French Legislation In English

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Showing 821830 of 4213 articles for Art. CE 31 Mar 2017 n° 401059

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 L1125-18

At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. T…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Subsection 3: Obligations of establishments mentioned in b of 2° of article R. 1245-31

Article R1245-37

The establishments or organisations mentioned in b of 2° of article R. 1241-31 ensure that the unique donation number that they allocate is unique on the basis of the provisions of the order and good…

AI translation · Updated 5 Nov 2023Open Article
French Public Health CodeIn force
Subsection 3: Obligations of establishments mentioned in b of 2° of article R. 1245-31

Article R1245-35

I. - Unless the single European code has already been allocated to tissues or cells from a Member State of the European Union, the single European code is allocated at the latest before the tissues or…

AI translation · Updated 5 Nov 2023Open Article
French Public Health CodeIn force
Subsection 3: Obligations of establishments mentioned in b of 2° of article R. 1245-31

Article R1245-36

Unless the donation identification sequence has already been allocated to tissues or cells from a Member State of the European Union, the donation identification sequence is allocated by the establish…

AI translation · Updated 5 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

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 L1126-24

…t has sole jurisdiction to rule on any action for compensation for damage resulting from a performance study. This action is time-barred under the conditions set out inarticle 2226 of the Civil Code.

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

…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 protection…

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
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