Medical Devices Directive
Encyclopedia
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

s, OJ No L 169/1 of 1993-07-12) is intended to harmonise
Harmonisation of law
Harmonisation of law comes from the root word harmonise which under the OED means “make or form a pleasing or consistent whole”. In the case of harmonisation of law, the aim is to make a consistent whole of law...

 the laws relating to medical devices within the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

. 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
CE mark
CE marking is a mandatory conformity mark for products placed on the market in the European Economic Area . With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives...

 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.

See also

  • European Medical Devices Industry Group
    European Medical Devices Industry Group
    The European Medical Devices Industry Group is a non-profit trade association, and represents the medical devices industry in Europe as defined by the European Union Medical Devices Directives...

  • Journal of Medical Device Regulation

External links

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