Book I: Health protection for individuals

I.-For the duration of the clinical investigation involving an intervention on the patient which is not justified by the patient’s usual care and which exposes the patient to risks and constraints which are not minimal, the sponsor provides free of charge the medical devices which are the subject of the clinical investigation. II – Non-commercial clinical investigations are clinical investigations whose results are not exploited for profit, which pursue a…

Before a clinical investigation is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this information is provided by that person or by another qualified person representing him. The information shall be communicated in accordance with paragraphs 2 to 6 of Article 63 of Regulation (EU) 2017/745 of the European Parliament and of…

No clinical investigation may be carried out on a person without his free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 63 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, after he has been given the information provided for in paragraphs 2 to 6 of that same Article. Where it is impossible for the…

At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. The person may withdraw their consent to this subsequent use or exercise their right to object at any time.

I.-The Data Protection Committee gives its opinion on the conditions for the validity of the clinical investigation, particularly with regard to : the protection of individuals, in particular the protection of participants; -the adequacy, completeness and comprehensibility of the written information to be provided and the procedure to be followed to obtain informed consent, and the justification for conducting a clinical investigation on persons incapable of giving informed consent; -the…

The competent authority may, at any time, request additional information on the clinical investigation from the sponsor. Where the competent authority considers that the requirements set out in Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 are not being met, it may at any time request that changes be made to the arrangements for carrying out the clinical investigation, to any documents…

Performing or having performed a clinical investigation in breach of Articles 63 to 66 of Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-6, is punishable by three years’ imprisonment and a fine of €45,000.

I.-Natural persons guilty of the offence referred to in article L. 1125-21 shall also be liable to the following penalties: 1° disqualification from civic, civil and family rights, in accordance with the provisions ofarticle 131-26 of the French Penal Code; 2° disqualification, for a period of up to five years, from engaging in the professional or social activity in the course of which, or in the course of which, the…

The following is punishable by one year’s imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a personal protection committee and, in the case of clinical investigations mentioned in the second and third paragraphs of II of Article L. 1125-1, the authorisation of the competent authority; 2° Under conditions contrary to the provisions of article L. 1125-11; 3° The performance of which has been…

Any promoter whose civil liability is not covered by the insurance provided for in the third paragraph of article L. 1125-9 shall be punished by one year’s imprisonment and a fine of 15,000 euros.