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Showing 10511060 of 44338 articles for Art. CE 24-2-2017 n° 387972

French Public Health CodeIn force
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

Article L1125-21

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-…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1125-2

…data protection committee appointed at random from among the committees available and having the necessary competence to examine the project, under the conditions provided for in Article L. 1123-14 o…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1126-20

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.…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1126-26

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 adv…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1126-29

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 d…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1126-25

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 sponso…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1126-28

…rliament 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, and repealing Directive 95/46/EC, sh…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1126-21

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…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1126-2

…7/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the project for the opinion of a personal data protection committ…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
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

Article L1126-22

…he 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…

AI translation · Updated 8 Nov 2023Open Article
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