Article R5211-64
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…
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Showing 4921–4930 of 16327 articles for “Art. CA Paris 28-6-1994”
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…
…manufacturers' instructions, it is considered to be a device in its own right subject to the certification procedures.
…and kits are accompanied by the information mentioned in Article R. 5211-22, including, where applicable, the information supplied by the manufacturers of the devices that have been assembled. They d…
The approved body may require the manufacturer to provide any information and to carry out any test or assessment necessary for it to carry out the verifications for which it is responsible.
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have be…
…it and provided users with information containing the relevant manufacturers' instructions; 3° have carried out all these operations using appropriate methods. This declaration is kept at the disposal…
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…
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