Medical Devices Directive
From Wikipedia, the free encyclopedia
The Medical Devices 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 reviewed in 2007 and a number of changes made.
[edit] External links
- Obelis.net EAR for Medical Devices
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
