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.
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 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 Council is expected to reach an agreement on the 30 November 2006.
More information can be found on the DG Enterprise website.
More information on the European Parliament process in the members’only section.
