Section 8: Declaration.

Manufacturers who place in vitro diagnostic medical devices on the French market and who do not have their registered office on the territory of a Member State of the European Union or a party to the Agreement on the European Economic Area must first appoint an authorised representative.

The declaration provided for in article L. 5221-3 is made by the manufacturer or his authorised representative, the importer, distributor or exporter of in vitro diagnostic medical devices. The same natural or legal person may declare several activities. The manufacturer or its authorised representative is not required to declare itself as an importer or distributor for the in vitro diagnostic medical devices it places on the market. Importers are not…

The content and methods of presentation of the declaration are 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. This order may provide for specific content and presentation procedures for establishments engaged in the manufacture of in vitro diagnostic medical devices mentioned in Article L. 5221-5.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé is notified of any changes to the information contained in the declaration.