Medical Devices Directive

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
History
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 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.

The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.[3]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".
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