Annex III of the Medical Devices Directive-EC type examination

A type test which is used to assess the conformity of a product with the requirements of the Medical Devices Directive and is used for classes IIb and III products when the Annex II (“full quality assurance”) route is not chosen is called an EC type examination. Such a test must be carried out by, or on behalf of, an Annex III Notified Body. The wider technical documentation is assessed in addition to the product. Unlike traditional type tests which were to specific standards, EC type examinations may not be to clearly defined standards-but could be to selected parts of different standards