Subsection 9: EC declaration of conformity, product quality assurance.

As part of the EC declaration of conformity procedure, product quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the final inspection of medical devices and in particular the appropriate tests relating thereto. The approved body shall verify that the application of this quality system ensures compliance of the devices with an approved type described in an EC…

As part of the procedure for the EC declaration of conformity, product quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessment of the quality system relating to the final inspection and the associated tests. This application must include technical documentation setting out all the requirements and provisions adopted by the manufacturer for his quality system. The manufacturer undertakes to…

Within the framework of the EC declaration of conformity procedure, product quality assurance, for class II a medical devices or class I medical devices, the provisions laid down in Article R. 5211-49 apply subject to the following modifications: 1° For class II a medical devices, the authorised body shall verify that the application of the quality system relating to the final inspection ensures the conformity of the devices inspected with…