Section 8: Declarations.

Any manufacturer having its registered office in France and who, in any Member State of the European Union or party to the Agreement on the European Economic Area, places class I medical devices or custom-made medical devices on the market in its own name, shall make a declaration to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, indicating the address of its…

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…