EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

The current EU regulatory framework for in vitro diagnostic medical devices ('IVDs') consists of Directive 98/79/EC of the European Parliament and of the Council ('the IVD Directive')[1] IVDs cover a wide range of products that can be used for population screening and disease prevention, diagnosis, monitoring of prescribed treatments and assessment of medical interventions.

Like Council Directive 90/385/EEC on active implantable medical devices (AIMDD)[2] and Council Directive 93/42/EEC on medical devices (MDD)[3] the IVD Directive is based on the 'New Approach' and aims to ensure the smooth functioning of the internal market and a high level of protection of human health and safety. IVDs are not subject to any pre-market authorisation by a regulatory authority but to a conformity assessment which, for the majority of devices, is carried out under the sole responsibility of the manufacturer. For the high-risk devices listed in Annex II and devices for self-testing, the conformity assessment involves an independent third party, known as 'notified body'. Notified bodies 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 for in vitro diagnostic medical devices has demonstrated its merits but has also come under criticism in recent years.

In an internal market with 32 participating countries[4] and subject to constant scientific and technological progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the Directive, i.e. the safety and performance of IVDs and their free movement.

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

This proposal is adopted alongside a proposal for a Regulation on medical devices that are currently covered by the AIMDD and the MDD. While the specific features of IVDs and of the IVD sector require the adoption of a specific legislation distinct from the legislation on other medical devices, the horizontal aspects common to both sectors have been aligned.

2. RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

In preparation for the impact assessment on this proposal and the proposal for a Regulation on medical devices, 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 IVD Directive and showed wide support for this initiative.

During 2009, 2010 and 2011, the issues to be tackled in the revision of the regulatory framework for medical devices and in vitro diagnostic 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 in vitro diagnostic medical devices (IVDs), notified bodies, borderline and classification, clinical investigation and evaluation, vigilance and market surveillance, 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 into account, where appropriate, for the further development of the proposals.

In addition, 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)

To a large extent, the scope of the proposed Regulation matches the scope of Directive 98/79/EC, i.e. it covers in vitro diagnostic medical devices. The proposed changes clarify and extend the scope of the IVD Directive. They concern:

· high-risk devices manufactured and used within a single health institution, which are subject to most of the requirements set out in the proposal;

· tests providing information about the predisposition to a medical condition or a disease (e.g. genetic tests) and tests providing information to predict treatment response or reactions (e.g. companion diagnostics), which are considered as in vitro diagnostic medical devices ;

· medical software, which is explicitly mentioned in the definition of IVDs.

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[9], a group of experts from various sectors (such as IVDs, medical devices, medicinal products, human tissues and cells, cosmetics and biocides).

The definitions section has been significantly extended, aligning the definitions in the field of in vitro diagnostic medical devices with well-established European and international practice, such as the New Legislative Framework for the Marketing of Products[10] and guidance documents produced for in vitro diagnostic medical devices by the Global Harmonization Task-Force (GHTF)[11] .

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

This chapter covers mainly horizontal issues similar for both medical devices and IVDs. It 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). It also provides clarification with regard to the adoption and the scope of common technical specifications (CTS) for in vitro diagnostic medical devices.

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.

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 the devices placed on the market. Their minimum contents are laid down in Annexes II and III.

The following concepts are new in the field of IVDs:

· 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 Directive on medical devices in some Member States.

· Since in the case of 'parallel trade' with in vitro diagnostic 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 IVDs.

3.3. Identification and traceability of devices, registration of devices and of economic operators, summary of safety and 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 shall be able to identify who supplied them and to whom they have supplied IVDs;

· 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 shall 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[12], 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 performance studies, 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 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 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 IVDs 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)

Annex II to the IVD Directive addresses the level of risk posed by IVD medical devices by means of a positive list system. While this system was adapted to scientific and technological development at the time the IVD Directive was written, today it can no longer keep up with the fast pace of scientific and technological progress. The proposal introduces a new risk-rule based classification system, built on GHTF principles, which replaces the current list of IVD medical devices in Annex II to Directive 98/79/EC.

In the new classification system, IVDs will be divided into four classes of risk: A (lowest risk), B, C and D (highest risk). The conformity assessment procedures have been adapted to match each of these four device classes, using the existing modules established under the 'New Approach'. The conformity assessment procedure for class A devices will 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 A devices are intended for near-patient testing, have a measuring function or are sold sterile, a notified body shall verify respectively the aspects related to design, the measuring function or to the sterilisation process. For devices of classes B, C and D an appropriate level of involvement of a notified body is compulsory proportionate to the risk class, with devices of class D 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 B and C devices, the notified body checks the quality management system and, for class C, the technical documentation of representative samples. After initial certification, notified bodies shall 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. One conformity assessment procedure provided for under the IVD Directive (EC verification) has been deleted as the responses to the public consultation highlighted that it was under-used. The concept of batch testing has been clarified. 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 devices for performance evaluation continue to be subject to specific provisions.

In addition, the proposal introduces the obligation for notified bodies to notify an expert committee 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[13], 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[14]). Its use should be the exception rather than the rule and should follow clear and transparent criteria.

3.6. Clinical evidence (Chapter VI)

The proposal spells out the requirements for clinical evidence for in vitro diagnostic medical devices which are proportionate to the risk class. The key obligations are set out in Chapter VI while more detailed provisions are laid down in Annex XII.

While most clinical performance studies follow an observational design and therefore the results obtained are not used for patient management and do not impact treatment decisions, specific requirements have been introduced in Annex XIII for the conduct of interventional clinical performance studies and other clinical performance studies where the conduct of the study, including specimen collection, involves invasive procedures or other risks for the subjects of the studies.

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[15].

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

In accordance with recognised international ethical principles, every interventional clinical performance study and other clinical performance study involving risks for the subjects of the study shall 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 interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies 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 an interventional clinical performance study or any other clinical performance study involving risks for the subjects of the study, the sponsor shall submit an application to confirm that there are no health and safety aspects or ethical aspects which would oppose it. A new possibility will be opened up for sponsors of an interventional clinical performance study or any other clinical performance study involving risks for the subjects of the study to be conducted in more than one Member State: in future they may, if they wish, submit a single application through the electronic system to be set up by the Commission. As a consequence, the health and safety-related aspects regarding the device for performance evaluation 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 clinical performance studies 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 performance study 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 interventional clinical performance studies or any other clinical performance study involving risks for the subjects of the study. 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 because complications with devices may 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 shall report serious incidents and corrective actions they have taken to reduce the risk of recurrence. The information will be automatically made available 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 fields of medical devices and in vitro diagnostic medical devices and set up by Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices[16]. 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 or for verifying compliance with common technical specifications by devices posing the highest risk, 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 option either the extension of the responsibility of the European Medicines Agency (EMA) to in vitro diagnostic medical devices or the management of the in vitro diagnostic 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 this Regulation, or delegated acts to complement the regulatory framework for in vitro diagnostic medical devices over time.

The new Regulation will become applicable five years after its entry into force in order to take into account the significant changes to the classification system for IVDs and to the conformity assessment procedures. This will, on the one hand, allow time to set up a sufficient number of notified bodies, and, on the other hand, mitigate the economic impact on manufacturers. The Commission needs also 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 this 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 in vitro diagnostic medical devices on the market. Special transitional provisions are foreseen for the registration of in vitro diagnostic 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 will replace and repeal Directive 98/79/EC of the European Parliament and of the Council.

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. With the entry into force of the Lisbon Treaty, the legal basis 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 IVDs, the Union is exercising its shared power under Article 4(2) of the Treaty on the Functioning of the European Union.

Under the current IVD Directive, IVDs that bear the CE marking can, in principle, move freely within the EU. The proposed revision of the existing directive, 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 90% of the IVD 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 IVD Directive 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 performance studies, 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 in vitro diagnostic 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 in vitro diagnostic 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 performance study 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 IMPLICATION

This proposal does not have any additional direct budgetary implication because the cost-relevant arrangements are already covered by the proposal for a Regulation on medical devices. The financial statement of that proposal lists the details of the costs related to the implementation of both Regulations. A thorough discussion on the costs is contained in the impact assessment report.

2012/0267 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on in vitro diagnostic medical devices

(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[17],

Having regard to the opinion of the Committee of the Regions[18],

After consulting the European Data Protection Supervisor[19],

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices[20] constitutes the Union regulatory framework for in vitro diagnostic medical devices. However, a fundamental revision of that Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for 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 in vitro diagnostic 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 devices to meet common safety concerns as regards those products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union, this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic medical devices and their accessories on the Union market which may then benefit from the principle of free movement of goods. As regards Article 168(4)(c) of the Treaty on the Functioning of the European Union, this Regulation sets high standards of quality and safety for those devices by ensuring, among other things, that data generated in clinical performance studies is reliable and robust and that the safety of subjects participating in clinical performance studies is protected.

(3) Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices should be introduced to improve health and safety.

(4) To the extent possible, guidance developed for in vitro diagnostic medical devices at international level, in particular in the context of the Global Harmonization Task Force (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 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 evidence.

(5) There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of a specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned.

(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 legislation concerning products such as medical devices, general laboratory products and products for research use only.

(8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. If necessary, the Commission may decide, on a case-by-case basis, whether or not a product falls within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device.

(9) To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices manufactured and used, including measurement and delivery of results, only within a single health institution should be clarified and strengthened.

(10) It should be clarified that software specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic medical device is qualified as an in vitro diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being applications is not qualified as an in vitro diagnostic medical device.

(11) It should be made clear that all tests that provide information on the predisposition to a medical condition or a disease (e.g. genetic tests) and tests that provide information to predict treatment response or reactions, such as companion diagnostics, are in vitro diagnostic medical devices.

(12) 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[21] 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[22] are an integral part of the general safety and performance requirements for in vitro diagnostic medical devices. Consequently, this Regulation should be considered a lex specialis in relation to those Directives.

(13) This Regulation should include requirements regarding the design and manufacture of in vitro diagnostic medical devices emitting ionising 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[23], nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure and repealing Directive 84/466/Euratom[24] which pursue other objectives.

(14) 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[25], the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment[26] and the Agreement of 12 September 1963 establishing an association between the European Economic Community and Turkey[27].

(15) It should be made clear that in vitro diagnostic 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[28] 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.

(16) To recognise the important role of standardisation in the field of in vitro diagnostic medical devices, compliance with harmonised standards as defined in Regulation (EU) No [Ref. of future Regulation on European standardisation] on European standardisation[29] 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.

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

(18) The rules applicable to in vitro diagnostic 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[30] 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[31].

(19) The rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to in vitro diagnostic 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.

(20) 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.

(21) To ensure that in vitro diagnostic 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 in vitro diagnostic 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 in vitro diagnostic medical device.

(22) It should be ensured that supervision and control of the manufacture of in vitro diagnostic medical devices is carried out within the manufacturer's organisation by a person who fulfils minimum conditions of qualification.

(23) For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the in vitro diagnostic 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.

(24) 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 an in vitro diagnostic medical device.

(25) 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 of the Treaty on the Functioning of the European Union subject to the limitations set by the protection of health and safety and by the protection of intellectual property rights provided by Article 36 of the Treaty on the Functioning of the European Union. 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[32] in other relevant sectors and existing good practices in the field of in vitro diagnostic medical devices.

(26) In vitro diagnostic 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.

(27) The traceability of in vitro diagnostic 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 in vitro diagnostic 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.

(28) 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.

(29) 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 in vitro diagnostic medical devices on the market and the relevant economic operators, certificates, interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies, 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) by further developing the databank set up by Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices[33].

(30) 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 performance studies 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.

(31) 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[34] applies to the processing of personal data carried out in the Member States, under the supervision of the Member States competent authorities, in particular the public independent authorities designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council 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[35], applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. In accordance with Article 2(d) of Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems.

(32) For high-risk in vitro diagnostic 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.

(33) The proper functioning of notified bodies is crucial for ensuring a high level of health and safety 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.

(34) 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 in vitro diagnostic medical devices to ensure continuous compliance by manufacturers after receipt of the original certification.

(35) For high risk in vitro diagnostic 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 devices for which no common technical specifications exist, devices which are novel or 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 in vitro diagnostic medical device before submitting the application to the notified body.

(36) To enhance patient safety and to take due account of technological progress, the risk classification system for in vitro diagnostic medical devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the corresponding conformity assessment procedures should be accordingly adapted.

(37) It is necessary, in particular for the purpose of the conformity assessment procedures, to classify in vitro diagnostic medical devices into four risk classes and to establish a set of robust risk-based classification rules, in line with international practice.

(38) The conformity assessment procedure for class A in vitro diagnostic medical devices should be carried out, as a general rule, under the sole responsibility of the manufacturers, since such devices pose a low risk to patients. For in vitro diagnostic medical devices in classes B, C and D, the involvement of a notified body should be compulsory to the appropriate degree.

(39) The conformity assessment procedures should be further developed whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field.

(40) It is necessary to clarify the requirements regarding batch release verification for the highest risk in vitro diagnostic medical devices.

(41) European Union reference laboratories should be enabled to verify compliance of such devices with the applicable common technical specifications, when such common technical specifications are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.

(42) To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements should be based on clinical evidence. It is necessary to clarify the requirements for such clinical evidence. As a general rule, clinical evidence should be sourced from clinical performance studies 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 performance study.

(43) The rules on clinical performance studies should be in line with major international guidance, 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 performance studies conducted in the Union are accepted elsewhere and that clinical performance studies conducted outside the Union in accordance with international guidelines can be accepted under this Regulation.

(44) An electronic system should be set up at Union level to ensure that every interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies are registered in a publicly accessible database. To protect the right to protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union, no personal data of subjects participating in a clinical performance studies should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical performance studies on in vitro diagnostic medical devices should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use.

(45) Sponsors of interventional clinical performance studies and other clinical performance studies involving risks for the subjects 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 device for performance evaluation and of the scientific design of the clinical performance study 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 performance study, including informed consent. Each Member State should retain the ultimate responsibility for deciding whether the clinical performance study may be conducted on its territory.

(46) Sponsors should report certain adverse events occurring during interventional clinical performance studies and other clinical performance studies involving risks for the subjects to the Member States concerned which should have the possibility to terminate or suspend these studies if considered necessary to ensure a high level of protection of the subjects enrolled in such studies. Such information should be communicated to the other Member States.

(47) This Regulation should only cover clinical performance studies which pursue regulatory purposes laid down in this Regulation.

(48) In order to better protect health and safety regarding devices on the market, the vigilance system for in vitro diagnostic medical devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions.

(49) 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.

(50) 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.

(51) The reporting of serious adverse events during interventional clinical performance studies and other clinical performance studies involving risks for the subjects, and the reporting of serious incidents occurring after an in vitro diagnostic medical device has been placed on the market should be clearly distinguished to avoid double reporting.

(52) 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.

(53) 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.

(54) Whilst this Regulation should not affect the right of the 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.

(55) 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 in accordance with the conditions and modalities defined in Article 78 of Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices[36] to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation.

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

(57) The Commission should provide scientific, technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for in vitro diagnostic medical devices is effectively implemented at Union level based on sound scientific evidence.

(58) The Union should actively participate in international regulatory cooperation in the field of in vitro diagnostic medical devices to facilitate the exchange of safety-related information regarding in vitro diagnostic medical devices and 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.

(59) 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.

(60) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the 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 performance studies; the establishment of the UDI system; the information to be submitted for the registration of in vitro diagnostic 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 performance studies; 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.

(61) 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[37].

(62) 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 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.

(63) 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 an in vitro diagnostic 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 an in vitro diagnostic medical device presenting a risk, imperative grounds of urgency so require.

(64) 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 in vitro diagnostic medical devices on the market.

(65) In order to ensure a smooth transition to the registration of in vitro diagnostic 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 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC 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 Directive to avoid multiple registrations.

(66) Directive 98/79/EC should be repealed to ensure that only one set of rules applies to the placing of in vitro diagnostic medical devices on the market and the related aspects covered by this Regulation.

(67) Since the objective of this Regulation, namely to ensure high standards of quality and safety for in vitro diagnostic medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot 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 in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices that are placed on the market or put into service in the Union for human use.

For the purposes of this Regulation, in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices shall hereinafter be referred to as 'devices'.

2. This Regulation shall not apply to:

(a) products for general laboratory use, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

(b) invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen;

(c) higher metrological order reference materials.

3. Any device which, when placed on the market or used in accordance with the manufacturer's instructions, incorporates as an integral part a medical device as defined in Article 2 of Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices without being an in vitro diagnostic medical device, shall be governed by this Regulation, provided that the principal intended purpose of the combination is that of an in vitro diagnostic medical device referred to in Article 2(2) of this Regulation. The relevant general safety and performance requirements set out in Annex I to Regulation (EU) [Ref. of future Regulation on medical devices] shall apply as far as the safety and performance of the medical device part that is not an in vitro diagnostic medical device are concerned.

4. 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.

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

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

7. 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

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 intended function by such means.

(2) 'in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

– concerning a physiological or pathological state;

– concerning a congenital abnormality;

– concerning the predisposition to a medical condition or a disease;

– to determine the safety and compatibility with potential recipients;

– to predict treatment response or reactions;

– to define or monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. For the purposes of this Regulation, ‘specimen receptacle’ means devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

(3) 'accessory to an in vitro diagnostic medical device' means an article which, whilst not being an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable or assist the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s);

(4) 'device for self-testing' means any device intended by the manufacturer to be used by lay persons;

(5) 'device for near-patient testing' means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient;

(6) 'companion diagnostic' means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy;

(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) '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;

(10) '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;

(11) '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;

(12) '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;

Definitions related to the making available of devices:

(13) 'making available on the market' means any supply of a device, other than a device for performance evaluation, 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;

(14) 'placing on the market' means the first making available of a device, other than a device for performance evaluation, on the Union market;

(15) 'putting into service' means the stage at which a device, other than a device for performance evaluation, 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:

(16) '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;

(17) '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;

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

(19) '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;

(20) 'economic operators' means the manufacturer, the authorised representative, the importer and the distributor;

(21) 'health institution' means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health;

(22) 'user' means any healthcare professional or lay person who uses a device;

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

Definitions related to conformity assessment:

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

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

(26) 'notified body' means a conformity assessment body designated in accordance with this Regulation;

(27) '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 evidence:

(28) 'clinical evidence' means the information that supports the scientific validity and performance for the use of a device as intended by the manufacturer;

(29) 'scientific validity of an analyte' means the association of an analyte to a clinical condition or a physiological state;

(30) 'performance of a device' means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting the intended purpose of the device;

(31) 'analytical performance' means the ability of a device to correctly detect or measure a particular analyte;

(32) 'clinical performance' means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological state in accordance with the target population and intended user;

(33) 'clinical performance study’ means a study undertaken to establish or confirm the clinical performance of a device;

(34) 'clinical performance study protocol' means the document(s) setting out the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study;

(35) 'performance evaluation' means the assessment and analysis of data to establish or verify the analytical and, where applicable, the clinical performance of a device;

(36) 'device for performance evaluation' means a device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside the manufacturer's own premises. Devices intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation;

(37) 'interventional clinical performance study' means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment;

(38) 'diagnostic specificity' means the ability of a device to recognize the absence of a target marker associated with a particular disease or condition;

(39) 'diagnostic sensitivity' means the ability of a device to identify the presence of a target marker associated with a particular disease or condition;

(40) 'predictive value' means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition;

(41) 'positive predictive value' means the ability of a device to separate true positive results from false positive results for a given attribute in a given population;

(42) 'negative predictive value' means the ability of a device to separate true negative results from false negative results for a given attribute in a given population;

(43) 'likelihood ratio' means the likelihood that a given result would be expected in an individual with the target clinical condition or physiological state compared to the likelihood that the same result would be expected in an individual without that clinical condition or physiological state;

(44) 'calibrators and control materials' means any substance, material or article intended by the manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended purpose of that device;

(45) 'sponsor' means any individual, company, institution or organisation which takes responsibility for the initiation and management of a clinical performance study;

(46) '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 performance study, whether or not related to the device for performance evaluation;

(47) '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.

(48) 'device deficiency' means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance evaluation, including malfunction, use errors or inadequacy in the information supplied by the manufacturer;

Definitions related to vigilance and market surveillance:

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

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

(51) '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 effect;

(52) '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;

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

(54) '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;

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

(56) '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:

(57) ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of Regulation (EU) No [Ref. of future Regulation on European standardisation];

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

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 an in vitro diagnostic medical devices or of an accessory to an in vitro diagnostic medical device. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).

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

Chapter II

Making available of devices, obligations of economic operators, 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 be based on clinical evidence in accordance with Article 47.

4. Devices that are manufactured and used within a single health institution shall be considered as being put into service.

5. With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, and manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution's single quality management system, and the health institution is compliant with standard EN ISO 15189 or any other equivalent recognised standard. Member States may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements.

Devices classified as class D in accordance with the rules set out in Annex VII, even if manufactured and used within a single health institution, shall comply with the requirements of this Regulation. However, the provisions regarding CE marking set out in Article 16 and the obligations referred to in Articles 21 to 25 shall not apply to those devices.

6. The Commission shall be empowered to adopt delegated acts in accordance with Article 85, 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 is 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 performance studies, clinical evidence or post-market 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.

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 evidence and post-market follow-up set out in Annex XII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 84(3).

2. Devices which are in conformity with the CTS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CTS or parts thereof.

3. Manufacturers shall comply with the CTS unless they can duly justify that they have adopted solutions ensuring a level of safety and performance that is at least equivalent thereto.

Article 8

General obligations of the manufacturer

1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.

2. Manufacturers shall draw up the technical documentation which shall allow assessment of the conformity of the device with the requirements of this Regulation. The technical documentation shall include the elements set out in Annex II.

The Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing, in the light of technical progress, the elements in the technical documentation set out in Annex II.

3. Where compliance of a device with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devices for performance evaluation, shall draw up an EU declaration of conformity in accordance with Article 15 and affix the CE marking of conformity in accordance with Article 16.

4. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement, issued in accordance with Article 43, available to the competent authorities for a period of at least five years after the last device covered by the declaration of conformity has been placed on the market.

Where the technical documentation is voluminous or held in different locations, the manufacturer shall provide, upon request by a competent authority, a summary technical documentation (STED) and grant access to the full technical documentation upon request.

5. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised standards or CTS by reference to which conformity of a product is declared shall be adequately taken into account. Proportionate to the risk class and the type of device, manufacturers of devices, other than devices for performance evaluation, shall institute and keep up to date a quality management system that shall address at least the following aspects:

(a) the responsibility of the management;

(b) resource management, including selection and control of suppliers and sub-contractors;

(c) product realisation;

(d) processes for monitoring and measurement of output, data analysis and product improvement.

6. Proportionate to the risk class and the type of device, manufacturers of devices shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service, and to apply any necessary corrective action, hereinafter referred to as 'post-market surveillance plan'. The post-market surveillance plan shall set out the process for collecting, recording and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market follow-up in accordance with Part B of Annex XII. Where post-market follow-up is not deemed necessary, this shall be duly justified and documented in the post-market surveillance plan.

If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures.

7. Manufacturers shall ensure that the device is accompanied by the information to be supplied in accordance with Section 17 of Annex I in an official Union language which can be easily understood by the intended user. The language(s) of the information to be supplied by the manufacturer may be determined by the law of the Member State where the device is made available to the user.

For devices for self-testing or near-patient-testing, the information supplied in accordance with Section 17 of Annex I shall be provided in the language(s) of the Member State where the device reaches its intended user.

8. Manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that product into conformity, withdraw it or recall it, as appropriate. They shall inform the distributors and, where applicable, the authorised representative accordingly.

9. Manufacturers shall, in response to a reasoned request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.

10. Where manufacturers have their devices designed and manufactured by another legal or natural person, the information on the identity of that person shall be part of the information to be submitted in accordance with Article 23.

Article 9

Authorised representative

1. A manufacturer of a device that is placed on the Union market, or bears the CE marking without being placed on the Union market, who does not have a registered place of business in a Member State or does not carry out relevant activities at a registered place of business in a Member State, shall designate a single authorised representative.

2. The designation shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.

3. The authorised representative shall perform the tasks specified in the mandate agreed between the manufacturer and the authorised representative.

The mandate shall allow and require the authorised representative to perform at least the following tasks in relation to the devices that it covers:

(a) keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any supplement, issued in accordance with Article 43 at the disposal of competent authorities for the period referred to in Article 8(4);

(b) in response to a reasoned request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device;

(c) cooperate with the competent authorities on any corrective action taken to eliminate the risks posed by devices;

(d) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(e) terminate the mandate if the manufacturer acts contrary to his obligations under this Regulation.

To allow the authorised representative to fulfil the tasks mentioned in this paragraph, the manufacturer shall at least ensure that the authorised representative has permanent immediate access to the necessary documentation in one of the official Union languages.

4. The mandate referred to in paragraph 3 shall not include the delegation of the manufacturer's obligations laid down in Article 8(1), (2), (5), (6), (7) and (8).

5. An authorised representative who terminates the mandate on the grounds referred to in point (e) of paragraph 3 shall immediately inform the competent authority of the Member State in which he is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.

6. Any reference in this Regulation to the competent authority of the Member State where the manufacturer has his registered place of business shall be understood as a reference to the competent authority of the Member State where the authorised representative, designated by a manufacturer referred to in paragraph 1, has his registered place of business.

Article 10

Change of authorised representative

The modalities of a change of authorised representative shall be clearly defined in an agreement between the manufacturer, the outgoing authorised representative and the incoming authorised representative. This agreement shall address at least the following aspects:

(a) the date of termination of the mandate with the outgoing authorised representative and date of beginning of the mandate with the incoming authorised representative;

(b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;

(c) the transfer of documents, including confidentiality aspects and property rights;

(d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or to the incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which he had been designated as authorised representative.

Article 11

General obligations of importers

1. Importers shall place on the Union market only devices that are in conformity with this Regulation.

2. Before placing a device on the market importers shall ensure the following:

(a) that the appropriate conformity assessment procedure has been carried out by the manufacturer;

(b) that an authorised representative in accordance with Article 9 has been designated by the manufacturer;

(c) that the EU declaration of conformity and the technical documentation has been drawn up by the manufacturer;

(d) that the device bears the required CE marking of conformity;

(e) that the device is labelled in accordance with this Regulation and accompanied by the required instructions for use and EU declaration of conformity;

(f) that, where applicable, a Unique Device Identification has been assigned by the manufacturer in accordance with Article 22.

Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not place the device on the market until it has been brought into conformity. Where the device presents a risk, the importer shall inform the manufacturer and his authorised representative to that effect, as well as the competent authority of the Member State in which he is established.

3. Importers shall indicate their name, registered trade name or registered trade mark and the address of their registered place of business at which they can be contacted and their location can be established on the device or on its packaging or in a document accompanying the device. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.

4. Importers shall ensure that the device is registered in the electronic system in accordance with Article 23(2).

5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I.

6. When deemed appropriate with regard to the risks presented by a device, importers shall, in order to protect the health and safety of patients and users, carry out sample testing of marketed products, investigate complaints and keep a register of complaints, of non-conforming products and of product recalls and withdrawals, and shall keep the manufacturer, authorised representative and distributors informed of such monitoring.

7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised representative and, if appropriate, take the necessary corrective action to bring that device into conformity, withdraw or recall it. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 43 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.

8. Importers