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Showing 671680 of 3694 articles for Art. 30 mars 2017

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 L1125-25

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 resulti…

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 L1125-4

…n the event of a refusal of validation provided for in paragraph 3 of Article 70 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, a refusal of authorisation o…

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 L1125-11

For each clinical investigation with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…

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 L1125-13

No clinical investigation 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 fam…

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 L1125-26

…h the medical devices that are the subject of the clinical investigation is punishable by a fine of 30,000 euros.

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 L1125-14

With a view to the application of the provisions of the first paragraph of article L. 1125-6 and article L. 1125-7, a national register shall be kept of persons who are free of any disease and who vol…

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 L1125-20

…ponsor. Where the competent authority considers that the requirements set out in Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 are not being met, it may at…

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 L1125-28

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 inform…

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 L1125-7

…icles L. 3212-1 and L. 3213-1 who do not come under the provisions of Article 64 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a hea…

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 L1125-23

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 inv…

AI translation · Updated 8 Nov 2023Open Article
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Mariela Petrova

Mariela Petrova

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