Medical Devices Directive

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European Union European Union directive:
Directive 93/42/EEC
Council Directive concerning medical devices
Made by Council
Made under Art. 100a TEEC
Journal reference L169, 12.07.1993 pp. 1-43
History
Made 1993-06-14
Came into force 1993-07-12
Implementation date 1994-07-01
Preparative texts
Other legislation
Replaces Directive 76/764/EEC
Amends Directive 84/539/EEC, Directive 90/385/EEC
Status: Current legislation

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 [1] concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards'[2] have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.


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