Medical Devices Directive
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 21 March 2010.
| European Union directive | |
 | |
| Title | Council Directive concerning medical devices |
|---|---|
| Made by | Council |
| Made under | Art. 100a TEEC |
| Journal reference | L169, 12 July 1993 pp. 1-43 |
| History | |
| Date made | 1993-06-14 |
| Came 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 |
| Current legislation | |
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.[3]
See also
- European Medical Devices Industry Group
- Registration of medical devices in Italy