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

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.

Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulting from a clinical investigation; this action is time-barred under the conditions set out in article 2226 of the Civil Code.

In the context of a clinical investigation involving an intervention that is not justified by the patient’s usual care and that involves risks and constraints that are not minimal, failure by the sponsor to provide the investigators, free of charge for the duration of the clinical investigation, with the medical devices that are the subject of the clinical investigation is punishable by a fine of 30,000 euros.

Where a clinical investigation is carried out at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to communicate in advance to the pharmacist managing this pharmacy the data relating to clinical investigations 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 paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 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 73 of the aforementioned Regulation (EU), is 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,…

Subject to the provisions of articles L. 1123-15 to L. 1123-20, the provisions of this chapter apply to clinical investigations which are classified as national defence secrets within the meaning of article 413-9 of the French Criminal Code.