French Public Health Code
In forceI.-The clinical investigations of the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are governed by the provisions of the aforementioned Regulation (EU) and the provisions of this chapter.
II-The competent authority for carrying out the scientific examination as part of the assessment of the clinical investigation request provided for in Article 62(3) and referred to in Articles 70, 74, 75, 78 and 82 of this Regulation is the National Agency for the Safety of Medicines and Health Products. A scientific examination is required for the following clinical investigations:
pursuant to article 70(7) of the above-mentioned EU regulation: clinical investigations carried out on a device not bearing the CE mark or bearing the CE mark but used outside its intended purpose, in the case of class IIa invasive medical devices, class IIb medical devices and class III medical devices;
-pursuant to Article 82 of the aforementioned Regulation (EU): clinical investigations not intended to obtain the CE marking or to establish conformity within the meaning of Article 62, and which are conducted on any device bearing the CE marking and used outside its intended purpose or on any device not bearing the CE marking.
For these clinical investigations, the competent authority, in accordance with the provisions of Article 71(3) of the aforementioned Regulation (EU), shall decide on their authorisation with regard to the safety of persons, taking into account:
1° The safety and quality of the products used during the clinical investigation in accordance, where applicable, with the standards in force;
2° The conditions of use of the products and the safety of persons with regard to the procedures performed and the methods used;
3° The arrangements made for monitoring persons;
4° The relevance of the clinical investigation;
5° The satisfactory nature of the assessment of the expected benefits and risks;
6° The appropriateness of the conclusions.
In addition, the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) issues an opinion to the Committees for the Protection of Individuals mentioned in III on the safety of the additional cumbersome or invasive procedure that it is planned to carry out as part of the following clinical investigations:
-any clinical investigation covered by Article 74(1) of the aforementioned Regulation (EU);
-any clinical investigation carried out on a CE marked device used for its intended purpose, and not intended to establish the conformity of the medical device within the meaning of Article 62 of the aforementioned EU Regulation.
III - The ethical review provided for in paragraph 3 of Article 62 of this Regulation (EU) and referred to in Articles 70, 74, 75, 78 and 82 thereof is the responsibility of the committees for the protection of individuals referred to in Articles L. 1123-1 and L. 1123-16. With the exception of clinical investigations covered by national defence secrecy, requests for ethical review of clinical investigations are submitted to one of the personal data protection committees designated at random from among the competent committees available in accordance with article L. 1125-2. This ethical review and the procedures applicable to the coordinated assessment procedure described in Article 78 of the aforementioned EU Regulation are carried out under the conditions and within the timeframes laid down by decree in the Conseil d'Etat.
IV - The examination of the validation of any application mentioned in Articles 70, 74, 75 and 82 of the aforementioned EU Regulation is coordinated by the National Agency for the Safety of Medicines and Health Products, with the exception of applications for substantial amendments mentioned in Article 75 of the aforementioned EU Regulation which fall within the sole remit of the Committee for the Protection of Individuals. In this case, the Committee for the Protection of Individuals validates the application and examines the application for a substantial amendment.
