Paragraph 1: Assessment of clinical data

The evaluation of the clinical data referred to in Article L. 5211-3-2, hereinafter referred to as the “clinical evaluation”, must, taking into account any relevant harmonised standards, follow a procedure based on either: -either a critical assessment of the relevant scientific literature currently available concerning the safety, performance, characteristics, design and intended purpose of the device, demonstrating the equivalence of the device with the device to which the data refer…

The clinical evaluation and its results are included or duly referenced in the technical documentation for the device referred to in Article R. 5211-39. The clinical evaluation and its documentation are updated using data obtained during post-marketing surveillance. The decision not to conduct clinical follow-up as part of the post-marketing surveillance plan for the device must be duly justified and documented.