Subsection 7: EC verification.

As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under the conditions described in this sub-section. In addition, in the case of medical…

In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees conformity of the medical devices manufactured with the type described in the EC type-examination certificate and with the essential requirements defined in Section 5 of this Chapter which apply to them. He shall draw up technical documentation relating…

For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 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. In the…