European Regulation of Medical Devices

Confirmation of conformity must include evaluation of clinical data for all medical devices, generated from either a compilation of scientific literature or the results of clinical investigations on the product, for which prior ethical and regulatory approval is required. CE marking, which must be marked on the device, acts in effect as the passport that authorises the device to be placed on the market and to circulate freely within the European Economic Area (EEA). Each Member State has designated a competent authority, which is the governmental authority responsible for implementing the Directive in that Member State. The EEA law on the marketing of medical devices is governed by three principal Directives, each of which adopt the Community's matrix scheme for product regulation known as the ‘new approach’. They are Directive 90/385/EEC on active implantable medical devices (AIMDs), Directive 93/42/EEC on medical devices, and Directive 98/79/EC on in vitro diagnostics (IVDs).