Subsection 1: Common provisions.

Where the conformity certification procedure applied by a manufacturer involves the intervention of an authorized body, the manufacturer may apply to the body of his choice within the framework of the tasks for which that body has been authorized. Each procedure relating to a medical device may be the subject of an application to only one approved body.

The manufacturer or his authorised representative shall, for a period of at least five years and, in the case of implantable devices, at least fifteen years after the last copy of the product has been manufactured, keep at the disposal of the Director General of the Agence nationale de sécurité du médicament et des produits de santé the declarations of conformity and technical documentation which he has drawn up as…

The documents mentioned in article R. 5211-26 shall be presented by the manufacturer or his authorised representative at the request of the agents mentioned in article L. 5431-1.

In carrying out certification procedures, manufacturers and approved bodies shall take account of the available results of any assessment and verification operations which may have been carried out, pursuant to this Title, at an intermediate stage of manufacture.

Files and correspondence relating to certification procedures are drawn up in French or in a language of a Member State of the European Union or party to the Agreement on the European Economic Area accepted by the authorised body involved in the procedure.