Medical Devices Directive
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.
|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The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.