| European Union directive | |
 | |
| Title | Council Directive concerning medical devices |
|---|---|
| Made by | Council |
| Made under | Art. 100a TEEC |
| Journal reference | |
| 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| Repealed | |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 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' 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.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
See also
References
- Harmonised Standards under the MDD
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- "Date of application of the Medical Devices Regulation postponed until May 2021".
External links
- UDI Webinar Series and how it will affect European Medical Device manufacturers
- EU legislation summary
- European Medical Device Usability Requirements
- Essential links for CE Marking in the UK