The Medical Device Directive— 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'Harmonised Standards under the MDD 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The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
See also European Medical Devices Industry Group Registration of medical devices in Italy
References
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