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Showing 691700 of 3694 articles for Art. 30 mars 2017

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

…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 pun…

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 L1126-24

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 resultin…

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 L1126-8

The promoter is responsible for compensating for the harmful consequences of the performance study for the person taking part in it and their dependants, unless it can prove that the damage is not att…

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 L1126-18

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 prot…

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

…of the categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.

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 L1126-9

The performance study does not give rise to any direct or indirect financial compensation for the persons taking part, apart from the reimbursement of expenses incurred and, where applicable, compensa…

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

…dures 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…

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 L1126-5

Performance studies relating to dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Performance studies relating to midwi…

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 L1126-13

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 volu…

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 L1126-14

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 ar…

AI translation · Updated 8 Nov 2023Open Article
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Mariela Petrova

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