93/42/EEC

Short name	Medical devices
Base	Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993
Modification	Directive 93/68/EEC [CE Marking] Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
Directive repealed	76/764/EEC (repealed as from 1 January 1995)
Guide for application	Guidance on CE marking for professionals Guidelines related to medical devices directives

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 21 March 2010.

Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices - OJ C 389 of 17/11/2017