Article L1125-10
…plication of Chapters II to IV of Title I of Book II of Part Three of this Code or of Article 706-135 of the Code of Criminal Procedure and persons admitted to a health and social establishment for pu…
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Showing 9031–9040 of 29486 articles for “Art. al. 5 + Cass. com.”
…plication of Chapters II to IV of Title I of Book II of Part Three of this Code or of Article 706-135 of the Code of Criminal Procedure and persons admitted to a health and social establishment for pu…
I.-The clinical investigations of the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are governed by the provisions of the afo…
The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the…
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…
…vent 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 or an un…
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…
…vestigation may be carried out provided that the other holder consents. The provisions of article 225-17 of the Criminal Code do not apply to these clinical investigations.
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
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…
…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 any tim…
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