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.-Natural persons guilty of the offence referred to in article L. 1126-20 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 Criminal 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 committee for the protection of individuals and, in the case of performance studies mentioned in the second to fifth paragraphs of II of Article L. 1126-1, the authorisation of the competent authority; 2° Under conditions contrary to the provisions of article L. 1126-10; 3° Whose performance has…

Any promoter whose civil liability is not covered by the insurance provided for in article L. 1126-8 shall be punished by one year’s imprisonment and a fine of 15,000 euros.

Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court has sole jurisdiction to rule on any action for compensation for damage resulting from a performance study. This action is time-barred under the conditions set out inarticle 2226 of the Civil Code.

In the context of a performance study involving an intervention not justified by the usual management of the participant and entailing risks and constraints that are not minimal, failure by the sponsor to provide the investigators, free of charge for the duration of the performance study, with the in vitro diagnostic medical devices that are the subject of the performance study is punishable by a fine of 30,000 euros.

Where a performance study is conducted at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the promoter to communicate in advance to the pharmacist managing this pharmacy the data relating to performance studies falling into one of the categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.

Failure to comply with Article 73(1) and Article 76(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on the communication of information intended to be made available to the public in the electronic system provided for in Article 69 of the aforementioned Regulation (EU) shall be punishable by one year’s imprisonment and a fine of €15,000.

The provisions of Section 3 of Chapter III of Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data,…

The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d’Etat and in particular: 1° The procedures applicable to the coordinated assessment procedure described in Article 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable to the appeals provided for in Article L. 1126-4; 3° The minimum guarantees for the insurance…