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Showing 8281–8290 of 33886 articles for “Art. 3 juin 2004”
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.
For the purposes of placing a custom-made medical device on the market, the manufacturer shall follow the procedure defined in Article R. 5211-51. The Director General of the Agence nationale de sécur…
…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…
The content and methods of presentation of the declaration are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order o…
…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…
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…
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