Article R5222-1 of the French Public Health Code

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.

Original in French

Article R5222-1

La vigilance des dispositifs médicaux de diagnostic in vitro, dite réactovigilance, a pour objet la surveillance des incidents et des risques d’incidents définis au 1° de l’article R. 5222-2.

Elle s’exerce sur l’ensemble des dispositifs médicaux de diagnostic in vitro après leur mise sur le marché ainsi que sur les dispositifs médicaux de diagnostic in vitro mentionnés à l’article L. 5221-5.