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).
Directive 90/385/EEC is applicable to medical equipment or apparatus relying for their functioning on a source of power other than directly generated by the human body or by gravity and which are totally or partially introduced into the human body. Directive 93/42/EEC is applicable to most medical equipment and apparatus exclusive from the active implantable medical devices.
According to these Directives, a business authorized to market its products in one EU Member State is entitled to market them in another Member State provided that the specific conditions imposed by the Directives have been observed, which will be attested by the affixing of a "CE" marking on the products.
The deadlines imposed on the Member States to implement Directives 90/385/EEC and 93/42/EEC were respectively July 1, 1992 and July 1, 1994. The application of the rules set forth in the Directives was required respectively as from January 1, 1993 and January 1, 1995 with a transition period until December 31, 1994 with regard to Directive 90/385/EEC and a transition period of five years as from the adoption of the Directive with regard to Directive 93/42/EEC. At present, however, Belgium has not yet adapted its legislation to either of these Directives.
As a consequence, the existing Belgian rules on medical devices remain applicable, including the obligation to obtain the authorization referred to above which requires the filing of an application with the Ministry of Public Health indicating, inter alia, the use of the device and the instructions for its use. The applicant for such authorization must also dispose of qualified personnel as well as suitable premises for the storage of the devices.
Although the above rules will remain applicable - at least, for non active medical devices - during the five-year transition period, from now on Belgium will have to accept the placing on the market and putting into service of devices bearing the "CE" marking evidencing that they conform to the rules set forth in the Directives.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
For further information contact Tanguy Van Overstraeten on +32.2.517.94.05.
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