Article R5211-60
…out any test or assessment necessary for it to carry out the verifications for which it is responsible.
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Showing 4601–4610 of 42566 articles for “Art. L 152-6”
…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…
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…
…in any Member State of the European Union or party to the Agreement on the European Economic Area, places class I medical devices or custom-made medical devices on the market in its own name, shall ma…
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…
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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