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Showing 8351–8360 of 47447 articles for “Art. 3 mai 2011”
For medical devices to be subject to clinical investigations, the manufacturer must comply with the provisions of Title II of Book I of Part I of this Code.
…e quality control has led to the reporting of a risk of incident as provided for in Article R. 5212-31, the operator shall notify the Director General of the Agence nationale de sécurité du médicament…
…cond quality control carried out on the device in accordance with the provisions of Article R. 5212-30.If, after this second inspection, the expected performance of the device is still not achieved, t…
…n Articles R. 5212-27 and R. 5212-27-1. Each external quality control gives rise to a report on the maintenance of the performance of the device inspected. This report mentions the name of the operato…
…gal representative of health establishments, health cooperation groupings mentioned in article L. 6133-7 and cosmetic surgery establishments shall, after consulting the medical committee of the establ…
For medical devices, the list of which is set by order of the Minister for Health on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé (Fr…
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 data relating to the dispensing of medical devices on the list provided for in Article R. 5212-36. This record includes the following information:-the identification of each medical device: name,…
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