninger. I forbindelse med patientnær testning skal fabrikantens oplysninger og instruktioner gøre det klart, hvilket uddannelsesniveau, hvilke kvalifikationer og/eller hvilken erfaring der kræves af brugeren.
19.2.   Udstyr til selvtestning eller patientnær testning skal designes og fremstilles på en sådan måde:
a)
at det kan anvendes sikkert og korrekt i alle håndteringsfaser af den tilsigtede bruger, om nødvendigt efter passende uddannelse og/eller oplysninger, og
b)
at risikoen for, at den tilsigtede bruger begår fejl i forbindelse med håndtering af udstyret og en eventuel prøve samt i fortolkningen af resultatet, mindskes mest muligt.
19.3.   Udstyr til selvtestning og patientnær testning skal, hvis det er muligt, omfatte en procedure, hvormed den tilsigtede bruger:
a)
kan verificere, at udstyret på det tidspunkt, hvor det bruges, har den tilsigtede ydeevne, og
b)
advares, hvis der ikke er opnået et gyldigt resultat med udstyret.
KAPITEL III
KRAV TIL OPLYSNINGER, DER GIVES SAMMEN MED UDSTYR
20.   Mærkning og brugsanvisning
20.1.   Generelle krav til fabrikantens oplysninger
Hvert udstyr skal ledsages af de oplysninger, der er nødvendige for at identificere udstyret og dets fabrikant, og af eventuelle 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)
Medium, format, indhold, læsbarhed og placering hvad angår mærkningen og brugsanvisningen skal være afpasset det pågældende udstyr, dets erklærede formål og den eller de tilsigtede brugeres tekniske 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 enkelt enhed. Hvis det ikke er muligt fuldt ud at mærke hver enkelt enhed for sig, skal oplysningerne fremgå af emballagen til flere udstyr.
c)
Mærkning skal være i et menneskeligt læsbart format og kan suppleres med maskinlæsbare oplysninger såsom radiofrekvensidentifikation eller stregkoder.
d)
Udstyr skal leveres med en brugsanvisning. I behørigt begrundede undtagelsestilfælde er en brugsanvisning dog ikke påkrævet, eller den kan forkortes, hvis udstyret kan anvendes sikkert og som tilsigtet af fabrikanten uden brugsanvisning.
e)
Hvis flere udstyr, med undtagelse af udstyr til selvtestning eller patientnær testning, 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)
Når udstyr kun er beregnet til professionel brug, kan brugsanvisningen leveres til brugeren i ikkepapirformat (f.eks. elektronisk), medmindre udstyret er beregnet til patientnær testning.
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 under hensyntagen til de tilsigtede brugere. 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.
i)
I forbindelse med udstyr, som indeholder et stof eller en blanding, der kan anses for at være farlig henset til dets bestanddeles art og mængde og den form, hvori de forefindes, gælder de relevante farepiktogrammer og mærkningskrav i forordning (EF) nr. 1272/2008. Såfremt der ikke er tilstrækkelig plads til, at alle oplysningerne kan anføres på selve udstyret eller på dets mærkning, anbringes de relevante farepiktogrammer på mærkningen, og de øvrige oplysninger i henhold til forordning (EF) nr. 1272/2008 anføres i brugsanvisningen.
j)
Bestemmelserne i forordning (EF) nr. 1907/2006 om sikkerhedsdatabladet er gældende, medmindre alle relevante oplysninger allerede foreligger i passende form i brugsanvisningen.
20.2.   Oplysninger på mærkningen
Mærkningen skal indeholde alle de følgende oplysninger:
a)
udstyrets navn eller handelsnavn
b)
de angivelser, som er absolut nødvendige for, at en bruger kan identificere udstyret, 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 adressen på den autoriserede repræsentants registrerede forretningssted, hvis fabrikanten har sit registrerede forretningssted uden for Unionen
e)
en angivelse af, at udstyret er et medicinsk udstyr til in vitro-diagnostik, eller hvis udstyret er »udstyr, hvis ydeevne skal undersøges«, en angivelse af dette
f)
ordet »LOTNUMMER« eller »SERIENUMMER« eller et tilsvarende symbol efterfulgt af udstyrets lotnummer eller serienummer
g)
UDI-bæreren, jf. artikel 24 og bilag VI, del C
h)
en entydig angivelse af fristen for sikker anvendelse uden forringelse af ydeevnen angivet med mindst år og måned og, hvor det er relevant, dag i denne rækkefølge
i)
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
j)
hvis det er relevant, en angivelse af nettoindholdet, udtrykt i vægt eller mængde, numerisk antal eller en kombination heraf eller på anden måde, som på korrekt vis afspejler emballagens indhold
k)
angivelse af særlige betingelser vedrørende opbevaring og/eller håndtering
l)
hvis det er relevant, en angivelse af udstyrets sterile tilstand og steriliseringsmetoden, eller en angivelse af enhver speciel mikrobiel tilstand eller renhedstilstand
m)
advarsler eller forholdsregler, som det er nødvendigt omgående at meddele brugeren af udstyret og andre personer. Disse oplysninger kan holdes på et minimum, i hvilket tilfælde mere detaljerede oplysninger anføres i brugsanvisningen under hensyntagen til de tilsigtede brugere
n)
en henvisning til, hvor det er muligt at få adgang til brugsanvisningen (eller hvor den er tilgængelig), og i givet fald adressen på det websted, hvor den kan konsulteres, hvis brugsanvisningen ikke leveres i papirform i overensstemmelse med punkt 20.1, litra f)
o)
eventuelle særlige brugsanvisninger, hvis det er relevant
p)
hvis udstyret er beregnet til engangsbrug, en angivelse af dette. En fabrikants angivelse af engangsbrug skal være konsekvent i hele Unionen
q)
hvis udstyret er beregnet til selvtestning eller patientnær testning, en angivelse af dette
r)
hvis hurtige test ikke er bestemt til selvtestning eller patientnær testning, den udtrykkelige udelukkelse heraf
s)
hvis udstyrsprøvesæt omfatter individuelle reagenser og artikler, som er tilgængelige som separat udstyr, skal hvert enkelt af disse udstyr opfylde mærkningskravene i dette punkt og kravene i denne forordning
t)
udstyret og løsdele skal identificeres, hvis det er relevant, ved et batchnummer, således at det bliver muligt at træffe de relevante forholdsregler til påvisning af en potentiel fare i forbindelse med udstyret og løsdelene. Oplysningerne skal, så vidt det er praktisk muligt og hensigtsmæssigt, anbringes på selve udstyret og/eller eventuelt på handelsemballagen
u)
mærkningen for udstyr til selvtestning skal omfatte følgende oplysninger:
i)
den prøvetype, der kræves for at udføre prøvningen (f.eks. blod, urin eller spyt)
ii)
behovet for yderligere materialer til sikring af, at prøvningen gennemføres korrekt
iii)
kontaktoplysninger med henblik på yderligere rådgivning og bistand.
Navnet på udstyr til selvtestning må ikke afspejle et andet erklæret formål end det, som fabrikanten har angivet.
20.3.   Oplysninger på den emballage, der opretholder et udstyrs sterile tilstand (»steril emballage«)
Følgende oplysninger 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)
fremstillingsmåned og -år
g)
en entydig angivelse af fristen for sikker anvendelse angivet med mindst år og måned og, hvor det er relevant, dag i denne rækkefølge
h)
en anvisning om at se i brugsanvisningen, hvad man skal gøre, hvis den sterile emballage er beskadiget eller utilsigtet er blevet åbnet inden brug.
20.4.   Oplysninger i brugsanvisningen
20.4.1.   Brugsanvisningen skal indeholde alle de følgende oplysninger:
a)
udstyrets navn eller handelsnavn
b)
oplysninger, der er absolut nødvendige, for at brugeren entydigt kan identificere udstyret
c)
udstyrets erklærede formål:
i)
hvad der påvises og/eller måles
ii)
funktion (f.eks. screening, monitorering, diagnosticering eller hjælp til diagnosticering, prognose, forudsigelse, ledsagende diagnosticering)
iii)
de specifikke oplysninger, der tiltænkes leveret i forbindelse med:
—
en fysiologisk eller patologisk tilstand
—
medfødte fysiske eller mentale handicap
—
disposition for en medicinsk tilstand eller sygdom
—
fastsættelse af sikkerhed for og kompatibilitet med potentielle recipienter
—
forudsigelse af respons eller reaktioner på behandlinger
—
definition eller monitorering af terapeutiske foranstaltninger
iv)
om det er automatisk eller ej
v)
om det er kvalitativt, semikvantitativt eller kvantitativt
vi)
de(n) krævede prøvetype(r)
vii)
eventuelt testgruppe, og
viii)
for udstyr til ledsagende diagnosticering, det internationale fællesnavn (INN) på det tilknyttede lægemiddel, som det udgør en ledsagende prøvning for
d)
en angivelse af, at udstyret er medicinsk udstyr til in vitro-diagnostik, eller hvis udstyret er »udstyr, hvis ydeevne skal undersøges«, en angivelse af dette
e)
eventuelt den tilsigtede bruger (f.eks. til selvtestning, til brug tæt på patienten og til laboratoriemæssig professionel brug, sundhedspersoner)
f)
testprincip
g)
en beskrivelse af kalibratorerne og kontroller og enhver begrænsning af anvendelsen heraf (f.eks. kun egnet til et bestemt instrument)
h)
en beskrivelse af reagenserne og enhver begrænsning af anvendelsen heraf (f.eks. kun egnet til et bestemt instrument) og reagensproduktets sammensætning i form af art og mængde eller koncentration af aktive bestanddele i reagenser eller prøvesæt samt, hvor det er relevant, en erklæring om, at udstyret indeholder andre bestanddele, som vil kunne påvirke målingen
i)
en liste over materialer, der medfølger, og en liste over særlige materialer, der kræves, men ikke medfølger
j)
for udstyr, der er bestemt til at blive brugt eller installeret sammen med eller tilsluttet andet udstyr og/eller anordninger til generelle formål:
—
oplysninger til identifikation af sådant udstyr eller sådanne anordninger for at opnå en valideret og sikker kombination, herunder de vigtigste ydeevnekarakteristika, og/eller
—
oplysninger om eventuelle kendte begrænsninger for kombinationer af udstyr og anordninger
k)
angivelse af særlige betingelser vedrørende opbevaring (f.eks. temperatur, lys, fugt osv.) og/eller håndtering
l)
stabilitet i brug, som kan omfatte opbevaringsvilkår og holdbarhed, efter at den primære emballage er åbnet første gang, samt eventuelt arbejdsopløsningers opbevaringsvilkår og stabilitet
m)
hvis udstyret leveres i steril tilstand, en angivelse af dets sterile tilstand og steriliseringsmetoden og de nødvendige anvisninger i tilfælde af brud på den sterile emballage inden brug
n)
oplysninger, der gør det muligt for brugeren at blive informeret om eventuelle advarsler, forholdsregler, foranstaltninger, der skal træffes, og begrænsninger i anvendelsen af udstyret. Disse oplysninger skal i givet fald omfatte:
i)
advarsler, forholdsregler og/eller foranstaltninger, der skal træffes i tilfælde af funktionsfejl ved udstyret eller forringelser, der fremgår af udseendet, som kan påvirke sikkerheden
ii)
advarsler, forholdsregler og/eller foranstaltninger, der skal træffes vedrørende 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
iii)
advarsler, forholdsregler og/eller foranstaltninger, der skal træffes vedrørende 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
iv)
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
v)
hvis udstyret er beregnet til engangsbrug, en angivelse af dette. En fabrikants angivelse af engangsbrug skal være konsekvent i hele Unionen
vi)
for genanvendeligt udstyr oplysninger om, hvilke metoder der bør anvendes, for at genanvendelse kan finde sted, herunder rengøring, desinfektion, dekontaminering, emballering og i givet fald den validerede gensteriliseringsmetode. Der skal forelægges oplysninger til fastlæggelse af, hvornår udstyret ikke længere bør genanvendes, såsom tegn på materialeforringelse eller det maksimale antal tilladte genanvendelser
o)
eventuelle advarsler og/eller forholdsregler, der vedrører potentielt smittefarligt materiale, som er en del af udstyret
p)
eventuelle krav om særlige faciliteter, såsom renrumsmiljø, eller særlig uddannelse, såsom strålingssikkerhed eller særlige kvalifikationer, til den tilsigtede bruger
q)
betingelser for indsamling, håndtering og forberedelse af prøven
r)
oplysninger om eventuel forberedende behandling eller håndtering af udstyret, inden udstyret er klar til anvendelse, såsom sterilisering, endelig samling, kalibrering mv., for at sikre, at udstyret anvendes som tiltænkt af fabrikanten
s)
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, herunder 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
—
metoder til at mindske af de risici, som personer, der beskæftiger sig med installering, kalibrering eller vedligeholdelse af udstyr, er udsat for
t)
eventuelt anbefalinger vedrørende kvalitetskontrolprocedurer
u)
den metrologiske sporbarhed af værdier, der er fastsat for kalibratorer og kontrolmateriale, herunder beskrivelse af anvendt referencemateriale og/eller referencemåleprocedurer af højere orden og oplysninger om maksimale (af fabrikanten selv accepterede) forskelle fra batch til batch sammen med relevante tal og måleenheder
v)
testmetode, herunder beregning og fortolkning af resultater og, hvis det er relevant, om eventuelle konfirmatoriske undersøgelser skal tages i betragtning; brugsanvisningen vedlægges, når det er relevant, oplysninger om forskelle fra batch til batch sammen med relevante tal og måleenheder
w)
analytiske ydeevnekarakteristika, f.eks. analytisk sensitivitet, analytisk specificitet, korrekthed (bias), præcision (repeterbarhed og reproducerbarhed), nøjagtighed (som følge af korrekthed og præcision), detektionsgrænser og målespektrum, (nødvendige oplysninger til brug for kontrol af kendte former for relevant interferens, krydsreaktioner og metodens begrænsninger), måleskala, linearitet og oplysninger om brugerens anvendelse af foreliggende referencemåleprocedurer og -materialer
x)
kliniske ydeevnekarakteristika som defineret i dette bilags punkt 9.1
y)
den matematiske fremgangsmåde, der er grundlaget for beregningen af analyseresultatet
z)
eventuelt kliniske ydeevnekarakteristika som f.eks. tærskelværdi, diagnostisk sensitivitet og diagnostisk specificitet samt positiv og negativ prognoseværdi
aa)
eventuelt referenceintervaller i normale og berørte populationer
ab)
oplysninger om interfererende stoffer eller begrænsninger (f.eks. synlige tegn på hyperlipidæmi eller hæmolyse og prøvens alder), som kan påvirke udstyrets ydeevne
ac)
advarsler eller forholdsregler, der skal træffes for at fremme sikker bortskaffelse af udstyret og dets tilbehør og eventuelle hjælpematerialer. Disse oplysninger skal i givet fald omfatte:
i)
infektionsfare eller mikrobielle farer, såsom hjælpematerialer, der er forurenet med potentielt smittefarlige stoffer af human oprindelse
ii)
miljøfarer, f.eks. batterier eller materialer, som udsender potentielt farlige strålingsdoser
iii)
fysiske farer, f.eks. eksplosion
ad)
fabrikantens navn, registrerede firmanavn eller registrerede varemærke, og hovedsædets adresse, hvor vedkommende kan kontaktes og fysisk kan lokaliseres, samt telefonnummer og/eller faxnummer og/eller websted, hvor der kan fås teknisk bistand
ae)
dato for udstedelse af brugsanvisningen eller, hvis den er blevet revideret, dato og referencenummer for seneste revision af brugsanvisningen med en klar angivelse af de indførte ændringer
af)
en meddelelse til brugeren om, at enhver alvorlig hændelse, der er indtruffet i forbindelse med udstyret, skal indberettes til fabrikanten og den kompetente myndighed i den medlemsstat, hvor brugeren og/eller patienten er etableret
ag)
hvis udstyrsprøvesæt omfatter individuelle reagenser og artikler, som også er tilgængelige som separat udstyr, skal hvert enkelt af disse udstyr opfylde kravene vedrørende brugsanvisninger i dette punkt og kravene i denne forordning
ah)
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.
20.4.2.   Udstyr til selvtestning skal desuden være i overensstemmelse med alle de følgende principper:
a)
Der skal oplyses om testproceduren, herunder eventuel forberedelse af reagenser, indsamling og/eller forberedelse af prøver og oplysninger om, hvordan testen gennemføres og resultaterne fortolkes.
b)
Specifikke enkeltheder kan udelades, hvis fabrikantens øvrige oplysninger er tilstrækkelige til at sætte brugeren i stand til at anvende udstyret og til at forstå det eller de resultater, det frembringer.
c)
Udstyrets erklærede formål skal indeholde tilstrækkelige oplysninger til, at brugeren er i stand til forstå den medicinske sammenhæng, og at den tilsigtede bruger kan fortolke resultaterne korrekt.
d)
Resultaterne skal udtrykkes og fremstå på en sådan måde, at de er letforståelige for den tilsigtede bruger.
e)
Brugeren skal gøres opmærksom på og vejledes om, hvorledes han skal forholde sig (i tilfælde af et positivt, negativt eller ubestemt resultat), om testens begrænsninger og om muligheden for falsk positive eller falsk negative resultater. Der skal også oplyses om faktorer, som eventuelt kan påvirke testresultatet, såsom alder, køn, menstruation, infektion, motion, faste, diæt eller medicin.
f)
Der skal gøres tydeligt opmærksom på, at brugeren ikke bør træffe nogen beslutning af medicinsk art, før han har rådspurgt den relevante sundhedsperson, og der gives oplysninger om sygdomsvirkninger og -forekomst og, såfremt de foreligger, oplysninger om, hvor en bruger kan få yderligere rådgivning i den eller de medlemsstater, hvor udstyret markedsføres, såsom nationale hjælpetjenester, websteder.
g)
Det skal endvidere fremgå af oplysningerne, at når udstyr til selvtestning anvendes til monitorering i forbindelse med en tidligere diagnosticeret sygdom eller tilstand, bør patienten kun ændre behandlingen, hvis han er blevet behørigt instrueret med henblik herpå.
(
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 136 af 29.5.2007, s. 3
).
(
3
)
  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)
udstyrets erklærede formål, som kan omfatte oplysninger om:
i)
hvad der skal påvises og/eller måles
ii)
funktion, såsom screening, monitorering, diagnosticering eller hjælp til diagnosticering, prognose, forudsigelse eller ledsagende diagnosticering
iii)
den specifikke forstyrrelse, tilstand eller risikofaktor, som det skal påvise, definere eller differentiere
iv)
om det er automatisk eller ej
v)
om det er kvalitativt, semikvantitativt eller kvantitativt
vi)
de(n) krævede prøvetype(r)
vii)
eventuelt testgruppe
viii)
den tilsigtede bruger
ix)
for udstyr til ledsagende diagnosticering desuden den relevante målgruppe og de(t) tilknyttede lægemiddel/lægemidler
d)
beskrivelse af princippet for testmetoden eller principperne for anvendelse af instrumentet
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)
beskrivelse af enkeltdelene og eventuelt beskrivelse af de relevante enkeltdeles reaktive ingredienser, f.eks. antistoffer, antigener og primere for nukleinsyre,
samt om fornødent:
h)
beskrivelse af indsamlingen af prøver og transportmaterialer, der leveres sammen med udstyret, eller beskrivelser af de specifikationer, der anbefales for anvendelsen
i)
for instrumenter til automatiske test en beskrivelse af de relevante testkarakteristika eller særlige test
j)
for automatiske test en beskrivelse af de relevante instrumenteringskarakteristika eller særlig instrumentering
k)
en beskrivelse af eventuel software, der skal anvendes med udstyret
l)
en beskrivelse af eller fuldstændig liste over de forskellige konfigurationer/varianter af udstyret, som er bestemt til at blive gjort tilgængelige på markedet
m)
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.
1.2.   Henvisning til tidligere og tilsvarende generationer af udstyret
a)
en oversigt over den eller de tidligere generationer af udstyret fremstillet af fabrikanten, 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
a)
mærkningen på udstyret og på emballagen hertil, 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
b)
brugsanvisningen på de sprog, der accepteres i de medlemsstater, hvor det er hensigten at sælge udstyret.
3.   DESIGN- OG FREMSTILLINGSOPLYSNINGER
3.1.   Designoplysninger
Oplysninger, der gør det muligt at forstå de designfaser, som udstyret har gennemgået, skal omfatte:
a)
en beskrivelse af udstyrets kritiske ingredienser som f.eks. antistoffer, antigener, enzymer og primere for nukleinsyre, der leveres sammen med eller anbefales til anvendelse med udstyret
b)
for instrumenter en beskrivelse af større undersystemer, analytisk teknologi, f.eks. betjeningsprincipper og kontrolmekanismer, samt særlig computerhardware og -software
c)
for instrumenter og software en oversigt over hele systemet
d)
for software en beskrivelse af datafortolkningsmetoden, navnlig algoritmen
e)
for udstyr til selvtestning eller patientnær testning en beskrivelse af de designaspekter, der gør udstyret egnet til selvtestning eller patientnær testning.
3.2.   Fremstillingsoplysninger
a)
oplysninger, der gør det muligt at forstå fremstillingsprocesserne, f.eks. produktion, samling, prøvning af slutproduktet og emballering af det færdige udstyr. Mere detaljerede oplysninger skal forelægges i forbindelse med audit af kvalitetsstyringssystemet eller andre gældende overensstemmelsesvurderingsprocedurer
b)
identifikation af alle faciliteter, herunder leverandører og underentreprenører, hvor der udføres 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 også 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
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.
Dette omfatter:
6.1.   Oplysninger om udstyrets analytiske ydeevne
6.1.1.   Prøvetype
Dette punkt skal beskrive de forskellige prøvetyper, som kan analyseres, herunder deres stabilitet, f.eks. opbevaring, eventuelt vilkår for transport af prøver og med henblik på tidskritiske analysemetoder oplysninger om, hvor lang tid der må gå mellem prøvens udtagning og analyse heraf, og opbevaringsvilkår, f.eks. varighed, temperaturgrænser og cykler for frysning og optøning.
6.1.2.   Karakteristika for analytisk ydeevne
6.1.2.1.   Målenøjagtighed
a)
Målekorrekthed
Dette punkt skal indeholde oplysninger om korrektheden af måleproceduren og sammenfatte dataene tilstrækkelig detaljeret til, at der kan foretages en vurdering af de valgte midlers egnethed til at fastlægge korrektheden. Korrekthedsforanstaltninger finder kun anvendelse på kvantitative og kvalitative test, når der findes et certificeret referencemateriale eller en certificeret referencemetode.
b)
Målepræcision
Repeterbarheds- og reproducerbarhedsundersøgelserne skal beskrives i dette punkt.
6.1.2.2.   Analytisk sensitivitet
Dette punkt skal omfatte oplysninger om undersøgelsens design og resultater. Det skal indeholde en beskrivelse af prøvetypen og forberedelsen, herunder matrix, analytniveauer, og hvorledes niveauerne blev fastsat. Antallet af replikater, der er blevet testet ved hver enkelt koncentration skal også oplyses sammen med en beskrivelse af den beregning, der er anvendt til fastlæggelse af testfølsomhed.
6.1.2.3.   Analytisk specificitet
I dette punkt beskrives de interferens- og krydsreaktionsundersøgelser, der foretages for at fastlægge den analytiske specificitet, når der optræder andre stoffer/agenser i prøven.
Der skal forelægges oplysninger om evaluering af stoffer eller agenser, der potentielt medfører interferens og krydsreaktioner i testen, om den undersøgte stoftype eller agenstype og dens koncentration, prøvetype, analyttestkoncentration og resultater.
Påvirkninger og stoffer eller agenser med krydsreaktioner, som varierer kraftigt alt afhængigt af testtype og -design, kan skyldes eksogene eller endogene kilder som f.eks.:
a)
stoffer, der anvendes til patientbehandling, f.eks. lægemidler
b)
stoffer indtaget af patienten, f.eks. alkohol og fødevarer
c)
stoffer, der er tilsat under prøveforberedelsen, f.eks. konserveringsmidler og stabilisatorer
d)
stoffer, der findes i specifikke prøvetyper, f.eks. hæmoglobin, fedtstoffer, bilirubin og proteiner
e)
analytter med tilsvarende struktur, f.eks. prækursorer og metabolitter, eller sygdomstilstande, der ikke er forbundet med den sygdom, der testes for, herunder prøver, der viser et negativt testresultat, men et positivt testresultat for en sygdom, der kan minde om den sygdom, der testes for.
6.1.2.4.   Metrologisk sporbarhed af kalibratorer og kontrolmaterialeværdier
6.1.2.5.   Testens måleskala
Dette punkt skal omfatte oplysninger om måleskalaen, uanset om målesystemerne er lineære eller ikkelineære, herunder detektionsgrænserne, og om, hvordan måleskalaen og detektionsgrænserne er fastlagt.
Disse oplysninger skal omfatte en beskrivelse af prøvetypen, antallet af prøver, antallet af replikater og prøveforberedelse, herunder oplysninger om matrixen, analytniveauer, og hvorledes niveauerne er fastsat. Der skal, hvis det er relevant, tilføjes en beskrivelse af eventuelle hook-effekter ved høje doser og data vedrørende afbødende foranstaltninger, f.eks. fortynding.
6.1.2.6.   Definition af testafgrænsning
Dette punkt skal indeholde et resumé af de analytiske data med en beskrivelse af undersøgelsens design, herunder metoder til fastlæggelse af testafgrænsningen, f.eks.:
a)
undersøgt population: demografi, udvælgelse, inklusions- og eksklusionskriterier, antal omfattede personer
b)
metode til karakterisering af prøver, og
c)
statistiske metoder, f.eks. ROC-kurve, til frembringelse af resultater og i givet fald definition af gråzone/tvetydighed.
6.1.3.   Rapporten om analytisk ydeevne, jf. bilag XIII
6.2.   Oplysninger om klinisk ydeevne og klinisk dokumentation. Rapport om ydeevneevaluering
Dokumentationen skal omfatte rapporten om ydeevneevaluering, der omfatter rapporterne om den videnskabelige validitet og den analytiske og kliniske ydeevne, jf. bilag XIII, samt en vurdering af disse rapporter.
Dokumenterne om undersøgelse af klinisk ydeevne, jf. bilag XIII, del A, punkt 2, skal vedlægges og/eller gengives i sin fulde ordlyd i den tekniske dokumentation.
6.3.   Stabilitet (eksklusive prøvestabilitet)
Den angivne holdbarhed, stabilitet i brug og undersøgelser vedrørende stabilitet under forsendelse skal beskrives i dette punkt.
6.3.1.   Angivet holdbarhed
I dette punkt skal der gives oplysninger om undersøgelser af stabilitetstestning til støtte for den holdbarhed, der er angivet for udstyret. Testningen skal udføres på mindst tre forskellige partier, der er fremstillet under betingelser, som i al væsentlighed svarer til de normale produktionsbetingelser. Der behøver ikke at være tale om tre partier fremstillet i fortløbende rækkefølge. Fremskyndede undersøgelser eller ekstrapolerede data fra realtidsdata accepteres for de første angivelser af holdbarhed, men skal følges op med stabilitetsundersøgelser i realtid.
Disse detaljerede oplysninger skal omfatte:
a)
undersøgelsesrapporten, herunder plan, antal partier, acceptkriterier og testintervaller
b)
hvis der er foretaget fremskyndede undersøgelser forud for undersøgelser i realtid, skal den metode, der er anvendt ved de fremskyndede undersøgelser, være beskrevet
c)
konklusioner og angivet holdbarhed.
6.3.2.   Stabilitet i brug
Dette punkt skal indeholde oplysninger om undersøgelser af stabiliteten i brug for et parti, der afspejler den almindelige brug af udstyret, uanset om den er virkelig eller simuleret. Dette kan omfatte stabilitet i åben beholder og/eller »on board stability« for automatiske instrumenter.
I tilfælde af automatisk instrumentering, hvor der er påstand om kalibreringsstabilitet, skal der forelægges baggrundsdata.
Disse detaljerede oplysninger skal omfatte:
a)
undersøgelsesrapporten (herunder plan, acceptkriterier og testintervaller)
b)
konklusioner og angivet stabilitet i brug.
6.3.3.   Stabilitet under forsendelse
Dette punkt skal omfatte oplysninger om undersøgelser af stabiliteten under forsendelse for et parti udstyr med henblik på evaluering af udstyrets tolerance under de forventede forsendelsesforhold.
Forsendelsesundersøgelserne kan foretages under virkelige og/eller simulerede forhold og skal omfatte forskellige forsendelsesforhold som f.eks. ekstrem varme og/eller kulde.
Disse oplysninger skal omfatte:
a)
undersøgelsesrapporten (herunder plan og acceptkriterier)
b)
den metode, der er anvendt til simulerede forhold
c)
konklusion og anbefalede forsendelsesforhold.
6.4.   Softwareverifikation og -validering
Dokumentation skal omfatte dokumentation for validering af softwaren, som den anvendes i det færdige udstyr. Sådanne oplysninger skal typisk omfatte et sammendrag af resultaterne af al verifikation, validering og testning, der er gennemført internt og eventuelt hos den faktiske bruger inden den endelige frigivelse. De skal også omfatte alle de forskellige hardwarekonfigurationer og i givet fald styresystemer angivet på mærkningen.
6.5.   Yderligere oplysninger, der kræves i særlige tilfælde
a)
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
b)
for udstyr, der indeholder væv, celler og stoffer af animalsk, human eller mikrobiel oprindelse, oplysninger om oprindelsen og om de vilkår, hvorunder disse materialer er indsamlet
c)
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
d)
hvis udstyret skal tilsluttes andet udstyr for at kunne fungere efter hensigten, en beskrivelse af den deraf følgende kombination, herunder dokumentation for, at det opfylder de generelle krav til sikkerhed og ydeevne i bilag I, når det er tilsluttet sådant udstyr, under hensyntagen til de karakteristika, der er anført af fabrikanten.
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 78-81, fremlægges på en tydelig, organiseret og utvetydig måde, som er let at søge i, og skal navnlig indeholde elementerne i dette bilag.
1.   Planen for overvågning, efter at udstyret er bragt i omsætning, udarbejdet i overensstemmelse med artikel 79
Fabrikanten skal i en plan for overvågning, efter at udstyret er bragt i omsætning, dokumentere, at den opfylder den i artikel 78 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 skal 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 markedsrelateret erfaring på området
—
metoder og protokoller til at behandle hændelser omfattet af indberetningen af tendenser, jf. artikel 83, 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 78, 79 og 81
—
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 PMPF-plan, jf. bilag XIII, del B, eller en begrundelse for, hvorfor PMPF ikke er relevant.
2.   Den periodiske opdaterede sikkerhedsindberetning, jf. artikel 81, og rapporten om overvågning, efter at udstyret er bragt i omsætning, jf. artikel 80.
BILAG IV
EU-OVERENSSTEMMELSESERKLÆRING
EU-overensstemmelseserklæringen skal indeholde følgende oplysninger:
1.
navn, registreret firmanavn eller registreret varemærke og SRN, hvis det allerede er udstedt, jf. artikel 28, for fabrikanten 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 handelsnavn 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, som er anvendt, og som der erklæres overensstemmelse med
8.
hvis det er relevant, navn og identifikationsnummer på det bemyndigede organ, 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, og en angivelse af, for og på hvis vegne vedkommende har underskrevet, samt 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 26, STK. 3, OG ARTIKEL 28, CENTRALE DATAELEMENTER, DER SAMMEN MED UDI-DI SKAL INDSENDES TIL UDI-DATABASEN, JF. ARTIKEL 25 og 26, OG UDI-SYSTEMET
DEL A
OPLYSNINGER, DER SKAL INDSENDES VED REGISTRERING AF UDSTYR OG ERHVERVSDRIVENDE, JF. ARTIKEL 26, STK. 3, OG ARTIKEL 28
Fabrikanter eller eventuelle autoriserede repræsentanter og eventuelle importører skal forelægge de oplysninger, der er omhandlet i punkt 1, og 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 link 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 B, C eller D: de medlemsstater, hvor udstyret er blevet gjort tilgængeligt eller skal gøres tilgængeligt
2.5.
tilstedeværelse af væv eller celler af human oprindelse eller derivater heraf (ja/nej)
2.6.
tilstedeværelse af væv eller celler af animalsk oprindelse eller derivater heraf, jf. forordning (EU) nr. 722/2012 (ja/nej)
2.7.
tilstedeværelse af celler eller stoffer af mikrobiel oprindelse (ja/nej)
2.8.
udstyrets risikoklasse
2.9.
hvis det er relevant, det individuelle identifikationsnummer for undersøgelsen af ydeevne
2.10.
for udstyr, der er designet og fremstillet af en anden fysisk eller juridisk person, jf. artikel 10, stk. 14, navn, adresse og kontaktoplysninger på den pågældende fysiske eller juridiske person
2.11.
for udstyr i klasse C eller D, sammenfatning af sikkerhed og ydeevne
2.12.
udstyrets status (på markedet, ikke længere i omsætning, trukket tilbage, sikkerhedsrelateret korrigerende handling iværksat)
2.13.
anførsel af, om udstyret er »nyt«.
Udstyr anses for at være »nyt«,
a)
hvis det ikke permanent har været til rådighed på EU-markedet for den relevante analyt eller en anden parameter i de forudgående tre år
b)
hvis proceduren omfatter analytisk teknologi, som ikke kontinuerligt er blevet anvendt i forbindelse med en given analyt eller en anden parameter på EU-markedet i de foregående tre år
2.14.
anførsel af, om udstyret er beregnet til selvtestning eller patientnær testning.
DEL B
CENTRALE DATAELEMENTER, DER SAMMEN MED UDI-DI SKAL INDSENDES TIL UDI-DATABASEN, JF. ARTIKEL 25 OG 26
Fabrikanten skal indsende UDI-DI og følgende oplysninger om fabrikanten og udstyret til UDI-databasen:
1.
mængde pr. emballagekonfiguration
2.
den grundlæggende UDI-DI, jf. artikel 24, stk. 6, 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 brugsenhed (hvis der ikke er en UDI-mærkning på udstyrets brugsenhed, skal brugsenheden tildeles en UDI-DI for at knytte brugen af udstyret til en patient)
5.
fabrikantens navn og adresse som anført på mærkningen
6.
SRN udstedt i overensstemmelse med artikel 28, stk. 2
7.
hvis det er relevant, den autoriserede repræsentants navn og adresse som anført på mærkningen
8.
nomenklaturkoden for medicinsk udstyr, jf. artikel 23
9.
udstyrets risikoklasse
10.
hvis det er relevant, navn eller handelsnavn
11.
hvis det er relevant, udstyrsmodel, reference eller katalognummer
12.
yderligere produktbeskrivelse (valgfrit)
13.
hvis det er relevant, betingelser vedrørende opbevaring og/eller håndtering som angivet på mærkningen eller i brugsanvisningen
14.
hvis det er relevant, yderligere handelsnavne for udstyret
15.
hvorvidt det er mærket som engangsudstyr (ja/nej)
16.
i givet fald, det maksimale antal genanvendelser
17.
udstyr mærket som sterilt (ja/nej)
18.
behov for sterilisering inden anvendelse (ja/nej)
19.
URL for yderligere oplysninger, f.eks. brugsanvisning i elektronisk form (valgfrit)
20.
hvis det er relevant, vigtige advarsler og kontraindikationer
21.
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 et udstyr 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.
Konfiguration
Konfiguration er en kombination af udstyrsdele, som angivet af fabrikanten, der fungerer sammen som udstyr for at opnå et erklærede formål. Kombinationen af dele kan ændres, justeres eller tilpasses for at opfylde specifikke behov.
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.
Produktionsidentifikationskode (UDI-PI)
UDI-PI er en numerisk eller alfanumerisk kode, der identificerer enheden af udstyrets produktion.
De forskellige typer af UDI-PI omfatter serienummer, lotnummer, softwareidentifikation og/eller 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 24, 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.   Fragtbeholdere er fritaget fra kravet i punkt 3.1. For eksempel kræves der ikke en UDI på en logistikenhed; hvis en sundhedstjenesteyder bestiller flere stykker udstyr ved hjælp af det enkelte udstyrs UDI eller modelnummer, og fabrikanten anbringer det pågældende udstyr i en beholdere 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.   Prøvesæt skal tildeles og være forsynet med deres egen UDI.
3.8.   Fabrikanten skal tildele en UDI 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.
3.10.   Fabrikanter, der omemballerer 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 og på alle højere udstyrsemballageniveauer. Højere niveauer omfatter ikke fragtbeholdere.
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 A og B, 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 indeholdende flere emballager. Når sundhedstjenesteyderen, f.eks. i hjemmeplejemiljøer, imidlertid ikke forventes at have adgang til det højere udstyrsemballageniveau skal UDI'en anbringes på emballagen.
4.4.   For så vidt angår udstyr, der udelukkende er beregnet til detailsalgssteder, kræves det ikke, at UDI-PI'er 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 anvendelse 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 dette 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 desinfektion, sterilisering eller genopbygning mellem patientanvendelser, skal være permanent og læsbar efter hver gennemført proces, således at udstyret er klart til efterfølgende anvendelse i hele udstyrets tilsigtede levetid.
4.11.   UDI-bæreren skal være læsbar ved normal anvendelse og i hele udstyrets forventede levetid.
4.12.   Hvis UDI-bæreren er umiddelbart læsbar eller kan scannes gennem udstyrets emballage, kræves det ikke, at UDI-bæreren anbringes på emballagen.
4.13.   Med hensyn til et enkelt færdigt udstyr, der består af flere dele, som skal samles inden 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 for anvendelse af udstyret, eller andre data.
5.   Generelle principper for UDI-databasen
5.1.   UDI-databasen skal understøtte anvendelsen af alle centrale dataelementer i UDI-databasen, jf. dette bilags del B.
5.2.   Fabrikanter er ansvarlige for den første indsendelse af identificerende oplysninger og andre udstyrsdataelementer til UDI-databasen og for opdateringer heraf.
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.   Tilstedeværelse 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 dataindsendelse og -opdatering skal, hvor det er muligt, anvendes i forbindelse med UDI-databasen.
5.10.   UDI-databasens brugergrænseflade skal være tilgængelig på alle officielle EU-sprog. Anvendelse af fritekstfelter skal dog minimeres for at begrænse oversættelsesbehovet.
5.11.   Data vedrørende udstyr, der ikke længere er tilgængeligt på markedet, skal bibeholdes i UDI-databasen.
6.   Regler for specifikke udstyrstyper
6.1.   Genanvendeligt udstyr, der indgår i prøvesæt, og som kræver rengøring, desinfektion, sterilisering eller genopbygning mellem patientanvendelser
6.1.1.   Sådant udstyrs UDI skal anbringes på udstyret og være læsbar efter hver behandling, således at udstyret er klart til næste anvendelse.
6.1.2.   UDI-PI-karakteristika, f.eks. parti- eller serienummer, skal fastlægges af fabrikanten.
6.2.   Software til udstyr
6.2.1.   UDI-tildelingskriterier
UDI skal tildeles på softwarens 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.
6.2.2.   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.
6.2.3.   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.
6.2.4.   Kriterier for UDI'ens placering i forbindelse med software
a)
Når softwaren leveres på et fysisk medium, f.eks. på en 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)
Kun den menneskeligt læsbare del af UDI'en kræves 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. Denne 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 ydeevne og til resultaterne af de overensstemmelsesvurderingsaktiviteter, som det udfører.
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 ydeevne 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:
a)
tilvejebringelse af tilstrækkelige ressourcer til overensstemmelsesvurderingsaktiviteter
b)
udvikling af procedurer og politikker for driften af det bemyndigede organ
c)
tilsyn med det bemyndigede organs gennemførelse af procedurer, politikker og kvalitetsstyringssystemer
d)
tilsyn med det bemyndigede organs finanser
e)
aktiviteter og beslutninger, som det bemyndigede organ træffer, herunder kontraktmæssige aftaler
f)
fordelingen af beføjelser til personale og/eller udvalg, hvis det er relevant, med henblik på at udføre bestemte aktiviteter
g)
interaktion med myndigheden med ansvar for bemyndigede organer og forpligtelserne vedrørende kommunikation med andre kompetente myndigheder, Kommissionen og andre bemyndigede organer.
1.2.   Uafhængighed og upartiskhed
1.2.1.   Det bemyndigede organ skal være et tredjepartsorgan, der er uafhængigt af fabrikanten af det udstyr, i forbindelse med hvilket det udfører overensstemmelsesvurderingsaktiviteter. Det bemyndigede organer skal ligeledes være uafhængigt af andre erhvervsdrivende, der har interesse i dette udstyr, såvel som alle konkurrenter til fabrikanten. Dette forhindrer ikke, at et bemyndiget 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 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 dets personale og i alle dets vurderingsaktiviteter. Sådanne procedurer skal give mulighed for 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 og resultatet og dets løsning skal dokumenteres.
1.2.3.   Det bemyndigede organ, dets øverste ledelse og det personale, der er ansvarligt for at foretage overensstemmelsesvurderinger, må ikke:
a)
være designer, fabrikant, leverandør, montør, køber, ejer eller reparatør af 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 overensstemmelsesvurderinger, 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, upartiskhed 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 yder konsulenttjenester som omhandlet i litra d). En sådan restriktion forhindrer ikke generelle uddannelsesaktiviteter, der ikke er kundespecifikke, og som vedrører regler for udstyr eller relaterede 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 en bestemt kunde eller ydede konsulenttjenester på udstyrsområdet til denne bestemte kunde forud for ansættelse hos et bemyndiget organ, må ikke tildeles overensstemmelsesvurderingsopgaver for denne bestemte kunde eller virksomheder, der hører til 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 vurderinger. Bemyndigede organer skal offentliggøre den øverste ledelses interesseerklæringer.
1.2.6.   Hvis et bemyndiget organ er ejet af en offentlig enhed eller institution, sikres og dokumenteres det, at det er uafhængigt, og at der ikke er interessekonflikter mellem myndigheden 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 uafhængigheden, uvildigheden og 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 interesserne 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 anmoder om overensstemmelsesvurdering.
1.3.   Tavshedspligt
1.3.1.   Det bemyndigede organ skal have indført dokumenterede procedurer, der sikrer, at dets personale, udvalg, dattervirksomheder, underentreprenører og eventuelle tilknyttede organer eller personalet i eksterne organer behandler de oplysninger, som de 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 myndighederne med ansvar for de bemyndigede organer, de kompetente myndigheder for 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 deres overensstemmelsesvurdering.
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 til at udføre dets overensstemmelsesvurderingsaktiviteter inden for det område, som udpegelsen omfatter, og dertil knyttede forretningsaktiviteter. Det skal dokumentere og forelægge oplysninger om dets finansielle kapacitet og dets økonomiske levedygtighed på lang sigt, idet der tages hensyn til eventuelle 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 er orienteret om relevante standardiseringsaktiviteter og i aktiviteterne i den i artikel 49 i forordning (EU) 2017/745 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, gennemføre, 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:
a)
struktur af styringssystemet og dokumentation, herunder politikker og mål for dets aktiviteter
b)
politikker for opgave- og ansvarsfordeling blandt personalet
c)
vurderings- og beslutningsprocesser i overensstemmelse med de opgaver, ansvarsområder og funktioner, som det bemyndigede organs personale og den øverste ledelse varetager
d)
planlægning, udførelse, evaluering og om nødvendigt tilpasning af dets overensstemmelsesvurderingsprocedurer
e)
kontrol af dokumenter
f)
kontrol af registre
g)
gennemgang af ledelsesforhold
h)
intern revision
i)
korrigerende og forebyggende handlinger
j)
klager og appeller
k)
løbende efter- og videreuddannelse.
Hvis 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 fastlægges af det bemyndigede organ. Denne forpligtelse omhandler 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 nødvendige personale og råde over eller have adgang til alt udstyr, alle faciliteter og al kompetence, som der er behov for til 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, til stadighed har tilstrækkeligt administrativt, teknisk og videnskabeligt personale med erfaring og viden vedrørende det pågældende udstyr og de tilhørende teknologier til rådighed. Dette personale skal være tilstrækkelig stort til at sikre, at det pågældende bemyndigede organ kan udføre de overensstemmelsesvurderingsopgaver, herunder vurdering af medicinsk funktion, evalueringer af ydeevne samt ydeevne og sikkerhed for udstyr, 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 overensstemmelses-vurderingsaktiviteter 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 grund- og videreuddannelse og til tildeling af dets pligter og til at føre tilsyn med dette personale for at sikre, at personale, der foretager 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 begrænsninger for opgaver og ansvarsområder og det godkendelsesniveau, som det personale, herunder alle underentreprenører og eksterne eksperter, der deltager i overensstemmelsesvurderingsaktiviteter, 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, f.eks. audit, produktevaluering eller -testning, kontrol af teknisk dokumentation, beslutningstagning og batchfrigivelse, samt det udstyr, de teknologier og de områder, f.eks. bioforligelighed, sterilisering, selvtestning og patientnær testning, ledsagende diagnosticering og ydeevneevaluering, som er omfattet af rammerne for udpegelsen.
3.2.2.   De kvalifikationskriterier, der er nævnt i punkt 3.2.1, skal henvise til rammerne for det bemyndigede organs udpegelse i overensstemmelse med den beskrivelse heraf, som medlemsstaten bruger i forbindelse med den notifikation, der er omhandlet i artikel 38, stk. 3; de skal 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:
—
biologisk sikkerhed
—
ydeevneevaluering
—
udstyr til selvtestning og patientnær testning
—
ledsagende diagnosticering
—
funktionel sikkerhed
—
software
—
emballage
—
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 vejledninger
—
overensstemmelsesvurderingsprocedurerne fastlagt i denne forordning
—
en bred viden om 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.   Det bemyndigede organ 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 ydeevneevalueringen, 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 følgerne af deres vurdering og rådgivning
—
kunne gennemgå og på et videnskabeligt grundlag anfægte de kliniske data, der er indeholdt i ydeevneevalueringen og eventuelle tilknyttede undersøgelser af ydeevne, og på passende vis vejlede eksterne kliniske eksperter i vurderingen af den ydeevneevaluering, som fabrikanten har forelagt
—
kunne evaluere på et videnskabeligt grundlag og om nødvendigt anfægte den forelagte ydeevneevaluering og resultaterne af de eksterne kliniske eksperters vurdering af fabrikantens ydeevneevaluering
—
kunne sikre sammenlignelighed af og konsistens i de vurderinger af evalueringer af ydeevne, der foretages af kliniske eksperter
—
kunne foretage en vurdering af fabrikantens ydeevneevaluering 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 produktrelateret kontrol (produktkontrollanterne), f.eks. kontrol af den tekniske dokumentation eller typeafprøvning, herunder aspekter såsom ydeevneevaluering, biologisk sikkerhed, sterilisering og softwarevalidering, skal have alle følgende dokumenterede kvalifikationer:
—
en afsluttet uddannelse fra et universitet eller en faghøjskole eller en tilsvarende kvalifikation inden for et relevant fag, såsom medicin, farmaci, ingeniørvidenskab eller andre relevante videnskaber
—
fire års erhvervserfaring på området sundhedsprodukter eller relaterede aktiviteter, f.eks. fremstilling, audit eller forskning, hvoraf de to år skal være inden for design, fremstilling, afprøvning eller brug af det udstyr eller den teknologi, der skal vurderes, eller vedrøre de videnskabelige aspekter, der skal vurderes
—
kendskab til lovgivningen 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 i forbindelse med udstyr, herunder relevante standarder og retningslinjer
—
tilstrækkeligt kendskab til og erfaring med ydeevneevaluering
—
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 bemyndigelse til at foretage 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, f.eks. medicin, farmaci, ingeniørvidenskab eller andre relevante videnskaber
—
fire års erhvervserfaring på området for sundhedsprodukter eller relaterede aktiviteter, f.eks. 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 for udstyr 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 bemyndigelse til at udføre disse audit
—
uddannelse i auditmetoder, som giver det mulighed for at anfægte kvalitetsstyringssystemer
—
den nødvendige færdighed i at udarbejde 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 certificering, skal være ansat af det bemyndigede organ selv og må ikke være eksterne eksperter eller underentreprenør. 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 overensstemmelsesvurdering af udstyr
—
en bred viden om 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 krævede 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 opfyldelse af de kvalifikationskriterier, der er fastsat i punkt 3.2, ikke fuldt ud kan dokumenteres, skal det bemyndigede organ over for myndigheden med ansvar for bemyndigede organer begrunde, at disse medarbejdere er godkendt til at udføre specifikke overensstemmelsesvurderingsaktiviteter.
3.3.2.   For alt 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
—
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.
Underentreprise i forbindelse med audit af kvalitetsstyringssystemer eller af produktrelateret kontrol som helhed er ikke tilladt, men dele af disse aktiviteter kan udføres af underentreprenører og eksterne auditorer og eksperter, der arbejder på vegne af det bemyndigede organ. Det pågældende bemyndigede organ skal bevare 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 kvalifikationer og tilsyn med eksterne eksperters indsats
—
audit- og certificeringsaktiviteter, hvor den pågældende underentreprise er til audit- eller certificeringsorganisationer
—
tildeling af arbejde til eksterne eksperter i forbindelse med specifikke overensstemmelsesvurderingsaktiviteter
—
endelig evaluering og beslutningstagningsfunktioner.
3.4.2.   Hvis et bemyndiget organ overdrager bestemte overensstemmelsesvurderingsaktiviteter enten til en organisation eller en 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
—
den fysiske eller juridiske person, der anmodede om 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 omfatter 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 udstyr eller nye teknologier, skal det pågældende bemyndigede organ på hvert produktområde, hvortil det er udpeget, råde over interne kompetencer, der er tilstrækkelige til at lede den samlede overensstemmelsesvurdering, verificere ekspertudtalelsers 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 præstationen for 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-ret og national ret om udstyr, relevante harmoniserede standarder, fælles specifikationer, vejledningsdokumenter og resultaterne af koordineringsaktiviteterne i henhold til punkt 1.6
—
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 tilstrækkelig detaljerede procedurer for udførelse af hver overensstemmelsesvurderingsaktivitet, som det er udpeget til, herunder de enkelte trin fra aktiviteter før indsendelse af en ansøgning frem til beslutningstagning og overvågning, idet der tages hensyn til udstyrets specifikke forhold, når det er nødvendigt.
De krav, der er fastsat i punkt 4.3, 4.4, 4.7 og 4.8, skal opfyldes som led i bemyndigede organers interne aktiviteter og må ikke gives i underentreprise.
4.2.   Bemyndigede organers priser 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 reklame for dets overensstemmelsesvurderingstjenester. Disse procedurer skal sikre, at reklameaktiviteter eller salgsfremmende aktiviteter på ingen måde antyder eller kan føre til den følgeslutning, at deres overensstemmelsesvurdering giver fabrikanter 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 oplysninger før indsendelse af en ansøgning, herunder foreløbig verifikation af, om produktet er omfattet af denne forordning, og dets klassificering forud for afgivelse af et pristilbud til fabrikanten vedrørende en bestemt overensstemmelsesvurdering
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 underskrevet af en fabrikant eller en autoriseret repræsentant, der indeholder alle 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 henhold til 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 til at gennemgå ansøgninger, der vedrører:
a)
ansøgningers fuldstændighed med hensyn til kravene i den relevante overensstemmelsesvurderingsprocedure, jf. det tilsvarende bilag, efter hvilken der er søgt om godkendelse
b)
verifikation af kvalificeringen af produkter, der er omfattet af disse ansøgninger, som udstyr og deres respektive klassificering
c)
hvorvidt de overensstemmelsesvurderingsprocedurer, som ansøgeren har valgt, kan anvendes på det pågældende udstyr i henhold til denne forordning
d)
det bemyndigede organs ret til at vurdere en ansøgning på grundlag af dets udpegelse og
e)
tilstedeværelse 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 52, 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 ansvar for at sikre, at vurderingen af ansøgningen foretages 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 overensstemmelsesvurderingsaktiviteter 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 udføre 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 følgende krav:
—
hensigtsmæssigt at planlægge gennemførelsen af hvert enkelt projekt
—
at sikre, at vurderingsholdene er sammensat på en sådan måde, at der er tilstrækkelig erfaring med den pågældende teknologi, og at der hele tiden er objektivitet og uafhængighed, og sørge for at vurderingsholdenes medlemmer roterer med passende mellemrum
—
at angive et rationale for fastsættelse af frister for afslutning af overensstemmelsesvurderingsaktiviteter
—
at vurdere fabrikantens tekniske dokumentation og de løsninger, der er valgt til at opfylde kravene i bilag I
—
at gennemgå fabrikantens procedurer og dokumentation vedrørende ydeevneevalueringen
—
at se på grænsefladen mellem fabrikantens risikostyringsproces og dens vurdering og analyse af ydeevneevalueringen og evaluere deres relevans for påvisningen af overensstemmelse med de relevante krav i bilag I
—
at følge de i bilag IX, punkt 5, omhandlede specifikke procedurer
—
for så vidt angår udstyr i klasse B eller C, at vurdere den tekniske dokumentation for udstyr, der er udvalgt på et repræsentativt grundlag
—
at planlægge og regelmæssigt foretage passende overvågningsaudit og evalueringer, at udføre eller anmode om bestemte prøver for at verificere, om kvalitetsstyringssystemet fungerer korrekt, og at foretage uanmeldte audit på stedet
—
i forbindelse med udtagning af udstyrsprøver verificere, at det fremstillede udstyr er i overensstemmelse med den tekniske dokumentation; de pågældende krav skal definere de relevante prøveudtagningskriterier og den relevante prøvningsprocedure inden prøveudtagningen
—
at 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 forelagt i overensstemmelse med det relevante bilag om overensstemmelsesvurdering, og udarbejde et auditprogram, der klart fastlægger 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 forbindelser mellem og fordeling af ansvarsområder blandt de forskellige fremstillingssteder og identificere fabrikantens relevante leverandører og/eller underentreprenører og overveje behovet for specifikt at foretage audit af disse leverandører eller underentreprenører eller begge
—
for hver audit, der er fastlagt i auditprogrammet, klart definere audittens mål, kriterier og omfang og udarbejde en auditplan, der fyldestgørende omhandler og tager hensyn til de specifikke krav til det udstyr, de teknologier og de processer, der er involveret
—
for udstyr i klasse B og C udarbejde og opdatere en stikprøveplan for 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 prøver af alt udstyr, der er omfattet af certifikatet, i certifikatets gyldighedsperiode
—
udvælge og fordele behørigt kvalificeret og bemyndiget personale til at foretage 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 kvalitetskontrol og løbende overvågning, 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 og 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
—
PMPF,
—
og gennemgå og foretage audit af krav og bestemmelser vedtaget af fabrikanten, herunder krav og bestemmelser vedrørende opfyldelse af 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 hos fabrikantens leverandører, når overensstemmelsen af færdigt 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 stikprøveplan og under hensyntagen til punkt 4.5.4 for så vidt angår ydeevneevaluering
—
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, ydeevneevaluering, risikostyring og sterilisering, og
—
vurdering af designets overensstemmelse med denne forordning under hensyntagen til punkt 4.5.4 og 4.5.5. Denne 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 overensstemmelsen med kravene i denne forordning, gennemfører det pågældende bemyndigede organ passende fysiske prøvninger eller laboratorieprøvninger vedrørende udstyret eller anmoder fabrikanten om at gennemføre sådanne 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 og 4.5.5 og verificere, at den pågældende type er fremstillet i overensstemmelse med denne dokumentation
—
udarbejde en afprøvningsplan, der fastlægger alle relevante og kritiske parametre, der skal prøves af det bemyndigede organ eller på dets ansvar
—
dokumentere deres rationale for udvælgelsen af disse parametre
—
udføre de nødvendige undersøgelser og prøvninger for at verificere, om de løsninger, som fabrikanten har valgt, 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
—
tage det fulde ansvar for prøvningsresultater. De prøvningsrapporter, som fabrikanten indsender, tages kun i betragtning, hvis de er udstedt af overensstemmelsesvurderingsorganer, der er kompetente og uafhængige af fabrikanten.
Verifikation ved undersøgelse og prøvning af hver produktbatch
Det bemyndigede organ skal:
a)
have dokumenterede procedurer, tilstrækkelig ekspertise og faciliteter til verifikation ved undersøgelse og prøvning af hver produktbatch i overensstemmelse med bilag IX og XI
b)
udarbejde en afprøvningsplan, der fastlægger 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 C, 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 B, overensstemmelsen med den tekniske dokumentation, der er omhandlet i bilag II og III, samt med de krav i denne forordning, der finder anvendelse for dette udstyr
c)
dokumentere deres rationale for udvælgelsen af disse parametre, jf. 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 hver produktbatch som angivet i bilag XI, punkt 5
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
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 ydeevneevaluering
Bemyndigede organers vurdering af procedurer 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 har været afvigelser fra procedurerne, skal det pågældende bemyndigede organ kritisk gennemgå den begrundelse, som fabrikanten fremlægger.
Det bemyndigede organ skal have indført dokumenterede procedurer for vurdering af en fabrikants procedurer og dokumentation vedrørende ydeevneevaluering både for den indledende overensstemmelsesvurdering og på løbende basis. Det bemyndigede organundersøger, validerer og verificerer, at fabrikantens procedurer og dokumentation i tilstrækkelig grad omfatter:
a)
planlægningen, gennemførelsen, vurderingen, rapporteringen og opdateringen af ydeevneevaluering som omhandlet i bilag XIII
b)
overvågning, efter at udstyret er bragt i omsætning, og opfølgning af ydeevne, efter at udstyret er bragt i omsætning
c)
grænsefladen med risikostyringsprocessen
d)
vurderingen og analysen af de tilgængelige data og deres relevans med hensyn til at påvise overensstemmelse med de relevante krav i bilag I
e)
de konklusioner, der drages vedrørende den kliniske dokumentation, og udarbejdelse af rapporten om ydeevneevaluering.
De procedurer, der er nævnt i andet afsnit, skal tage hensyn til tilgængelige fælles specifikationer, vejledningsdokumenter og dokumenter om bedste praksis.
Det bemyndigede organs vurdering af ydeevneevalueringen, jf. bilag XIII, skal omfatte:
—
den tilsigtede brug, som fabrikanten har anført, og angivelser om udstyret, som denne har fastsat
—
planlægningen af ydeevneevalueringen
—
litteratursøgningsmetoden
—
relevant dokumentation fra litteratursøgningen
—
undersøgelser af ydeevne
—
overvågning, efter at udstyret er bragt i omsætning, og opfølgning af ydeevne, efter at udstyret er bragt i omsætning
—
gyldighed af ækvivalens angivet i forhold til andet udstyr, påvisning af ækvivalens, egnethed og resultatdata fra tilsvarende og lignende udstyr
—
rapporten om ydeevneevaluering
—
begrundelser for ikke at foretage undersøgelser af ydeevne eller PMPF.
Med hensyn til data fra undersøgelser af ydeevne, der indgår i ydeevneevalueringen, skal det pågældende bemyndigede organ sikre, at fabrikantens konklusioner er gyldige i lyset af den godkendte plan for undersøgelse af ydeevne.
Det bemyndigede organ skal sikre, at ydeevneevalueringen i tilstrækkelig grad dækker de relevante krav til sikkerhed og ydeevne, der er fastsat i bilag I, at den på behørig vis er i overensstemmelse med kravene om risikostyring, at den foretages i overensstemmelse med bilag XIII, og at den er korrekt afspejlet i de oplysninger, der er givet om udstyret.
4.5.5.   Specifikke procedurer
Det bemyndigede organ skal råde over dokumenterede procedurer, tilstrækkelig ekspertise og faciliteter til de procedurer, der er omhandlet i bilag IX, punkt 5, som de er udpeget til.
For så vidt angår udstyr til ledsagende diagnosticering skal det bemyndigede organhave indført dokumenterede procedurer, der sigter mod at opfylde kravene i denne forordning om høring af EMA eller en kompetent myndighed for lægemidler i forbindelse med dets vurdering af sådanne typer af udstyr.
4.6.   Indberetning
Det bemyndigede organskal:
—
sikre, at alle trin i overensstemmelsesvurderingen er dokumenteret, så vurderingens konklusioner er klare og påviser overensstemmelse med kravene i denne forordning og kan tjene som objektiv dokumentation for den pågældende 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 kvalitetsstyringssystemer
—
tydeligt dokumentere konklusionerne af dets vurdering af evaluering af ydeevne i en vurderingsrapport om ydeevneevaluering
—
for hvert specifikt projekt forelægge en detaljeret rapport, der skal være baseret på et standardformat, som omfatter et mindstemål af elementer, der bestemmes af MDCG.
Det bemyndigede organs rapport skal:
—
klart dokumentere resultatet af dets vurdering og drage klare konklusioner fra 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 hos det bemyndigede organ
—
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 vurderingen
—
verificere, at indberetningen eller indberetningerne og tilhørende dokumentation, der kræves for at kunne træffe en beslutning, herunder vedrørende afhjælpning af mangler, som 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 med hensyn til fordeling af ansvar for udstedelse, suspension, begrænsning og tilbagekaldelse af certifikater. Disse procedurer skal omfatte underretningskravene i denne forordnings kapitel V. 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 for overvågning, efter at udstyret er bragt i omsætning, herunder PMPF-planen, er fyldestgørende, på grundlag af resultaterne af dets vurdering af ydeevneevalueringen og risikostyringen
—
træffe beslutning om specifikke milepæle for det bemyndigede organs yderligere gennemgang af den opdaterede ydeevneevaluering
—
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, ydeevneevalueringen og konklusionerne fra risikoanalysen af udstyret
—
dokumentere beslutningstagning og godkendelsestrin klart, herunder godkendelse ved underskrift af det ansvarlige personale
—
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 XII 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
—
sikre, at fabrikanten underrettes om resultatet af vurderingen og den heraf følgende beslutning, og at de indlæses i det elektroniske system, der er nævnt i artikel 52.
4.9.   Ændringer
Det bemyndigede organ skal have indført dokumenterede procedurer og kontraktlige aftaler med fabrikanter vedrørende fabrikanters oplysningskrav og vurdering af ændringer af:
—
det eller de godkendte kvalitetsstyringssystemer eller det omfang af produkter, der er omfattet
—
den godkendte design af udstyr
—
den godkendte udstyrstype
—
ethvert stof, der indgår i eller benyttes til fremstilling af udstyr, og som er underlagt specifikke procedurer i overensstemmelse med punkt 4.5.5.
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 fabrikanter indsender 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
—
underrette fabrikanten om sin afgørelse og forelægge en rapport eller, hvis det er relevant, en tillægsrapport, der skal indeholde de begrundede konklusioner fra dets vurdering.
4.10.   Overvågningsaktiviteter og tilsyn efter certificering
Det bemyndigede organ skal have dokumenterede procedurer:
—
der fastlægger, hvordan og hvornår der skal udføres overvågningsaktiviteter vedrørende fabrikanter. 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 opfyldelse af eventuelle betingelser, som fabrikanter er bundet af, og som har forbindelse med 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 udstyr er bragt i omsætning, vedrørende omfanget af deres udpegelse. Disse oplysninger skal tages i betragtning i forbindelse med planlægning og udførelse af overvågningsaktiviteter
—
med henblik på at gennemgå sikkerhedsovervågningsoplysninger, som de har adgang til i henhold til artikel 87, 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 træffe foranstaltninger på det grundlag, at sikkerhedsovervågningssagen klart ikke er knyttet til den tildelte certificering
—
observere fabrikantens og de kompetente myndigheders aktiviteter og resultaterne af fabrikantens undersøgelse med henblik på at afgøre, om den tildelte certificeringer i fare, eller om passende korrigerende handlinger er foretaget
—
gennemføre ekstraordinære overvågningsforanstaltninger, f.eks. dokumentgennemgang, audit med kort varsel eller uanmeldte audit og produktprøvning, såfremt det er sandsynligt, at den tildelte certificeringer i fare
—
forøge hyppigheden af overvågningsaudit
—
gennemgå specifikke produkter eller processer i forbindelse med den næste audit af fabrikanten eller
—
træffe alle andre relevante foranstaltninger.
I forbindelse med overvågningsaudit af fabrikanter skal det bemyndigede organ have dokumenterede procedurer til at:
—
foretage overvågningsaudit af fabrikanten mindst en gang om året, hvilket planlægges og foretages i overensstemmelse med de relevante krav i punkt 4.5
—
sikre, at den foretager en tilstrækkelig vurdering af fabrikantens dokumentation om og anvendelse af bestemmelserne om sikkerhedsovervågning, overvågning, efter at udstyret er bragt i omsætning, og PMPF
—
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 dens procedurer tager hensyn til bedste praksis i forbindelse med gennemførelse af kvalitetsstyringssystemer
—
sikre, at fabrikanten ikke bruger godkendelser af kvalitetsstyringssystemer eller udstyr på en vildledende måde
—
indhente tilstrækkelige oplysninger til at fastslå, om kvalitetsstyringssystemet fortsat opfylder kravene i denne forordning
—
anmode den pågældende fabrikant om at foretage korrektioner, korrigerende handlinger og, hvis det er relevant, forebyggende foranstaltninger ved opdagelse af mangler, og
—
hvis det er nødvendigt, pålægge 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 evaluering af ydeevne, der senest er opdateret af fabrikanten, på grundlag af fabrikantens overvågning, efter at udstyret er bragt i omsætning, på grundlag af dens PMPF 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
—
sikre, at den ydeevneevaluering, 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 gennemgang 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 indsender en sammenfatning af 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 opfyldelse af de generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I
e)
erfaringer fra gennemgange af ydeevneevaluering, herunder resultaterne af eventuelle undersøgelser af ydeevne og PMPF
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 undersøgelser af ydeevne 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 overvågning, efter at udstyret er bragt i omsætning, og PMPF-aktiviteter siden den foregående certificering eller fornyede certificering, herunder passende opdateringer af fabrikanters rapporter af ydeevneevaluering.
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 skal gennemgås med henblik på certificering, såsom ansøgning og ansøgningsgennemgang.
BILAG VIII
KLASSIFICERINGSREGLER
1.   GENNEMFØRELSESREGLER
1.1.   Klassificeringsreglernes anvendelse er afhængig af udstyrs erklærede formål.
1.2.   Hvis det pågældende udstyr er bestemt til at skulle anvendes sammen med andet udstyr, gælder klassificeringsreglerne særskilt for hvert udstyr.
1.3.   Tilbehør til medicinsk udstyr til in vitro-diagnostik klassificeres selvstændigt og adskilt fra det udstyr, sammen med hvilket det anvendes.
1.4.   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.
1.5.   Kalibratorer, der er beregnet til brug sammen med et udstyr, klassificeres i samme klasse som udstyret.
1.6.   Kontrolmaterialer med kvantitative eller kvalitative fastsatte værdier, der er beregnet til brug med en specifik analyt eller en række analytter, klassificeres i samme klasse som udstyret.
1.7.   For at kunne foretage en korrekt klassificering af udstyr skal en fabrikant tage hensyn til alle klassificering- og implementeringsregler.
1.8.   Hvis en fabrikant angiver, at et udstyr har flere erklærede formål, og udstyret som følge heraf henhører under mere end én klasse, skal det klassificeres i den højeste klasse.
1.9.   Hvis flere klassificeringsregler finder anvendelse på samme udstyr, finder reglen om placering i den højeste klasse anvendelse.
1.10.   Hver klassificeringsregel finder anvendelse på indledende test, konfirmatoriske test og supplerende test.
2.   KLASSIFICERINGSREGLER
2.1.   Regel 1
Udstyr, der skal anvendes til følgende formål klassificeres i klasse D:
—
påvisning af tilstedeværelse af eller eksponering for overførbare agenser i blod, blodkomponenter, celler, væv eller organer eller i derivater heraf for at vurdere deres egnethed til transfusion, transplantation eller indgift af celler
—
påvisning af tilstedeværelse af eller eksponering for overførbare agenser, som forårsager livstruende sygdomme med en høj eller formodet høj risiko for spredning
—
fastlæggelse af en smittefarlig koncentration af en livstruende sygdom, hvis monitorering er afgørende for patientbehandlingsprocessen.
2.2.   Regel 2
Udstyr, der skal anvendes til blodtypebestemmelse eller vævstypebestemmelse for at sikre immunologisk kompatibilitet af blod, blodkomponenter, celler, væv eller organer, der skal anvendes til transfusion eller transplantation eller indgift af celler, klassificeres i klasse C, medmindre det skal anvendes til bestemmelse af en eller flere af følgende markører:
—
AB0-systemet [A (AB01), B (AB02), AB (AB03)]
—
rhesussystemet [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]
—
Kellsystemet [Kel1 (K)]
—
Kiddsystemet [JK1 (Jka), JK2 (Jkb)]
—
Duffysystemet [FY1 (Fya), FY2 (Fyb)],
idet de i så fald klassificeres i klasse D.
2.3.   Regel 3
Udstyr klassificeres i klasse C, hvis det er beregnet til:
a)
påvisning af tilstedeværelse af eller eksponering for en seksuelt overført agens
b)
påvisning af tilstedeværelse af et smitstof uden en høj eller formodet høj risiko for spredning i cerebrospinalvæske eller blod
c)
påvisning af tilstedeværelse af et smitstof, hvis der en betydelig risiko for, at et fejlagtigt resultat vil medføre død eller alvorligt handicap for den person eller det foster eller det embryon, der testes, eller for den pågældende persons afkom
d)
prænatal screening af kvinder for at fastslå deres immunstatus vedrørende overførbare agenser
e)
fastlæggelse af status for en smitsom sygdom eller immunstatus, hvis der er risiko for, at et fejlagtigt resultat vil føre til en patientbehandlingsbeslutning, der medfører en livstruende situation for patienten eller for patientens afkom
f)
at blive anvendt til ledsagende diagnosticering
g)
at blive anvendt til evaluering af en sygdoms stadium, hvis der er risiko for, at et fejlagtigt resultat vil føre til en patientbehandlingsbeslutning, der medfører en livstruende situation for patienten eller for patientens afkom
h)
at blive anvendt til screening, diagnosticering eller stadieinddeling af cancer
i)
genetisk testning på mennesker
j)
monitorering af mængden af lægemidler, stoffer eller biologiske komponenter, hvis der er risiko for, at et fejlagtigt resultat vil føre til en patientbehandlingsbeslutning, der medfører en livstruende situation for patienten eller for patientens afkom
k)
behandling af patienter, der lider af en livstruende sygdom eller tilstand
l)
screening for medfødte lidelser i et embryon eller foster
m)
screening for medfødte lidelser hos nyfødte, hvor manglende påvisning og behandling af sådanne lidelser kan føre til livstruende situationer eller alvorlige handicap.
2.4.   Regel 4
a)
Udstyr, der skal anvendes til selvtestning, klassificeres i klasse C, bortset fra udstyr til påvisning af graviditet, fertilitetstest og bestemmelse af kolesterolindhold, og udstyr til påvisning af glukose, erytrocytter, leukocytter og bakterier i urin, der klassificeres i klasse B.
b)
Udstyr, der skal anvendes til patientnær testning, klassificeres selvstændigt.
2.5.   Regel 5
Følgende udstyr klassificeres i klasse A:
a)
produkter til almindelig laboratoriebrug, tilbehør, som ikke indeholder nogen kritiske karakteristika, bufferopløsninger, vaskeopløsninger og generelle vækstmedier og histologiske farvninger, som ifølge fabrikanten er bestemt til at gøre det egnet til procedurer for in vitro-diagnostik i forbindelse med en specifik undersøgelse
b)
instrumenter, som ifølge fabrikanten er bestemt til specifikt at blive anvendt til procedurer for in vitro-diagnostik
c)
prøvebeholdere.
2.6.   Regel 6
Udstyr, som ikke er omfattet af ovennævnte klassificeringsregler, klassificeres i klasse B.
2.7.   Regel 7
Udstyr, som er kontroludstyr uden kvantitative eller kvalitative fastsatte værdier, klassificeres i klasse B.
BILAG IX
OVERENSSTEMMELSESVURDERING BASERET PÅ ET KVALITETSSTYRINGSSYSTEM OG PÅ VURDERING AF TEKNISK DOKUMENTATION
KAPITEL I
KVALITETSSTYRINGSSYSTEM
1.   Fabrikanten skal etablere, dokumentere og gennemføre et kvalitetsstyringssystem som beskrevet i artikel 10, stk. 8, 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 overvågning, 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:
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fabrikantens navn 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
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alle relevante oplysninger om det udstyr eller den gruppe af udstyr, som kvalitetsstyringssystemet vedrører
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en skriftlig erklæring om, at der ikke er indsendt en ansøgning vedrørende samme udstyrsrelaterede kvalitetssikringssystem til et andet bemyndiget organ, eller oplysninger om en eventuel tidligere ansøgning vedrørende samme udstyrsrelaterede kvalitetsstyringssystem
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et udkast til EU-overensstemmelseserklæring, jf. artikel 17 og bilag IV, for den udstyrsmodel, der er omfattet af overensstemmelsesvurderingsproceduren
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dokumentation vedrørende fabrikantens kvalitetsstyringssystem
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en dokumenteret beskrivelse af de procedurer, der er indført for at opfylde de forpligtelser, der er forbundet med kvalitetsstyringssystemet, og som kræves i henhold til denne forordning, og et tilsagn fra den pågældende fabrikant om at anvende disse procedurer
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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
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dokumentation vedrørende fabrikantens system til overvågning, efter udstyr er bragt i omsætning, og, hvor det er relevant, vedrørende PMPF-planen og de procedurer, der er indført for at sikre opfyldelse af de forpligtelser, der følger af sikkerhedsovervågningsbestemmelserne i artikel 82-87
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en beskrivelse af de procedurer, der er indført for at opdatere systemet til overvågning, efter udstyr er bragt i omsætning, og, hvis det er relevant, PMPF-planen, og de procedurer, der skal sikre opfyldelse af de forpligtelser, der følger af sikkerhedsovervågningsbestemmelserne, der er fastsat i artikel 82-87, samt et tilsagn fra fabrikanten om at anvende disse procedurer
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dokumentation om planen for ydeevneevaluering og
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en beskrivelse af de procedurer, der er indført for at opdatere planen for ydeevneevaluering 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 forelægges til vurdering af kvalitetsstyringssystemet, indeholde en fyldestgørende beskrivelse af navnlig:
a)
fabrikantens kvalitetsmålsætninger
b)
virksomhedens opbygning, herunder:
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organisationsstrukturer med fordeling af personaleansvar i forbindelse med kritiske procedurer og ledelsens ansvarsområder og dens organisationsmæssige beføjelser
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metoder til monitorering af, om kvalitetsstyringssystemet fungerer effektivt, og navnlig om systemet er egnet til at opnå den ønskede design- og udstyrskvalitet, herunder kontrol af udstyr, som ikke er i overensstemmelse med kravene
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metoder til monitorering af, at kvalitetsstyringssystemet fungerer effektivt, hvis designet, fremstillingen og/eller den endelige verifikation og testning af udstyr eller dele af enhver af disse processer udføres af en anden part, og navnlig typen og omfanget af kontrol, der føres med den anden part
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hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, et udkast til fuldmagt vedrørende udpegelse af en autoriseret repræsentant og en erklæring fra den autoriserede repræsentant om, at denne har til hensigt at acceptere fuldmagten
c)
procedurer og teknikker til monitorering, verifikation, validering og kontrol af udstyrs design samt dokumentation, data og registreringer i forbindelse med disse procedurer og teknikker. Disse procedurer og teknikker skal nærmere bestemt omfatte:
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en strategi for overholdelse af reguleringen, herunder processer til identifikation af relevante lovkrav, kvalifikationer, klassificering, håndtering af ækvivalens samt valg og overholdelse af overensstemmelsesvurderingsprocedurer
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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 løsninger
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risikostyring, jf. bilag I, punkt 3
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ydeevneevaluering i henhold til artikel 56 og bilag XIII, herunder PMPF
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løsninger til opfyldelse af gældende specifikke krav til design og konstruktion, herunder passende præklinisk evaluering, navnlig kravene i bilag I, kapitel II
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løsninger til opfyldelse af gældende specifikke krav til oplysninger, der skal gives sammen med udstyr, navnlig kravene i bilag I, kapitel III
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procedurer for identifikation af udstyr, der udarbejdes og opdateres på grundlag af tegninger, specifikationer eller andre relevante dokumenter i alle fremstillingsfaser, og
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styring af designændringer eller ændringer af kvalitetsstyringssystemet
d)
teknikker til 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 passende sporbarhed.
Endvidere skal fabrikanter give bemyndigede organer adgang til den tekniske dokumentation, der er omhandlet i bilag II og III.
2.3.   Audit
Det bemyndigede organ skal foretage 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 med erfaring fra vurderinger af den pågældende teknologi i overensstemmelse med bilag VII, punkt 4.3-4.5. I tilfælde, hvor en sådan erfaring ikke umiddelbart kan konstateres eller ikke forekommer, skal det bemyndigede organ give et dokumenteret rationale for sammensætningen af det pågældende hold. Auditproceduren skal omfatte audit hos fabrikanten og, hvis det er relevant, hos fabrikantens leverandører og/eller underentreprenører for at verificere fremstillingsprocesserne og andre relevante processer.
For udstyr i klasse C 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 bestemmelserne i punkt 4.4-4.8. Ved udvælgelse af repræsentative prøver skal det bemyndigede organ tage hensyn til de offentliggjorte retningslinjer, der er udarbejdet af MDCG i henhold til artikel 99, og navnlig hvor nyskabende teknologien er, den potentielle virkning for patienten og almindelig medicinsk praksis, ligheder, hvad angår design, teknologi, fremstilling og, hvor det er relevant, steriliseringsmetoder, det erklærede formål og resultaterne af tidligere relevante vurderinger, som er foretaget i overensstemmelse med denne forordning. Det pågældende bemyndigede organ skal dokumentere rationalet for udvælgelsen af prøverne.
Hvis kvalitetssikringssystemet er i overensstemmelse med de relevante bestemmelser i denne forordning, skal det bemyndigede organ udstede et EU-certifikat for kvalitetsstyringssystemet. 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 omfang af udstyr, der er omfattet. Det bemyndigede organ vurderer de foreslåede ændringer, fastlægger 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 fra vurderingen og i givet fald konklusionerne fra yderligere audit. Godkendelse af en væsentlig ændring af kvalitetsstyringssystemet eller det omfang af udstyr, der er omfattet, skal have form af et tillæg til EU-certifikatet for kvalitetsstyringssystemet.
3.   Overvågningsvurdering, som finder anvendelse på udstyr i klasse C og klasse D
3.1.   Formålet med overvågning 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 alle nødvendige audit, herunder audit på stedet, og giver det alle relevante oplysninger, navnlig:
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dokumentation vedrørende sit kvalitetsstyringssystem
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dokumentation for eventuelle resultater og konklusioner fra anvendelsen af planen for overvågning, efter at udstyret er bragt i omsætning, herunder PMPF-planen, for en repræsentativ prøve af udstyr, og af de sikkerhedsovervågningsbestemmelser, der er fastsat i artikel 82-87
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de data, som foreskrives for 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
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de data, som foreskrives for den del af kvalitetsstyringssystemet, der vedrører fremstilling, 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 én gang hver 12. 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 hos fabrikanten og, hvis det er relevant, 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 fabrikanten en overvågningsauditrapport og i givet fald en prøvningsrapport.
3.4.   Det bemyndigede organ skal mindst én gang hvert femte år stikprøvevis foretage uanmeldte audit på stedet hos fabrikanten og, hvis det er relevant, på stedet hos fabrikantens leverandører og/eller underentreprenører, som kan kombineres med den periodiske overvågningsvurdering, som er omhandlet i punkt 3.3, eller kan foretages som supplement til overvågningsvurderingen. 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 prøve en passende stikprøve af udstyr, der er fremstillet, eller en passende stikprøve fra fremstillingsprocessen for at verificere, at det fremstillede udstyr er i overensstemmelse med den tekniske dokumentation. 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 omhandlet i andet afsnit skal bemyndigede organer udtage prøver af udstyr på markedet for at verificere, at det fremstillede udstyr er i overensstemmelse med den tekniske dokumentation. Forud for prøveudtagningen skal det pågældende bemyndigede organ specificere de relevante prøveudtagningskriterier og den relevante prøvningsprocedure.
Det bemyndigede organ forelægger den pågældende fabrikant en rapport om auditten på stedet; denne rapport skal i givet fald omfatte resultatet af stikprøvningen.
3.5.   For udstyr i klasse C skal overvågningsvurderingen 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 rationale, som det bemyndigede organ har dokumenteret i overensstemmelse med punkt 2.3, tredje afsnit.
3.6.   Bemyndigede organer skal sikre, at vurderingsholdet er sammensat på en sådan måde, at der er tilstrækkelige erfaringer med evaluering af det pågældende udstyr og de pågældende systemer og processer samt fortsat objektivitet og upartiskhed sikres; dette omfatter rotation af medlemmerne af vurderingsholdet med passende mellemrum. Som hovedregel må en ledende auditor hverken lede eller deltage i audit hos samme fabrikant i mere end tre på hinanden følgende år.
3.7.   Hvis det bemyndigede organ konstaterer en afvigelse mellem en prøve, der udtaget fra produktionen eller på markedet, og specifikationerne i den tekniske dokumentation eller det godkendte design, skal det suspendere eller tilbagekalde det relevante certifikat eller pålægge begrænsninger for det.
KAPITEL II
VURDERING AF DEN TEKNISKE DOKUMENTATION
4.   Vurdering af den tekniske dokumentation for udstyr og batchverifikation gældende for udstyr i klasse D
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.
For udstyr til selvtestning eller patientnær testning skal ansøgningen også omfatte de i punkt 5.1, litra b), omhandlede aspekter.
4.3.   Det bemyndigede organ behandler ansøgningen ved hjælp af ansat personale med dokumenteret viden om og erfaring med evaluering af teknologien og det pågældende udstyr og evaluering af klinisk dokumentation. Det bemyndigede organ kan kræve, at ansøgningen suppleres ved udførelse af yderligere prøvninger eller krav om indsendelse af yderligere dokumentation, så det kan vurdere, om udstyret er i overensstemmelse med de relevante krav i denne forordning. Det bemyndigede organ skal gennemføre passende fysiske prøvninger eller laboratorieprøvninger vedrørende udstyret eller anmode fabrikanten om at gennemføre sådanne prøvninger.
4.4.   Det bemyndigede organ gennemgår den kliniske dokumentation, som fabrikanten har fremlagt i rapporten om ydeevneevaluering og den relaterede ydeevneevaluering, som er foretaget. Det bemyndigede organ skal anvende ansatte udstyrskontrollanter med tilstrækkelig klinisk ekspertise og herunder eksterne kliniske eksperter med direkte og aktuel erfaring med klinisk anvendelse af det pågældende udstyr med henblik på den pågældende gennemgang.
4.5.   Det bemyndigede organ vurderer i tilfælde, hvor den kliniske dokumentation delvis eller helt er baseret på data fra udstyr, der angives at 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 til at påvise overensstemmelse.
4.6.   Det bemyndigede organ skal verificere, at den kliniske dokumentation og ydeevneevalueringen er tilstrækkelig, og verificere konklusionerne fra fabrikanten om overensstemmelse med de relevante generelle krav til sikkerhed og ydeevne. Denne verifikation skal omfatte overvejelser om tilstrækkeligheden af afvejningen af fordele og risici, risikostyringen, brugsanvisningen, 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 PMPF-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 ydeevneevalueringen og afvejningen af fordele og risici og til, om der skal fastlægges specifikke milepæle, så det bemyndigede organ kan gennemgå opdateringer af den kliniske dokumentation, der hidrører fra data fra overvågning, efter at udstyret er bragt i omsætning, og PMPF-data.
4.8.   Det bemyndigede organ skal klart dokumentere udfaldet af sin vurdering i vurderingsrapporten om ydeevneevaluering.
4.9.   Inden udstedelse af et EU-certifikat for vurdering af teknisk dokumentation skal det bemyndigede organ anmode et EU-referencelaboratorium, hvis et sådant er udpeget i overensstemmelse med artikel 100, om at verificere den ydeevne, der er angivet af fabrikanten, og udstyrets overensstemmelse med de fælles specifikationer, hvis sådanne foreligger, eller med andre løsninger, som er valgt af fabrikanten for at sikre et niveau af sikkerhed og ydeevne, der mindst svarer hertil. Verifikationen skal omfatte laboratorieprøvninger udført af EU-referencelaboratoriet, jf. artikel 48, stk. 5.
Desuden skal det bemyndigede organ i de tilfælde, der er omhandlet i artikel 48, stk. 6 i denne forordning, høre de relevante eksperter omhandlet i artikel 106 i forordning (EU) 2017/745 i overensstemmelse med proceduren i artikel 48, stk. 6, i nærværende forordning om fabrikantens rapport om ydeevneevaluering.
EU-referencelaboratoriet skal afgive en videnskabelig udtalelse inden for 60 dage.
Den videnskabelige udtalelse fra EU-referencelaboratoriet og i givet fald de hørte eksperters synspunkter, jf. proceduren i artikel 48, stk. 6, samt eventuelle opdateringer skal indgå i det bemyndigede organs dokumentation vedrørende udstyret. Det bemyndigede organ skal, når det træffer sin afgørelse, tage behørigt hensyn til den videnskabelige udtalelse fra EU-referencelaboratoriet og i givet fald til de synspunkter, som de hørte eksperter har givet udtryk for i overensstemmelse med artikel 48, stk. 6. Det bemyndigede organ må ikke udstede et certifikat, hvis den videnskabelige udtalelse fra EU-referencelaboratoriet er negativ.
4.10.   Det bemyndigede organ sender en rapport om vurdering af den tekniske dokumentation til fabrikanten, herunder en vurderingsrapport om ydeevneevaluering. 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 fra vurderingen af den tekniske dokumentation, betingelserne for certifikatets gyldighed, de nødvendige oplysninger til identifikation af det godkendte udstyr og, hvis det er relevant, en beskrivelse af udstyrets erklærede formål.
4.11.   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 den underrette det bemyndigede organ, der har udstedt EU-certifikatet for vurdering af teknisk dokumentation, herom. Det bemyndigede organ vurderer de planlagte ændringer og afgør, om de kræver en ny overensstemmelsesvurdering, jf. artikel 48, 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.
Hvis ændringerne kan påvirke overensstemmelsen med de fælles specifikationer eller andre løsninger, som er valgt af fabrikanten, og som er godkendt ved EU-certifikatet for vurdering af teknisk dokumentation, skal det bemyndigede organ høre det EU-referencelaboratorium, som var involveret i den første høring, med henblik på at bekræfte, at overensstemmelsen med de fælles specifikationer eller andre løsninger, som er valgt af fabrikanten for at sikre et niveau af sikkerhed og ydeevne, som mindst svarer hertil, stadig gælder.
EU-referencelaboratoriet skal afgive en videnskabelig udtalelse inden for 60 dage.
4.12.   For at verificere overensstemmelse for fremstillet udstyr i klasse D skal fabrikanten gennemføre test af hver fremstillet batch af udstyr. Efter afslutning af kontrol og test skal denne straks fremsende de relevante rapporter om testene til det bemyndigede organ. Fabrikanten skal desuden stille prøverne af fremstillede batcher af udstyr til rådighed for det bemyndigede organ i overensstemmelse med på forhånd aftalte betingelser og nærmere bestemmelser, som skal omfatte, at det bemyndigede organ eller fabrikanten sender prøver af fremstillede batcher af udstyr til EU-referencelaboratoriet, hvis et sådant laboratorium er udpeget i overensstemmelse med artikel 100, med henblik på gennemførelse af relevante test. EU-referencelaboratoriet skal oplyse det bemyndigede organ om sine resultater.
4.13.   Fabrikanten kan bringe udstyret i omsætning, medmindre det bemyndigede organ inden for den aftalte frist, men højst 30 dage efter modtagelse af prøverne, giver fabrikanten meddelelse om enhver anden afgørelse, herunder navnlig en eventuel betingelse for gyldigheden af udstedte certifikater.
5.   Vurdering af den tekniske dokumentation for specifikke typer udstyr
5.1.   Vurdering af den tekniske dokumentation for udstyr i klasse B, C og D til selvtestning og patientnær testning
a)
Fabrikanten af udstyr i klasse B, C og D til selvtestning og patientnær testning skal indsende en ansøgning om vurdering af den tekniske dokumentation til det bemyndigede organ.
b)
Ansøgningen skal gøre det muligt at forstå designet af udstyrets egenskaber og ydeevne og at vurdere, om de designrelaterede krav i denne forordning er opfyldt. Den skal indeholde:
i)
prøvningsrapporterne, herunder resultaterne af undersøgelser, der er udført med de tilsigtede brugere
ii)
hvis muligt, et eksemplar af udstyret. Hvis påkrævet, skal udstyret returneres efter afslutningen af vurderingen af den tekniske dokumentation
iii)
data, der viser, at udstyret i lyset af dets erklærede formål er egnet til selvtestning eller patientnær testning
iv)
de oplysninger, der skal gives på udstyrets mærkning og i brugsanvisningen.
Det bemyndigede organ kan kræve, at ansøgningen suppleres ved at gennemføre yderligere prøvninger eller ved at forelægge yderligere dokumentation, så det kan vurdere, om produktet er i overensstemmelse med kravene i denne forordning.
c)
Det bemyndigede organ skal verificere udstyrets overensstemmelse med de relevante krav i denne forordnings bilag I.
d)
Det bemyndigede organ vurderer ansøgningen ved hjælp af personale, der er ansat af det, med dokumenteret viden om og erfaring med den pågældende teknologi og udstyrets erklærede formål og forelægger fabrikanten en rapport om vurdering af den tekniske dokumentation.
e)
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 resultaterne af vurderingen, betingelserne for certifikatets gyldighed, de nødvendige oplysninger til identifikation af det godkendte udstyr og i givet fald en beskrivelse af udstyrets erklærede formål.
f)
Hvis ændringer af det godkendte udstyr kan få indflydelse på udstyrets sikkerhed og ydeevne eller de foreskrevne betingelser for anvendelse af udstyret, skal ændringerne også 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 i henhold til artikel 48, 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 forelægger denne, hvis ændringerne godkendes, et tillæg til EU-certifikatet for vurdering af teknisk dokumentation.
5.2.   Vurdering af den tekniske dokumentation for udstyr til ledsagende diagnosticering
a)
Fabrikanten af udstyr til ledsagende diagnosticering skal indsende en ansøgning om vurdering af den tekniske dokumentation til det bemyndigede organ. Det bemyndigede organ skal vurdere ansøgningen i overensstemmelse med proceduren i dette bilags punkt 4.1-4.8.
b)
Ansøgningen skal gøre det muligt at forstå udstyrets karakteristika og ydeevne og at vurdere, om de designrelaterede krav i denne forordning er opfyldt, navnlig hvad angår udstyrets egnethed i forbindelse med det pågældende lægemiddel.
c)
Det bemyndigede organ anmoder inden udstedelse af et EU-certifikat for vurdering af den tekniske dokumentation for udstyr til ledsagende diagnosticering og på grundlag af udkastet til sammenfatning af sikkerhed og ydeevne og udkastet til brugsanvisning om en udtalelse fra en af de kompetente myndigheder, der er udpeget af medlemsstaterne i overensstemmelse med direktiv 2001/83/EF, eller fra EMA, begge i dette punkt benævnt »den hørte myndighed for lægemidler«, afhængigt af hvilken der er blevet hørt i henhold til dette litra, hvad angår udstyrets egnethed for så vidt angår det pågældende lægemiddel. Hvis lægemidlet udelukkende henhører under anvendelsesområdet for bilaget til Europa Parlamentets og Rådets forordning (EF) nr. 726/2004 
(
1
)
, skal det bemyndigede organ anmode om en udtalelse fra EMA. Hvis det pågældende lægemiddel allerede er godkendt, eller hvis der er indsendt en ansøgning om godkendelse, hører det bemyndigede organ myndigheden for lægemidler eller EMA, som er ansvarlig for godkendelsen.
d)
Den hørte myndighed for lægemidler afgiver sin udtalelse senest 60 dage efter modtagelse af al nødvendig dokumentation. Denne periode på 60 dage kan én gang forlænges med yderligere 60 dage af berettigede grunde. Udtalelsen samt en eventuel opdatering skal indgå i det bemyndigede organs dokumentation vedrørende udstyret.
e)
Det bemyndigede organ skal tage behørigt hensyn til den videnskabelige udtalelse, jf. litra d), når det træffer sin afgørelse. Det bemyndigede organ sender sin endelige afgørelse til den hørte myndighed for lægemidler. EU-certifikatet for vurdering af den tekniske dokumentation udstedes i overensstemmelse med punkt 5.1, litra e).
f)
Før der foretages ændringer, som påvirker udstyrets ydeevne og/eller tilsigtede brug og/eller egnethed, for så vidt angår det pågældende lægemiddel, skal fabrikanten underrette det bemyndigede organ om ændringerne. Det bemyndigede organ vurderer de påtænkte ændringer og afgør, om de påtænkte ændringer kræver en ny overensstemmelsesvurdering i henhold til artikel 48, 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 og anmoder om en udtalelse fra den hørte myndighed for lægemidler. Den hørte myndighed for lægemidler afgiver sin udtalelse senest 30 dage efter modtagelse af al nødvendig dokumentation vedrørende ændringerne. Et tillæg til EU-certifikatet for vurdering af teknisk dokumentation udstedes i overensstemmelse med punkt 5.1, litra f).
KAPITEL III
ADMINISTRATIVE BESTEMMELSER
6.   Fabrikanten eller, hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, dennes autoriserede repræsentant skal i mindst 10 år, efter at det sidste udstyr er bragt i omsætning, kunne forelægge de kompetente myndigheder:
—
EU-overensstemmelseserklæringen
—
den i punkt 2.1, femte led, omhandlede dokumentation og navnlig data og registreringer fra procedurerne omhandlet i punkt 2.2, stk. 2, litra c)
—
oplysninger om de i punkt 2.4 omhandlede ændringer
—
den i punkt 4.2 og punkt 5.1, litra b), omhandlede dokumentation, og
—
de i dette bilag omhandlede afgørelser og rapporter fra det bemyndigede organ.
7.   Hver medlemsstat kræver, at den i punkt 6 omhandlede dokumentation kan 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 sin virksomhed inden udgangen af den pågældende periode.
(
1
)
  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
).
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 prøve, 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 dennes registrerede forretningssted og, hvis ansøgningen indsendes af den autoriserede repræsentant, navnet på den autoriserede repræsentant og adressen på dennes registrerede forretningssted
—
den tekniske dokumentation, der er omhandlet i bilag II og III. 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
—
for så vidt angår udstyr til selvtestning eller patientnær testning, prøvningsrapporterne, herunder resultaterne af undersøgelser, der er foretaget med tilsigtede brugere, og data, der viser, at udstyret i forhold til dets erklærede formål er egnet til at blive anvendt til selvtestning eller patientnær testning
—
hvis praktisk muligt, et eksemplar af udstyret. Hvis påkrævet, skal udstyret returneres efter afslutningen af vurderingen af den tekniske dokumentation
—
data, der viser, at udstyret i forhold til dets erklærede formål er egnet til selvtestning eller patientnær testning
—
de oplysninger, der skal gives på udstyrets mærkning og i brugsanvisningen
—
en skriftlig erklæring om, at der ikke er indsendt en ansøgning vedrørende samme type til et andet bemyndiget organ, eller oplysninger om eventuelle 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 pågældende 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 evaluering af teknologien og det pågældende udstyr og evaluering af klinisk dokumentation. Det bemyndigede organ kan kræve, at ansøgningen suppleres ved at gennemføre yderligere prøvninger eller forelægge yderligere dokumentation, så det kan vurdere, om udstyret er i overensstemmelse med de relevante krav i denne forordning. Det bemyndigede organ skal gennemføre passende fysiske prøvninger eller laboratorieprøvninger i forbindelse med udstyret eller anmode fabrikanten om at gennemføre sådanne prøvninger
b)
undersøger og vurderer den tekniske dokumentation for overensstemmelse med de krav i denne forordning, der gælder for udstyret, og verificerer, at typen er fremstillet i overensstemmelse hermed; det registrerer ligeledes, hvilke elementer der er designet i overensstemmelse med de i artikel 8 nævnte relevante standarder eller med de relevante fælles specifikationer, og registrerer, hvilke elementer der er designet, uden at de i artikel 8 nævnte relevante standarder eller de relevante fælles specifikationer er blevet anvendt
c)
gennemgår den kliniske dokumentation, som fabrikanten har fremlagt i rapporten om ydeevneevaluering i overensstemmelse med bilag XIII, punkt 1.3.2. Det bemyndigede organ skal ansætte udstyrskontrollanter med tilstrækkelig klinisk ekspertise og, om nødvendigt, anvende eksterne kliniske eksperter med direkte og aktuel erfaring med klinisk anvendelse af det pågældende udstyr 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, hensigtsmæssigheden 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 til at påvise overensstemmelse
e)
dokumenterer klart udfaldet af sin vurdering i vurderingsrapporten om ydeevneevaluering, jf. bilag IX, punkt 4.8
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 tilfælde, hvor fabrikanten har valgt at anvende disse
h)
aftaler med ansøgeren, hvor de nødvendige vurderinger og prøvninger skal gennemføres,
i)
udarbejder en EU-typeafprøvningsrapport om resultaterne af de vurderinger og prøvninger, der er gennemført i medfør af litra a) til g)
j)
anmoder for så vidt angår udstyr i klasse D det EU-referencelaboratorium, hvis et sådant er udpeget i overensstemmelse med artikel 100, om at verificere den ydeevne, der er angivet af fabrikanten, og udstyrets overensstemmelse med de fælles specifikationer, hvis sådanne foreligger, eller med andre løsninger, som er valgt af fabrikanten for at sikre et niveau af sikkerhed og ydeevne, der mindst svarer hertil. Verifikationen skal omfatte laboratorieprøvninger udført af EU-referencelaboratoriet i overensstemmelse med artikel 48, stk. 5.
Desuden skal det bemyndigede organ i de tilfælde, der er omhandlet i artikel 48, stk. 6, i denne forordning, høre de relevante eksperter i artikel 106 i forordning (EU) 2017/745 efter proceduren i artikel 48, stk. 6, i nærværende forordning om fabrikantens rapport om ydeevneevaluering.
EU-referencelaboratoriet skal afgive en videnskabelig udtalelse inden for 60 dage.
Den videnskabelige udtalelse fra EU-referencelaboratoriet og, når proceduren i artikel 48, stk. 6, finder anvendelse, de hørte eksperters synspunkter samt en eventuel opdatering 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 EU-referencelaboratoriet, og i givet fald de synspunkter, som de hørte eksperter har givet udtryk for i overensstemmelse med artikel 48, stk. 6, når det træffer sin afgørelse. Det bemyndigede organ må ikke udstede et certifikat, hvis den videnskabelige udtalelse fra EU-referencelaboratoriet er negativ.
k)
anmoder for udstyr til ledsagende diagnosticering om en udtalelse fra en af de kompetente myndigheder udpeget af medlemsstaterne i medfør af direktiv 2001/83/EF eller fra EMA (begge i det følgende benævnt »den hørte myndighed for lægemidler«, afhængigt af hvilken der er blevet hørt i henhold til dette litra) om udstyrets egnethed for så vidt angår det pågældende lægemiddel på grundlag af udkastet til sammenfatning af sikkerhed og ydeevne og udkastet til brugsanvisning. Hvis lægemidlet udelukkende henhører under anvendelsesområdet for bilaget til forordning (EF) nr. 726/2004, skal det bemyndigede organ høre EMA. Hvis det pågældende lægemiddel allerede er godkendt, eller hvis der er indsendt en ansøgning om godkendelse, hører det bemyndigede organ den kompetente myndighed for lægemidler eller EMA, som er ansvarlig for godkendelsen. Den hørte myndighed for lægemidler afgiver sin udtalelse senest 60 dage efter modtagelse af al nødvendig dokumentation. Denne periode på 60 dage kan én gang forlænges med yderligere 60 dage af berettigede grunde. Udtalelsen fra den hørte myndighed for lægemidler samt en eventuel opdatering skal indgå i det bemyndigede organs dokumentation vedrørende udstyret. Det bemyndigede organ skal tage behørigt hensyn til den udtalelse, som den hørte myndighed for lægemidler har afgivet, når det træffer sin afgørelse. Det sender sin endelige afgørelse til den hørte myndighed for lægemidler, og
l)
udarbejder en EU-typeafprøvningsrapport om resultaterne af de gennemførte vurderinger og prøvninger og de videnskabelige udtalelser, jf. litra a)-k), herunder en vurderingsrapport om ydeevneevaluering for udstyr i klasse C eller D eller omfattet af punkt 2, tredje led.
4.   Certifikat
Hvis typen er i overensstemmelse med denne forordning, udsteder det bemyndigede organ et EU-typeafprøvningscertifikat. 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 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 forelægger fabrikanten et tillæg til EU-typeafprøvningsrapporten. Godkendelsen af ændringer af den godkendte type har 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 en ny ansøgning om overensstemmelsesvurdering.
5.4.   Hvis ændringerne kan påvirke den ydeevne, der er angivet af fabrikanten, eller overensstemmelsen med de fælles specifikationer eller andre løsninger, som er valgt af fabrikanten, og som er godkendt gennem EU-typeafprøvningscertifikatet, skal det bemyndigede organ høre det EU-referencelaboratorium, som var involveret i den første høring, for at få bekræftet, at overensstemmelsen med de fælles specifikationer, hvis sådanne foreligger, eller med andre løsninger, som er valgt af fabrikanten for at sikre et niveau af sikkerhed og ydeevne, som mindst svarer hertil, er opretholdt.
EU-referencelaboratoriet skal afgive en videnskabelig udtalelse inden for 60 dage.
5.5.   Hvis ændringerne påvirker ydeevnen ved eller den tilsigtede brug af udstyr beregnet til ledsagende diagnosticering, som blev godkendt gennem EU-typeafprøvningscertifikatet, eller dets egnethed i forbindelse med et lægemiddel, skal det bemyndigede organ høre den kompetente myndighed for lægemidler, som var involveret i den første høring, eller EMA. Den hørte myndighed for lægemidler afgiver i givet fald sin udtalelse senest 30 dage efter modtagelse af gyldig dokumentation vedrørende ændringerne. Godkendelsen af ændringer af den godkendte type udstedes i form af et tillæg til det oprindelige EU-typeafprøvningscertifikat.
6.   Administrative bestemmelser
Fabrikanten eller, hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, dennes autoriserede repræsentant skal i mindst 10 år, efter at det sidste udstyr er bragt i omsætning, kunne forelægge de kompetente myndigheder:
—
den i punkt 2, andet led, omhandlede dokumentation
—
oplysninger om de i punkt 5 omhandlede ændringer
—
kopier af EU-typeafprøvningscertifikater, videnskabelige udtalelser og rapporter og tillæg/tilføjelser dertil.
Bilag IX, punkt 7, finder anvendelse.
BILAG XI
OVERENSSTEMMELSESVURDERING BASERET PÅ KVALITETSSIKRING AF PRODUKTIONEN
1.   Fabrikanten sørger for, at det kvalitetsstyringssystem, der er godkendt til fremstilling af det pågældende udstyr, anvendes og udfører en endelig verificering som angivet i punkt 3 og er underlagt den overvågning, der er beskrevet i punkt 4.
2.   Når fabrikanten opfylder kravene i punkt 1, udarbejder og opbevarer denne en EU-overensstemmelseserklæring, jf. artikel 17 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 opfylder de relevante krav i denne forordning, som udstyret er omfattet af, og for så vidt angår udstyr i klasse C og D, som underkastes typeafprøvning, er i overensstemmelse med den type, som er beskrevet i EU-typeafprøvningscertifikatet.
3.   Kvalitetsstyringssystem
3.1.   Fabrikanten indsender en ansøgning om vurdering af sit kvalitetsstyringssystem til et bemyndiget organ.
Anmodningen skal indeholde:
—
alle de elementer, der er anført i bilag IX, punkt 2.1
—
den i bilag II og III omhandlede tekniske dokumentation for de godkendte typer
—
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 opdateringer heraf og de udstedte certifikater.
3.2.   Kvalitetsstyringssystemet skal implementeres på en sådan måde, at det sikres, 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).
3.3.   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 e EU-certifikat om kvalitetssikring af produktionen. 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.
3.4.   Bilag IX, punkt 2.4, finder anvendelse.
4.   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.
5.   Verifikation af fremstillet udstyr i klasse D
5.1.   For udstyr i klasse D skal fabrikanten gennemføre test på hver fremstillet batch af udstyr. Efter afslutning af kontrollerne og testene skal fabrikanten straks fremsende de relevante rapporter om disse test til det bemyndigede organ. Fabrikanten skal desuden stille prøver af fremstillede udstyr eller batcher af udstyr til rådighed for det bemyndigede organ i overensstemmelse med på forhånd fastsatte betingelser og nærmere ordninger, som skal omfatte, at det bemyndigede organ eller fabrikanten sender prøver, der er udtaget af de fremstillede udstyr eller batcher af udstyr, til et EU-referencelaboratorium, hvis et sådant laboratorium er blevet udpeget i overensstemmelse med artikel 100, med henblik på gennemførelse af relevante laboratorieprøvninger. EU-referencelaboratoriet skal oplyse det bemyndigede organ om sine resultater.
5.2.   Fabrikanten kan bringe udstyret i omsætning, medmindre det bemyndigede organ inden for den aftalte frist, men højst 30 dage efter prøvernes modtagelse, giver fabrikanten meddelelse om enhver anden afgørelse, herunder specielt enhver betingelse for gyldigheden af de udstedte certifikater.
6.   Administrative bestemmelser
Fabrikanten eller, hvis fabrikanten ikke har et registreret forretningssted i en medlemsstat, dennes autoriserede repræsentant skal i mindst 10 år, efter at det sidste udstyr er 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 7, finder anvendelse.
BILAG XII
CERTIFIKATER, DER UDSTEDES AF ET BEMYNDIGET ORGAN
KAPITEL I
GENERELLE KRAV
1.
Certifikater skal udarbejdes på et af EU's officielle sprog.
2.
Hver attest må kun vedrøre én overensstemmelsesvurderingsprocedure.
3.
Certifikater udstedes kun til én fabrikant. Fabrikantens navn og adresse i certifikatet skal være det/den samme som det navn og den adresse, der er registreret i det elektroniske system, jf. artikel 27.
4.
Certifikaters indhold skal utvetydigt beskrive det omfattede udstyr:
a)
EU-certifikater for vurdering af teknisk dokumentation og EU-typeafprøvningscertifikater 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 24, stk. 6.
b)
EU-kvalitetsstyringssystemcertifikater og EU-certifikater om kvalitetssikring af produktionen skal indeholde identifikationsoplysninger om udstyr og grupper af udstyr, risikoklassificering og 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, der udstedes i overensstemmelse med denne forordning.
7.
EU-kvalitetsstyringssystemcertifikater og EU-certifikater om kvalitetssikring af produktionen for sterilt udstyr i klasse A skal indeholde en erklæring om, at det bemyndigede organs audit var begrænset til de aspekter af fabrikationen, der vedrører sikring og vedligeholdelse af sterile forhold.
8.
Hvis et certifikat suppleres, ændres eller genudstedes, skal det nye certifikat indeholde en henvisning til det tidligere certifikat og dets udstedelsesdato med angivelse af ændringerne.
KAPITEL II
CERTIFIKATERS MINIMUMSINDHOLD
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 28, stk. 2
5.
udstedelsesdato
6.
udløbsdato
7.
data, der er nødvendige for utvetydigt at kunne identificere udstyret, hvis det er relevant, jf. dette bilags punkt 4
8.
hvis det er relevant, en henvisning til eventuelle tidligere certifikater, jf. kapitel I, punkt 8
9.
henvisning til denne forordning og til det relevante bilag, i overensstemmelse med hvilket overensstemmelsesvurderingen er foretaget
10.
gennemførte undersøgelser og prøvninger, f.eks. 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 overvågning
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 overensstemmelse med gældende national ret.
BILAG XIII
YDEEVNEEVALUERING, UNDERSØGELSER AF YDEEVNE OG OPFØLGNING AF YDEEVNE, EFTER AT UDSTYRET ER BRAGT I OMSÆTNING
DEL A
YDEEVNEEVALUERING OG UNDERSØGELSER AF YDEEVNE
1.   YDEEVNEEVALUERING
Evaluering af et udstyrs ydeevne er en kontinuerlig proces, hvorved data vurderes og analyseres for at påvise det pågældende udstyrs videnskabelige validitet, analytiske ydeevne og kliniske ydeevne i forbindelse med dets erklærede formål som angivet af fabrikanten. Med henblik på at planlægge, løbende udføre og dokumentere en ydeevneevaluering skal fabrikanten udarbejde og opdatere en plan for ydeevneevaluering. Planen for ydeevneevaluering skal specificere udstyrets karakteristika og ydeevne og den procedure og de kriterier, der er anvendt for at udarbejde den nødvendige kliniske dokumentation.
Ydeevneevalueringen skal være grundig og objektiv og tage hensyn til både positive og negative data.
Grundigheden og omfanget skal være rimelige og stå i forhold til udstyrets karakteristika, herunder risici, risikoklasse, ydeevne og dets erklærede formål.
1.1.   Plan for ydeevneevaluering
Som hovedregel skal planen for ydeevneevaluering mindst omfatte:
—
specifikation af udstyrets erklærede formål
—
specifikation af udstyrets karakteristika, jf. bilag I, kapitel II, punkt 9, og kapitel III, punkt 20.4.1, litra c)
—
specifikation af den analyt eller markør, der skal fastsættes af udstyret
—
specifikation af udstyrets tilsigtede brug
—
identifikation af certificeret referencemateriale eller referencemåleprocedurer til sikring af metrologisk sporbarhed
—
en klar identifikation af bestemte patientmålgrupper med klare indikationer, begrænsninger og kontraindikationer
—
identifikation af de generelle krav til sikkerhed og ydeevne, jf. bilag I, punkt 1-9, hvortil der er behov for relevante data for videnskabelig validitet, analytisk ydeevne og klinisk ydeevne
—
specifikation af metoderne, herunder de relevante statistiske redskaber, der anvendes til at undersøge udstyrets analytiske og kliniske ydeevne og udstyrets begrænsninger og oplysninger herfra
—
en beskrivelse af det aktuelle tekniske niveau, herunder identifikation af eksisterende relevante standarder, fælles specifikationer, vejledningsdokumenter eller dokumenter om bedste praksis
—
angivelse 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 i forbindelse med udstyrets erklærede formål og dets analytiske og kliniske ydeevne
—
for software, der anses for udstyr, identifikation og specifikation af referencedatabaser og andre datakilder, der anvendes som grundlag for dets beslutningstagning
—
en oversigt over de forskellige udviklingsfaser, herunder rækkefølgen for og metoderne til fastlæggelse af den videnskabelige validitet, den analytiske og kliniske ydeevne, herunder en angivelse af milepæle og en beskrivelse af potentielle acceptkriterier
—
PMPF-planlægningen, jf. dette bilags del B.
Hvis nogle af ovennævnte elementer ikke anses for hensigtsmæssige i planen for ydeevneevaluering som følge af særlige karakteristika ved udstyret, skal der gives en begrundelse herfor i planen.
1.2.   Påvisning af den videnskabelige validitet og den analytiske og kliniske ydeevne:
Som et generelt metodologisk princip skal fabrikanten:
—
gennem en systematisk gennemgang af videnskabelig litteratur identificere de tilgængelige data, der er relevante for udstyret og dets erklærede formål, og identificere eventuelle tilbageværende uløste spørgsmål eller mangler i dataene
—
bedømme alle relevante data ved at evaluere deres egnethed til fastlæggelse af udstyrets sikkerhed og ydeevne
—
generere nye eller supplerende data, der er nødvendige til at behandle udestående problemstillinger.
1.2.1.   Påvisning af den videnskabelige validitet
Fabrikanten skal påvise den videnskabelige validitet ved hjælp af en eller en kombination af følgende kilder:
—
relevante oplysninger om den videnskabelige validitet af udstyr, der måler samme analyt eller markør
—
videnskabelig litteratur (der har været underkastet peer review)
—
konsensusudtalelser/-holdninger fra eksperter fra relevante faglige organisationer
—
resultater af »proof of concept«-undersøgelser
—
resultater af undersøgelser af klinisk ydeevne.
Analyttens eller markørens videnskabelige validitet skal påvises og dokumenteres i rapporten om videnskabelig validitet.
1.2.2.   Påvisning af analytisk ydeevne
Fabrikanten skal påvise udstyrets analytiske ydeevne i forhold til alle de parametre, der er beskrevet i bilag I, punkt 9.1, litra a), medmindre det kan begrundes, at en undladelse ikke er relevant.
Den analytiske ydeevne skal som hovedregel altid påvises på grundlag af undersøgelser af den analytiske ydeevne.
For nye markører eller andre markører uden tilgængeligt certificeret referencemateriale eller referencemåleprocedurer kan det være umuligt at påvise korrektheden. Hvis der ikke findes sammenligningsmetoder, kan der anvendes andre metoder, hvis det påvises, at de er relevante, såsom sammenligning med en anden veldokumenteret metode eller den sammensatte referencestandard. Uden sådanne metoder er der behov for en undersøgelse af klinisk ydeevne, hvor det nye udstyrs ydeevne sammenlignes med den nuværende kliniske standardpraksis.
Den analytiske ydeevne skal påvises og dokumenteres i rapporten om analytisk ydeevne.
1.2.3.   Påvisning af klinisk ydeevne
Fabrikanten skal påvise udstyrets kliniske ydeevne i forbindelse med alle de parametre, der er beskrevet i bilag I, punkt 9.1, litra b), medmindre det kan begrundes, at en undladelse ikke er relevant.
Et udstyrs kliniske ydeevne påvises ved hjælp af en eller en kombination af følgende kilder:
—
undersøgelser af klinisk ydeevne
—
videnskabelig litteratur (der har været underkastet peer review)
—
publicerede erfaringer opnået gennem rutinediagnosticering.
Der skal foretages undersøgelser af klinisk ydeevne, medmindre der gives en behørig begrundelse for at anvende andre kilder til data for klinisk ydeevne.
Den kliniske ydeevne skal påvises og dokumenteres i rapporten om klinisk ydeevne.
1.3.   Klinisk dokumentation og rapport om ydeevneevaluering
1.3.1.   Fabrikanten skal vurdere alle relevante data for videnskabelig validitet, analytisk ydeevne og klinisk ydeevne for at verificere sit udstyrs overensstemmelse med de generelle krav til sikkerhed og ydeevne, jf. bilag I. Dataenes mængde og kvalitet skal gøre det muligt for fabrikanten at foretage en kvalificeret vurdering af, om udstyret vil opnå den eller de tilsigtede kliniske fordele og den tilsigtede sikkerhed, når det anvendes som tilsigtet af fabrikanten. Dataene og konklusionerne fra vurderingen udgør udstyrets kliniske dokumentation. Den kliniske dokumentation skal videnskabeligt påvise, at den eller de tilsigtede kliniske fordele og den tilsigtede sikkerhed vil blive opnået i henhold til det aktuelle tekniske niveau inden for medicin.
1.3.2.   Rapport om ydeevneevaluering
Den kliniske dokumentation skal dokumenteres i en rapport om ydeevneevaluering. Denne rapport skal omfatte rapporten om videnskabelig validitet, rapporten om analytisk ydeevne og rapporten om klinisk ydeevne og en vurdering af disse rapporter, hvormed det er muligt at påvise den kliniske dokumentation.
Rapporten om ydeevneevaluering skal især omfatte:
—
begrundelsen for den fremgangsmåde, der er valgt til indsamling af klinisk dokumentation
—
litteratursøgningsmetoden og litteratursøgningsprotokollen og rapporten om litteratursøgning i forbindelse med en litteraturgennemgang
—
den teknologi, udstyret er baseret på, udstyrets erklærede formål og eventuelle angivelser vedrørende udstyrets ydeevne eller sikkerhed
—
arten og omfanget af dataene for videnskabelig validitet, analytisk ydeevne og klinisk ydeevne, der er blevet evalueret
—
den kliniske dokumentation i form af den acceptable ydeevne i forhold til det aktuelle tekniske niveau inden for medicin
—
eventuelle nye konklusioner udledt fra PMPF-rapporterne i overensstemmelse med dette bilags del B.
1.3.3.   Den kliniske dokumentation og vurderingen heraf i rapporten om ydeevneevaluering skal opdateres i hele det pågældende udstyrs livscyklus med data fra gennemførelsen af fabrikantens PMPF-plan i overensstemmelse med dette bilags del B som del af systemet til ydeevneevaluering og systemet til overvågning, efter at udstyret er bragt i omsætning, jf. artikel 10, stk. 9. Rapporten om ydeevneevaluering skal indgå i den tekniske dokumentation. Både positive og negative data betragtet i forbindelse med den kliniske evaluering skal fremgå af den tekniske dokumentation.
2.   UNDERSØGELSER AF KLINISK YDEEVNE
2.1.   Formål med undersøgelser af klinisk ydeevne
Formålet med undersøgelser af klinisk ydeevne er at fastlægge eller bekræfte aspekter af udstyrets ydeevne, som ikke kan fastlægges gennem undersøgelser af analytisk ydeevne, litteratur og/eller erfaringer opnået gennem rutinediagnosticering. Disse oplysninger anvendes til at godtgøre, at udstyret er i overensstemmelse med de relevante generelle krav til klinisk ydeevne. Når der gennemføres undersøgelser af klinisk ydeevne, skal de data, der opnås, anvendes i processen for ydeevneevaluering og indgå i udstyrets kliniske dokumentation.
2.2.   Etiske hensyn i forbindelse med undersøgelser af klinisk ydeevne
Hver fase i undersøgelsen af klinisk ydeevne fra den første overvejelse om behovet for undersøgelsen og dens berettigelse til offentliggørelsen af resultaterne foretages i overensstemmelse med anerkendte etiske principper.
2.3.   Metoder i forbindelse med undersøgelser af klinisk ydeevne
2.3.1.   Undersøgelse af klinisk ydeevne — designtype
Undersøgelser af klinisk ydeevne skal designes således, at de maksimerer relevansen af data, samtidig med at de minimerer potentiel bias.
2.3.2.   Plan for undersøgelse af klinisk ydeevne
Undersøgelser af klinisk ydeevne skal foretages på grundlag af en plan for undersøgelse af klinisk ydeevne.
Planen for undersøgelse af klinisk ydeevne skal fastlægge rationale, formål, design og foreslået analyse, metodologi, monitorering, gennemførelse og registrering i forbindelse med undersøgelsen af klinisk ydeevne. Den skal navnlig indeholde følgende oplysninger:
a)
det individuelle identifikationsnummer for undersøgelsen af klinisk ydeevne, jf. artikel 66, stk. 1
b)
identifikation af sponsor, herunder sponsors navn, registrerede forretningssteds adresse og kontaktoplysninger og, hvis det er relevant, dennes kontaktpersons eller retlige repræsentants navn, registrerede forretningssteds adresse og kontaktoplysninger i overensstemmelse med artikel 58, stk. 4, i Unionen
c)
oplysninger om investigator eller investigatorer, dvs. den primære investigator, koordinerende investigator eller anden investigator, kvalifikationer, kontaktoplysninger og afprøvningsstedet eller -stederne, f.eks. nummer, kvalifikation, kontaktoplysninger og for så vidt angår udstyr til selvtestning det sted, hvor afprøvningen foretages, og antallet af involverede lægfolk
d)
startdato for og planlagt varighed af undersøgelsen af klinisk ydeevne
e)
identifikation og beskrivelse af udstyret, dets erklærede formål, analytten eller analytterne eller markøren eller markørerne, den metrologiske sporbarhed og fabrikanten
f)
oplysninger om den prøvetype, der skal afprøves
g)
generel synopsis for undersøgelsen af klinisk ydeevne og dens designtype, f.eks. observationsbaseret eller interventionel, samt undersøgelsens mål og hypoteser og en henvisning til det aktuelle tekniske niveau inden for diagnosticering og/eller medicin
h)
en beskrivelse af de forventede risici og fordele ved udstyret og undersøgelsen af klinisk ydeevne i forbindelse med det aktuelle tekniske niveau inden for klinisk praksis og med undtagelse af undersøgelser, der anvender overskydende prøver, de involverede medicinske procedurer og patientbehandling
i)
udstyrets brugsanvisning eller prøvningsprotokollen, brugerens nødvendige uddannelse og erfaring, passende kalibreringsprocedurer og kontrolmidler, angivelse af andet udstyr, medicinsk udstyr, lægemidler og andre artikler, der skal inddrages eller udelukkes, og specifikationerne for eventuelle komparatorer eller sammenligningsmetoder, der anvendes som reference
j)
beskrivelse af og begrundelse for design af undersøgelsen af klinisk ydeevne, dens videnskabelige robusthed og validitet, herunder den statistiske udformning, og nærmere oplysninger om foranstaltninger, der skal træffes for at minimere bias, f.eks. randomisering, og håndtering af potentielle confoundere
k)
den analytiske ydeevne i overensstemmelse med bilag I, kapitel I, punkt 9.1, litra a), med begrundelse for eventuelle udeladelser
l)
parametre for klinisk ydeevne, der i overensstemmelse med bilag I, punkt 9.1, litra b), skal fastsættes, med begrundelse for eventuelle udeladelser og med undtagelse af undersøgelser, der anvender overskydende prøver, anvendte specifikke kliniske resultater/endepunkter (primære, sekundære) med angivelse af en begrundelse og de potentielle virkninger for beslutninger om forvaltning af den enkeltes sundhed og/eller folkesundheden
m)
oplysninger om populationen i undersøgelsen af ydeevne: specifikation af forsøgspersoner, udvælgelseskriterier, populationsstørrelsen i undersøgelsen af ydeevne, målpopulationens repræsentativitet og eventuelt oplysninger om sårbare deltagende forsøgspersoner, f.eks. børn, gravide kvinder, immunsvækkede og ældre forsøgspersoner
n)
oplysninger om anvendelse af data fra biobanker med overskydende prøvemateriale, gen- og vævsbanker, patient- og sygdomsregistre osv. med beskrivelse af pålideligheden og repræsentativiteten og tilgangen til den statistiske analyse samt sikkerhed for relevant metode til bestemmelse af patientprøvers virkelige kliniske status
o)
monitoreringsplan
p)
datahåndtering
q)
beslutningsalgoritmer
r)
politik for ændringer, herunder ændringer i overensstemmelse med artikel 71, til eller afvigelser fra planen for undersøgelse af klinisk ydeevne med et klart forbud mod anvendelse af dispensation fra planen for undersøgelse af klinisk ydeevne
s)
ansvarlighed i forbindelse med udstyret, navnlig kontrol af adgang til udstyret, opfølgning i forhold til udstyr anvendt i undersøgelsen af klinisk ydeevne og tilbagesendelse af udstyr, der er ubrugt eller udløbet, eller som ikke fungerer
t)
erklæring om overensstemmelse med anerkendte etiske principper for medicinsk forskning med mennesker og principper for god klinisk praksis i forbindelse med undersøgelser af klinisk ydeevne samt med de gældende reguleringskrav
u)
beskrivelse af proceduren for indhentning af informeret samtykke, herunder en kopi af patientoplysningsskemaet og samtykkeformularerne
v)
procedurer for sikkerhedsregistrering og -indberetning, herunder definitioner af registrerings- og indberetningspligtige hændelser samt procedurer og frister for indberetning
w)
kriterier og procedurer for suspension eller afbrydelse af undersøgelsen af klinisk ydeevne
x)
kriterier og procedurer for opfølgning af forsøgspersoner efter afslutning af en undersøgelse af ydeevne, procedurer for opfølgning af forsøgspersoner i tilfælde af suspension eller afbrydelse, procedurer for opfølgning af forsøgspersoner, der har trukket deres samtykke tilbage, og procedurer for forsøgspersoner, der er tabt for opfølgning
y)
procedurer for meddelelse af prøvningsresultater uden for undersøgelsen, herunder meddelelse af prøvningsresultaterne til forsøgspersonerne i undersøgelsen af ydeevne
z)
retningslinjer vedrørende udarbejdelsen af rapporten om undersøgelse af klinisk ydeevne og offentliggørelse af resultaterne i overensstemmelse med lovkravene og de etiske principper, der er omhandlet i punkt 2.2
aa)
en liste over udstyrets tekniske og funktionelle kendetegn, herunder forhold, der er omfattet af undersøgelsen af ydeevne
ab)
bibliografi.
Hvis en del af de i andet afsnit nævnte oplysninger indsendes i et særskilt dokument, skal det oplyses i planen for undersøgelse af klinisk ydeevne. For undersøgelser, der anvender overskydende prøver, finder litra u), x), y) og z) ikke anvendelse.
Hvis det ikke anses for hensigtsmæssigt at medtage nogle af de i andet afsnit nævnte elementer i planen for undersøgelse af klinisk ydeevne på grund af det valgte specifikke design af undersøgelsen, f.eks. anvendelse af overskydende prøver versus interventionsundersøgelser af klinisk ydeevne, skal det begrundes.
2.3.3.   Rapport om undersøgelse af klinisk ydeevne
En rapport om undersøgelse af klinisk ydeevne, underskrevet af en læge eller en anden adkomstberettiget person, skal indeholde dokumenterede oplysninger om planen for protokollen for undersøgelse af klinisk ydeevne, resultater og konklusioner af undersøgelsen, herunder negative resultater. Resultater og konklusioner skal være gennemsigtige, objektive og klinisk relevante. Rapporten skal indeholde tilstrækkelige oplysninger til at kunne forstås af en uafhængig part uden reference til andre dokumenter. Det skal desuden fremgå af rapporten, hvilke ændringer af protokollen og afvigelser herfra der i givet fald er foretaget, samt hvilke data der ikke er medtaget, med en begrundelse herfor.
3.   ANDRE UNDERSØGELSER AF YDEEVNE
Analogt dokumenteres planen for undersøgelse af ydeevne, jf. punkt 2.3.2, og rapporten om undersøgelse af ydeevne, jf. punkt 2.3.3, for andre undersøgelser af ydeevne end undersøgelser af klinisk ydeevne.
DEL B
OPFØLGNING AF YDEEVNE, EFTER AT UDSTYRET ER BRAGT I OMSÆTNING (PMPF)
4.   PMPF skal forstås som en kontinuerlig proces, der opdaterer ydeevneevalueringen, jf. artikel 56 og dette bilags del A, og skal specifikt behandles i fabrikantens plan for overvågning, efter at udstyret er bragt i omsætning. Ved gennemførelsen af PMPF skal fabrikanten proaktivt indsamle og evaluere data om ydeevne og relevante videnskabelige data fra anvendelsen af udstyr, der er forsynet med CE-mærkning, og som er bragt i omsætning eller ibrugtaget som tilsigtet, jf. den relevante overensstemmelsesvurderingsprocedure, med det erklærede formål at bekræfte udstyrets sikkerhed, ydeevne og videnskabelige validitet i hele dets forventede levetid, sikre at forholdet mellem fordele og risici fortsat er acceptabelt og påvise nye risici på grundlag af faktuel evidens.
5.   PMPF skal udføres i henhold til en dokumenteret metode, der er fastlagt i en PMPF-plan.
5.1.   PMPF-planen skal specificere metoderne og procedurerne til proaktiv indsamling og evaluering af data om sikkerhed og ydeevne samt videnskabelige data med det formål at:
a)
bekræfte udstyrets sikkerhed og ydeevne i hele dets forventede levetid
b)
identificere hidtil ukendte risici eller begrænsninger af ydeevnen og kontraindikationer
c)
identificere og analysere nye risici på grundlag af faktuelle oplysninger
d)
sikre at den kliniske dokumentation og forholdet mellem fordele og risici fortsat er acceptabelt, jf. bilag I, kapitel I, punkt 1 og 8, og
e)
identificere eventuel systematisk forkert brug.
5.2.   PMPF-planen skal mindst indeholde:
a)
de generelle metoder og procedurer i forbindelse med PMPF, der skal anvendes, som f.eks. indsamling af kliniske erfaringer, feedback fra brugere, gennemgang af videnskabelig litteratur og af andre kilder til data om ydeevne eller videnskabelige data
b)
de særlige metoder og procedurer i forbindelse med PMPF, der skal anvendes, f.eks. ringtest og andre kvalitetssikringsaktiviteter, epidemiologiske undersøgelser, evaluering af egnede patient- og sygdomsregistre, genetiske databaser eller undersøgelser af klinisk ydeevne, efter at udstyret er bragt i omsætning
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 rapporten om ydeevneevaluering, jf. dette bilags punkt 1.3, og risikostyringen, jf. bilag I, punkt 3
e)
de specifikke formål, som PMPF skal fokusere på
f)
en evaluering af dataene om ydeevne vedrørende tilsvarende eller lignende udstyr samt det aktuelle tekniske niveau
g)
en henvisning til eventuelle relevante fælles specifikationer, harmoniserede standarder, når de anvendes af fabrikanten, og relevante retningslinjer vedrørende PMPF og
h)
en detaljeret og behørigt begrundet tidsplan for PMPF-aktiviteter, f.eks. analyse af PMPF-data og -afrapportering, der skal gennemføres af fabrikanten.
6.   Fabrikanten skal analysere resultaterne af PMPF og dokumentere dem i en PMPF-evalueringsrapport, som skal opdatere rapporten om ydeevneevaluering og indgå i den tekniske dokumentation.
7.   Konklusionerne i PMPF-evalueringsrapporten tages i betragtning ved ydeevneevalueringen, jf. artikel 56 og dette bilags del A, og i forbindelse med risikostyringen, jf. bilag I, punkt 3. Hvis der i forbindelse med PMPF konstateres et behov for forebyggende og/eller korrigerende foranstaltninger, skal disse iværksættes af fabrikanten.
8.   Hvis PMPF ikke anses som hensigtsmæssig for et specifikt udstyr, skal der gives en begrundelse herfor, og det skal dokumenteres i rapporten om ydeevneevaluering.
BILAG XIV
INTERVENTIONSUNDERSØGELSER AF KLINISK YDEEVNE OG VISSE ANDRE UNDERSØGELSER AF YDEEVNE
KAPITEL I
DOKUMENTATION FOR ANSØGNING OM INTERVENTIONSUNDERSØGELSER AF KLINISK YDEEVNE OG ANDRE UNDERSØGELSER AF YDEEVNE, DER INDEBÆRER RISICI FOR DE FORSØGSPERSONER, DER ER GENSTAND FOR UNDERSØGELSERNE
For udstyr, der er beregnet til at blive anvendt i forbindelse med interventionsundersøgelser af klinisk ydeevne og andre undersøgelser af ydeevne, der indebærer risici for de forsøgspersoner, der er genstand for undersøgelserne, skal sponsoren udarbejde og indsende en ansøgning i overensstemmelse med artikel 58 sammen med følgende dokumentation:
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 58, stk. 4, i Unionen
1.2.
hvis forskelligt fra punkt 1.1, navn, adresse og kontaktoplysninger for fabrikanten af udstyret bestemt til ydeevneevaluering og, hvis det er relevant, for dennes autoriserede repræsentant
1.3.
titel på undersøgelsen af ydeevne
1.4.
det individuelle identifikationsnummer i overensstemmelse med artikel 66, stk. 1
1.5.
status for undersøgelsen af ydeevne, f.eks. første indsendelse af en ansøgning, genindsendelse, væsentlig ændring
1.6.
nærmere oplysninger og/eller henvisning til planen for undersøgelse af ydeevne, herunder f.eks. nærmere oplysninger om designfasen af undersøgelsen af ydeevne
1.7.
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
1.8.
hvis ansøgningen indsendes samtidig med en ansøgning om et klinisk forsøg i overensstemmelse med forordning (EU) nr. 536/2014, henvises der til det officielle registreringsnummer for det kliniske forsøg
1.9.
identifikation af de medlemsstater og tredjelande, hvor undersøgelsen af klinisk ydeevne skal foretages som led i en multicenterundersøgelse eller multinational undersøgelse på ansøgningstidspunktet
1.10.
kort beskrivelse af udstyr, hvis ydeevne skal undersøges, dets klassificering og andre oplysninger, der er nødvendige for at kunne identificere udstyret og udstyrstypen
1.11.
sammenfatning af planen for undersøgelse af ydeevne
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 vurdere den kliniske undersøgelse af ydeevne i overensstemmelse med planen for undersøgelse af ydeevne
1.14.
nærmere oplysninger om den forventede startdato og varigheden af undersøgelsen af ydeevne
1.15.
nærmere oplysninger til identifikation af det bemyndigede organ, hvis et sådant allerede er involveret på det tidspunkt, hvor ansøgningen om undersøgelse af ydeevne indsendes
1.16.
bekræftelse af, at sponsor er klar over, at den kompetente myndighed kan kontakte den etiske komité, der vurderer eller har vurderet ansøgningen
1.17.
den erklæring, der er nævnt i punkt 4.1.
2.
Investigators brochure
Investigators brochure (IB) skal indeholde de oplysninger om udstyr, hvis ydeevne skal undersøges, der er relevante for undersøgelsen, 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, risikoklassificering og gældende klassificeringsregel 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 krav til brug, herunder krav til opbevaring og håndtering, samt i det omfang sådanne oplysninger er tilgængelige, oplysninger, der anføres på mærkningen, og brugsanvisning, der skal leveres med udstyret, når det bringes i omsætning. Desuden oplysninger om enhver relevant påkrævet uddannelse
2.3.
analytisk ydeevne
2.4.
eksisterende kliniske data, navnlig:
—
fra relevant videnskabelig litteratur, der har været underkastet peer review, og tilgængelige konsensusudtalelser eller -holdninger fra eksperter fra relevante faglige organisationer, som vedrører udstyrets og/eller tilsvarende eller lignende udstyrs sikkerhed, ydeevne, kliniske fordele for patienter, designkarakteristika, videnskabelige validitet, kliniske ydeevne og erklærede formål
—
andre relevante tilgængelige kliniske data, som vedrører sikkerhed, videnskabelig validitet, klinisk ydeevne, kliniske fordele for patienter, designkarakteristika og erklæret formål for tilsvarende udstyr, herunder oplysninger om deres ligheder og forskelle i forhold til det pågældende udstyr
2.5.
resumé af analysen af forholdet mellem fordele og risici, herunder oplysninger om kendte eller forudsigelige risici og advarsler
2.6.
for udstyr, der indeholder væv, celler og stoffer af human, animalsk, eller mikrobiel oprindelse, detaljerede oplysninger om det eller de pågældende væv, celler og stoffer samt om overensstemmelse med de generelle krav til sikkerhed og ydeevne og de særlige risikostyringsforanstaltninger for dette eller disse væv, celler og stoffer
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 delvis overholdt, samt en beskrivelse af de løsninger, der er anvendt til at opfylde de relevante generelle krav til sikkerhed og ydeevne, for så vidt som de pågældende standarder og fælles specifikationer ikke eller kun delvis er overholdt eller mangler
2.8.
en detaljeret beskrivelse af de kliniske procedurer og diagnostiske prøvninger, der er brugt i løbet af undersøgelsen af ydeevne, navnlig oplysninger om enhver afvigelse fra normal klinisk praksis.
3.
Plan for undersøgelse af ydeevne, jf. bilag XIII, punkt 2 og 3.
4.
Andre oplysninger
4.1.
erklæring underskrevet af den fysiske eller juridiske person, der er ansvarlig for fremstillingen af udstyr, hvis ydeevne skal undersøges, om, at det pågældende udstyr er i overensstemmelse med de generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I, undtagen de aspekter, der er omfattet af undersøgelsen af klinisk ydeevne, og at der med hensyn til de pågældende 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 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 65 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.
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 fortrolighed af registreringer og personoplysninger om forsøgspersoner
—
en beskrivelse af de foranstaltninger, der vil blive iværksat i tilfælde af 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, indsendes efter anmodning til den kompetente myndighed, der behandler en ansøgning.
KAPITEL II
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 dette bilags kapitel I. Hvis sponsor ikke er den fysiske eller juridiske person, der er ansvarlig for fremstillingen af udstyret bestemt til undersøgelse af ydeevne, kan dette krav opfyldes af den pågældende person på vegne af sponsor.
2.
Sponsor skal have indgået en aftale til sikring af, at enhver alvorlig uønsket hændelse eller enhver anden hændelse, der er omhandlet i artikel 76, 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 undersøgelse af ydeevne med det pågældende udstyr er afsluttet, eller, hvis udstyret efterfølgende bringes i omsætning, i mindst 10 år, efter at det sidste udstyr er bragt i omsætning.
Hver medlemsstat skal kræve, at den i dette bilag omhandlede dokumentation kan stilles til rådighed for de kompetente myndigheder i den periode, der er omhandlet i første afsnit, hvis sponsor eller dennes kontaktperson, der 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 undersøgelsen af klinisk ydeevne foretages i overensstemmelse med planen for undersøgelse af klinisk ydeevne, principperne for god klinisk praksis og denne forordning.
5.
Sponsor skal fuldføre opfølgningen af afprøvningens forsøgspersoner.
BILAG XV
SAMMENLIGNINGSTABEL
Direktiv 98/79/EF
Denne forordning
Artikel 1, stk. 1
Artikel 1, stk. 1
Artikel 1, stk. 2
Artikel 2
Artikel 1, stk. 3
Artikel 2, nr. 54) og 55)
Artikel 1, stk. 4
—
Artikel 1, stk. 5
Artikel 5, stk. 4 og 5
Artikel 1, stk. 6
Artikel 1, stk. 9
Artikel 1, stk. 7
Artikel 1, stk. 5
Artikel 2
Artikel 5, stk. 1
Artikel 3
Artikel 5, stk. 2
Artikel 4, stk. 1
Artikel 21
Artikel 4, stk. 2
Artikel 19, stk. 1 og 2
Artikel 4, stk. 3
Artikel 19, stk. 3
Artikel 4, stk. 4
Artikel 10, stk. 10
Artikel 4, stk. 5
Artikel 18, stk. 6
Artikel 5, stk. 1
Artikel 8, stk. 1
Artikel 5, stk. 2
—
Artikel 5, stk. 3
Artikel 9
Artikel 6
—
Artikel 7
Artikel 107
Artikel 8
Artikel 89 og 92
Artikel 9, stk. 1, første afsnit
Artikel 48, stk. 10, første afsnit
Artikel 9, stk.1, andet afsnit
Artikel 48, stk. 3, andet afsnit, stk. 7, andet afsnit, og stk. 9, andet afsnit
Artikel 9, stk. 2
Artikel 48, stk. 3-6
Artikel 9, stk. 3
Artikel 48, stk. 3-9
Artikel 9, stk. 4
Artikel 5, stk. 6
Artikel 9, stk. 5
—
Artikel 9, stk. 6
Artikel 11, stk. 3 og 4
Artikel 9, stk. 7
Artikel 10, stk. 7
Artikel 9, stk. 8
Artikel 49, stk. 1
Artikel 9, stk. 9
Artikel 49, stk. 4
Artikel 9, stk. 10
Artikel 51, stk. 2
Artikel 9, stk. 11
Artikel 48, stk. 12
Artikel 9, stk. 12
Artikel 54, stk. 1
Artikel 9, stk. 13
Artikel 48, stk. 2
Artikel 10, stk. 1 og 2, artikel 10, stk. 3, andet punktum, og artikel 10, stk. 4
Artikel 26, stk. 3, og artikel 27 og 28
Artikel 10, stk. 3, første punktum
Artikel 11, stk. 1
Artikel 11, stk. 1
Artikel 82, stk. 1, og artikel 84, stk. 2
Artikel 11, stk. 2
Artikel 82, stk. 10, og artikel 82, stk. 11, første afsnit
Artikel 11, stk. 3
Artikel 84, stk. 7
Artikel 11, stk. 4
—
Artikel 11, stk. 5
Artikel 86
Artikel 12
Artikel 30
Artikel 13
Artikel 93
Artikel 14, stk. 1, litra a)
—
Artikel 14, stk. 1, litra b)
Artikel 47, stk. 3 og 6
Artikel 14, stk. 2
—
Artikel 14, stk. 3
—
Artikel 15, stk. 1
Artikel 38 og 39
Artikel 15, stk. 2
Artikel 32
Artikel 15, stk. 3
Artikel 40, stk. 2 og 4
Artikel 15, stk. 4
—
Artikel 15, stk. 5
Artikel 51, stk. 5
Artikel 15, stk. 6
Artikel 51, stk. 4
Artikel 15, stk. 7
Artikel 34, stk. 2, og artikel 40, stk. 2
Artikel 16
Artikel 18
Artikel 17
Artikel 89-92
Artikel 18
Artikel 94
Artikel 19
Artikel 102
Artikel 20
Artikel 97
Artikel 21
—
Artikel 22
—
Artikel 23
—
Artikel 24
—

Summary:
Medicinsk udstyr til in vitro-diagnostik — sikkerhed og ydeevne
RESUMÉ AF:
Forordning (EU) 2017/746 om medicinsk udstyr til in vitro-diagnostik
HVAD ER FORMÅLET MED FORORDNINGEN?
Den ajourfører reglerne om at bringe 
medicinsk udstyr til 
in vitro
-diagnostik
1
 i omsætning i 
Den Europæiske Union
 (EU), gøre det tilgængeligt og ibrugtagning af det 
til humant brug
 og tilbehør hertil.
Den fastsætter også regler om gennemførelse af 
undersøgelser af ydeevne
2
 for medicinsk udstyr til in vitro-diagnostik eller tilbehør hertil.
Derudover har forordningen til formål at forbedre 
patientsikkerheden
 ved at indføre strengere procedurer for 
overensstemmelsesvurdering
 (for at sikre, at produkter, der ikke er sikre eller ikke opfylder kravene, ikke ender på markedet) og 
overvågning, efter at udstyret er bragt i omsætning
.
HOVEDPUNKTER
Anvendelsesområde
Forordningen dækker medicinsk udstyr til in vitro-diagnostik til humant brug og tilbehør hertil (i det følgende benævnt udstyr). Udstyr, der fremstilles og anvendes på samme sundhedsinstitution, er dog undtaget fra reglerne, bortset fra dem vedrørende krav til generel sikkerhed og ydelse, forudsat at en række betingelser er opfyldt.
Klassificeringssystem
Klassificeringssystemet for udstyret er blevet tilpasset i forhold til de betydelige forskningsmæssige fremskridt på området og internationale retningslinjer. Udstyret klassificeres i henhold til det erklærede formål og de dermed forbundne risici (klasse A, B, C og D — for yderligere oplysninger henvises til forordningens bilag VIII).
Harmoniserede standarder og fælles specifikationer
En 
gennemførelsesretsakt
 vedtaget af 
Europa-Kommissionen
 — gennemførelsesafgørelse (EU) 
2021/1195
, som ændret — indeholder en liste over harmoniserede standarder, der blev udarbejdet til støtte for forordning (EU) 2017/746.
Kommissionens gennemførelsesforordning (EU) 
2022/1107
 fastlægger fælles specifikationer for ydeevnen af bestemt udstyr i klasse D. Fabrikanterne skal følge specifikationerne eller vise, at deres alternative løsning som minimum er tilsvarende med hensyn til udstyrets sikkerhed og ydeevne.
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 høje kvalitetsstandarder i hele EU og skal have det fornødne personale til at kunne udføre deres opgaver i forbindelse med overensstemmelsesvurdering.
Der skal foretages inspektioner på stedet hos fabrikanter, hvoraf nogle skal være uanmeldte.
Gennemførelsesforordning (EU) 
2017/2185
 fastlægger en liste over koder og tilsvarende typer af udstyr med henblik på at præcisere rammerne for udpegelsen af bemyndigede organer på området medicinsk udstyr til in vitro-diagnostik.
Undersøgelser af ydeevne
Fabrikanten skal understøtte sine angivelser om udstyrets ydeevne med velfunderet dokumentation, herunder videnskabelig validitet samt analytiske og kliniske ydeevnedata.
Forordningen fastsætter krav i forbindelse med dataindsamling af højrisikoundersøgelser af ydeevne af udstyr.
Undersøgelser af ydeevne, der gennemføres i mere end én 
medlemsstat
, skal undergå en 
koordineret vurdering
.
Forordningen gælder også undersøgelser af ydeevne, der udføres i ikke-EU-lande, hvis de benytter prøvemateriale fra EU-patienter.
Fabrikanternes forpligtelser
Fabrikanter:
pålægges klarere og strengere forpligtelser til at overvåge kvalitet, ydeevne og sikkerhed for de producerede enheder
skal indføre foranstaltninger, der svarer til risikoniveau, enhedstype og virksomhedens størrelse
skal sikre, at de har tilstrækkelig økonomisk dækning for et eventuelt erstatningsansvar i henhold til 
produktansvarsdirektivet
 (re 
resumé
) samt 
systemer til kvalitetssikring og overvågning, efter at udstyret er bragt i omsætning
.
I tilfælde af skade som følge af defekt udstyr hæfter fabrikantens autoriserede repræsentant solidarisk.
Sporbarhed
Et system med 
unikke udstyrsidentifikatorer (UDI’er)
 til registrering af udstyr og fabrikanter, importører og autoriserede repræsentanter sikrer udstyrs sporbarhed i hele forsyningskæden, og at der hurtigt kan træffes foranstaltninger i tilfælde af problemer.
Gennemførelsesafgørelse (EU) 
2019/939
 indeholder en liste over enheder, som er udpeget til at drive et system til tildeling af UDI’er inden for medicinsk udstyr.
Højrisikoudstyr
Hvad angår 
første certificering af nyt udstyr i klasse D
, for hvilket der ikke findes fælles specifikationer, vil et 
ekspertpanel
 fremlægge sine synspunkter’ om udstyrets ydeevne. Selvom panelets udtalelse ikke er bindende for det bemyndigede organ, skal der dog fremlægges begrundelse for ikke at følge udtalelsen.
Kommissionen kan udpege 
EU-referencelaboratorier
, som skal afprøve, om udstyr i klasse D har den af fabrikanten anførte ydeevne. Det bemyndigede organ må ikke udstede et certifikat for udsyret, hvis den videnskabelige udtalelse fra EU’s referencelaboratorium er negativ.
EU-referencelaboratoriernes opgaver og kriterier i forbindelse med medicinsk udstyr til in vitro-diagnostik er fastlagt i gennemførelsesforordning (EU) 
2022/944
.
Gennemførelsesforordning (EU) 
2022/945
 fastlægger regler for gebyrer, som EU-referencelaboratorierne kan opkræve med hensyn til medicinsk udstyr til in vitro-diagnostik.
Genetisk rådgivning
Patienter, der gennemgår en genetisk test, skal modtage alle relevante oplysninger om den genetiske tests karakter, betydning og implikationer. De skal tilbydes passende adgang til rådgivning, hvis der anvendes genetiske test, som giver oplysninger om genetisk disposition for medicinske tilstande og/eller sygdomme, som generelt anses for at være uhelbredelige.
Indberetning af hændelser
Ud over fabrikanternes pligt til at indberette alvorlige hændelser (som medfører dødsfald eller alvorlig forværring af personens helbredstilstand) og tendenser inden for hændelser, der ikke er alvorlige (f.eks. bivirkninger ved brug af udstyret), 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.
Markedsovervågning
De relevante myndigheder i medlemsstaterne er ansvarlige for at kontrollere, at udstyr på deres markeder overholder forordningen og ikke bringer patienters, brugeres eller andre personers sundhed eller sikkerhed i fare.
Eudamed
Der udarbejdes en central database med titlen 
europæisk database for medicinsk udstyr (Eudamed)
 med det formål at tilvejebringe oplysninger om medicinsk udstyr, der er tilgængeligt i EU, for medlemsstaterne, erhvervsvirksomheder, patienter, sundhedsfaglige personer og offentligheden.
Gennemførelsesforordning (EU) 
2021/2078
 fastlægger de nødvendige ordninger for etablering og vedligeholdelse af Eudamed.
Overgangsperioder
Eftersom covid-19-pandemien skabte udfordringer i forbindelse med at sikre korrekt gennemførelse og anvendelse, blev forordning (EU) 2017/746 ændret ved forordning (EU) 
2022/112
, som forlængede nogle overgangsperioder for allerede markedsført udstyr i henhold til disses risikoklasse på følgende måde:
for højrisikoudstyr, såsom HIV- eller hepatitistest (klasse D) og visse influenzatest (klasse C) udløber overgangsperioden henholdsvis den 
26. maj 2025
 og 
26. maj 2026
for udstyr med lavere risiko, såsom udstyr i klasse B og sterilt udstyr i klasse A, udløber overgangsperioden den 
26. maj 2027
.
Overgangsperioden for de fleste af de krav, der gælder for udstyr, der er fremstillet og anvendt inden for samme sundhedsinstitution (internt udstyr), blev forlænget frem til maj 2024. Kravet om at godtgøre, at patienternes behov ikke kan opfyldes af tilsvarende udstyr på markedet, gælder fra maj 2028.
Ophævelse af lovgivning
Forordningen ophæver direktiv 
98/79/EF
 og afgørelse 
2010/227/EU
 fra den 
26. maj 2022
 med visse undtagelser, der er fastlagt i artikel 112.
HVORNÅR GÆLDER FORORDNINGEN FRA?
Den trådte i kraft den 
26. maj 2022
. Anvendelsesdatoerne for nogle af artiklerne i forordningen varierer og er anført i artikel 110 og 113.
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) 2017/745
) omhandler medicinsk udstyr.
Som følge af behovet for at teste for tilstedeværelse af eller tidligere eksponering for coronavirus under covid-19-pandemien vedtog Kommissionen 
retningslinjer vedrørende test til 
in vitro
-diagnostik af covid-19 og deres ydeevne
 i april 2020.
For yderligere oplysninger henvises til:
Medicinsk udstyr
 (Europa-Kommissionen)
In vitro
-diagnostik
 — pressemeddelelse (Europa-Kommissionen)
Gradvis implementering af forordningen om medicinsk udstyr til 
in vitro
-diagnostik
 — pressemeddelelse (Europa-Kommissionen).
VIGTIGE BEGREBER
Medicinsk udstyr til in vitro-diagnostik.
 Begrebet dækker mange forskellige typer udstyr, der bruges til at få oplysninger om: a) en fysiologisk eller patologisk proces eller tilstand, b) medfødte fysiske eller mentale handicap, c) disposition for en medicinsk tilstand eller sygdom, d) sikkerhed for og kompatibilitet af anvendte materialer med prøver fra potentielle recipienter, e) reaktioner på behandlinger, f) definition eller monitorering af terapeutiske foranstaltninger. Det kan for eksempel være graviditetstest og test af meget overførbare agenser ved hjælp af menneskelige vævsprøver.
Undersøgelser af ydeevne.
 Undersøgelser, der fastlægger eller bekræfter et udstyrs analytiske eller kliniske ydeevne.
HOVEDDOKUMENTER
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
).
Efterfølgende ændringer til forordning (EU) 2017/746 er blevet indarbejdet i grundteksten. Denne 
konsoliderede udgave
 har ingen retsvirkning.
Meddelelse
 fra Kommissionen — Retningslinjer vedrørende test til in vitro-diagnostik af covid-19 og deres ydeevne (EUT C 122I af 
15.4.2020
, 
s. 1-7
).
TILHØRENDE DOKUMENTER
Kommissionens gennemførelsesforordning (EU) 
2022/1107
 af 
4. juli 2022
 om fastlæggelse af fælles specifikationer for visse former for medicinsk udstyr til in vitro-diagnostik i klasse D i overensstemmelse med Europa-Parlamentets og Rådets forordning (EU) 2017/746 (EUT L 178 af 
5.7.2022
, 
s. 3-56
).
Kommissionens gennemførelsesforordning (EU) 
2022/944
 af 
17. juni 2022
 om regler for anvendelsen af Europa-Parlamentets og Rådets forordning (EU) 2017/746 for så vidt angår opgaver og kriterier for EU-referencelaboratorier med hensyn til medicinsk udstyr til in vitro-diagnostik (EUT L 164 af 
20.6.2022
, 
s. 7-19
).
Kommissionens gennemførelsesforordning (EU) 
2022/945
 af 
17. juni 2022
 om regler for anvendelsen af Europa-Parlamentets og Rådets forordning (EU) 2017/746 for så vidt angår de gebyrer, som EU-referencelaboratorier kan opkræve med hensyn til medicinsk udstyr til in vitro-diagnostik (EUT L 164 af 
20.6.2022
, 
s. 20-22
).
Kommissionens gennemførelsesforordning (EU) 
nr. 
2021/2078
 af 
26. november 2021
 om regler for anvendelsen af Europa-Parlamentets og Rådets forordning (EU) 2017/745 for så vidt angår den europæiske database for medicinsk udstyr (Eudamed) (EUT L 426 af 
29.11.2021
, 
s. 9-15
).
Kommissionens gennemførelsesafgørelse (EU) 
2021/1195
 af 
19. juli 2021
 om harmoniserede standarder for medicinsk udstyr til in vitro-diagnostik, der er udarbejdet til støtte for Europa-Parlamentets og Rådets forordning (EU) 2017/746 (EUT L 258 af 
20.7.2021
, 
s. 50-52
).
Efterfølgende ændringer af gennemførelsesafgørelse (EU) 2021/1195 er indarbejdet i grundteksten. Denne 
konsoliderede udgave
 har ingen retsvirkning.
Kommissionens gennemførelsesafgørelse (EU) 
2019/939
 af 
6. juni 2019
 om udpegelse af udstedende enheder, som er udpeget til at drive et system til tildeling af unikke udstyrsidentifikatorer (UDI), på området for medicinsk udstyr (EUT L 149 af 
7.6.2019
, 
s. 73-75
).
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
).
Se den 
konsoliderede udgave
.
Kommissionens afgørelse 
2010/227/EU
 af 
19. april 2010
 om den europæiske database for medicinsk udstyr (Eudamed) (EUT L 102 af 
23.4.2010
, 
s. 45-48
).
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. 1-37
).
Se den 
konsoliderede udgave
.
seneste ajourføring 
24.8.2022