Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
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Proc Inst Mech Eng H · Jan 1996
ReviewThe medical device directives and their impact on the development and manufacturing of medical implants.
The introduction of a legal framework for the supply of medical implants is discussed with reference to the Active Implantable Medical Device Directive and the Medical Device Directive. The definitions of medical device and manufacturer are discussed. The application of the Directives to device/drug combinations is considered. ⋯ The role of standards and the new approach to writing them in Europe is presented. After placing a product on the market, the manufacturer must set up a system of post-market surveillance, including a vigilance procedure, in order to monitor product performance. Individual Member States can exercise the safeguard clause when a product appears to have had the CE marking incorrectly applied.