Medical Devices Directive
|European Union directive|
|Title||Council Directive concerning medical devices|
|Made under||Art. 100a TEEC|
|Journal reference||L169, 12 July 1993 pp. 1–43|
|Came into force||1993-07-12|
|Amends||Directive 84/539/EEC, Directive 90/385/EEC|
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 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' 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.
In 2017 a new Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices has been published in the Official Journal of the European Union on 5 May 2017, 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. At the same time also a Regulation (EU) 2017/746 on in vitro diagnostic medical devices, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, has been published.
- European Medical Devices Industry Group
- Journal of Medical Device Regulation[dead link]
- Registration of medical devices in Italy