ARTICLE · 01 FEBRUARY 1995
Belgian Implementation of the European Directive on Medical Devices
The manufacture, import and/or distribution in Belgium of certain medical devices require the granting of an authorization in accordance with Royal Decree of June 6, 1960. These medical devices include, among other things, disinfectants and antiseptics, certain dietary products, ligatures, sterilized bandages, sterilized injection, perfusion, transfusion or draining machines as well as the receptacles and pipes relating thereto, and internal implants.
With a view to facilitating the marketing of medical devices within the European Union, two Directives have been enacted, the first one on June 20, 1990 (Directive 90/385/EEC on active implantable medical devices) and the second one on June 14, 1993 (Directive 93/42/EEC on medical devices).
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