| 词条 | Medical Devices Directive |
| 释义 |
|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=http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML |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= |status=Current }} The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993[1] 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'[2] 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. In 2017 a new Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices has been published in the Official Journal of the European Union on 5 May 2017, 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. At the same time also a Regulation (EU) 2017/746 on in vitro diagnostic medical devices, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, has been published. See also
References1. ^Text of directive (html) 2. ^Harmonised Standards under the MDD External links
4 : European Union directives|Regulation of medical devices|1993 in law|1993 in the European Union |
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