The medical devices directives (90/385/EEC, 93/42/EEC and 98/79/EC) require medical device manufacturers to assess the conformity according to the requirements stipulated in the above directives.
The aim of the conformity assessment is to achieve the CE marking and thus to prove the marketability in the European Union.
Since 1998 CE-Mark is required on all medical devices marketed in Europe. The CE-Mark is a proof of compliance with so called Essential Requirements of the Medical Device Directive.
For manufacturers outside the EU, this means that:
The CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations.