Medical Devices Directive

{{EngvarB|date=July 2018}}

{{Use dmy dates|date=July 2018}}

{{Infobox EU legislation

|type=Directive

|title=Council Directive concerning medical devices

|number=93/42/EEC

|madeby=Council

|madeunder=Art. 100a TEEC

|OJref=L169, 12 July 1993 pp. 1-43

|OJrefurl={{CELEX|31993L0042}}

|made=1993-06-14

|commenced=1993-07-12

|implementation=1994-07-01

|CommProp=

|ESCOpin=

|ParlOpin=

|Reports=

|replaces=Directive 76/764/EEC

|amends=Directive 84/539/EEC, Directive 90/385/EEC

|amendedby=

|replacedby=Directive EU 2017/745

|status=Repealed

}}

The Medical Device Directive—{{CELEX|31993L0042|text=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'[http://ec.europa.eu/growth/single-market/european-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.{{cn|date=April 2023}}

The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745),{{CELEX|32017R0745|text=Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC}} effective on 26 May 2021.{{cite web |url=https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en |title=Date of application of the Medical Devices Regulation postponed until May 2021}}