Article L531-10
…s vulnerability sent to it by the French Office for Immigration and Integration pursuant to Article L. 522-4 and the elements of vulnerability of which it alone may be aware from the application or st…
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Showing 3401–3410 of 61039 articles for “Art. L. 112-1”
…s vulnerability sent to it by the French Office for Immigration and Integration pursuant to Article L. 522-4 and the elements of vulnerability of which it alone may be aware from the application or st…
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…
…to be set up. Before giving its opinion, the Committee shall ensure that the conditions of article L. 1126-11 have been met. The competent authority shall be informed of any changes made to the perfo…
With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who volu…
…llowing conditions: 1° In vitro diagnostic medical devices included on the list mentioned inarticle L. 165-1 of the Social Security Code or covered by the list of acts and services mentioned in articl…
Before a performance study is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this inform…
For each study of performance, 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…
The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulatio…
Performance studies may only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the per…
No performance study 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 family. Ho…
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