P7_TA(2014)0267

In vitro diagnostic medical devices ***I

European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (COM(2012)0541 — C7-0317/2012 — 2012/0267(COD))

(Ordinary legislative procedure: first reading)

(2017/C 408/16)

The European Parliament,

having regard to the Commission proposal to the European Parliament and the Council (COM(2012)0541),

having regard to Article 294(2) and Articles 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0317/2012),

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

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

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Employment and Social Affairs and the Committee on the Internal Market and Consumer Protection (A7-0327/2013),

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

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

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

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

(2) P7_TA(2013)0427.

P7_TC1-COD(2012)0267

Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on 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 (1),

After consulting the Committee of the Regions,

After consulting the European Data Protection Supervisor (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

(1) Directive 98/79/EC of the European Parliament and of the Council (4) 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 for patients, users and operators . 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 (TFEU) , this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic medical devices and their accessories on the Union market 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 TFEU , 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. [Am. 1]

(3) Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence investigations and clinical evaluation , 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 for health professionals, patients, users and operators, including in the waste disposal chain . [Am. 2]

(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 without compromising the need for innovation in the Union . [Am. 3]

(5a) The high number of small and medium enterprises (SMEs) active in the area of in-vitro diagnostic medical devices should be taken into account when regulating that area, while avoiding the creation of health and safety risks. [Am. 4]

(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.

(7a) A multidisciplinary Medical Device Advisory Committee (MDAC) composed of experts and representatives of the relevant stakeholders should be set up to provide scientific advice to the Commission, the Medical Device Coordination Group (MDCG) and Member States on issues of medical technology, the regulatory status of devices and other aspects of implementation of this Regulation as necessary. [Am. 5]

(8) It In order to ensure consistent classification across all Member States, particularly with regard to borderline cases, it should be the responsibility of the Member States Commission, having consulted the MDCG and the MDAC, to decide on a case-by-case basis whether or not a product falls or groups of products fall within the scope of this Regulation. If necessary, the Commission may decide, on a case-by-case basis, whether or not a product falls within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device. Member States should also have the possibility to request the Commission to take a decision on the appropriate regulatory status of a product, or category or group of products. [Am. 6]

(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.

(9a) In the case of urgent or unmet medical needs for patients, such as emerging pathogens and rare diseases, single health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby addressing, within a non-commercial and flexible framework, specific needs which cannot be met by an available CE-marked device. [Am. 7]

(9b) However, devices which are manufactured within non-health institution laboratories and put into service without being placed onto the market should be subject to this Regulation. [Am. 8]

(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 (5) and aspects addressed by Directive 2006/42/EC of the European Parliament and of the Council (6) 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 (7), nor of Council Directive 97/43/Euratom (8) which pursue other objectives.

(13a) Directive 2013/35/EU of the European Parliament and of the Council (9) should be the reference text for ensuring that people working in the vicinity of magnetic resonance imaging equipment when it is in operation are properly protected. [Am. 9]

(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 (10), the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (11) and the Agreement of 12 September 1963 establishing an association between the European Economic Community and Turkey (12).

(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 (13) 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 (14) 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 (15) and Decision No 768/2008/EC of the European Parliament and of the Council (16).

(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. In addition to regulatory compliance, that person could also be responsible for compliance in other fields such as manufacturing processes and quality assessment. The required qualifications of the person responsible for the regulatory compliance should be without prejudice to national provisions regarding professional qualifications, in particular for manufacturers of custom-made devices where such requirements could be met through different educational and professional training systems at national level. [Am. 10]

(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 (17) in other relevant sectors and existing good practices in the field of in vitro diagnostic medical devices.

(25a) To ensure that patients harmed are compensated for any damage and associated treatment as a result of a faulty in vitro diagnostic medical device, that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by a faulty in vitro diagnostic medical device, manufacturers should be obliged to take liability insurance with sufficient minimum coverage. [Am. 11]

(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. However Member States should be allowed to decide whether to restrict the use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation. [Am. 12]

(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 purchasing and waste disposal policies and hospitals’, wholesalers’ and pharmacists’ management of stock and, where possible, be compatible with other authentication systems already in place in those settings . [Am. 13]

(28) Transparency and better adequate access to information , appropriately presented for the intended user, are essential to empower patients and healthcare professionals and all others concerned, and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system. [Am. 14]

(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, via better access to information for the public and healthcare professionals, to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission, to avoid multiple reporting requirements and to enhance the coordination between Member States. Within an internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices (Eudamed) by further developing the databank set up by Commission Decision 2010/227/EU (18). [Am. 15]

(30) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public and healthcare professionals to be adequately informed about devices on the Union market. Adequate levels of access for the public and healthcare professionals to those parts of Eudamed's electronic systems which provide key information on in vitro diagnostic medical devices that may pose a risk to public health and safety is essential. Where such access is limited, it should be possible, upon a reasoned request, to disclose the existing information on in vitro diagnostic medical devices, unless the limitation of access is justified on grounds of confidentiality. 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. A regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public. [Am. 16]

(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 (19) 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 (20), 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, in the interests of increased transparency, manufacturers should summarise the main draw up a report on the safety and performance aspects of the device and the outcome of the clinical evaluation in a document that . A summary of the safety and performance report should be publicly available via Eudamed . [Am. 17]

(32a) According to the policy of the European Medicines Agency (EMA) on access to documents, the EMA releases documents submitted as part of applications for marketing authorisation for medicinal products, including clinical trial reports, on request once the decision-making process for the medicinal product in question has been completed. Corresponding standards on transparency and access to documents should be upheld and reinforced for high-risk in vitro diagnostic medical devices, in particular as they are not subject to pre-market approval. For the purposes of this Regulation, in general the data included in clinical performance studies should not be considered commercially sensitive provided that compliance of a device with the applicable requirements has been demonstrated following the applicable conformity assessment procedure. This should be without prejudice to intellectual property rights concerning the use by other manufacturers of data from clinical performance studies by the manufacturer. [Am. 18]

(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, and where applicable by the EMA, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level. [Am. 19]

(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. [Am. 20]

(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.

(40a) Clinical expertise and specialist product knowledge within notified bodies, special notified bodies and the MDCG should be appropriate for the specifications of in vitro diagnostic medical devices. Clinical experts should have expertise in clinical interpretation of in vitro diagnostic results, metrology and good laboratory practice. Clinical experts and product specialists should have expertise in fields such as virology, haematology, clinical analysis and genetics. [Am. 262]

(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.

(43a) The Declaration of Helsinki of the World Medical Association (21) states in Article 23 that ‘The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins.’ Interventional clinical performance studies and other clinical performance studies involving risk for the subject should only be allowed after assessment and approval by an ethics committee. The reporting Member State and the other concerned Member States need to organise themselves in a way that the competent authority concerned receives approval from an ethics committee on the clinical performance study protocol. [Am. 22]

(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.

(44a) For the sake of transparency, sponsors should submit the results of a clinical performance study together with a ‘layperson’ summary within the deadlines specified by the regulation. The Commission should be empowered to adopt delegated acts on the preparation of the layperson's summary and the communication of the clinical performance study report. The Commission should provide guidelines for managing, and facilitating the sharing of, raw data from all clinical performance studies. [Am. 23]

(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. [Am. 24]

(45a) Strict rules for persons unable to give informed consent such as children and incapacitated persons should be established at the same level as in Directive 2001/20/EC of the European Parliament and of the Council (22) . [Am. 25]

(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 within and outside the Union . [Am. 26]

(49) Member States should take all necessary measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be empowered and enabled to report suspected serious incidents at national level using harmonised formats. The and guaranteeing anonymity, where appropriate . In order to minimise the recurrence of such incidents, the national competent authorities should inform manufacturers and, if appropriate, their subsidiaries and sub-contractors, and share report the information with their peers via the respective electronic system in Eudamed when they confirm that a serious an incident has occurred in order to minimise recurrence of those incidents. [Am. 27]

(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 should levy fees for the designation and monitoring of notified bodies to ensure sustainability of the monitoring of those bodies by Member States and to establish a level playing field for notified bodies. These fees should be comparable across Member States and should be made public. [Am. 28]

(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 comparable level and structure of the fees to ensure transparency. [Am. 29]

(54a) Member States should adopt provisions on standard fees for notified bodies, which should be comparable across Member States. The Commission should provide guidelines to facilitate the comparability of those fees. Member States should transmit their list of standard fees to the Commission and ensure that the notified bodies registered on their territory make the lists of standard fees for their conformity assessment activities publicly available. [Am. 30]

(55) An expert committee, the Medical Device Coordination Group A MDCG, composed of persons designated by the Member States, based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices, should be established in accordance with the conditions and modalities defined in Article 78 of Regulation (EU) …/…[Ref. of future Regulation on medical devices] on medical devices (23) 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. Prior to taking up their duties, members of the MDCG should make available a declaration of commitment and a declaration of interests indicating either the absence of any interests which could be considered prejudicial to their independence or any direct or indirect interests which could be prejudicial to their independence. Those declarations should be verified by the Commission. [Am. 31]

(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 principle of free and informed consent of the person concerned, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property , as well as the European Convention on Human Rights and Biomedicine as well as the Additional Protocol to that Convention concerning Genetic Testing for Health Purposes . This Regulation should be applied by the Member States in accordance with those rights and principles. [Am. 32]

(59a) Clear rules on the application of DNA tests are important. It is however advisable to regulate only on some basic elements and leave room for the Member States for more specific regulation in this area. Member States should for example regulate, that all devices providing an indication of a genetic disease which develops in adulthood or affects family planning may not be used on minors unless preventive treatment is available. [Am. 33]

(59b) While genetic counselling should be mandatory in specific cases it should not be mandatory in cases where a diagnosis of a patient already suffering from a disease is confirmed by a genetic test or where a companion diagnostic is used. [Am. 34]

(59c) This Regulation is in keeping with the United Nations Convention on the Rights of Persons with Disabilities of 13 December 2006, ratified by the European Union on 23 December 2010, pursuant to which the signatories commit themselves, in particular, to promote, protect and guarantee the full and equal exercise of all human rights and basic freedoms by all persons with disabilities and to promote the respect of their inherent dignity, inter alia by raising awareness about the abilities of disabled persons and the contribution they make. [Am. 35]

(59d) Whereas, in view of the need to protect the integrity of the human person during the sampling, collection and use of substances derived from the human body, it is appropriate to apply the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. [Am. 270]

(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. However, basic aspects elements of this Regulation such as general safety and performance requirements , elements to be addressed in technical documentation, the minimum content of the Union declaration of conformity, amending or supplementing the conformity assessment procedures, should only be amended through the ordinary legislative procedure . It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. [Am. 36]

(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 (24).

(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 especially SMEs, to adapt to the changes introduced by this Regulation and to ensure its proper application , it is appropriate to provide for a sufficient transitional period for that adaptation and for the to allow for organisational arrangements to be taken for its proper application to be made. However, parts of the Regulation that concern Member States and the Commission should be implemented as soon as possible . It is particularly important that by the date of application, a sufficient number of notified bodies are designated is designated in accordance with the new requirements, as soon as possible, to avoid any shortage of in vitro diagnostic medical devices on the market. [Am. 37]

(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, operational as soon as possible. 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. [Am. 38]

(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.

(67a) It is a long standing policy of the Union not to interfere with national policy allowing, prohibiting or limiting at national level ethically controversial technologies, such as pre-implantation genetic testing. This Regulation should not interfere with this principle, and the decision to allow, prohibit or restrict such technologies should therefore remain at national level. Where a Member State allows such technologies whether with or without restriction, the standards laid down in this Regulation should apply. [Am. 39]

(67b) Although internationally certified reference materials and materials used for external quality assessment schemes are not covered by this Regulation, calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices. [Am. 272]

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

6. This Regulation provides that certain devices may only be supplied on a medical prescription but it shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this Regulation shall be illegal.

The following devices may only be supplied on a medical prescription:

1) Class D devices;

2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics.

By derogation, justified by the attainment of a high level of public health protection, Members States may maintain or introduce national provisions allowing special class D tests to also be available without a medical prescription. In that case, they shall duly inform the Commission.

The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide that other class C tests may only be supplied on a medical prescription after consultation with stakeholders. [Am. 268]

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.

7a. The regulation of in-vitro diagnostic medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation. [Am. 41]

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 direct or indirect medical purposes of: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological process or state, — control or support of conception, — disinfection or sterilisation of any of the above-mentioned products, — providing information concerning direct or indirect impacts on health, 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. [Ams 42 and 43]

(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 physical or mental impairments ; [Am. 44] — 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. In vitro diagnostic medical devices used for DNA-testing shall be subject to this Regulation. [Am. 45]

(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 , including testing services offered to lay persons by means of information society services ; [Am. 46]

(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 for and essential to the selection of patients with a previously diagnosed condition or predisposition as eligible suitable or unsuitable for a targeted specific therapy with a medicinal product or a range of medicinal products ; [Am. 47]

(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;

(12a) ‘novel device’ means: — a device which incorporates technology (the analyte, technology or test platform) not previously used in diagnostics, or; — an existing device which is being used for a new intended purpose for the first time; [Am. 48]

(12b) ‘device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development; [Am. 49]

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;

(15a) ‘Information society service’ means any service, normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services; [Am. 50]

Definitions related to economic operators, users and specific processes:

(16) ‘manufacturer’ means the natural or legal person who manufactures or with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under that person's own name, regardless of whether those operations are carried out by that person or on that person's behalf by a third party. The obligations of this Regulation to be met by manufacturers also apply to natural or legal persons who assemble, package, process, fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device refurbish or label one or more ready-made products and/or assign to them their intended purpose as devices with a view to their being placed on the market under his that person's own name or trademark. [Am. 51] 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 and which has the legal capacity to carry out such activities ; commercial laboratories which provide diagnostic services shall not be considered to be health institutions ; [Am. 52]

(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; [Am. 53]

(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 data, positive and negative, supporting the evaluation of the scientific validity and performance for the use of a device as intended by the manufacturer; [Am. 54]

(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 attainment of technical capabilities, analytical performance and, where applicable, the clinical performance supporting the intended purpose of the device; [Am. 55]

(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 that the device performs as intended by the manufacturer, including the technical, analytical and, where applicable, the clinical performance of a device; [Am. 56]

(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;

(37a) ‘ethics committee’ means an independent body in a Member State, consisting of health-care professionals and non-medical members including at least one well-experienced, knowledgeable patient or patient representative. Its responsibility is to protect the rights, safety, physical and mental integrity, dignity and well-being of subjects involved in interventional clinical performance studies and other clinical performance studies involving risk for the subject and to provide public assurance of that protection in full transparency. In cases of such studies involving minors, the ethics committee shall include at least one healthcare professional with paediatric expertise. [Am. 57]

(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;

(43a) ‘calibrator’ means a measurement standard used in the calibration of a device; [Am. 58]

(44) ‘calibrators and control materials material ’' means any a substance, material or article intended by the its manufacturer either to establish measurement relationships or to be used to verify the performance characteristics of a device in conjunction with the intended purpose of that device; [Am. 59]

(45) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation and management , conduct or financing of a clinical performance study; [Am. 60]

(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 prolongation of patient hospitalisation, [Am. 61] (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 stability , reliability, safety or performance of a device for performance evaluation, including malfunction, use errors or inadequacy in the information supplied by the manufacturer; [Am. 62]

(48a) ‘inspection’ means an official review, carried out by a competent authority, of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by that authority to be related to a clinical performance study and that may be located at the site of the trial, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect; [Am. 63]

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 , waste disposal operators or customers in relation to a field safety corrective action; [Am. 64]

(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;

(56a) ‘unannounced inspection’ means an inspection conducted without advance notice; [Am. 65]

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 on its own initiative or shall at the request of a Member State or on its own initiative, by means of implementing acts on the basis of the opinions of the MDCG and the MDAC referred to in Articles 76 and 76a respectively , determine whether or not a specific product, or category or group of products, including borderline 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. [Am. 66]

SECTION 1 CHAPTER II

CLASSIFICATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES [AM. 135]

Article 39

Classification of in vitro diagnostic medical devices

1. Devices shall be divided into class A, B, C and D, taking into account their intended purpose , novelty, complexity and inherent risks. Classification shall be carried out in accordance with the classification criteria set out in Annex VII. [Am. 136]

2. Any dispute between the manufacturer and the notified body concerned, arising from the application of the classification criteria, shall be referred for a decision to the competent authority of the Member State where the manufacturer has his registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State where the authorised representative referred to in the last indent of point (b) of Section 3.2. of Annex VIII has his registered place of business.

At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision. That decision shall be made publicly available in the European databank . [Am. 137]

3. The Commission may, on its own initiative or shall at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices with a view to determining their classification. Such a decision shall in particular be taken in order to resolve divergent decisions as regards the classification of devices between Member States. [Am. 138]

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).

4. In the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in Articles 59 to 73, the Commission , having consulted relevant stakeholders, including healthcare professionals' organisations, and manufacturers’ associations, shall be empowered to adopt delegated acts in accordance with Article 85 as regards the following: [Am. 139]

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

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

Chapter V III

Classification and conformity Conformity assessment [Am. 134]

SECTION 2 — CONFORMITY ASSESSMENT

Article 40

Conformity assessment procedures

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

2. Manufacturers of devices classified as class D, other than devices for performance evaluation, shall be subject to a conformity assessment based on full quality assurance, design dossier examination and batch verification, as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex IX, coupled with a conformity assessment based on production quality assurance including batch verification, as specified in Annex X.

In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on, in particular, analytic sensitivity and specificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established infection . [Am. 140]

For companion diagnostics intended to be used to assess the patient eligibility for treatment with a specific medicinal product, the notified body shall consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council (25) or the European Medicines Agency (EMA) in accordance with the procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IX.

3. Manufacturers of devices classified as class C, other than devices for performance evaluation, shall be subject to a conformity assessment based on full quality assurance, as specified in Annex VIII, with assessment of the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination, as specified in Annex IX coupled with conformity assessment based on production quality assurance, as specified in Annex X.

In addition, for devices for self-testing and near-patient testing, the manufacturer shall fulfil the supplementary requirements set out in Section 6.1 of Annex VIII or in Section 2 of Annex IX.

For companion diagnostic intended to be used to assess the patient eligibility to a treatment with a specific medicinal product, the notified body shall consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the European Medicines Agency (EMA) in accordance with the procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IX.

4. Manufacturers of devices classified as class B, other than devices for performance evaluation, shall be subject to a conformity assessment based on full quality assurance, as specified in Annex VIII.

In addition, for devices for self-testing and near-patient testing, the manufacturer shall fulfil the supplementary requirements set out in Section 6.1 of Annex VIII. [Am. 141]

5. Manufacturers of devices classified as class A, other than devices for performance evaluation, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 15, after drawing up the technical documentation set out in Annex II.

However, if the devices are intended for near-patient testing, or if they are placed on the market in sterile condition or have a measuring function, the manufacturer shall apply the procedures set out in Annex VIII or in Annex X. Involvement of the notified body shall be limited:

(a) in the case of devices for near-patient testing, to the requirements set out in Section 6.1 of Annex VIII, [Am. 142]

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

(c) in the case of devices with a measuring function, to the aspects of manufacture concerned with the conformity of the devices with the metrological requirements. [Am. 143]

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

7. Devices for performance evaluation shall be subject to the requirements set out in Articles 48 to 58.

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

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

— the frequency and the sampling basis of the assessment of the design documentation within the technical documentation on a representative basis as set out in Sections 3.3.(c) and 4.5 of Annex VIII, in the case of devices classified as class C;

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

— the frequency of samples of the manufactured devices or batches of devices classified as class D to be sent to a reference laboratory designated under Article 78 in accordance with Section 5.7 of Annex VIII and Section 5.1 of Annex X, or

— the physical, laboratory or other tests to be carried out by notified bodies in the context of sample checks, design dossier examination and type examination in accordance with Sections 4.4 and 5.3 of Annex VIII and Sections 3.2 and 3.3 of Annex IX.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).

10. In the light of technical progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 26 to 38, or of the vigilance and market surveillance activities described in Articles 59 to 73, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing the conformity assessment procedures set out in Annexes VIII to X. [Am. 144]

Article 41

Involvement of notified bodies in conformity assessment procedures

1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer of devices other than those listed in Article 41a(1), may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. Where a manufacturer applies to a notified body located in a Member State other than the one where it is registered, the manufacturer shall inform its national authority responsible for notified bodies of the application. An application may not be lodged in parallel with more than one notified body for the same conformity assessment activity. [Am. 145]

2. The notified body concerned shall inform the other notified bodies of any manufacturer who withdraws his application prior to the notified body's decision regarding the conformity assessment.

3. The notified body may require any information or data from the manufacturer which is necessary in order to properly conduct the chosen conformity assessment procedure.

4. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities.

SECTION 2A — ADDITIONAL PROVISIONS FOR THE CONFORMITY ASSESSMENT OF HIGH-RISK DEVICES: INVOLVEMENT OF SPECIAL NOTIFIED BODIES [Am. 146]

Article 41a

Involvement of special notified bodies in conformity assessment procedures of high-risk devices

1. Only special notified bodies (SNB) shall be entitled to conduct conformity assessments for class D devices.

2. Applicant special notified bodies which consider they fulfil the requirements for special notified bodies referred to in Annex VI, point 3.6, shall submit their application to the EMA.

3. The application shall be accompanied by the fee payable to the EMA to cover the costs relating to the examination of the application.

4. The EMA shall select the special notified bodies among applicants, in accordance with requirements listed in Annex VI, and adopt its opinion on the authorisation to perform conformity assessments for devices referred to in paragraph 1 within 90 days and send it to the Commission.

5. The Commission shall then publish the notification accordingly and the names of the special notified bodies.

6. This notification shall become valid the day after its publication in the database of notified bodies developed and managed by the Commission. The published notification shall determine the scope of lawful activity of the special notified body.

This notification shall be valid for five years and subject to renewal every five years, following a new application to the EMA.

7. The manufacturer of devices specified in paragraph 1 may apply to a special notified body of its choice, whose name appears in the electronic system of Article 41b.

8. An application may not be lodged in parallel with more than one special notified body for the same conformity assessment activity.

9. The special notified body shall notify the EMA and the Commission of applications for conformity assessments for devices specified in paragraph 1.

10. Article 41(2), (3) and (4) apply to special notified bodies. [Am. 147]

Article 41b

Electronic system on special notified bodies

1. The Commission, in collaboration with the Agency, shall establish and regularly update an electronic registration system for:

— the registration of applications and granted authorisations to perform conformity assessments as special notified bodies under this Section and to collate and process information on the name of the special notified bodies;

— the exchange of information with national authorities; and

— the publication of assessment reports.

2. The information collated and processed in the electronic system which relates to special notified bodies shall be entered into the electronic registration system by the EMA.

3. The information collated and processed in the electronic system and which relates to special notified bodies shall be accessible to the public. [Am. 148]

Article 41c

Network of special notified bodies

1. The EMA shall establish, host, coordinate and manage the network of special notified bodies.

2. The network shall have the following objectives:

(a) to help realise the potential of European cooperation regarding highly specialised medical technologies in the area of in vitro diagnostic medical devices;

(b) to contribute to the pooling of knowledge regarding in vitro diagnostic medical devices;

(c) to encourage the development of conformity assessment benchmarks and to help develop and spread best practice within and outside the network;

(d) to help identify the experts in innovative fields;

(e) to develop and update rules on conflicts of interest; and

(f) to find common answers to similar challenges concerning the conduct of conformity assessment procedures in innovative technologies.

3. Meetings of the network shall be convened whenever requested by at least two of its members or by the EMA. It shall meet at least twice a year. [Am. 149]

Article 42

Mechanism for scrutiny of certain conformity assessments

1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class D, with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and performance referred to in Article 24. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG.

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

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

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

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

5. Where deemed necessary for the protection of patient safety and public health, the Commission may determine, by means of implementing acts, specific categories or groups of devices, other than devices classified as class D, to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).

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

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

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

(c) an increased rate of serious incidents reported in accordance with Article 59 in respect of a specific category or group of devices;

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

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

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

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

8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3). [Am. 150]

Article 42a

Case-by-case assessment procedure for the conformity assessments of certain high-risk devices

1. Special notified bodies shall notify the Commission of applications for conformity assessments for Class D devices, with the exception of applications to renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 24. In its notification the special notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the Coordination Group (CG) of the Assessment Committee for Medical Devices (ACMD), referred to in Article 76a. The CG shall immediately transmit the notification and the accompanying documents to the relevant sub-groups.

2. Within 20 days of receipt of the information referred to in paragraph 1, the CG may decide, upon the suggestion of at least three of the members of the relevant sub-groups of the ACMD or by the Commission, to request the special notified body to submit the following documents prior to issuing a certificate:

— the summary of the preliminary conformity assessment;

— the clinical evidence report and the clinical performance study report as referred to in Annex XII;

— data obtained from the post-market follow-up referred to in Annex XII; and

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

The members of the relevant sub-groups of the ACMD shall decide on making such case-by-case requests notably on the basis of the following criteria:

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

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

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

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

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

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

In the absence of a request from the ACMD within 20 days of receipt of the information referred to in paragraph 1, the special notified body shall proceed with the conformity assessment procedure.

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

4. In its opinion the ACMD may recommend modifications of the documents referred to in paragraph 2.

5. The ACMD shall inform the Commission, the special notified body and the manufacturer of its opinion within five days of its adoption.

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

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

7. Within 15 days after its adoption, the ACMD shall send its final opinion to the Commission, the special notified body and the manufacturer.

8. Within 15 days after receipt of the opinion referred to in paragraph 6 in case of agreement by the special notified body or of the final opinion as referred to in paragraph 7, the Commission shall prepare, on the basis of the opinion, a draft of the decision to be taken in respect of the examined application for conformity assessment. This draft decision shall include or make reference to the opinion referred to in paragraphs 6 and 7 as applicable. Where the draft decision is not in accordance with the ACMD opinion, the Commission shall annex a detailed explanation of the reasons for the differences.

The draft decision shall be forwarded to the Member States, the special notified body and the manufacturer.

The Commission shall take a final decision in accordance with and within 15 days after the end of, the examination procedure referred to in Article 84(3).

9. Where deemed necessary for the protection of patient safety and public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 to determine, specific categories or groups of devices, other than devices referred to in paragraph 1, to which paragraphs 1 to 8 shall apply during a predefined period of time.

Measures pursuant to this paragraph may be justified only by one or more of the criteria referred to in paragraph 2.

10. The Commission shall make a summary of the opinions referred to in paragraphs 6 and 7 accessible to the public. It shall not disclose any personal data or information of a commercially confidential nature.

11. The Commission shall set up the technical infrastructure for the data-exchange by electronic means between special notified bodies and the ACMD and between the ACMD and itself for the purposes of this Article.

12. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the documentation provided in accordance with this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).

13. Special notified bodies shall notify the Commission of applications for conformity assessments for Class D devices, with the exception of applications to renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 24. In its notification the special notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the Coordination Group (CG) of the Assessment Committee for Medical Devices (ACMD), referred to in Article 76a. The CG shall immediately transmit the notification and the accompanying documents to the relevant sub-groups. [Am. 151]

Article 43

Certificates

1. The certificates issued by the notified bodies in accordance with Annexes VIII, IX and X shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates is set out in Annex XI.

2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.

3. Where a notified body finds that requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective measures taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision.

4. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information on certificates issued by notified bodies. The notified body shall enter into the electronic system information regarding certificates issued, including amendments and supplements, and information regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. This information shall be accessible to the public.

5. In the light of technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing the minimum content of the certificates set out in Annex XI.

Article 44

Voluntary change of notified body

1. In cases Where a manufacturer terminates decides to terminate his contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, it shall inform its national authority responsible for notified bodies of this change. The modalities of the change of notified body shall be clearly defined in an agreement between the manufacturer, the outgoing notified body and the incoming notified body. This agreement shall address at least the following aspects: [Am. 152]

(a) the date of invalidity of certificates issued by the outgoing notified body;

(b) the date until which the identification number of the