Article R5213-3
The information contained in each advertisement must be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the m…
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Showing 8291–8300 of 33667 articles for “Art. 3 déc. 2020”
The information contained in each advertisement must be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the m…
At the operator's request, 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 giv…
…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…
…al investigations, in particular the report on clinical investigations mentioned in Article R. 5211-37 and the information listed in Article R. 5211-38, as well as access to information relating to th…
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,…
…orted in accordance with the same article, accompanied by the report referred to in article R. 5212-30, if the device has undergone external quality control. A copy of the report is sent to the Direct…
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