• Source: Medical Devices Directive

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The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.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

Kata Kunci Pencarian:

• Raksa
• Medical Devices Directive
• Medical device
• Regulation (EU) 2017/745
• Medical software
• ISO 14971
• List of European Union directives
• European Authorized Representative
• ISO 13485
• Directive (European Union)
• MDD