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Showing 48314840 of 13081 articles for Art. 7 sept. 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 L1125-31

…rticular: 1° The procedures applicable to the coordinated assessment procedure described in Article 78 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017; 2° The…

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 L1126-17

The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…

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

…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

…ormance studies; -the methodology of the performance study with regard to the provisions of law no. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, the nee…

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

…ance 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.

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

…tric care pursuant to Chapters II to IV of Title I of Book II of Part Three of this Code or Article 706-135 of the Code of Criminal Procedure and persons admitted to a health and social establishment…

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

…rticular: 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…

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
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