French Public Health Code
In forceI.-The approved bodies must comply with the following obligations:
1° The approved body, its director and the personnel responsible for carrying out the assessment and verification operations may not be the designer, manufacturer, supplier, installer or user of the devices they inspect, nor the authorised representative of any of these persons. They may not intervene either directly or as agents of the parties involved in these activities, in the design, construction, marketing or maintenance of these devices. This does not exclude the possibility of an exchange of technical information between the manufacturer and the organisation;
2° The assessment and verification operations are carried out with the greatest professional integrity and the greatest competence required in the medical devices sector and in complete independence.
When an approved body entrusts specific work to a subcontractor relating to the establishment and verification of facts, it must first ensure that the provisions of Book II of Part V of this Code are complied with by the subcontractor. The approved body must make available to the Director General of the Agence nationale de sécurité du médicament et des produits de santé the relevant documents relating to the assessment of the subcontractor's competence and to the work carried out by the subcontractor in this context;
3° In particular, the authorised body has the human and material resources required to perform the tasks for which it has been authorised;
4° The personnel responsible for the inspections have :
a) sound professional training covering all the assessment and verification operations for which the body has been designated ;
b) satisfactory knowledge of the requirements relating to the inspections it carries out and sufficient practical experience of the inspections ;
c) The ability required to draw up the certificates, records and reports which constitute the evidence of the inspections carried out.
5° The approved body takes out insurance covering its civil liability;
6° At the request of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the accredited body provides all the information and documents, including budgetary documents, that enable him to verify compliance with the requirements laid down in this article, in particular those relating to its independence with regard to persons likely to be interested in the results of the tests or examinations that it carries out.
It undertakes to allow persons designated by the Director General of the Agence nationale de sécurité du médicament et des produits de santé access to its premises and to carry out any investigations, in order to verify that it continues to satisfy the conditions of authorisation.
II. - The obligations defined in I of this Article shall be understood to be in accordance with the provisions of Annex I to Implementing Regulation (EU) No 920/2013.
The independence of control staff shall be guaranteed. The remuneration of each member of staff may not depend on the number of checks carried out or on the results of such checks.
The staff of the inspection body shall be bound by professional secrecy with regard to anything they learn in the course of their duties.
