Medical Devices Directive
- Medical Devices Directive
-
 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.
See also
References
External links
Categories:
- European Union directives
- Medical Devices regulations
- 1993 in law
- 1993 in the European Union
- European law stubs
- Medicine stubs
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