Made by Council Date made 1993-06-14 | Made under Art. 100a TEEC Came into force 1993-07-12 | |
Title Council Directive concerning medical devices Journal reference L169, 12.07.1993 pp. 1-43 | ||
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.
2016 - The Medical Devices Directive is being repealed and replaced by a Medical Device Regulation (MDR).