Section 7: Authorised bodies

Where the authorised body encounters difficulties in implementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicament et des produits de santé for specific recommendations on their application.

The decisions taken by the approved bodies under the procedures referred to in subsections 5, 6, 8 and 9 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods on application submitted on the date contractually agreed between the manufacturer and the body. For duly justified reasons, the decisions of the approved body may be valid for less than five years. As…

Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have been issued, it shall suspend or cancel the certificate issued or place restrictions on it, unless the manufacturer applies appropriate corrective measures to ensure that these requirements are met.

Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn or refused. They shall make any additional relevant information available to the Director General on request. They inform the other organisations authorised in France or by any other Member State of the European Union or party to the Agreement on the European…