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

For each clinical investigation 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 Data Protection Committee and the competent authority must determine whether it is necessary for the person not to be able to participate simultaneously in another clinical investigation and, if so,…

Clinical investigations may only be carried out in a place that has the human, material and technical resources appropriate to the clinical investigation and compatible with the safety requirements of the persons undergoing it. This location must be authorised for this purpose, for a specific period of time, in the case of clinical investigations involving an intervention on a person which is not justified by his/her usual care and which…

No clinical investigation may be carried out on a deceased person, in a state of brain death, without his or her consent expressed during his or her lifetime or through the testimony of his or her family. However, when the deceased is a minor, this consent is expressed by each of the holders of parental authority. If it is impossible to consult one of the holders of parental authority, the…

With a view to the application of the provisions of the first paragraph of article L. 1125-6 and article L. 1125-7, a national register shall be kept of persons who are free of any disease and who voluntarily lend themselves to clinical investigations, as well as sick persons when the purpose of the clinical investigation is unrelated to their pathological condition. However, the Personal Data Protection Committee may decide in…

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…