Opinion of the European Economic and Social Committee on the Proposal for a Directive of theEuropean Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EECand Directive 98/8/EC of the European Parliament and the Council as regards the review of themedical 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, underArticle 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 theCommittee'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 Economicand 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, whichhas long been awaited by the Member States and operators inthe sector. Its objectives may be endorsed, and the proposalsare generally sound. However, the EESC offers a number of practical suggestions aimed at furthering the aims of legalcertainty, 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 combina-tion of medical devices, medicinal products, human blood deri-vatives and human tissue. It also asks that a deadline be set forthe evaluation by the competent authorities, and that a guideto the specific competences and procedures for this evaluationbe drawn up.1.3 The EESC believes that it should be compulsory to sendinformation regarding registration, clinical data, certificates andvigilance to the existing European databank, which should bestrengthened. It also asks that means be found for securingwide circulation of non-confidential information, not only among the notified bodies and the competent authorities butalso among the operators concerned.1.4 Health operators' role and responsibilities in the post-marketing surveillance system should be made clearer, andsteps should be taken to ensure appropriate dissemination of information and results arising from this surveillance.1.5 The EESC appreciates the proposals regarding clinicalinvestigations, which relate to the safety and performance of adevice. It suggests a few changes designed to make them evenclearer, more particularly as regards the point at which clinicalresearch may begin, once the relevant ethics committee hasgiven its authorisation in accordance with the classification of the device.1.6 The EESC is against the exclusion of ‘reprocessing’ fromthe proposed text. The re-use of medical devices designed andproduced to be used only once poses a danger to patienthealth. 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 fromimplementing Directives 90/385/EEC (
) relating to activeimplantable medical devices and 93/42/EEC (
) concerningmedical devices has been positive, legislative modification isnecessary in the interests of better implementation, both toclarify certain existing requirements and to provide a legal basisfor planned initiatives.2.2 Directive 93/42/EEC requires the Commission to submita report to the Council within five years of the implementationdate, concerning certain aspects of the functioning of the direc-tive. The review process gave rise to a report on the func-tioning of the Medical Devices Directives, published in June2002. Its conclusions were taken up by the Commission in itsCommunication COM (2003)386 (
), which was welcomed by the Council in its Conclusions of December 2003 and by theParliament.2.3 The communication highlighted the most importantareas where improvements should be made:— conformity assessment, in particular concerning designexamination by notified bodies (
);— the adequacy of clinical data for all classes of devices;18.8.2006C 195/14 Official Journal of the European Union
) OJ L 189, 20.7.1990.(
) OJ L 169, 12.7.1993, last amended by Regulation (EC) No1882/2003 (OJ L 284, 31.10.2003).(
) COM(2003) 386 in OJ C 96, 21.4.2004.(
) ‘Notified bodies’ are the bodies to which manufacturers must submittheir documentation in order to receive, as appropriate, either acertificate of conformity as required under the directive, ormarketing authorisation. There may be more than one such organi-sation per Member State and they may specialise in different areas.