Chapter V: Specific provisions applicable to clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017

I.-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…

Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submit the project to 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 Article L. 1123-16….

Once the Data Protection Committee has issued a favourable opinion and the investigation has been authorised by the Agence nationale de sécurité du médicament et des produits de santé, where applicable, any substantial modification at the initiative of the sponsor must obtain a favourable opinion from the Data Protection Committee prior to its implementation and, in the case of clinical investigations referred to in II of Article L. 1125-1, authorisation…

In the event of a refusal of validation provided for in paragraph 3 of Article 70 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, a refusal of authorisation or an unfavourable opinion of a clinical investigation provided for in paragraph 4 of Article 71 of the aforementioned Regulation (EU), the sponsor may submit a request for review to the National Agency for…

The provisions of Articles 72, 75, 76, 77, 80, 87, 88, 89 and 90 of the aforementioned Regulation (EU) shall apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.

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

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 come under the provisions of Article 64 of Regulation (EU) 2017/745 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 clinical investigation may be asked to lend themselves…

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 clinical investigations which do not involve any risk or constraint. By way of derogation, the Data Protection Committee may authorise a person who is not affiliated to a social security scheme or who is a beneficiary of such a scheme to take part in clinical…

The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the damage is not attributable to his 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…

The clinical investigation does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applicable, compensation for 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…