Council Conclusions

on 2 December 2003

on Medical Devices

(2004/C 20/01)

THE COUNCIL OF THE EUROPEAN UNION,

1. RECALLS the Council Conclusions of 26 June 2002 on the role of medical devices;

2. ACKNOWLEDGES:

- the importance of medical devices in health and social care and for improving the level of health protection as well as the fact that medical devices today account for an ever increasing share of public health expenditure;

- that the Directives 90/385/EEC(1), 93/42/EEC(2) and 98/79/EC(3), subject to amendment of some of their provisions, constitute an appropriate legal framework for the placing on the market and putting into service of medical devices, and in general provide appropriate guarantees for protecting health whilst allowing access to new technology to the benefit of European citizens, patients and users;

- that the correct implementation of this legal framework, the use of the various instruments which it provides to address specific issues, and the concomitant availability of appropriate resources at both Community and national level are of paramount importance for the protection of safety of citizens, patients and users;

- that in particular, the designation and monitoring of Notified Bodies, the correct implementation of conformity assessment procedures and, as need be, the reclassification of particular medical devices, constitute essential elements with a view to the proper implementation of Directive 93/42/EEC on medical devices;

- the importance that the EU continues to play a leading role in the field of international regulatory convergence and best regulatory practice, and is part of global initiatives such as global vigilance and a global nomenclature for medical devices;

3. WELCOMES:

- the Commission's Communication on Medical Devices of July 2, 2003;

- the launch of a study on innovation, public health impact and competitiveness and the Commission's intention to examine the possibilities, under the Community's Public Health Programme, to promote health aspects in relation to medical devices;

- the Commission's intention to promote enhanced consultation and coordination between the national authorities and the Commission, alongside the Medical Devices Experts Group;

- the Commission's announcement that it will present a proposal for a directive amending Directives 90/385/EEC and 93/42/EEC in respect of the main areas as identified in the Commission's Communication;

4. UNDERLINES that implementation of the legal framework has to be improved by all parties concerned, in particular as regards conformity assessments, including the need for manufacturers to provide appropriate clinical and laboratory data as part of the technical file;

5. ENDORSES:

- the various initiatives announced in the Communication in order to increase transparency and trust in relation to the placing on the market and putting into use of medical devices;

- the working programmes attached to the Communication intended to improve implementation, as presented by the Commission, in particular in relation to market surveillance, Notified Bodies, clinical evaluation, and regulatory clarification;

- the Commission's intention to carry out within 5 years a review of the impact of the working programmes announced in the Communication;

6. INVITES the Member States to actively engage in the reporting of information as requested by the Directive 93/42/EEC on medical devices in relation to the consultation mechanisms foreseen in those cases where medical devices contain medicinal products or human blood derivatives, clinical investigation and vigilance, allowing complete and consistent data to be made available for analysis in conformity with the provisions of the Directive;

7. INVITES THE COMMISSION AND THE MEMBER STATES:

- to set up and maintain the European Database for Medical Devices and, as a basis for the database, to start implementation of the Global Medical Devices Nomenclature;

- to strengthen coordination between the Commission and the national authorities in charge of implementing the directives in order to ensure a consistent and coherent interpretation and implementation of the directives and to achieve greater efficiency in the interest of protecting public health.

(1) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).

(2) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).

(3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).