Medical Devices Directive

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.

Directive 93/42/EEC

European Union directive
Title	Council Directive concerning medical devices
Made by	Council
Made under	Art. 100a TEEC
Journal reference	[31993L0042 L169, 12 July 1993 pp. 1-43]
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Repealed

The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.

See also

• European Medical Devices Industry Group
• Registration of medical devices in Italy

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