Euro Commission Revises Medical Device Directives

December 28, 2005

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The European Commission proposed amendments to the legislative framework for medical devices and the health care industry. 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.

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

The commission believes the proposal enjoys widespread support and its adoption will assist in a resurgence in the sector, both in terms of competitiveness and safety.

A recent commission study underlined the importance of this sector, which consists of some 7,000 business entities in Europe (employing about 350,000 Europeans) and regularly records the highest production growth rates among 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, may be found at: http://europa.eu.int/comm/enterprise/medical_devices/revision_mdd_en.htm.

Information on the proposal on advanced therapies may be found at: http://pharmacos.eudra.org/F2/advtherapies/index.htm.

Source: European Union (EU).