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Showing 9361–9370 of 40353 articles for “Art. 25-3 et seq.”
…equest, the accredited bodies carry out the inspections in accordance with the specific provisions set out in Articles R. 5212-27 and R. 5212-27-1. Each external quality control gives rise to a report…
…ative of health establishments, health cooperation groupings mentioned in article L. 6133-7 and cosmetic surgery establishments shall, after consulting the medical committee of the establishment menti…
The exercise of material vigilance may involve, in addition to the communication by the manufacturer of the documents mentioned in Article R. 5211-26, access to data in the pre-clinical experimental f…
The provisions of Section 7 of Chapter I of Title I of this Book, with the exception of Article R. 5211-54, the second paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211…
The approved body shall inform the other approved bodies in France or in the other Member States of the European Union or parties to the Agreement on the European Economic Area and which have been pub…
Each user department of a medical device on the list provided for in Article R. 5212-36 completes the information mentioned in Article R. 5212-38 by recording:-the date of use ;the identification of t…
The pharmacist in charge of managing the in-house pharmacy or, for establishments without an in-house pharmacy, the person in charge of ordering and managing stocks in the establishment, under the sup…
If a quality control reveals a deterioration in the performance or characteristics of the device, the operator shall take appropriate measures relating to its use and shall bring the device back into…
…They may be renewed for five-year periods on application submitted at a time contractually agreed between the manufacturer and the body. For duly justified reasons, the decisions of the approved body…
Manufacturers who place in vitro diagnostic medical devices on the French market and who do not have their registered office on the territory of a Member State of the European Union or a party to the…
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