Directive 93/42/EEC
European Union directive
TitleCouncil Directive concerning medical devices
Made byCouncil
Made underArt. 100a TEEC
Journal reference[31993L0042 L169, 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
Replaced byDirective EU 2017/745
Repealed

The Medical Device DirectiveCouncil 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'[1] 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The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745),[2] effective on 26 May 2021.[3]

See also

References

  1. Harmonised Standards under the MDD
  2. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
  3. "Date of application of the Medical Devices Regulation postponed until May 2021".
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