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Showing 4281–4290 of 14378 articles for “Art. 815-6”
A natural or legal person who assembles devices bearing the CE marking, in accordance with their intended purpose and within the limits of use laid down by their manufacturers, in order to place them…
A custom-made device is any medical device manufactured specifically in accordance with the written prescription of a duly qualified practitioner, or any other person who is authorised to do so by vir…
When medicated feed is supplied to a distributor or breeder in closed packaging or containers, the way in which the packaging or containers are closed prevents them from being reused after opening.
When advertising in favour of a veterinary pharmaceutical company or establishment mentions a veterinary medicinal product, it is governed by the provisions of Section 8 of Chapter I of this Title. Th…
The medical devices which must be notified in accordance with Article L. 5211-4 are class IIa, IIb and III medical devices and active implantable medical devices. The communication is made to the Dire…
Any manufacturer having its registered office in France and who, in any Member State of the European Union or party to the Agreement on the European Economic Area, places class I medical devices or cu…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail sends a warning to the company in question, together with the inspection report o…
Where the authorised body encounters difficulties in implementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicam…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform without delay of any incident or risk of incident defined in Article L. 5212-2:the Etabliss…
In vitro diagnostic medical devices, other than in vitro diagnostic medical devices undergoing performance evaluation, are classified in two categories: 1° In vitro diagnostic medical devices whose re…
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