The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 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' 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 March 21, 2010.
In 2017 a new Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices has been published in the Official Journal of the European Union on the 5 May 2017, 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. At the same time also a Regulation (EU) 2017/746 on in vitro diagnostic medical devices, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, has been published.
Video Medical Devices Directive
See also
- European Medical Devices Industry Group
- Journal of Medical Device Regulation
- Registration of medical devices in Italy
Maps Medical Devices Directive
References
External links
- UDI Webinar Series and how it will affect European Medical Device manufacturers (Archivated)
- EU legislation summary
- European Medical Device Usability Requirements
- Essential links for CE Marking in the UK
- Online database of medical devices
Source of article : Wikipedia
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