EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

The current EU regulatory framework for medical devices, other than in vitro diagnostic medical devices, consists of Council Directive 90/385/EEC on active implantable medical devices (AIMDD)[1] and Council Directive 93/42/EEC on medical devices (MDD)[2] which cover a huge spectrum of products. The MDD divides them into four classes of risk: class I (low risk, e.g. sticking plasters, corrective glasses), class IIa (medium-low risk, e.g. tracheal tubes, dental filling material), class IIb (medium-high risk, e.g. X-ray machines, bone plates and screws) and class III (high risk, e.g. heart valves, total hip replacements, breast implants). Active implantable medical devices (e.g. pacemakers, implantable defibrillators) covered by the AIMDD fall de facto into class III.

The two Directives, adopted in the 1990s, are based on the ‘New Approach’ and aim to ensure the smooth functioning of the internal market and a high level of protection of human health and safety. Medical devices are not subject to any pre-market authorisation by a regulatory authority but to a conformity assessment which, for medium and high risk devices, involves an independent third party, known as ‘notified body’. Notified bodies, of which there are around 80 across Europe, are designated and monitored by the Member States and act under the control of the national authorities. Once certified, devices bear the CE marking which allows them to circulate freely in the EU/EFTA countries and Turkey.

The existing regulatory framework has demonstrated its merits but has also come under harsh criticism, in particular after the French health authorities found that a French manufacturer (Poly Implant Prothèse, PIP) had for several years apparently used industrial silicone instead of medical grade silicone for the manufacture of breast implants contrary to the approval issued by the notified body, causing harm to thousands of women around the world.

In an internal market with 32 participating countries[3] and subject to constant technological and scientific progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the Directives, i.e. the safety of medical devices and their free movement within the internal market. Moreover, regulatory gaps or uncertainties exist with regard to certain products (e.g. products manufactured utilising non-viable human tissues or cells; implantable or other invasive products for cosmetic purposes).

This revision aims to overcome these flaws and gaps and to further strengthen patient safety. A robust, transparent and sustainable regulatory framework should be put in place that is ‘fit for purpose’. This framework should be supportive of innovation and the competitiveness of the medical device industry and should allow rapid and cost-efficient market access for innovative medical devices, to the benefit of patients and healthcare professionals.

This proposal is adopted alongside a proposal for a Regulation on in vitro diagnostic medical devices (IVDs), such as blood tests, which are covered by Directive 98/79/EC of the European Parliament and of the Council (IVDD)[4]. The horizontal aspects that are common to both sectors are aligned whilst the specific features of each sector require separate legal acts.

2. RESULTS OF CONSULTATIONS WITH INTERESTED PARTIES AND IMPACT ASSESSMENTS

In preparation for the impact assessment on this proposal and the proposal for a Regulation on IVDs, the Commission held two public consultations, the first from 8 May to 2 July 2008, and the second from 29 June to 15 September 2010. In both public consultations, the general principles and minimum standards for consultation of interested parties by the Commission were applied; responses received within a reasonable period after the deadlines were taken into account. After analysing all the responses, the Commission published a summary outcome and the individual responses on its website[5].

The majority of respondents to the 2008 public consultation (in particular Member States and industry) considered the proposed revision to be premature. They pointed to Directive 2007/47/EC of the European Parliament and of the Council[6], which amended the AIMDD and the MDD and was to be implemented by 21 March 2010, and also to the New Legislative Framework for the Marketing of Products which was due to enter into force with effect from 1 January 2010, and argued that it would be advisable to wait for these changes to be implemented, in order to assess the need for further adjustments better.

The 2010 public consultation focussed on aspects related to the revision of the IVDD and showed wide support for this initiative, linked to the revision of the regulatory framework for medical devices in general.

During 2009, 2010 and 2011, the issues to be tackled in the revision of the regulatory framework for medical devices were regularly discussed at meetings of the Medical Devices Expert Group (MDEG), the Competent Authorities for Medical Devices (CAMD) and specific working groups in the fields of notified bodies, borderline and classification, clinical investigation and evaluation, vigilance, market surveillance, in vitro diagnostics medical devices (IVD) and in an ad hoc working group on Unique Device Identification (UDI). A special meeting of the MDEG was held on 31 March and 1 April 2011 to discuss issues related to the impact assessment. Moreover, the Heads of Medicines Agencies (HMA) and the CAMD organised joint workshops on the development of the legal framework for medical devices on 27 April and 28 September 2011.

A further special meeting of the MDEG was held on 6 and 13 February 2012 to discuss issues related to the two legislative proposals, based on working documents containing initial drafting proposals. Written comments made on these working documents were taken in account for the further development of the proposals.

In addition, the Commission’s representatives regularly participated in conferences to present ongoing work on the legislative initiative and hold discussions with stakeholders. Targeted meetings took place at senior level with representatives from associations representing industry, notified bodies, healthcare professionals and patients.

Aspects linked to the appropriate regulatory framework were also discussed in the course of the ‘Exploratory Process on the Future of the Medical Device Sector’ organised by the Commission from November 2009 to January 2010. On 22 March 2011, the Commission and the Hungarian Presidency organised a high-level conference on innovation in medical technology, the role of the medical device sector in addressing the healthcare challenges facing Europe and the appropriate regulatory framework for this sector to meet the needs of tomorrow. This conference was followed by Conclusions of the Council of the European Union on innovation in the medical device sector adopted on 6 June 2011[7]. In its Conclusions, the Council requested the Commission to adapt the EU medical device legislation to the needs of tomorrow so as to achieve a suitable, robust, transparent and sustainable regulatory framework, which is central to fostering the development of safe, effective and innovative medical devices for the benefit of European patients and healthcare professionals.

Triggered by the PIP breast implants scandal, the European Parliament adopted on 14 June 2012 a Resolution on defective silicone gel breast implants made by the French company PIP[8] also calling on the Commission to develop an adequate legal framework to guarantee the safety of medical technology.

3. LEGAL ELEMENTS OF THE PROPOSAL 3.1. Scope and definitions (Chapter I)

The scope of the proposed Regulation corresponds to a large extent to the combined scopes of Council Directives 90/385/EEC and 93/42/EEC, i.e. it covers all medical devices other than in vitro diagnostic medical devices. On the one hand, however, the scope is extended to some products currently not covered by the AIMDD/MDD. And on the other hand, some products which, in some Member States, are placed on the market as medical devices are excluded from its scope.

The extension of the scope concerns:

· products manufactured utilising non-viable human tissues or cells, or their derivatives, that have undergone substantial manipulation (e.g. syringes prefilled with human collagen), unless they are covered by Regulation (EC) No 1394/2007 on advanced therapy medicinal products[9]. Human tissues and cells, or products derived from human tissues or cells, that are not substantially manipulated and that are regulated by Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells[10] are not covered by the proposal;

· certain implantable or other invasive products without a medical purpose that are similar to medical devices in terms of characteristics and risk profile (e.g. non-corrective contact lenses, implants for aesthetic purposes);

Additional provisions as regards products that are not covered by the Regulation have been included, more to clarify the scope with a view to ensuring harmonised implementation than to substantially change the scope of the EU legislation. They concern:

· products that contain or consist of viable biological substances (e.g. living micro-organisms);

· food covered by Regulation (EC) No 178/2002 on general principles and requirements of food law[11] (e.g. this may affect certain slimming products); in return, medical devices are excluded from the scope of Regulation 178/2002 (diagnostic probes or cameras, even when introduced orally, are therefore clearly excluded from the food legislation).

As regards products composed of substances or combinations of substances that are intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body, the borderline between medicinal products and medical devices is difficult to draw. To ensure a high level of safety of those products regardless of their qualification, those products which fall under the definition of a medical device are classified in the highest risk class and should comply with the relevant requirements of Annex I of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use[12].

To support Member States and the Commission in determining the regulatory status of products, the Commission may set up, in accordance with its internal rules[13], a group of experts from various sectors (such as medical devices, IVDs, medicinal products, human tissues and cells, cosmetics and biocides).

The definitions section has been significantly extended, aligning the definitions in the field of medical devices with well established European and international practice, such as the New Legislative Framework for the Marketing of Products[14] and guidance documents produced by the Global Harmonization Task Force (GHTF) for medical devices[15].

3.2. Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement (Chapter II)

This chapter contains provisions that are typical for product-related internal market legislation and sets out the obligations of the relevant economic operators (manufacturers, authorised representatives of non-EU manufacturers, importers and distributors). The regulatory instrument of ‘common technical specification’ (CTS), which has proven useful in the context of the IVDD, has been introduced in the broader field of medical devices to allow the Commission to further specify the general safety and performance requirements (laid down in Annex I) and the requirements on clinical evaluation and post-market clinical follow-up (laid down in Annex XIII). Such requirements however, leave manufacturers the possibility of adopting other solutions that ensure at least an equivalent level of safety and performance.

The legal obligations on manufacturers are proportionate to the risk class of the devices they produce. For example, this means that even though all manufacturers should have a quality management system (QMS) in place to ensure that their products consistently meet the regulatory requirements, the QMS-related responsibilities are stricter for manufacturers of high risk devices than for manufacturers of low risk devices. Manufacturers of medical devices for an individual patient, so called ‘custom-made devices’, must ensure that their devices are safe and perform as intended, but their regulatory burden remains low.

Key documents for the manufacturer to demonstrate compliance with the legal requirements are the technical documentation and the EU declaration of conformity to be drawn up in respect of devices placed on the market. Their minimum contents are laid down in Annexes II and III.

The following concepts are also new in the field of medical devices:

· A requirement has been introduced that within the manufacturer’s organisation a 'qualified person' should be responsible for regulatory compliance. Similar requirements exist in EU legislation on medicinal products and in the national laws transposing the AIMDD/MDD in some Member States.

· Since in the case of 'parallel trade' with medical devices application of the principle of free movement of goods varies considerably from one Member State to another and, in many cases, de facto prohibits this practice, clear conditions are set for enterprises involved in relabelling and/or repackaging medical devices.

· Patients who are implanted with a device should be given essential information on the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken, for example indication as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.

· In accordance with Article 12a of the MDD, introduced by Directive 2007/47/EC, the Commission had to prepare a report on the reprocessing of medical devices and submit, where appropriate, a legislative proposal on this issue. On the basis of the Commission's findings set out in its report of 27 August 2010[16], which took into account the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) of 15 April 2010, the proposal contains strict rules on 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. Reprocessing of single-use devices is considered as manufacture of new devices so that the reprocessors must satisfy the obligations incumbent on manufacturers. The reprocessing of single-use devices for critical use (e.g. devices for surgically invasive procedures) should, as a general rule, be prohibited. Since certain Member States may have particular concerns in terms of safety regarding the reprocessing of single-use devices, they retain their right to maintain or impose a general ban on this practice including the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing and on the access of reprocessed single-use devices to their market.

3.3. Identification and traceability of devices, registration of devices and economic operators, summary of safety and clinical performance, Eudamed (Chapter III)

This chapter addresses one of the main shortcomings of the current system: its lack of transparency. It consists of:

· a requirement that economic operators must be able to identify who supplied them and to whom they have supplied medical devices;

· a requirement that manufacturers fit their devices with a Unique Device Identification (UDI) which allows traceability. The UDI system will be implemented gradually and proportionate to the risk class of the devices;

· a requirement that manufacturers/authorised representatives and importers must register themselves and the devices they place on the EU market in a central European database;

· an obligation for manufacturers of high-risk devices to make publicly available a summary of safety and performance with key elements of the supporting clinical data;

· and the further development of the European databank on medical devices (Eudamed), set up by Commission Decision 2010/227/EU[17], which will contain integrated electronic systems on a European UDI, on registration of devices, relevant economic operators and certificates issued by notified bodies, on clinical investigations, on vigilance and on market surveillance. A large part of the information in Eudamed will become publicly available in accordance with the provisions regarding each electronic system.

The establishment of a central registration database will not only provide a high level of transparency but also do away with diverging national registration requirements which have emerged over recent years and which have significantly increased compliance costs for economic operators. It will therefore also contribute to reducing the administrative burden on manufacturers.

3.4. Notified bodies (Chapter IV)

Proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens' confidence in the system which has come under severe criticism in recent years due to significant differences as regards, on the one hand, the designation and monitoring of notified bodies and, on the other, the quality and depth of the conformity assessment performed by them, in particular in their assessment of the manufacturers' clinical evaluation.

In line with the New Legislative Framework for the Marketing of Products, the proposal sets out requirements for national authorities responsible for notified bodies. It leaves the ultimate responsibility for designating and monitoring notified bodies, based on stricter and detailed criteria laid down in Annex VI, with the individual Member State. The proposal thus builds on existing structures already available in most Member States instead of lifting the responsibility to the Union level which might have caused concerns in terms of subsidiarity. But any new designation and, in regular intervals, the monitoring of notified bodies are made subject to ‘joint assessments’ with experts from other Member States and the Commission, thus ensuring an effective control at Union level.

At the same time, the position of notified bodies vis-à-vis manufacturers will be significantly strengthened, including their right and duty to carry out unannounced factory inspections and to conduct physical or laboratory tests on devices. The proposal also requires rotation of the notified body's personnel involved in the assessment of medical devices at appropriate intervals to strike a reasonable balance between the knowledge and experience required to carry out thorough assessments and the need to ensure continuous objectivity and neutrality in relation to the manufacturer subject to those assessments.

3.5. Classification and conformity assessment (Chapter V)

The proposal keeps to the well established approach (in Europe and internationally) of dividing medical devices into four classes, taking account of the potential risks associated with the technical design and manufacture. The classification rules (laid down in Annex VII) have been adapted to technical progress and experience gained from vigilance and market surveillance. For example, further to incidents that had occurred to blood plasma donors and a request submitted by France, aphaeresis machines have been moved from class IIb to class III. Active implantable medical devices and their accessories have been classified in the highest risk class (class III) to maintain the same level of safety as provided by Council Directive 90/385/EEC.

The classification of a medical device determines the applicable conformity assessment procedure for which the proposal follows the general lines of the AIMDD/MDD. The conformity assessment procedure for class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturer in view of the low level of vulnerability associated with these products. However, when class I devices have a measuring function or are sold sterile, a notified body must verify the aspects related to the measuring function or to the sterilisation process. For devices of classes IIa, IIb and III, an appropriate level of involvement of a notified body is compulsory proportionate to the risk class, with devices of class III requiring explicit prior approval of the design or of the type of the device and of the quality management system before they may be placed on the market. In the case of class IIa and IIb devices, the notified body checks the quality management system and, for representative samples, the technical documentation. After initial certification, notified bodies must regularly conduct surveillance assessments in the post-market phase.

The different conformity assessment procedures during which the notified body audits the manufacturer's quality management system, checks the technical documentation, examines the design dossier or approves the type of a device are laid down in Annexes VIII to X. They have been tightened and streamlined. The proposal reinforces the powers and responsibilities of notified bodies and specifies the rules according to which notified bodies perform their assessments, both in the pre-market and the post-market phase (e.g. documentation to be submitted, scope of the audit, unannounced factory inspections, sample checks) to ensure a level playing field and avoid notified bodies being overly lenient. Manufacturers of custom-made devices continue to be subject to a specific procedure (laid down in Annex XI) which does not involve a notified body.

In addition, the proposal introduces the obligation for notified bodies to notify an expert committee (see below under 3.8.) of new applications for conformity assessment of high-risk devices. On scientifically valid health grounds, the expert committee will have the power to request the notified body to submit a preliminary assessment on which the committee can issue comments within a deadline of 60 days[18], before the notified body can issue a certificate. This scrutiny mechanism empowers the authorities to have a 'second look' at individual assessments and make their views heard before a device is placed on the market. A similar procedure is currently already applied for medical devices manufactured utilising animal tissues (Commission Directive 2003/32/EC[19]). Its use should be the exception rather than the rule and should follow clear and transparent criteria.

3.6. Clinical evaluation and clinical investigations (Chapter VI)

Building on the current Annex X of the MDD, this chapter lays down the key obligations of manufacturers as regards the performance of the clinical evaluation needed to demonstrate the safety and performance of their devices. More detailed requirements are set out in Annex XIII which addresses the pre-market clinical evaluation and post-market clinical follow-up that together constitute a continuous process during the life cycle of a medical device.

The process for conducting clinical investigations (the equivalent of clinical trials in the field of medicinal products), which is currently described in basic terms in Article 15 of the MDD, is further developed. First of all, the concept of ‘sponsor’ is introduced and aligned with the definition used in the recent Commission's Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use which aims at repealing Directive 2001/20/EC[20].

The sponsor can be the manufacturer, his authorised representative or another organisation, in practice often a ‘contract research organisation’ conducting clinical investigations for the manufacturers. The scope of the proposal, however, remains restricted to clinical investigations carried out for regulatory purposes, i.e. for obtaining or confirming regulatory approval for market access. Non-commercial clinical investigations that do not pursue a regulatory purpose are not covered by this Regulation.

In accordance with recognised international ethical principles, every clinical investigation must be registered in a publicly accessible electronic system which the Commission will set up. 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 future EU database to be set up in accordance with the future Regulation on clinical trials on medicinal products for human use.

Before commencing a clinical investigation, the sponsor must submit an application to confirm that there are no health and safety or ethical aspects which would oppose it. A new possibility will be opened up for sponsors of clinical investigations to be conducted in more than one Member State: in future, they may submit a single application through the electronic system to be set up by the Commission. As a consequence, the health and safety aspects regarding the device intended for clinical investigation will be assessed by the Member States concerned under the direction of a coordinating Member State. The assessment of intrinsically national, local and ethical aspects (e.g. liability, suitability of the investigators and investigation sites, informed consent) will, however, need to be carried out at the level of each Member State concerned which will retain the ultimate responsibility for deciding whether the clinical investigation may be conducted on its territory. In line with the above-mentioned Commission's Proposal for a Regulation on clinical trials on medicinal products, also this proposal leaves it to the Member States to define the organisational set-up at national level for the approval of clinical investigations. In other words, it moves away from a legally required dualism of two distinct bodies, i.e. a national competent authority and an ethics committee.

3.7. Vigilance and market surveillance (Chapter VII)

A well functioning vigilance system is the 'backbone' of a robust regulatory framework in this sector because complications with medical devices that are designed to be implanted or to operate for many years or even decades might come to light only after a certain period of time. The main progress which the proposal will bring in this field is the introduction of an EU portal where manufacturers must report serious incidents and corrective actions they have taken to reduce the risk of recurrence. The information will be automatically forwarded to the national authorities concerned. Where the same or similar incidents have occurred, or where a corrective action has to be taken, in more than one Member State, a coordinating authority will take the direction in coordinating the analysis of the case. The emphasis is placed on work- and expertise-sharing to avoid inefficient duplication of procedures.

As regards market surveillance, the main objectives of the proposal are 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.

3.8. Governance (Chapters VIII and IX)

The Member States will be responsible for implementation of the future Regulation. A central role in achieving harmonised interpretation and practice will be assigned to an expert committee (the Medical Device Coordination Group or MDCG) made up of members appointed by the Member States due to their role and experience in the field of medical devices and chaired by the Commission. The MDCG and its subgroups will allow to build a forum for discussions with stakeholders. The proposal creates the legal basis that for specific hazards or technologies EU reference laboratories, a concept that has proven successful in the food sector, may in the future be designated by the Commission.

As regards the management at EU level, the impact assessment identified as preferred policy options either the extension of the responsibility of the European Medicines Agency (EMA) to medical devices or the management of the medical devices regulatory system by the Commission. Taking into account the clear preference expressed by stakeholders, including many Member States, the proposal mandates the Commission to provide technical, scientific and logistic support to the MDCG.

3.9. Final provisions (Chapter X)

The proposal empowers the Commission to adopt, where appropriate, either implementing acts to ensure uniform application of the Regulation or delegated acts to complement the regulatory framework for medical devices over time.

With this proposal, other Union legislation is amended where a link exists with medical devices. In the case of medicinal product/medical device combination products that are regulated under Directive 2001/83/EC, the AIMDD and MDD already require the device part to comply with the applicable essential requirements set out in the medical device legislation. However, compliance with this requirement is not currently verified as part of the authorisation process for the medicinal product. Annex I of Directive 2001/83/EC, which lays down the content of an application for marketing authorisation, is therefore amended to require the applicant to submit evidence (e.g. an EU declaration of conformity or a certificate issued by a notified body) that the device part is in conformity with the applicable general safety and performance requirements of the future Regulation on medical devices.

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products[21] is amended to empower the Commission to determine whether or not a product falls within the definition of a cosmetic product. Such possibility already exists in the AIMDD and the MDD and is kept in this proposal. It also exists in the new Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products[22]. This will facilitate the adoption of EU-wide decisions regarding 'borderline' cases where the regulatory status of a product needs to be clarified.

The Food Regulation 178/2002 is amended to exclude medical devices from its scope (see 3.1. above).

The new Regulation will become applicable three years after its entry into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. The Commission needs time to put in place the IT infrastructure and the organisational arrangements necessary for the functioning of the new regulatory system. The designation of notified bodies pursuant to the new requirements and process needs to start shortly after the entry into force of the Regulation in order to ensure that by the date of its application, sufficient notified bodies are designated in accordance with the new rules to avoid any shortage of medical devices on the market. Special transitional provisions are foreseen for the registration of medical devices, relevant economic operators and certificates issued by notified bodies to allow for a smooth transition from registration requirements at national level to a central registration at EU level.

The future Regulation replaces and repeals Council Directives 90/385/EEC and 93/42/EEC.

3.10. Union competence, subsidiarity and legal form

The proposal has a ‘double legal basis‘, i.e. Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU). With the entry into force of the Lisbon Treaty, the legal base for the establishment and functioning of the internal market, on which the current Medical Devices Directives were adopted, has been complemented by a specific legal basis to set high standards for the quality and safety of devices for medical use. In regulating medical devices, the Union is exercising its shared powers under Article 4(2) of the TFEU.

Under the current Medical Devices Directives, devices that bear the CE marking can, in principle, move freely within the EU. The proposed revision of the existing directives, which will integrate the changes introduced by the Lisbon Treaty regarding public health, can be achieved only at Union level. This is necessary in order to improve the level of protection of public health for all European patients and users, and also to prevent Member States from adopting diverging product regulations which would result in further fragmentation of the internal market. Harmonised rules and procedures allow manufacturers, especially SMEs which make up more than 80% of the sector, to reduce costs related to national regulatory differences, while ensuring a high and equal level of safety throughout the Union. In accordance with the principles of proportionality and subsidiarity, as set out in Article 5 of the Treaty on European Union, this proposal does not go beyond what is necessary in order to achieve those objectives.

The proposal takes the form of a Regulation. This is the appropriate legal instrument as it imposes clear and detailed rules which will become applicable in a uniform manner and at the same time throughout the Union. Diverging transposition of the AIMDD and MDD by Member States has led to different levels of health and safety protection and created obstacles to the internal market which only a Regulation can avoid. Replacing the national transposition measures also has a strong simplification effect since it allows economic operators to conduct their business on the basis of a single regulatory framework, rather than a 'patchwork' of 27 national laws.

The choice of a Regulation, however, does not mean that decision-making is centralised. Member States retain their competence for implementing the harmonised rules, e.g. as regards approval of clinical investigations, the designation of notified bodies, the assessment of vigilance cases, the conduct of market surveillance and enforcement action (e.g. penalties).

3.11. Fundamental Rights

In line with the Charter of Fundamental Rights of the EU, this proposal seeks to ensure a high level of human health protection (Article 35 of the Charter) and consumer protection (Article 38) by assuring a high level of safety of medical devices made available on the Union market. The proposal affects the freedom of economic operators to conduct business (Article 16) but the obligations imposed on manufacturers, authorised representatives, importers and distributors of medical devices are necessary to guarantee a high level of safety of those products.

The proposal sets guarantees for the protection of personal data. In respect to medical research, the proposal requires that any clinical investigation with participation of human subjects is conducted respecting the human dignity, the right to physical and mental integrity of the persons concerned and the principle of free and informed consent, as required by Articles 1, 3(1) and 3(2)(a) of the Charter.

4. BUDGETARY IMPLICATIONS

The budgetary implications of this proposal are as follows:

· Costs for the further development of the Eudamed databank (one-off costs and maintenance);

· Commission staff to organise and participate in 'joint assessments' of notified bodies;

· Costs for national assessors participating in 'joint assessments' of notified bodies in accordance with the Commission's rules on the reimbursement of expenses incurred by experts;

· Commission staff to provide scientific, technical and logistic support to the MDCG, to its sub-groups and to the coordinating Member States in the fields of clinical investigations and vigilance;

· Commission staff to manage and further develop the EU regulatory framework for medical devices (functioning of this Regulation and preparation of delegated/implementing acts) and to support Member States in ensuring its effective and efficient implementation;

· Costs for organising meetings of the MDCG and its sub-groups and of the Committee under Regulation 182/2011, including reimbursement of their members, appointed by the Member States, to ensure a high level of coordination between Member States;

· Costs for the establishment and management of the scrutiny mechanism in respect of conformity assessments by notified bodies for high risk devices, including the technical infrastructure for data-exchange;

· Costs for running EU reference laboratories when these are designated;

· Costs for participation in international regulatory cooperation.

Details of the costs are set out in the legislative financial statement. A thorough discussion on the costs is contained in the impact assessment report.

2012/0266 (COD)

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

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the opinion of the European Economic and Social Committee[23],

Having regard to the opinion of the Committee of the Regions[24],

After consulting the European Data Protection Supervisor[25],

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices[26] and Council Directive 93/42/EEC of 14 June 1993 concerning medical devices[27] constitute the Union regulatory framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.

(2) This Regulation aims to ensure the functioning of the internal market as regards medical devices, taking as a base a high level of protection of health. 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.

(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.

(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, Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[28] should be amended to exclude medical devices from its scope.

(8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. 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 No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products[29].

(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 of 6 November 2001 on the Community code relating to medicinal products for human use[30]. 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 of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004[31]. 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 of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells[32], 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.

(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 are also not covered by this Regulation.

(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 protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial[33], 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 released to the human body and those devices should be subject to the most severe conformity assessment procedure.

(14) Aspects addressed by Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC[34] and aspects addressed by Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95/16/EC[35] 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 of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation[36] nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure and repealing Directive 84/466/Euratom[37] which pursue other objectives.

(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[38], the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment[39] and the Agreement of 12 September 1963 establishing an association between the European Economic Community and Turkey[40].

(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 of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations[41] 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 in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No […/…] on European standardisation[42] 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.

(20) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices[43] 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.

(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 of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93[44] and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC[45].

(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.

(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.

(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.

(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[46] 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 of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC[47], 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[48], 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.

(32) Patients who are implanted with a device should be given essential information related to the implanted device allowing it to be identified and containing any necessary 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.

(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.

(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.

(35) Transparency and better information are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.

(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, 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 of 19 April 2010 on the European Databank for Medical Devices[49].

(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. 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.

(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 of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data[50] 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 of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data[51] 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, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.

(40) The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.

(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.

(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 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.

(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 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.

(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.

(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 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 be communicated to the other Member States.

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

(52) In order to better protect health and safety 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.

(53) Healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats. The national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents.

(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 with the objective of sharing resources and ensuring consistency regarding the corrective action.

(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.

(57) The Member States shall 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.

(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 the level and structure of the fees to ensure transparency.

(59) An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices 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[52], to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation.

(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 implemented at Union level based on sound scientific evidence.

(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 protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should be applied by the Member States in accordance with those rights and principles.

(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.

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.

(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 of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers[53].

(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 to adapt to the changes introduced by this Regulation, 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. 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.

(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 sufficiently be achieved by the Member States and can, 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.

HAVE ADOPTED THIS REGULATION:

Chapter I Scope and definitions

Article 1 Scope

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

For the purposes of this Regulation, medical devices and accessories to medical devices shall hereinafter be referred to as ‘devices’.

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) products that contain or consist of biological substances or organisms other than those referred to in points (c) and (e) that are viable, including living micro-organisms, bacteria, fungi or virus;

(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.

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.

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 Council Directive 96/29/Euratom nor of Council Directive 97/43/Euratom.

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 medical purposes of:

– diagnosis, prevention, monitoring, treatment or alleviation of disease,

– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,

– investigation, replacement or modification of the anatomy or of a physiological 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, intended to be used for human beings, which are listed in Annex XV shall be considered medical devices, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose.

(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);

(3) ‘custom-made device’ means any device specifically made in accordance with 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;

(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 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.

Stand alone software shall be considered an active device;

(5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended

– to be totally introduced into the human body or

– to replace an epithelial surface or the surface of the eye,

by clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be 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.

The single procedure may involve several uses or prolonged use on the same patient;

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

(10) ‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements;

(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;

(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;

(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;

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;

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 of the device when used as intended by the manufacturer;

(33) ‘clinical investigation’ means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

(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 the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

– 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 of a clinical investigation;

(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 hospitalisation,

(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 or birth defect;

(40) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer;

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;

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, at the request of a Member State or on its own initiative, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of 'medical device' or 'accessory 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.

Chapter II Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement

Article 4 Placing on the market and putting into service

1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.

2. A device shall meet the general safety and performance requirements which apply to it, taking into account its intended purpose. General safety and performance requirements are set out in Annex I.

3. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 49.

4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 to 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system.

5. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing, in the light of technical progress and considering the intended users or patients, the general safety and performance requirements set out in Annex I, including the information supplied by the manufacturer.

Article 5 Distance sales

1. A device offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC to a natural or legal person established in the Union shall comply with this Regulation at the latest when the device is placed on the market.

2. Without prejudice to national legislation regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC or by other means of communication to a natural or legal person established in the Union shall comply with this Regulation.

Article 6 Harmonised standards

1. Devices which are in conformity with the relevant harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.

The first subparagraph shall also apply to system or process requirements to be fulfilled by economic operators or sponsors in accordance with this Regulation, including those related to the quality management system, risk management, the post-market surveillance plan, clinical investigations, clinical evaluation or post-market clinical follow-up.

2. Reference to harmonised standards also includes the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products.

Article 7 Common technical specifications

1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post-market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).

2. Devices which are in conformity with the CTS referred to in paragraph 1 shall be presumed to be in conformity with