The Medical Device Directives is a 'New Approach' directive relating to the safety and performance of medical devices which were harmonized in the EU in the 1990s. For a manufacturer to legally place a medical device on the European market the requirements of the Directive have to be met and a CE mark applied.
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The European Medical Device Directives
Any medical device placed on the European market must comply with relevant legislation. Manufacturers' products meeting 'harmonized standards' have a presumption of conformity to the Directive. Products conforming with the Directive must have a CE mark applied. The core legal framework consists of three directives:
All medical devices must fulfil the essential requirements set out in the above mentioned Directives. Where available, relevant standards may be used to demonstrate compliance with the essential requirements defined in the Directives list of harmonized standards.