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Showing 3551–3560 of 47923 articles for “Art. R 134-3”
As part of the EC declaration of conformity procedure, the manufacturer shall draw up technical documentation making it possible to assess the conformity of the medical device with the essential requi…
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.
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…
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…
The legal 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…
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 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…
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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