The declarations provided for in Articles L. 5211-3-1 and R. 5211-65 as well as the communication provided for in Article R. 5211-66 are made to the Agence nationale de sécurité du médicament et des produits de santé, by registered post with acknowledgement of receipt or by electronic means with acknowledgement of receipt.
The declaration provided for in Article L. 5211-3-1 shall indicate the address of the declarant’s registered office, the type of activity carried out and the classes of medical devices to which this activity relates.
Any change to the information contained in the initial declaration must be the subject of a new declaration to the Agence nationale de sécurité du médicament et des produits de santé.
The model declaration is laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health.