Section 1: General provisions.

The purpose of vigilance of in vitro diagnostic medical devices, known as reactovigilance, is to monitor incidents and risks of incidents as defined in 1° of article R. 5222-2. It is carried out on all in vitro diagnostic medical devices after they have been placed on the market, as well as on the in vitro diagnostic medical devices mentioned in article L. 5221-5.

Reactovigilance involves : 1° The reporting and declaration of any incident or risk of incident consisting of a failure or alteration in the characteristics or performance of an in vitro diagnostic medical device, or an inadequacy in the labelling or instructions for use likely to lead or to have led directly or indirectly to adverse effects on human health; 2° Recording, evaluating and using this information to protect human health;…