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Showing 6811–6820 of 54180 articles for “Art. II-4°”
In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees…
As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with…
For the application of this book in Martinique: 1° The last sentence of Article L. 264-1, the reference to article L. 754-3 is deleted.
In the absence of an agreement, the Social and Economic Committee is consulted at least once a year on the arrangements for using the annual overtime quota and any excess.
In the absence of an agreement referred to in Article L. 3142-40, the following provisions apply: 1° The maximum number of days that may be taken as leave is nine working days per year; 2° The time li…
For the application of the provisions of this book in French Guiana:1° Article R. 251-3 is not applicable;2° In Article R. 253-1, the reference to Article R. 614-1 is deleted.
The committees for the protection of individuals comprise thirty-six members divided into two colleges, each with 18 members: 1° The first college is made up of at least: a) Eight people with qualific…
The competent authority defined in Article L. 1123-12 implements the vigilance system relating to research involving the human person. Where necessary, it shall take appropriate measures to ensure the…
The investigator notifies the sponsor without delay from the day on which he becomes aware of all serious adverse events and all adverse reactions and serious incidents occurring in the course of rese…
For research involving medicinal products, the Director General of the Agence nationale de sécurité du médicament et des produits de santé ensures that all suspected serious unexpected adverse reactio…
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