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.

Directive 93/42/EEC
European Union directive
TitleCouncil Directive concerning medical devices
Made byCouncil
Made underArt. 100a TEEC
Journal referenceL169, 12 July 1993 pp. 1-43
Date made1993-06-14
Came into force1993-07-12
Implementation date1994-07-01
Other legislation
ReplacesDirective 76/764/EEC
AmendsDirective 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The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.[3]

Share this article:

This article uses material from the Wikipedia article Medical Devices Directive, and is written by contributors. Text is available under a CC BY-SA 4.0 International License; additional terms may apply. Images, videos and audio are available under their respective licenses.