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
Title	Council Directive concerning medical devices
Made by	Council
Made under	Art. 100a TEEC
Journal reference	L169, 12 July 1993 pp. 1-43
History
Date made	1993-06-14
Came 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
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The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.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]

See also

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

References

1. Text of directive (html)
2. Harmonised Standards under the MDD
3. "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