EN Official Journal of the European Union C 195/14

Opinion of the European Economic and Social Committee on the Proposal for a Directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives

(COM(2005) 681 final — 2005/0263 (COD))

(2006/C 195/04)

On 2 February 2006 the Council decided to consult the European Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the abovementioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 25 April 2006. The rapporteur was Mr Braghin.

At its 427th plenary session, held on 17 and 18 May 2006 (meeting of 17 May), the European Economic and Social Committee adopted the following opinion with 128 votes in favour and one abstention.

1. Gist of the opinion

1.1 The EESC welcomes the Commission proposal, which has long been awaited by the Member States and operators in the sector. Its objectives may be endorsed, and the proposals are generally sound. However, the EESC offers a number of practical suggestions aimed at furthering the aims of legal certainty, clarity, simplification and health protection.

1.2 The EESC calls for greater clarity as to which authority is responsible for the overall evaluation in cases of a combination of medical devices, medicinal products, human blood derivatives and human tissue. It also asks that a deadline be set for the evaluation by the competent authorities, and that a guide to the specific competences and procedures for this evaluation be drawn up.

1.3 The EESC believes that it should be compulsory to send information regarding registration, clinical data, certificates and vigilance to the existing European databank, which should be strengthened. It also asks that means be found for securing wide circulation of non-confidential information, not only among the notified bodies and the competent authorities but also among the operators concerned.

1.4 Health operators' role and responsibilities in the post-marketing surveillance system should be made clearer, and steps should be taken to ensure appropriate dissemination of information and results arising from this surveillance.

1.5 The EESC appreciates the proposals regarding clinical investigations, which relate to the safety and performance of a device. It suggests a few changes designed to make them even clearer, more particularly as regards the point at which clinical research may begin, once the relevant ethics committee has given its authorisation in accordance with the classification of the device.

1.6 The EESC is against the exclusion of ‘reprocessing’ from the proposed text. The re-use of medical devices designed and produced to be used only once poses a danger to patient health. The EESC therefore asks that the reprocessing company be at least required to submit a set of data on the type of operation conducted and provide similar guarantees of quality and safety to those that apply to the original product, informing users and patients of this.

2. Gist of the Commission proposal

2.1 Although, on the whole, the experience garnered from implementing Directives 90/385/EEC (1) relating to active implantable medical devices and 93/42/EEC (2) concerning medical devices has been positive, legislative modification is necessary in the interests of better implementation, both to clarify certain existing requirements and to provide a legal basis for planned initiatives.

2.2 Directive 93/42/EEC requires the Commission to submit a report to the Council within five years of the implementation date, concerning certain aspects of the functioning of the directive. The review process gave rise to a report on the functioning of the Medical Devices Directives, published in June 2002. Its conclusions were taken up by the Commission in its Communication COM (2003)386 (3), which was welcomed by the Council in its Conclusions of December 2003 and by the Parliament.

2.3 The communication highlighted the most important areas where improvements should be made: — conformity assessment, in particular concerning design examination by notified bodies (4); — the adequacy of clinical data for all classes of devices; — post-market surveillance, in particular for better coordination of activities; — notified bodies, in relation to their competence for the tasks designated to them, differences in interpretation between them, and a lack of transparency in their performance and in control over their activities; — and increased transparency vis à vis the general public in relation to the assessment of devices. The Commission began its consultation in 2003, primarily through the Commission services' Medical Device Experts Group (MDEG). This was followed by a public consultation over the Internet (5).

2.4 Since the proposal deals more with regulatory clarification than regulatory change, there are no significant economic impacts expected. Similarly, no environmental impacts were identified. The Commission intends to use the proposal to promote: — increased clarity, to support a high level of public health protection; — greater transparency and certainty for all market players and, in particular, the public; — an improved regulatory framework to support fast technical progress to benefit the public under clearer conditions, guaranteeing safety and greater confidence.

2.5 The legal basis for the proposal is Article 95 of the EC Treaty (formerly Article 100A) upon which Directive 93/42/EEC is based. In order to achieve the objective of abolishing technical barriers to trade and clarifying existing provisions in Directives 93/42/EEC and 90/385/EEC, it is necessary and appropriate to harmonise the laws, regulations and administrative provisions in the Member States on certain aspects concerning the placing on the market or putting into service of medical devices.

3. General comments

3.1 The EESC welcomes the Commission proposal, which has long been awaited by the Member States and operators in the sector. Its objectives are wholly laudable and the practical proposals should improve harmonisation in this highly complex and diversified sector, by providing clearer, simpler rules. The Committee does however have some reservations and these are outlined below.

3.2 Medical devices are an increasingly important health-sector segment, with a major impact on both health and on public healthcare spending. The provisions in the directives in question concern over 10 000 types of product, ranging from simple devices (such as gauze, syringes and glasses) to extremely sophisticated and complex instruments (such as life-saving implantable devices and diagnostic imaging equipment).

3.3 The sector has a high technological profile, as the public and the health authorities require ever safer and more sophisticated products. It is also of major economic importance: the European market is second only to the American, with a turnover of approximately EUR 55 billion, involving over 8 000 companies and some 450 000 employees.

3.4 It should be noted that a large and growing number of devices are imported into the EU. A clearer and more effective legal framework and more open cooperation between the relevant authorities could inject new life into the sector and minimise the risk of losing market share and jobs.

3.5 Although the Commission rightly judges that there will be no significant macroeconomic impact, the combined effect of the additional requirements could increase costs quite considerably for certain processes or product lines.

3.6 Legal certainty

3.6.1 The proposal defines changes to be made to the above-mentioned directives and clarifies certain implementation procedures for other directives and regulations in cases where it was not entirely clear which rules applied (devices incorporating a medicinal product (6), human blood derivatives (7) or human tissue engineered products (8)). It also provides clarification that in vitro diagnostic medical devices (9) are not covered by the biocides directive (10), which is modified accordingly.

3.6.2 The EESC agrees with the principle that if medical devices contain medicinal products or human blood derivatives or human tissue engineered products ‘with action that is ancillary to that of the device’, the medical devices directives should apply. It wonders however why there is no specific mention in the body of the regulation of tissues of animal origin, which are mentioned in certain annexes. It also fears that the definition of ‘action ancillary to that of the device’ could give rise once more to varying interpretations between Member States and notified bodies, and would therefore like to see this concept defined more precisely.

3.6.3 Greater clarity is required regarding which authority is responsible for the overall evaluation in cases of a combination of devices incorporating medicinal substances, blood derivatives and human tissue: in such cases the notified bodies may involve national or Community authorities (such as the EMEA) which do not always have the necessary expertise to assess medical devices as such and apply procedures designed for a different type of product, often leading to excessively long timeframes.

3.6.3.1 The EESC thinks that a deadline should be set for the evaluation, bearing in mind that in this sector an innovative product can very rapidly become obsolete. It also asks that a guide be drawn up regarding the specific responsibilities and procedures for evaluation by the competent authorities, in cooperation with the authorities responsible for the devices. Lastly, on the basis of the experience which manufacturers have built up over the years, it asks that the notified bodies be allowed to seek a scientific opinion from any recognised competent authority, and not just from EMEA.

3.6.4 By their very nature, the way they act and the manufacturing techniques used, a large proportion of human tissue engineered products are more similar to medical devices than to drugs. In order to avoid possible legislative vacuums, the EESC thinks that such products should come under the present proposal, with the exception of those that act on or in the human body by primarily pharmacological, metabolic or immunological means.

3.6.5 The EESC is against two directives (i.e. the Directive on medical devices and the Directive on personal protective equipment) simultaneously applying different requirements for the shared objective of protecting the user. It could complicate matters in practice and increase costs without bringing any benefits in terms of safety.

3.6.6 The EESC welcomes the new procedure based on comitology, added in Article 13, that paves the way for rapid, binding decisions on issues concerning the misinterpretation of a product as being or not being a medical device. It notes however that for an optimal result, the flow of information between the relevant authorities must be improved and data managed effectively by means of the European databank.

3.7 Information and transparency

3.7.1 The EESC believes that clearer and more wide-ranging provisions are needed for the collection and dissemination of information, and on coordination and communication with regard to surveillance activities.

3.7.2 It believes that the proposal is lacking in terms of the capacity of the notified bodies to carry out the tasks assigned to them. This shortcoming was already highlighted in the 2003 communication (11). New therapeutic advances and the growing complexity and sophistication of devices require scientific and technical expertise that cannot always be provided at national level. There should be a European plan or at least coordination to ensure that certain notified bodies are specialised in certain types of particularly complex and sophisticated products.

3.7.3 The EESC agrees on the need for every non-Community manufacturer to designate an authorised representative in an EU Member State to act on their behalf and to respond to the authorities with respect to the obligations arising from this directive. There are gaps and inconsistencies in the text, however, and clarifications are necessary (see point 4.3 below). In principle, the EESC is in favour of a flexible system allowing real freedom of choice for the industry.

3.7.4 The EESC believes that it should be compulsory rather than optional to send all information relating to registration, clinical data, certificates and vigilance (including serious undesired effects and events) to the EUDAMED European databank, which is already operating but in limited fields. Its duties should be redefined as soon as possible, in particular as regards the provision of non-confidential information for interested operators, and it should be endowed with appropriate facilities and resources.

3.7.4.1 A reasonable amount of non-confidential information, in a concise form, should be made available to the stakeholders directly concerned. Information on product safety and quality and on post-marketing surveillance should also be made available to health operator associations, to enable them to use the medical devices more knowledgeably and safely.

3.7.4.2 The EESC also thinks that a guide should be drawn up, in cooperation with stakeholders, whereby the operators responsible can compile and publish a summary of product characteristics. This guide, and the information collected and validated with respect to vigilance, should be made available to notified bodies and competent authorities. Appropriate means should also be found for securing wider circulation of this information.

3.7.5 The proposal allows the instructions for use to be provided in non-leaflet form. This is in tune with operators' demands, particularly given the wide range of medical device types. There should be more research into the possibilities of using electronic instruments (such as CD-ROMs and the Internet), using a simpler and more flexible procedure than the current one, so as not to require a qualified majority of Member States.

3.7.6 The EESC thinks that the directive should explicitly mention the MedDev guidance documents drawn up by ad hoc working groups and issued by the Commission. Simplified arrangements for their approval should be introduced, so as to reduce problems of interpretation and encourage greater harmonisation in the practices of manufacturers and notified bodies.

3.8 Safety

3.8.1 The post-market surveillance system is well defined in the proposal as regards the manufacturer, but the role and responsibilities of health operators are not made clear. The system for disseminating information and results arising from the surveillance mechanisms is still unsatisfactory, as it is still too nationally-oriented and is in need of a more European dimension.

3.8.2 The EESC welcomes the changes relating to Annex X on clinical data, concerning the safety and performance of a device. It recommends that the article be further clarified as regards the point at which clinical research may begin, once the relevant ethics committee has given its authorisation in accordance with the classification of the device.

3.8.3 The EESC is against the exclusion of ‘reprocessing’ from the proposed text. The re-use of medical devices designed and produced to be used only once, which has already been outlawed in certain Member States, does not provide an adequate guarantee of patient safety, as the reliability and safety tests that led to the authorisation of the single-use product have not been carried out.

3.8.3.1 This is a frequent practice in hospitals in various Member States. However, the EESC thinks that it should be outlawed, as it poses a danger to patient health and makes it difficult to determine liability. Sterilisation does not give a full guarantee of safety, not least because the structural characteristics of the materials used may be altered.

3.8.3.2 The EESC is aware that this is a matter of national responsibility, but thinks that action at EU level is needed if only because the free movement of citizens and the recent recognition of the possibility of receiving care in another Member State bring a need for practices to be universally accepted. As a transitional step, the principle could be established that the reprocessing company should at least be required to submit a set of data in line with the classification of the medical device and the type of operation conducted, in order to provide similar guarantees of quality and safety to those that apply to the original product; at the same time, users and patients should be clearly informed of the situation.

3.8.4 The EESC fully agrees with the clarifications proposed for conformity assessment and the obligation to submit design documentation for the medical device, in line with the classification of the device and the novelty of the technology or treatment involved. It also agrees on the need for the manufacturer to apply adequate controls to any third parties it uses for design and manufacture.

4. Comments on specific articles

4.1 Clarity of scope

4.1.1 The EESC feels that it is inconsistent with the principle of simplification and legal certainty to apply two separate directives to the same product, as is now being proposed for medical devices and personal protective equipment. It therefore calls for the original text of Article 1(6) of Directive 93/42/EEC to be re-instated.

4.1.2 Broadly speaking, the EESC feels that in the case of a medical device which could come under the definition of other directives (pharmaceuticals, cosmetic products, etc.), it should be specified that when deciding the applicable directive, the competent authorities and bodies must take account of the principal intended purpose of the product and the relevant mechanism of action.

4.1.3 In order to avoid any legal uncertainty, the EESC thinks that section 7.4 of Annex I should be amended (Translator's note: In the English version of the Commission document, the reference is to section 10). In particular, it should be made clear that if a medical device contains a substance which, considered separately, could be defined as a medicinal product, it is covered by the specific parts of pharmaceuticals legislation which refer to the safety and quality of the substance itself, and not by pharmaceuticals legislation in general.

4.1.4 In the case of medical devices which incorporate a product obtained through human tissue engineering, the EESC fears that the new paragraph 4b) does not resolve the difficulties of interpretation. Accordingly, the EESC would like these products to be explicitly defined in Article 1 in accordance with the directives in force and, in particular, with the regulation currently under discussion on advanced therapy medicinal products (12).

4.2 Information and the European databank

4.2.1 The EESC thinks that it should be obligatory for the various competent authorities and bodies, and for manufacturers or representatives, to send the relevant data, including clinical data and reporting of serious adverse and unexpected effects, to the EUDAMED European databank. However, for this collection of data to be effective, it will be necessary to redefine the duties of EUDAMED and establish an implementing programme that ensures it is appropriately structured and resourced.

4.2.2 In order to ensure the completeness of the data collected, and wider dissemination of relevant non-confidential information, the EESC thinks that a number of points in the proposal should be modified, in particular: — the seventh ‘whereas’ clause, so as to make centralisation of data on clinical investigations obligatory; — Article 10a of Directive 90/385/EEC, so as to make the sending of information on manufacturers and representatives obligatory; Article 10b of the same directive, on regulatory data; and Article 11(5) of that directive, on the certificates issued; — Article 16(5) of Directive 93/42/EEC, on the certificates issued.

4.2.3 The EESC would also like Article 20(3) to be amended, so as to enshrine the principle that non-confidential information should be made available to users, in summary form, involving manufacturers and representatives as well as the relevant authorities and bodies.

4.3 Representative

4.3.1 The EESC notes an inconsistency in the definition of the representative of a manufacturer who does not have a registered place of business in the Community. In the 14th ‘whereas’ clause, the reference is to a single individual person for all classes of devices, while Article 10a(3) and Article 14(2) do not specify whether all or only some categories of device are involved.

4.3.2 Bearing in mind the wide range of medical devices which a manufacturer might place on the market, the EESC calls for greater flexibility: a single representative could thus be designated for each type of product and not necessarily for the whole production range (while also making it clear in the different language versions that in legal terms this refers to both natural and legal persons).

4.4 Clinical investigations

4.4.1 Provisions on information for the competent authorities to facilitate the monitoring and management of clinical investigation data should be included in Article 2(2), and should specify that the manufacturer or his representative must inform the authorities of all Member States where these investigations are conducted, of the suspension, interruption or end of the investigations, with appropriate explanations.

4.4.2 The EESC welcomes the new wording of Article 15(2) and (3). However, it wonders whether it might be advisable to specify in Article 15(3) that for Class I devices the clinical investigations can start as soon as the relevant ethics committee has delivered its favourable opinion on the investigation plan.

Brussels, 17 May 2006. The President of the European Economic and Social Committee Anne-Marie SIGMUND

(1) OJ L 189, 20.7.1990.

(2) OJ L 169, 12.7.1993, last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003).

(3) COM(2003) 386 in OJ C 96, 21.4.2004.

(4) ‘Notified bodies’ are the bodies to which manufacturers must submit their documentation in order to receive, as appropriate, either a certificate of conformity as required under the directive, or marketing authorisation. There may be more than one such organisation per Member State and they may specialise in different areas.

(5) This consultation took place from 11 May 2005 to 25 June 2005.

(6) Regulated by Directive 2001/83/EC in OJ L 311, 28.11.2001, as last amended by Directive 2004/27/EC, in OJ L 136, 30.4.2004.

(7) Regulated by Directive 2002/98/EC of 23.1.2003.

(8) This refers to Regulation No 726/2004 and the proposal currently under discussion on medicines for advanced therapies on which the EESC has begun preparing its opinion.

(9) Directive 98/79/EC.

(10) Directive 98/8/EC in OJ L 123, 24.4.1998, as last modified by Regulation (EC) No 1882/2003.

(11) See COM (2003) 386 of 2.7.2003, cit.

(12) COM(2005) 567 final – Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.