French Public Health Code
In forceI.-The performance reviews of the devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 shall be governed by the provisions of the aforementioned Regulation (EU) and those of this chapter.
II.-The competent authority for carrying out the scientific review as part of the evaluation of the application for a performance study provided for in paragraph 3 of Article 58 and referred to in Articles 66,70,71 and 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 shall be the National Agency for the Safety of Medicines and Health Products.
A scientific review is required, pursuant to point b of paragraph 7 of Article 66 of the aforementioned Regulation (EU), for the following performance studies conducted on a device not bearing the CE marking or on a device bearing the CE marking but used outside the limits of its intended purpose, including on a device manufactured and used exclusively in a healthcare establishment within the meaning of the aforementioned Regulation (EU), under the conditions provided for, in paragraph 5 of Article 5 of the same Regulation not meeting all of the conditions set out in points a to i of that paragraph 5:
-a performance study in which samples are obtained by invasive surgical sampling for the sole purpose of the performance study;
-a performance study which constitutes an interventional clinical performance study within the meaning of point 46 of Article 2 of the above-mentioned Regulation (EU);
-a performance study involving additional invasive procedures or other risks for study participants.
For these performance studies, the competent authority, in accordance with the provisions of paragraph 3 of Article 67 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 performance study 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 performance study;
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) provides an opinion to the Committees for the Protection of Individuals mentioned in III on the safety of the additional cumbersome or invasive procedure planned to be carried out as part of the performance studies covered by paragraph 1 of Article 70 of the aforementioned Regulation (EU).
The procedures for notifying the Agence nationale de sécurité du médicament et des produits de santé of performance studies concerning companion diagnostics and using only residual samples, as referred to in the second sentence of paragraph 2 of Article 58 of the same Regulation, are laid down by order.
III. -The ethical review provided for in paragraph 3 of Article 58 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 and mentioned in Articles 66,70,71 and 74 falls within the competence and responsibility of the personal protection committees mentioned in Articles L. 1123-1 and L. 1123-16. With the exception of performance studies covered by national defence secrecy, requests for ethical review of performance studies are submitted to one of the personal data protection committees designated at random from among the competent committees available in accordance with article L. 1126-2. This ethical review and the procedures applicable to the coordinated evaluation procedure described in Article 74 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 - Examination of the validation of any application referred to in paragraph 1 and the first sentence of paragraph 2 of Article 58 and in Articles 70 and 71 of the aforementioned Regulation (EU) is coordinated by the National Agency for the Safety of Medicines and Health Products, with the exception of applications for substantial amendments referred to in Article 71 of the aforementioned Regulation (EU) 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.
