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Showing 3111–3120 of 61022 articles for “Art. L 416-1”
Certain medical devices for individual use appearing on a list drawn up by order of the ministers responsible for health and social security may be returned to a state of good repair with a view to re…
During the entire procedure for examining the application, the French Office for the Protection of Refugees and Stateless Persons may define the special examination procedures it deems necessary for t…
…he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scientific purposes. The person may withdraw their consent to this subsequent use or ex…
I.-The 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 prot…
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…
I.-For the duration of the performance study involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which ar…
…son taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this information is provided by that person or by another qualified person representi…
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…
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