Section 7: Authorised bodies.

The provisions of Section 7 of Chapter I of Title I of this Book, with the exception of Article R. 5211-54, the second paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211-64, are applicable to authorised bodies for in vitro diagnostic medical devices.

The bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé published on the Agency’s website. The authorisation shall specify the tasks for which it is granted. Organisations applying for authorisation must send the Agence nationale de sécurité du médicament et des…

The decisions taken by the approved bodies under the procedures referred to in sub-sections 4, 5 and 6 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods on application submitted at a time 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.

Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé : 1° of any modification likely to alter the conditions under which authorisation has been granted ; 2° All decisions taken by the Director General under the procedures defined in this chapter; 3° All certificates issued, modified, supplemented, suspended, refused or cancelled; 4° the need for the competent authority of…

The approved body shall inform the other approved bodies in France or in the other Member States of the European Union or parties to the Agreement on the European Economic Area and which have been published in the Official Journal of the European Union: 1° All suspended or cancelled certificates ; 2° On request, of all decisions taken under the procedures defined in this section and of all certificates issued…