P7_TA(2014)0266

Medical devices ***I

European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 — C7-0318/2012 — 2012/0266(COD))

(Ordinary legislative procedure: first reading)

(2017/C 408/15)

The European Parliament,

having regard to the Commission proposal to Parliament and the Council (COM(2012)0542),

having regard to Article 294(2) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0318/2012),

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

having regard to the opinion of the European Economic and Social Committee of 14 February 2013 (1) ,

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Employment and Social Affairs and the Committee on the Internal Market and Consumer Protection (A7-0324/2013),

Adopts as its position at first reading the text adopted on 22 October 2013 (2) ;

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

(1) OJ C 133, 9.5.2013, p. 52.

(2) P7_TA(2013)0428.

P7_TC1-COD(2012)0266

Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

(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 Articles 114 and 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),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.

(1a) The desire to provide swift access to new medical devices for patients should never take precedence over the need to ensure patient safety. [Am. 1]

(2) This Regulation aims to ensure the functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients, users and operators. At the same time, this Regulation sets high standards of quality and safety for medical devices to meet common safety concerns as regards these products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 TFEU, this Regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market which may then 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 those medical devices by ensuring, among other things, that data generated in clinical investigations is reliable and robust and that the safety of the subjects participating in a clinical investigation is protected. [Am. 2]

(2a) Council Directive 2010/32/EU (5) guarantees safety not just for patients but also for users of sharp needles. Directive 2010/63/EU of the European Parliament and of the Council (6) states that tests on vertebrate animals must be replaced, restricted or refined. [Ams. 3 and 4]

(3) Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding devices should be introduced, to improve health and safety for health professionals, patients, users and operators, including in the waste disposal chain. [Am. 5]

(3a) In the area of medical devices many SMEs are active. This should be taken into account when regulating the sector without compromising the safety and health aspects. [Am. 6]

(4) To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative the International Medical Devices Regulators Forum, 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 criteria, conformity assessment procedures and clinical investigations.

(5) For historic reasons active implantable medical devices, covered by Directive 90/385/EEC, and other medical devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments. In the interest of simplification, both directives, which have been amended several times, should be replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical devices.

(6) A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for divergent transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Union.

(7) The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food. Therefore, Since in some cases it is difficult to distinguish between medical devices and cosmetic, medicinal or food products, the possibility to take a Union-wide decision regarding the regulatory status of a product should be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council (7), Directive 2004/27/EC of the European Parliament and of the Council (8), Regulation (EC) No 178/2002 of the European Parliament and of the Council (9) of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety and Directive 2002/46/EC of the European Parliament and of the Council (10). Those Union acts Authority and laying down procedures in matters of food safety should therefore be amended to exclude medical devices from its scope. [Am. 7]

(7a) A multidisciplinary Medical Device Advisory Committee (MDAC) composed of experts and representatives of the relevant stakeholders should be set up to provide scientific advice to the Commission, the Medical Device Coordination Group (MDCG) and Member States on issues of medical technology, the regulatory status of devices and other aspects of implementation of this Regulation as necessary. [Am. 8]

(8) It In order to ensure consistent classification across all Member States, particularly with regards to borderline cases, it should be the responsibility of the Member States Commission, having consulted the MDCG and the MDAC, to decide on a case-by-case basis whether or not a product falls or groups of products fall within the scope of this Regulation. If necessary, the Commission may decide, on a case-by-case basis, whether or not a product falls within the definition of a medical device or of an accessory to a medical device. Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility to take an EU-wide decision regarding the regulatory status of a product should also be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products Member States should also have the possibility to request the Commission to take a decision on the appropriate regulatory status of a product, or category or group of products. [Am. 9]

(9) Products which combine a medicinal product or substance and a medical device, are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council (11). It should be ensured that appropriate interaction exists between the two legislative acts in terms of consultations during the pre-market assessment and exchange of information on vigilance cases occurring with combination products. For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements of the device part should be adequately assessed in the context of the marketing authorisation. Directive 2001/83/EC should therefore be amended.

(10) Union legislation is incomplete in respect of certain products manufactured utilising non-viable human tissues or cells that have undergone substantial manipulation and that are not covered by Regulation (EC) No 1394/2007 of the European Parliament and of the Council (12). Whilst donation, procurement and testing of the human tissues and cells used for the manufacture of those products should remain within the scope of Directive 2004/23/EC of the European Parliament and of the Council (13), the finished product should come under the scope of this Regulation. Human tissues and cells that are not substantially manipulated, such as human demineralised bone matrix, and products derived from such tissues and cells, should not be covered by this Regulation.

(11) Certain implantable and other invasive products for which the manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation.

(11a) Unregulated non-intrusive devices, such as non-corrective contact lenses for cosmetic purposes, can cause health complications — such as microbial keratitus — when manufactured or used incorrectly. Appropriate safety standards must be in place to protect the safety of consumers who decide to use such products. [Am. 10]

(12) Like for products that contain viable tissues or cells of human or animal origin, that are explicitly excluded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that products that contain living biological substances of other origin that achieve their intended purpose by pharmacological, immunological or metabolic means are also not covered by this Regulation. [Am. 11]

(12a) Devices for use in blood donation and blood therapy should meet the requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (14). [Am. 12]

(12b) The advertising of cosmetic surgery should be better regulated, in order to ensure that patients are fully aware of the risks as well as the benefits. [Am. 13]

(13) There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health and safety protection for health professionals, operators and patients, as well as free movement of goods, and legal certainty for manufacturers and responsibility on their part, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU (15), with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of medical devices, the manufacturers should take special care when using nanoparticles that can be which are intended to be intentionally released to in the human body and those devices should be subject to the most severe conformity assessment procedure. [Am. 14]

(13a) Medical devices used in the donation of substances of human origin and their subsequent use for treatment must conform to Union public health legislation ensuring minimum standards for quality and safety, including Directive 2002/98/EC on minimum standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and its additional directives. [Am. 15]

(14) Aspects addressed by Directive 2004/108/EC of the European Parliament and of the Council (16) and aspects addressed by Directive 2006/42/EC of the European Parliament and of the Council (17) are an integral part of the general safety and performance requirements for medical devices. Consequently, this Regulation should be considered a lex specialis in relation to those Directives.

(15) This Regulation should include requirements regarding the design and manufacture of medical devices emitting ionizing radiation without affecting the application of Council Directive 96/29/Euratom (18) nor of Council Directive 97/43/Euratom (19) which pursue other objectives.

(15a) This Regulation includes requirements regarding the design, safety and performance characteristics of medical devices intended to prevent occupational injuries as laid down in Directive 2010/32/EU. [Am. 16]

(16) It should be made clear that the requirements of this Regulation also apply to the countries that have entered into international agreements with the Union which confer on that country the same status as a Member State for the purpose of application of this Regulation, as it is currently the case with the Agreement on the European Economic Area (20), the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (21) and the Agreement of 12 September 1963 establishing an association between the European Economic Community and Turkey (22).

(17) It should be made clear that medical devices offered to persons in the Union by means of information society services within the meaning of Directive 98/34/EC of the European Parliament and of the Council (23) as well as devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union must comply with the requirements of this Regulation at the latest when the product is placed on the market or the service is provided in the Union.

(18) It is appropriate to adapt the general safety and performance requirements to technical and scientific progress, for example for software that is specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device.

(19) To recognise the important role of standardisation and traceability in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (24) should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as quality and risk management. [Am. 17]

(19a) With devices that consist of more than one implantable part, such as hip implants, compatibility of the parts of different manufacturers should be ensured in order to avoid the replacement of the functional part of the device and thus unnecessary risks and inconvenience for patients. The Commission should investigate the need for further measures to ensure the compatibility of the equivalent parts of hip implants from different manufacturers, bearing in mind that the hip operations are most often carried out on older people for whom the health risks of operations are higher. [Am. 18]

(20) Directive 98/79/EC of the European Parliament and of the Council (25) 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 not sufficient, the Commission should be empowered to lay down technical specifications which provide a means to comply with general safety and performance requirements and requirements for clinical evaluation and/or post-market clinical follow-up.

(21) The definitions in the field of medical devices, for example regarding economic operators, clinical investigations and vigilance, should be aligned with well-established practice at Union and international level in order to enhance legal certainty.

(21a) Directive 2013/35/EU of the European Parliament and of the Council (26) should be the reference text for ensuring that people working in the vicinity of magnetic resonance imaging equipment when it is functioning are properly protected. [Am. 19]

(22) The rules applicable to medical 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 (27) and Decision No 768/2008/EC of the European Parliament and of the Council (28).

(23) The rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to medical devices and their accessories covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks.

(24) It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors as laid down in the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the different parts of this Regulation, to enhance understanding of the legal requirements and thus to improve regulatory compliance by the relevant operators. Conditions enabling small and medium-sized enterprises with smart specialisation to have easier access to that market should be established. [Am. 20]

(25) Several of the obligations on manufacturers, such as clinical evaluation or vigilance reporting, that were set out only in the annexes of Directives 90/385/EEC and 93/42/EEC should be incorporated into the enacting provisions of this Regulation to enhance legal certainty.

(25a) To ensure that patients harmed are compensated for any damage and associated treatment as a result of a faulty medical device, that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by a faulty medical device, manufacturers should be obliged to take liability insurance with sufficient minimum coverage. [Am. 21]

(26) To ensure that medical devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of their medical devices is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance plan in place which should be proportionate to the risk class and the type of the medical device.

(27) It should be ensured that supervision and control of the manufacture of medical devices is carried out within the manufacturer's organisation by a person who fulfils minimum conditions of qualification. In addition to regulatory compliance, that person could also be responsible for compliance in other fields such as manufacturing processes and quality assessment. The required qualifications of the person responsible for the regulatory compliance should be without prejudice to national provisions regarding professional qualifications, in particular for manufacturers of custom-made devices where such requirements could be met through different educational and professional training systems at national level. [Am. 22]

(28) For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the medical devices produced by those manufacturers and in serving as their contact person established in the Union. The tasks of an authorised representative should be defined in a written mandate with the manufacturer which for example may allow the authorised representative to lodge an application for a conformity assessment procedure, to report events under the vigilance system or to register devices placed on the Union market. The mandate should empower the authorised representative to duly fulfil certain defined tasks. Considering the role of authorised representatives, the minimum requirements to be met by them 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 qualified person but, with a view to the authorised representative's tasks, could also be satisfied by a person with qualification in law.

(29) 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 medical device.

(30) 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 set by the protection of health and safety and by the protection of intellectual property rights provided by Article 36 TFEU. Application of this principle 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 European Court of Justice (29) in other relevant sectors and existing good practices in the field of medical devices.

(31) The findings of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), established by Commission Decision 2008/721/EC (30), in its scientific opinion of 15 April 2010 on the safety of reprocessed medical devices marketed for single-use, and of the Commission in its report of 27 August 2010 to the European Parliament and the Council on the issue of reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC (31), call for regulation of the reprocessing of single-use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions. By reprocessing a single-use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed device.

(31a) The current possibility to reprocess medical devices labelled as single-use is not acceptable from a safety point of view. Only devices labelled as reusable should therefore be reprocessed. Consequently, medical devices labelled as single-use should be real single-use and there should be only two possibilities: single-use or reusable. In order to avoid any systematic labelling of devices as single-use, all devices should be reusable as a rule, except if they are included in a list established by the Commission, after consultation of the MDAC, of categories and groups of medical devices which are unsuitable for reprocessing. The reprocessing of devices encompasses various activities to ensure that a medical device can be safely reused, ranging from decontamination, sterilisation, cleaning, disassembly, repair, component replacement and packaging. These activities should be subject to comparable and transparent standards. [Am. 24]

(32) Patients who are implanted with a device should be given clear and easily accessible essential information related to the implanted device allowing it to be identified and containing information about the principal characteristics of the device, and any necessary health risk warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls. [Am. 25]

(33) Medical 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 their placing on the market or putting into service for reasons related to 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 medical device in relation to aspects that are not covered by this Regulation. [Am. 26]

(34) The traceability of medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of medical devices due 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 counterfeit devices. Use of the UDI system should also improve purchase-policy and stock-management by hospitals, wholesalers and pharmacists and be compatible with the safety features as referred to in Directive 2011/62/EU of the European Parliament and of the Council (32) and other authentication systems already in place in those settings. [Am. 27]

(35) Transparency and better adequate access to information, appropriately presented for the intended user are essential to empower patients, users 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. [Am. 28]

(36) One key aspect is the creation of a central database that should integrate different electronic systems, with the UDI as an integral part of it, to collate and process information regarding medical devices on the market and the relevant economic operators, certificates, clinical investigations, vigilance and market surveillance. The objectives of the database are to enhance overall transparency through better access to information for the public and healthcare professionals, 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, to avoid multiple reporting requirements and to enhance the coordination between Member States. Within an 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 (Eudamed) set up by Commission Decision 2010/227/EU (33). [Am. 29]

(37) 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. Adequate levels of access for the public and healthcare professionals to those parts of Eudamed's electronic systems which provide key information on medical devices that may pose a risk to public health and safety is essential. Where such access is limited, it should be possible, upon a reasoned request, to disclose the existing information on medical devices, unless the limitation of access is justified on grounds of confidentiality. The electronic system on clinical investigations should serve as 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, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. A regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public. [Am. 30]

(38) 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 (34) 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 (35) 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 Article 2(d) of Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems.

(39) For high-risk medical devices, in the interests of increased transparency, manufacturers should summarise the main draw up a report on the safety and performance aspects of the device and the outcome of the clinical evaluation in a document that. A summary of the safety and performance report should be publicly available via Eudamed. [Am. 31]

(39a) According to the policy of the European Medicines Agency (EMA) on access to documents, the EMA releases documents submitted as part of applications for marketing authorisation for medicinal products, including clinical trial reports, on request once the decision-making process for the medicinal product in question has been completed. Corresponding standards on transparency and access to documents should be upheld and reinforced for high-risk medical devices, in particular as they are not subject to pre-market approval. For the purposes of this Regulation, in general the data included in clinical investigations should not be considered commercially sensitive once compliance of a device with the applicable requirements has been demonstrated following the applicable conformity assessment procedure. This should be without prejudice to intellectual property rights concerning the data in clinical investigations by the manufacturer with regard to the use of these data by other manufacturers. [Am. 32]

(39b) As regards invasive devices with a diagnostic and measuring function, Member States should take all necessary measures to prevent the risk of infection and microbial contamination between patients. To this end, the Member States should eliminate the known or foreseeable risks to patient safety by advocating inter alia the safest levels of and guidelines for disinfection and ensure their effective implementation by users and health establishments. In accordance with this Regulation, the Commission should ensure that these preventive health protection measures are appropriate. [Am. 33]

(40) The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection for health professionals, users and operators, including in the waste disposal chain, and for ensuring citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, and where applicable by the EMA, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level. [Am. 34]

(41) The position of notified bodies vis-à-vis manufacturers should be strengthened, including their right and duty to carry out unannounced factory inspections and to conduct physical or laboratory tests on medical devices to ensure continuous compliance by manufacturers after receipt of the original certification.

(42) For high risk medical devices, authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, on scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies, in particular regarding novel devices, devices for which a novel technology is being used, devices belonging to a category of devices with increased serious incident rates, or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices. The process foreseen in this Regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body. [Am. 35]

(42a) For high-risk medical devices, such as devices in class III, implantable devices and devices intended to administer medicinal products when failure or malfunctioning of these devices would have a major impact on health and safety, the conformity assessment should be the responsibility of special notified bodies. Those special notified bodies should be designated by the EMA on the basis of the reinforced requirements on staff qualification and training as referred to in Section 3.5a of Annex VI. These special notified bodies should meet in a network in order in particular to exchange good practice and ensure convergence in their work. The Assessment Committee for Medical Devices (ACMD) shall provide an opinion on the robustness of the clinical data by way of an assessment in specific cases. The need for such additional assessment should decrease once the new rules have been fully implemented and applied in particular to all notified bodies and as common technical standards are developed. The Commission should therefore review the functioning of and the experience with the additional assessment procedure after five years with a view to assessing whether it can be further restricted. [Ams. 363 and 370]

(42b) As this Regulation now combines active implantable medical devices covered by Directive 90/385/EEC, and implantable medical devices covered by Directive 93/42/EEC, and places all active implantable medical devices and implantable devices of public health concern in the highest risk class III category attracting the strictest controls, and as the vast majority of class IIb implantable medical devices such as pins, bone-screws, plates, staples etc., have a long history of safe implantation within the human body, and as special notified bodies will be specifically designated for such class IIb implantable devices, class IIb implantable devices need not be subject to the scrutiny procedure. [Am. 379]

(42c) The ACMD should be composed of clinical experts in the medical fields relevant to the medical device being assessed, one representative of the EMA and one representative of patients' organisations. The ACMD should meet on request from the MDCG or the Commission and its meetings should be chaired by a Commission representative. The Commission should provide logistic support to the secretariat and operations of the ACMD. [Am. 364]

(43) It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the division of medical devices into four product classes in line with international practice. The classification rules, which are based on the vulnerability of the human body taking into account the potential risks associated with the technical design and manufacture of the devices, need to be adapted to technical progress and experience gained from vigilance and market surveillance. To maintain the same level of safety as provided by Directive 90/385/EEC, active implantable medical devices and their accessories should be in the highest risk class.

(44) The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. For medical devices in classes IIa, IIb and III, an appropriate level of involvement of a notified body should be compulsory, with medical devices in class III requiring explicit prior approval of their design and manufacture before they can be placed on the market.

(45) The conformity assessment procedures should be simplified 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. [Am. 38]

(46) To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements should be based on clinical data that, for class III medical devices and implantable medical devices should, as a general rule, be sourced from clinical investigations to be carried out under the responsibility of a sponsor who can be the manufacturer or another legal or natural person taking responsibility for the clinical investigation.

(47) The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011, or any subsequent version of it, on good clinical practice for clinical investigations of medical devices for human subjects and the most recent (2008) version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects to ensure that clinical investigations conducted in the Union are accepted elsewhere and that clinical investigations conducted outside the Union in accordance with international guidelines can be accepted under this Regulation. [Am. 39]

(47a) The Declaration of Helsinki of the World Medical Association (36) states in Article 23 that ‘The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins’. Clinical investigations involving risk for the subject should only be allowed after assessment and approval by an ethics committee. The reporting Member State and the other concerned Member States need to organise themselves in a way that the competent authority concerned receives approval by an ethics committee on the clinical performance study protocol. [Am. 40]

(48) An electronic system should be set up at Union level to ensure that every clinical investigation is registered in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union, no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations on medical devices should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use.

(48a) For the sake of transparency, sponsors should submit the results of a clinical investigation together with a layperson summary within the deadlines specified by the regulation. The Commission should be empowered to adopt delegated acts on the preparation of the layperson's summary and the communication of the clinical investigation report. The Commission should provide guidelines for managing and facilitating the sharing of raw data from all clinical investigations. [Am. 41]

(49) Sponsors of clinical investigations to be conducted in more than one Member State should be given the possibility to submit a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety related aspects of the investigational device and of the scientific design of the clinical investigation to be conducted in several Member Stats, such single application should facilitate the coordination between the Member States under the direction of a coordinating Member State. The coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a clinical investigation, including informed consent. Each Member State should retain the ultimate responsibility for deciding whether the clinical investigation may be conducted on its territory.

(50) Sponsors should report certain adverse events occurring during clinical investigations to the Member States concerned, which should shall have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation. Such information should shall be communicated to the other Member States, the MDCG and the Commission. [Am. 43]

(51) This Regulation should only cover clinical investigations which pursue regulatory purposes laid down in this Regulation.

(51a) Strict rules for persons unable to give informed consent such as children and incapacitated persons should be established at the same level as in Directive 2001/20/EC of the European Parliament and of the Council (37). [Am. 44]

(52) In order to better protect the health and safety of health professionals, patients, users and operators, including in the waste disposal chain, regarding devices on the market, the vigilance system for medical devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions. [Am. 45]

(53) Member States should take all necessary measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be empowered and enabled to report suspected serious incidents at national level using harmonised formats. The and guaranteeing anonymity, where appropriate. In order to minimise the recurrence of such incidents, the national competent authorities should inform manufacturers, and, if appropriate, their subsidiaries and sub-contractors, and share report the information with their peers via the respective electronic system in Eudamed when they confirm that a serious an incident has occurred in order to minimise recurrence of those incidents. [Am. 46]

(54) The assessment 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 coordination, with the objective of sharing resources and ensuring consistency regarding the corrective action, and transparency of procedures should be ensured. [Am. 47]

(54a) Manufacturers should report periodically on medical devices classified as class III as regards the data relevant to the risk benefit ratio and the exposition of the population in order to evaluate whether any action concerning the medical device concerned is necessary. [Am. 48]

(55) The reporting of serious adverse events during clinical investigations and the reporting of serious incidents occurring after a medical device has been placed on the market should be clearly distinguished to avoid double reporting.

(56) 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. The Commission should clearly define the way these inspections should be conducted in order to ensure a full and harmonised implementation within the Union. [Am. 49]

(57) The Member States shall should levy fees for the designation and monitoring of notified bodies to ensure sustainability of the monitoring of those bodies by Member States and to establish a level playing field for notified bodies. These fees should be comparable across Member States and should be made public. [Am. 50]

(57a) Member States are invited to set and enforce serious penalties for manufacturers that commit fraud and cheat with regard to medical devices. Those penalties should be at least as large as the revenue gains from fraud or cheating. Penalties may include imprisonment. [Am. 51]

(58) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should inform the Commission and the other Member States before they adopt a comparable level and structure of the fees to ensure transparency. [Am. 52]

(58a) Member States should adopt provisions on standard fees for notified bodies, which should be comparable across Member States. The Commission should provide guidelines to facilitate the comparability of those fees. Member States should transmit their list of standard fees to the Commission and ensure that the notified bodies registered on their territory make the lists of standard fees for their conformity assessment activities publicly available. [Am. 53]

(59) An expert committee, the Medical Device Coordination Group (A MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices should be established to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) […/…] on in vitro diagnostic medical devices (38), to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation. [Am. 54]

(60) Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is fundamental for ensuring a consistently high level of health and safety within the internal market, in particular in the areas of clinical investigations and vigilance. This should also lead to more efficient use of scarce resources at national level.

(61) The Commission should provide scientific, technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for medical devices is effectively and uniformly implemented at Union level based on sound scientific evidence. [Am. 55]

(62) The Union should actively participate in international regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related information regarding medical devices and to foster the further development of international regulatory guidelines promoting the adoption of regulations in other jurisdictions with a level of health and safety protection equivalent to that set by this Regulation.

(63) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the principle of free and informed consent, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property, as well as the European Convention on Human Rights. This Regulation should be applied by the Member States in accordance with those rights and principles. [Am. 56]

(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certificates issued by notified bodies, of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them. However, basic aspects of this Regulation such as general safety and performance requirements, stipulations on technical documentation and the requirements for CE marking certification, as well as any amendments or additions to it, should be provided for only through the ordinary legislative procedure. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. [Am. 57]

(65) 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 (39).

(66) The advisory procedure should be used for the adoption of the form and presentation of the data elements of the manufacturers' summary of safety and clinical performance; of the codes defining the notified bodies' scopes of designation; and of the model for certificates of free sale, given that those acts have a procedural character and do not directly impact the health and safety at Union level.

(67) 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 in exceptional cases; relating to the Commission's position whether a provisional national measure against a medical device presenting a risk or a provisional national preventive health protection measure is justified or not; and relating to the adoption of a Union measure against a medical device presenting a risk, imperative grounds of urgency so require.

(68) To allow economic operators, notified bodies, Member States and the Commission especially SMEs, 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 to be taken for its proper application. However, parts of the Regulation that affect directly Member States and the Commission should be implemented as soon as possible. It is particularly important that by the date of application, a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of medical devices on the market. Also at the date of application, existing notified bodies that handle class III devices, shall be subject to an application for notification in accordance with this Regulation. [Am. 58]

(69) In order to ensure a smooth transition to the registration of medical devices, of relevant economic operators and of certificates, the obligation to submit the relevant information to the electronic systems put in place by this Regulation at Union level should become fully effective only 18 months after the date of application of this Regulation. During this transitional period, Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC should remain in force. However, economic operators and notified bodies who register in the relevant electronic systems provided for at Union level should be considered in compliance with the registration requirements adopted by the Member States pursuant to those provisions of the Directives to avoid multiple registrations.

(70) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation.

(71) Since the objective of this Regulation, namely to ensure high standards of quality and safety for medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale of the measure, 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 that objective.

(71a) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 8 February 2013 (40),

HAVE ADOPTED THIS REGULATION:

Chapter I

Scope and definitions

Article 1

Scope

1. This Regulation establishes rules to be complied with by medical devices for human use, and accessories to medical devices and medical devices for aesthetic purposes that are placed on the market or put into service in the Union for human use. [Am. 59]

For the purposes of this Regulation, medical devices and, accessories to medical devices and devices for aesthetic purposes shall hereinafter be referred to as ‘devices’. [Am. 60]

2. This Regulation shall not apply to:

(a) in vitro diagnostic medical devices covered by Regulation (EU) […/…];

(b) medicinal products covered by Directive 2001/83/EC and advanced therapy medicinal products covered by Regulation (EC) No 1394/2007. In deciding whether a product falls under Directive 2001/83/EC or Regulation (EC) No 1394/2007 or under this Regulation, particular account shall be taken of the principal mode of action of the product;

(c) human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or used in accordance with the manufacturer's instructions, such blood products, plasma or cells, except for devices referred to in paragraph 4;

(d) cosmetic products covered by Regulation (EC) No 1223/2009;

(e) transplants, tissues or cells of human or animal origin or their derivatives, or products containing or consisting of them, unless a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable. However, human tissues and cells that are non-viable or are rendered non-viable and that have undergone only non-substantial manipulation, in particular those listed in Annex I of Regulation (EC) No 1394/2007, and products derived from such tissues and cells, shall not be considered devices manufactured utilising tissues or cells of human origin or their derivatives;

(f) all products that contain or consist of biological substances or organisms other than those referred to in points (c) and (e) that are viable and that achieve their intended purpose by pharmacological, immunological or metabolic means, including certain living micro-organisms, bacteria, fungi or virus; [Am. 61]

(g) food covered by Regulation (EC) No 178/2002.

3. Any device which, when placed on the market or used in accordance with the manufacturer's instructions, incorporates as an integral part an in vitro diagnostic medical device as defined in Article 2 of Regulation (EU) […/…] [on in vitro diagnostic medical devices] shall be governed by this Regulation, unless it is covered by Article 1(3) of that Regulation. The relevant general safety and performance requirements set out in Annex I of that Regulation shall apply as far as the safety and performance of the in vitro diagnostic medical device part are concerned.

4. Where a device, when placed on the market or used in accordance with the manufacturer's instructions, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, with action ancillary to that of the device, that device shall be assessed and authorised in accordance with this Regulation following consultation with the national medicine agency or with the EMA. [Am. 62]

However, if the action of the medicinal substance is not ancillary to that of the device, the product shall be governed by Directive 2001/83/EC. In this case, the relevant general safety and performance requirements set out in Annex I of this Regulation shall apply as far as the safety and performance of the device part are concerned.

5. Where a device is intended to administer a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, that device shall be governed by this Regulation, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, the product shall be governed by Directive 2001/83/EC. In this case, the relevant general safety and performance requirements set out in Annex I of this Regulation shall apply as far as the safety and performance of the device part are concerned.

5a. This Regulation shall not impede the continued application of measures within Directive 2002/98/EC and its five daughter Directives setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components.

Articles 10 (Personnel), 14 (Traceability), 15 (Notification of serious adverse events and reactions), 19 (Examination of donors) and 29 (Technical requirements and their adaptation to technical and scientific progress) of Directive 2002/98/EC ensure donor and patient safety and as such those existing standards shall be maintained. [Am. 63]

6. This Regulation is a specific Union legislation within the meaning of Article 1(4) of Directive 2004/108/EC and within the meaning of Article 3 of Directive 2006/42/EC.

7. This Regulation shall not affect the application of Directive 96/29/Euratom nor of Directive 97/43/Euratom.

7a. The regulation of medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation. [Am. 64]

8. This Regulation shall not affect national laws which require that certain devices may only be supplied on a medical prescription.

9. References to a Member State in this Regulation shall be understood as including any other country with which the Union has concluded an agreement which confers on that country the same status as a Member State for the purpose of application of this Regulation.

Article 2

Definitions

1. For the purposes of this Regulation, the following definitions shall apply:

Definitions related to devices:

(1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific direct or indirect medical purposes of: [Am. 65] — diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease, [Am. 66] — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological process or state, — control or support of conception, — disinfection or sterilisation of any of the above-mentioned products, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The implantable or other invasive products, as well as products using external physical agents, intended to be used for human beings, which are listed on a non-exhaustive basis in Annex XV, shall be considered medical devices for the purposes of this Regulation, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose. [Am. 67]

(2) ‘accessory to a medical device’ means an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s); or to specifically assist the medical functionality of the medical device(s) in view of its/their intended purpose(s); [Am. 68]

(2a) ‘device for aesthetic purposes’ means any instrument, apparatus, appliance, software, implant, material, substance or other article, intended by the manufacturer to be used, alone or in combination, for the purposes of modifying the physical appearance of human beings, without any therapeutic or reconstructive intent, by implanting it in the human body, attaching it to the surface of the eye or using it to induce a tissue or cell reaction on external or non-external parts of the human body. Tattooing products and piercings shall not be considered devices for aesthetic purposes. [Am. 69]

(3) ‘custom-made device’ means any device specifically made in accordance with by an appropriately qualified person exclusively to meet a specific patient’s individual requirements and needs. In particular a ‘custom-made device’ may be produced on the basis of a written prescription of a doctor of medicine, of a dental practitioner or of any other person authorised by national law by virtue of this person's professional qualifications which gives, under his responsibility, specific design characteristics, and is intended for the sole use of a particular patient. However, mass-produced devices which need to be adapted to meet the specific requirements of a doctor of medicine, a dental practitioner or any other professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of doctors of medicine, dental practitioners or any other authorised person shall not be considered to be custom-made devices; [Am. 70]

(4) ‘active device’ means any device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity and which acts by changing the density of or converting this energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be considered to be active devices. [Am. 71] Stand alone software shall be considered an active device; [Am. 72]

(5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended — to be totally introduced into the human body or — to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be considered an implantable device;

(6) ‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;

(7) ‘generic device group’ means a set of devices having the same or similar intended purposes or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

(8) ‘single-use device’ means a device that is intended to be used on an individual patient during a single procedure and which has been tested and demonstrated to be impossible to reuse. [Am. 73] The single procedure may involve several uses or prolonged use on the same patient;

(8a) ‘reusable device’ means a device that is suitable for reprocessing and that is intended to be used on multiple patients or during multiple procedures; [Am. 357]

(9) ‘single-use device for critical use’ means a single-use device intended to be used for surgically invasive medical procedures; [Am. 75]

(10) ‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the clinical evaluation, to be reflected in the conformity certificate, the product label, in the instructions for use or and if applicable in promotional or sales materials or statements; [Am. 354]

(11) ‘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;

(12) ‘instructions for use’ means the information provided by the manufacturer to inform the user of the device's intended purpose and proper use and of any precautions to be taken;

(13) ‘Unique Device Identification’ (‘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;

(14) ‘non-viable’ means having no potential for metabolism or multiplication;

(15) ‘nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows: — ‘particle’ means a minute piece of matter with defined physical boundaries; — ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; — ‘aggregate’ means a particle comprising of strongly bound or fused particles;

Definitions related to the making available of devices:

(16) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; [Am. 76]

(17) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;

(18) ‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;

Definitions related to economic operators, users and specific processes:

(19) ‘manufacturer’ means the 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 his name or trademark. For the purposes of the definition of manufacturer, fully refurbishing is defined as 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 in conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;

(20) ‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;

(21) ‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market;

(22) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market;

(23) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(24) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health; [Am. 77]

(25) ‘user’ means any healthcare professional or lay person who uses a device;

(26) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;

(27) ‘reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoration of the technical and functional safety of the used device; routine device maintenance service activities are not included in this definition; [Am. 78]

Definitions related to conformity assessment:

(28) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

(29) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

(30) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;

(31) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which the manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

(31a) ‘performance’ means any technical characteristics, any effects and any benefit of the device when used for the intended purpose and in accordance with the instructions of use; [Am. 79]

(31b) ‘benefit’ means the positive health impact of a medical device based on clinical and non-clinical data; [Am. 80]

Definitions related to clinical evaluation and clinical investigations:

(32) ‘clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety, and performance and clinical benefits of the device when used as intended by the manufacturer; [Am. 82]

(33) ‘clinical investigation’ means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;. Clinical investigations for medical devices, where made compulsory in accordance with this Regulation, shall include clinical investigations in the appropriate target population and well-controlled investigations. [Am. 83]

(34) ‘investigational device’ means any device being assessed for safety and/or performance in a clinical investigation;

(35) ‘clinical investigation plan’ means the document(s) setting out the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation;

(36) ‘clinical data’ means all the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following: [Am. 84] — clinical investigation(s) of the device concerned, — clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, — published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

(37) ‘sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation and management, conduct or financing of a clinical investigation; [Am. 86]

(37a) ‘conformity assessment’ means, in relation to a clinical study, the checking by the authorities responsible of the relevant official documentation, facilities and records and of the existence of sufficient insurance cover. Such checking may be carried out on the premises of the sponsor and/or the research establishment or wherever the authority responsible may deem checks to be necessary. [Am. 87]

(37b) ‘ethics committee’ means an independent body in a Member State, consisting of health-care professionals and non-medical members including at least one well-experienced, knowledgeable patient or patient representative. Its responsibility is to protect the rights, safety, physical and mental integrity, dignity and well-being of subjects involved in clinical investigations and to provide public assurance of that protection in full transparency. In cases of such investigations involving minors, the ethics committee shall include at least one healthcare professional with paediatric expertise; [Am. 88]

(38) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;

(39) ‘serious adverse event’ means any adverse event that led to any of the following: — death, — serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or extending the duration of prolongation of patient hospitalisation, [Am. 89] (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, — foetal distress, foetal death or a congenital abnormality physical or mental impairment or birth defect; [Am. 90]

(40) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational a device, as defined in points 1 to 6 of this paragraph including malfunction, use errors or inadequacy in the information supplied by the manufacturer; [Am. 91]

Definitions related to vigilance and market surveillance:

(41) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;

(42) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from further being made available on the market;

(43) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, any inadequacy in the information supplied by the manufacturer and any unexpected undesirable side-effect;

(44) ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following: — death of a patient, user or other person, — temporary or permanent serious deterioration of the patient's, user's or other person's state of health, — serious public health threat;

(45) ‘corrective action’ means action taken to eliminate the cause of a potential or real non-conformity or other undesirable situation;

(46) ‘field safety corrective action’ means corrective action taken by the 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;

(47) ‘field safety notice’ means the communication sent by the manufacturer to users or customers in relation to a field safety corrective action;

(48) ‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that products 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;

(48a) ‘unannounced inspection’ means an inspection conducted without advance notice; [Am. 92]

Definitions related to standards and other technical specifications:

(49) ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of Regulation (EU) No […/…];

(50) ‘common technical specifications’ means a document other than a standard that prescribes technical requirements that provide a means to comply with the legal obligation applicable to a device, process or system.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 to amend the list in Annex XV referred to in the last subparagraph of number (1) of paragraph 1, in the light of technical progress and taking into account the similarity between a medical device and a product without a medical purpose in respect of their characteristics and risks.

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to adapt the definition of nanomaterial set out in number (15) of paragraph 1 in view of technical and scientific progress and taking into account definitions agreed at Union and international level.

Article 3

Regulatory status of products

1. The Commission may on its own initiative or shall, at the request of a Member State or on its own initiative, by means of implementing acts on the basis of the opinions of the MDCG and the MDAC referred to in Articles 78 and 78a respectively, determine whether or not a specific product, or category or group of products, including borderline products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).

2. The Commission shall ensure the sharing of expertise between Member States in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products. [Am. 93]

Chapter VII

Classification and conformity assessment of medical devices [Am. 260]

Article 41

Classification of medical devices

1. Devices shall be divided into classes I, IIa, IIb and III, taking into account their intended purpose and inherent risks. Classification shall be carried out in accordance with the classification criteria set out in Annex VII.

2. Any dispute between the manufacturer and the notified body concerned, arising from the application of the classification criteria, shall be referred for a decision to the competent authority of the Member State where the manufacturer has his 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 where the authorised representative referred to in the last indent of point (b) of Section 3.2. of Annex VIII has his registered place of business.

At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision. The final decision shall be made publicly available in the Eudamed. [Am. 150]

3. The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. Such decision should in particular be taken in order to resolve diverging decisions between Member States. [Am. 151]

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). Before adopting implementing acts, the Commission shall consult with relevant stakeholders and take into account their suggestions. [Am. 152]

4. In the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission, having consulted relevant stakeholders, including organisations of healthcare professionals, shall be empowered to adopt delegated acts in accordance with Article 89 as regards the following: [Am. 153]

(a) deciding that a device, or category or group of devices, should, by way of derogation from the classification criteria set out in Annex VII, be classified in another class;

(b) amending or supplementing the classification criteria set out in Annex VII.

Chapter IIa

Conformity assessment [Am. 261]

Article 26

Summary of safety Safety and clinical performance report

1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of report on the safety and clinical performance. It of the device based on the full information collected during the clinical investigation. The manufacturer shall also draw up a summary of that report which shall be written in a way that is clear to the intended user easy for a lay person to understand in the official language(s) of the country where the medical device is made available on the market. The draft of this summary report shall be part of the documentation to be submitted to and validated by the special notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body 43a.

1a. The summary referred to in paragraph 1 shall be made available to the public through Eudamed in accordance with provisions under point (b) of Article 27(2) and point 18 of Annex V Part A.

2. The Commission may, by means of implementing acts, set out the form and the format of the presentation of the data elements to be included in both the report and the summary of safety and clinical performance referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2). [Am. 130]

Article 42

Conformity assessment procedures

1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device. The conformity assessment procedures are set out in Annexes VIII to XI.

2. Manufacturers of devices classified as class III, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance and design dossier examination as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex IX coupled with a conformity assessment based on product conformity verification as specified in Annex X.

In the case of devices referred to in the first subparagraph of Article 1(4), the notified body shall follow the consultation procedure as specified in Section 6.1 of Chapter II of Annex VIII or Section 6 of Annex IX, as applicable.

In the case of devices that are covered by this Regulation in accordance with point (e) of Article 1(2), the notified body shall follow the consultation procedure as specified in Section 6.2 of Chapter II of Annex VIII or Section 6 of Annex IX, as applicable.

3. Manufacturers of devices classified as class IIb, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex IX coupled with a conformity assessment based on product conformity verification as specified in Annex X.

4. Manufacturers of devices classified as class IIa, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the prototype and the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annex II coupled with a conformity assessment based on product conformity verification as specified in Section 7 of Part A or Section 8 of Part B of Annex X. [Am. 154]

5. Manufacturers of devices classified as class I, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17 after drawing up the technical documentation set out in Annex II. If the devices are placed on the market in sterile condition or have a measuring function, the manufacturer shall apply the procedures set out in Annex VIII, except for its Chapter II, or in Part A of Annex X. However, involvement of the notified body shall be limited:

(a) in the case of devices placed on the market in sterile condition, to the aspects of manufacture concerned with securing and maintaining sterile conditions,

(b) in the case of devices with a measuring function, to the aspects of manufacture concerned with the conformity of the devices with the metrological requirements.

6. Manufacturers may choose to apply a conformity assessment procedure applicable to devices of a higher class than the device in question.

7. Manufacturers of custom-made devices shall follow the procedure set out in Annex XI and draw up the statement set out in that Annex before placing the device on the market.

8. The Member State in which the notified body is established may determine that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 6 shall be available in an official Union language. Otherwise they shall be available in an official Union language acceptable to the notified body.

9. Investigational devices shall be subject to the requirements set out in Articles 50 to 60.

10. The Commission may shall, by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects: [Am. 155]

— the frequency and the sampling basis of the assessment of the design documentation within the technical documentation on a representative basis as set out in Sections 3.3(c) and 4.5 of Annex VIII in the case of devices of classes IIa and IIb, and in Section 7.2 of Part A of Annex X in the case of devices of class IIa;

— the minimum frequency of unannounced factory inspections and sample checks to be conducted by notified bodies in accordance with Section 4.4 of Annex VIII, taking into account the risk-class and the type of device; [Am. 156]

— the physical, laboratory or other tests to be carried out by notified bodies in the context of sample checks, design dossier examination and type examination in accordance with Sections 4.4 and 5.3 of Annex VIII, Section 3 of Annex IX and Section 5 of Part B of Annex X.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).

10a. Unannounced inspections, in terms of their nature and extent, may be counted as regular inspections, with offsetting of economic operators’ costs resulting from unannounced inspections, provided that no significant non-conformities are recorded during unannounced inspections. Account must be taken at all times, when ordering unannounced inspections and carrying them out, of the proportionality principle, with due regard, in particular, for the risk potential of each individual product. [Am. 157]

11. In the light of technical progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 28 to 40, or of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the conformity assessment procedures set out in Annexes VIII to XI. [Am. 158]

Article 44

Mechanism for scrutiny of certain conformity assessments

1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class III, with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG.

2. Within 28 days of receipt of the information referred to in paragraph 1, the MDCG may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate. Upon suggestion by any of its members or by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4). In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminary conformity assessment. When selecting a specific file for submission, the principle of equal treatment shall be duly taken into account.

Within 5 days after receipt of the request by the MDCG, the notified body shall inform the manufacturer thereof.

3. The MDCG may submit comments on the summary of the preliminary conformity assessment at the latest 60 days after submission of this summary. Within that period and at the latest 30 days after submission, the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments.

4. The notified body shall give due consideration to any comments received in accordance with paragraph 3. It shall convey to the Commission an explanation of how they have been taken into consideration, including any due justification for not following the comments received, and its final decision regarding the conformity assessment in question. The Commission shall immediately transmit this information to the MDCG.

5. Where deemed necessary for the protection of patient safety and public health, the Commission, may determine, by means of implementing acts, specific categories or groups of devices, other than devices of class III, to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).

Measures pursuant to this paragraph may be justified only by one or more of the following criteria:

(a) the novelty of the device or of the technology on which it is based and the significant clinical or public health impact thereof;

(b) an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in case of failure;

(c) an increased rate of serious incidents reported in accordance with Article 61 in respect of a specific category or group of devices;

(d) significant discrepancies in the conformity assessments carried out by different notified bodies on substantially similar devices;

(e) public health concerns regarding a specific category or group of devices or the technology on which they are based.

6. The Commission shall make a summary of the comments submitted in accordance with paragraph 3 and the outcome of the conformity assessment procedure accessible to the public. It shall not disclose any personal data or information of commercially confidential nature.

7. The Commission shall set up the technical infrastructure for the data-exchange by an electronic means between notified bodies and MDCG for the purposes of this Article.

8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). [Am. 165]

Article 44a

Assessment procedure in specific cases

1. Special notified bodies shall notify the Commission of applications for conformity assessments for implantable Class III devices, Class IIb devices intended to administer and/or remove a medicinal product, as referred to in Article 1(5) and point 5.3. of Annex VII (Rule 11), and devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable with the exception of applications to renew or supplement existing certificates and devices for which specifications referred to in Articles 6 and 7 have been published for the clinical evaluation and the post-market clinical follow-up. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the special notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the Medical Device Coordination Group (MDCG) for an opinion. In making its opinion, the MDCG may seek a clinical assessment from the relevant experts of the Assessment Committee for Medical Devices (ACMD), referred to in Article 78.

2. Within 20 days of receipt of the information referred to in paragraph 1, the MDCG may decide to request the special notified body to submit the following documents prior to issuing a certificate:

— the clinical evaluation report as referred to in Annex XIII, including the clinical investigations report as referred to in Annex XIV,

— the post market clinical follow-up plan referred to in Annex XIII, and

— any information regarding the marketing or not of the device in third countries and, where available, the results of evaluation conducted by competent authorities in those countries.

The members of the MDCG shall decide on making such a request only on the basis of the following criteria:

(a) the novelty of the device with possible major clinical or health impact;

(b) an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in the case of failure;

(c) an increased rate of serious incidents reported in accordance with Article 61 in respect of a specific category or group of devices.

In the light of technical progress and any information which becomes available, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing these criteria.

In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file.

In the absence of request from the MDCG within 20 days of receipt of the information referred to in paragraph 1, the special notified body may continue with the conformity assessment procedure.

3. The MDCG, following the consultation of the ACMD shall issue a MDCG opinion on the documents referred to in paragraph 2 at the latest 60 days after its submission. Within that period and at the latest 30 days after submission, the ACMD through the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the documents referred to in paragraph 2. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this paragraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments.

4. In its opinion the MDCG shall take into account the clinical assessment of the ACMD. The MDCG may recommend modifications of the documents referred to in paragraph 2.

5. The MDCG shall immediately inform the Commission, the special notified body and the manufacturer of its opinion.

6. Within 15 days after receipt of the opinion referred to in paragraph 5, the special notified body shall indicate whether or not it agrees with the opinion of the MDCG. In the latter case, it may give written notice to the MDCG. that it wishes to request a re-examination of the opinion. In that case, the special notified body shall forward to the MDCG the detailed grounds for the request within 30 days after receipt of the opinion. The MDCG shall immediately transmit this information to the ACMD and the Commission.

Within 30 days following receipt of the grounds for the request, the MCDG shall re-examine its opinion, after consultation of the ACMD where necessary. The reasons for the conclusion reached shall be annexed to the final opinion.

7. Immediately after its adoption, the MCDG shall send its final opinion to the Commission, the special notified body and the manufacturer.

8. In the case of a favourable opinion MDCG opinion, the special notified body may proceed with the certification.

However if the favourable MDCG opinion is dependent on the application of specific measures (e.g. adaptation of the post-market clinical follow-up plan, certification with a time limit), the special notified body shall issue the certificate of conformity only on the conditions that those measures are fully implemented.

Following the adoption of a favourable opinion, the Commission shall always explore the possibility of adopting, common technical standards for the dev