Section 6: Conformity certification procedures

Implantable medical devices, active implantable medical devices and class III devices must be subject to clinical investigations, unless the use of existing clinical data can be duly justified.

The manufacturer who intends to have clinical investigations carried out in France to verify the performance of a medical device or to detect any undesirable side effects, or his authorised representative established in a Member State of the European Union or party to the Agreement on the European Economic Area, must, before undertaking his investigations : 1° Certify, in accordance with the procedures defined in Article R. 5211-38 , that…

As part of the procedure applicable to medical devices undergoing clinical investigations, the manufacturer shall draw up a declaration containing the information referred to in Articles R. 1123-37 to R. 1123-41 and certifying that the medical device concerned complies with the essential requirements defined in Section 5 of this Chapter, with the exception of the aspects to be investigated and for which he certifies that all precautions have been taken…