Section 2: Organisation of material safety monitoring

The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) carries out his duties relating to material vigilance under the conditions defined in Article R. 5311-2 and ensures compliance with the monitoring procedures organised by this chapter. It informs the manufacturer(s) concerned when the facts reported are brought to its attention by a…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform without delay of any incident or risk of incident defined in Article L. 5212-2: the Etablissement Français du Sang (French Blood Establishment), with regard to medical devices used in the collection, manufacture and administration of blood-derived products; -the Agence de la biomédecine, for medical devices used in the collection, processing, preservation and…

The regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.

Any health establishment or health cooperation group which uses or supplies medical devices or makes such devices available to its members, as well as any association distributing medical devices at home and appearing on a list drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, must appoint a local materialovigilance correspondent. However, below an activity threshold set by order of…

Every manufacturer of medical devices, or its authorised representative, appoints a material vigilance correspondent and communicates his name to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.