Subsection 8: EC declaration of conformity, production quality assurance.

As part of the EC declaration of conformity procedure, production quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the manufacture of his medical devices. The approved body shall verify that the application of this quality system ensures conformity of the devices with an approved type described in an EC type-examination certificate referred to in Article R. 5211-41…

As part of the EC declaration of conformity procedure, production quality assurance, for active implantable medical devices or medical devices in class IIb or class III, the manufacturer submits an application to the authorised body for assessment of this quality system, which includes technical documentation setting out all the requirements and provisions adopted by the manufacturer for his quality system, particularly, where applicable, with regard to sterilisation. The manufacturer undertakes…

For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-46 apply subject to the following modifications: 1° For class II a medical devices, the authorised body verifies the conformity of the devices with the technical documentation drawn up in application of the EC declaration of conformity procedure and not with an EC type certificate, and with the essential requirements applicable to them. Similarly, the…