Medical devices have become an increasingly important health care area in relation to their impact on health and health care expenditure. The sector covers some 10,000 types of products, ranging from simple bandages and spectacles, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment. The public expects that these devises meet the highest safety standards. Today, the European Commission has proposed amendments to the current legislative framework. The proposal has been developed involving extensive stakeholder consultation and has also been subject to a public consultation. This brought forward many relevant and important contributions which, where appropriate, were incorporated into the proposal. The most significant proposals concern conformity assessment, including design documentation and design review, clarification of the clinical evaluation requirements, post market surveillance, compliance of custom-made device manufacturers and the alignment of the original medical device directive 90/385/EEC.

Commission Vice President Günter Verheugen stated: “This is a good example of better regulation in this complex and highly diversified sector. We have listened to stakeholders and have clarified and simplified the current rules. At the same time we bring improved requirements for safety for the patients whilst continuing to provide a coherent legislative framework that fosters competitiveness.”

The proposal also brings increased transparency to the general public in relation to the approval of devices. It introduces the necessary regulatory clarification in order to continue the high level of protection of human health and support better implementation. It also foresees provisions necessary to regulate medical devices with an ancillary human tissue engineered product. This mirrors the proposed EU legislation on advanced therapies and fills a potential regulatory gap.

The proposal enjoys widespread support and it is anticipated, by authorities and industry alike, that its eventual adoption will see resurgence in this sector, both in terms of competitiveness and safety. Moreover, the proposal fits neatly into the European Commission’s policy to maintain the high competitiveness of this sector.

Indeed, a recent study commissioned by the European Commission has underlined again the importance of this sector which consists of some 7000 business entities in Europe, employing upwards of 350,000 Europeans and which regularly records the highest production growth rates amongst all industry sectors in the EU. The Commission proposal will now be forwarded to the European Parliament and Council for co-decision. Additional information, including the text of the study and the Commission proposal, can be found at: http://europa.eu.int/comm/enterprise/medical_devices/revision_mdd_en.htm

Information on the proposal on Advanced Therapies can be found at: http://pharmacos.eudra.org/F2/advtherapies/index.htm