Section 1: General provisions.

The purpose of materiovigilance is to monitor incidents or risks of incidents resulting from the use of medical devices which are defined in article L. 5211-1 and come under this title by virtue of articles R. 5211-1 to R. 5211-3. It is carried out on medical devices after they have been placed on the market.

Materiovigilance involves : 1° Reporting and recording the incidents or risks of incidents mentioned in articles R. 5212-14 and R. 5212-15; 2° Recording, evaluating and using this information for prevention purposes; 3° Carrying out any studies or work relating to the safe use of medical devices; 4° Carrying out and monitoring any corrective action decided upon.

The exercise of material vigilance may involve, in addition to the communication by the manufacturer of the documents mentioned in Article R. 5211-26, access to data in the pre-clinical experimental file and to data relating to clinical investigations, in particular the report on clinical investigations mentioned in Article R. 5211-37 and the information listed in Article R. 5211-38, as well as access to information relating to the design, manufacture, storage,…