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

Performance studies may only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the persons undergoing it. This place must be authorised for this purpose, for a specified period, in the case of performance studies involving an intervention on a person which is not justified by their usual care and which exposes them…

No performance study 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, where the deceased person is a minor, this consent shall be expressed by each of the holders of parental authority. If it is not possible to consult one of the holders of…

With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who voluntarily take part in performance studies, as well as of sick persons when the purpose of the performance study is unrelated to their pathological condition. However, the personal data protection committee may decide…

I.-For the duration of the performance study 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 the in vitro diagnostic medical devices which are the subject of the performance study free of charge. II.-Non-commercial performance studies are performance studies whose results are not exploited for profit, which pursue…

Before a performance study 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 59 of Regulation (EU) 2017/746 of the European Parliament and of…

No performance study may be carried out on a person without his or her free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, after he or she has been given the information provided for in paragraphs 2 to 6 of Article 59 of that Regulation…

The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scientific purposes. The person may withdraw their consent to this subsequent use or exercise their right to object at any time.

I.-The Data Protection Committee will give its opinion on the conditions for the validity of the performance study, in particular 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 for obtaining informed consent, and the justification for conducting a performance study on persons incapable of giving informed…

The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulation (EU) No 2017/746 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 performance study, to any documents…

Carrying out or causing to be carried out a performance study in breach of Articles 59 to 62 of Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 and Article L. 1126-6, is punishable by three years’ imprisonment and a fine of €45,000.