Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

I.-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…

Pursuant to Articles 58,66 and 70 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the project for the opinion of a personal data protection committee appointed at random from among the committees available and having the necessary competence to examine the project, under the conditions provided for in Article L. 1123-14 or…

Once the Committee for the Protection of Individuals has issued a favourable opinion and the performance study has been authorised, where applicable, by the Agence nationale de sécurité du médicament et des produits de santé, any substantial modification at the initiative of the sponsor must obtain a favourable opinion from the Committee for the Protection of Individuals prior to its implementation and, in the case of performance studies mentioned in…

In the event of a refusal of validation provided for in paragraph 3 of Article 66 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Article L. 1126-1, refusal of authorisation or unfavourable opinion of a performance study provided for in paragraph 4 of Article 67 of the aforementioned Regulation (EU), the sponsor may submit a request…

Performance studies relating to dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Performance studies relating to midwifery may only be carried out under the direction and supervision of a doctor or a midwife. Performance studies involving only minimal risks and constraints in the field of nursing may only be carried out under the direction and supervision of…

Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article 60 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a health or social establishment for purposes other than performance studies may be asked to take part…

Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in performance studies which do not involve any risk or constraint and in which all the procedures are carried out and the products used in the usual way. By way of derogation, the Personal Data Protection Committee may authorise a person who is not affiliated to…

The promoter is responsible for compensating for the harmful consequences of the performance study for the person taking part in it and their dependants, unless it can prove that the damage is not attributable to its fault or to the fault of any other party involved, without it being possible to invoke the action of a third party or the voluntary withdrawal of the person who had initially agreed to…

The performance study does not give rise to any direct or indirect financial compensation for the persons taking part, apart from the reimbursement of expenses incurred and, where applicable, compensation for the constraints suffered paid by the promoter. The total amount of compensation that a person may receive in any one year is limited to a maximum set by the Minister for Health. The payment of such compensation is prohibited…

For each study of performance, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the dossier submitted to the Committee for the Protection of Individuals and to the competent authority shall determine whether it is necessary for the person not to be able to participate simultaneously in any…