The Medical Device Directive (Council
Directive 93/42/EEC of 14 June 1993 concerning
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s, OJ No L 169/1 of 1993-07-12) is intended to
harmonise the laws relating to medical devices within the
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been de ...
. 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
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ...
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.
The Medical Devices Directive is being repealed and replaced by the 2017 EU
Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
See also
*
European Medical Devices Industry Group
*
Registration of medical devices in Italy
References
{{Reflist
External links
UDI Webinar Series and how it will affect European Medical Device manufacturersEuropean Medical Device Usability Requirements
Essential links for CE Marking in the UK
European Union directives
Regulation of medical devices
1993 in law
1993 in the European Union