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From Wikipedia, the free encyclopedia
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—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'[1] 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 21 March 2010.[citation needed]
| European Union directive | |
 | |
| Title | Council Directive concerning medical devices |
|---|---|
| Made by | Council |
| Made under | Art. 100a TEEC |
| Journal reference | [31993L0042 L169, 12 July 1993 pp. 1-43] |
| History | |
| Date made | 1993-06-14 |
| Entry into force | 1993-07-12 |
| Implementation date | 1994-07-01 |
| Other legislation | |
| Replaces | Directive 76/764/EEC |
| Amends | Directive 84/539/EEC, Directive 90/385/EEC |
| Replaced by | Directive EU 2017/745 |
| Repealed | |
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745),[2] effective on 26 May 2021.[3]
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