Medical Devices Directive

EU directive

Directive 93/42/EECEuropean 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| Regulation (EU) 2017/745
Repealed

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'[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.[citation needed]

The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745),[2] effective on 26 May 2021.[3]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

[edit]

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

## References

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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".

## External links

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* 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