Medical devices can only be put on the European Market if they satisfy a set of criteria called “essential requirements”, as set out in Annex I of the Directive.
All medical devices must comply, where applicable, with these requirements. Manufacturers are required to check each product type or model against each requirement, determine whether the requirement is applicable, acquire documented evidence of compliance and keep this evidence available in the technical file of the product. In this respect, it is fair to say that Annex I is the core of the whole Medical Device Directive.
The essential requirements give particular consideration to:
- the safety,
- the technical performance and
- medical performance of a medical device.
The conformity-assessment procedure is used to show proof that the requirements concerning safety and technical performance have been fulfilled while medical performance is verified in the context of clinical assessment.
The manufacturer demonstrates the conformity of a medical device to the essential requirements by affixing the CE marking to each individual device.