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Showing 8261–8270 of 33456 articles for “Art. al. 3”
…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…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may give formal notice to any operator of a medical device subject to the quality control provided for i…
The decisions taken by the approved bodies under the procedures referred to in sub-sections 4, 5 and 6 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods…
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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