Article L1125-1
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…
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Showing 3661–3670 of 68627 articles for “Art. s. L 451-1 and L 142-1”
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…
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…
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…
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…
No clinical investigation may be carried out on a person without his free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 63 of Regulation (EU) 2017/…
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…
No employee may be penalised or dismissed for exercising the right provided for in Article L. 2352-13. Any decision or act to the contrary shall be null and void.
The expenses necessary for the proper performance of the task of the special negotiating body shall be borne by the participating companies.
Time spent in meetings by members of the Special Negotiating Body is considered as working time and paid at the normal rate.
In order to negotiate, the special negotiating body may be assisted by experts of its choice at any level it deems appropriate. These experts participate in the meetings of the group in an advisory ca…
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