Section 2: Organisation of reactovigilance

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall carry out his duties relating to reactovigilance under the conditions defined in Article R. 5311-2. He shall ensure compliance with the monitoring procedures organised by this chapter. When informed of an incident or risk of incident, or of the recall of an in vitro diagnostic medical device, the Director General will arrange for…

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

Any establishment mentioned in 4° of article R. 5222-3 and any blood transfusion establishment shall appoint a local reactovigilance correspondent. The local reactovigilance correspondent is a doctor or pharmacist with experience in the field of in vitro diagnostic medical devices. The healthcare cooperation group’s reactovigilance correspondent may be the reactovigilance correspondent for a healthcare establishment that is a member of the group. As soon as it is appointed, the identity…

All manufacturers of in vitro diagnostic medical devices, or their representatives, shall appoint a person to be responsible for reactovigilance, whose identity and position shall be communicated to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.