Section 9: Devices subject to notification to the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products)

The medical devices which must be notified in accordance with Article L. 5211-4 are class IIa, IIb and III medical devices and active implantable medical devices. The communication is made to the Director General of the Agence nationale de sécurité du médicament et des produits de santé when the medical devices are put into service on national territory, by the manufacturers, agents or distributors who supply the medical devices directly…