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Showing 13441–13450 of 39711 articles for “Art. al. 3”
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…
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.
…EC declaration of conformity ; 2° The EC declaration of conformity, full quality assurance system ; 3° EC type-examination ; 4° EC verification; 5° EC declaration of conformity, production quality ass…
…conditions of preparation and control with regard to the good practices mentioned in article R. 5143-1 ; 3° Checks compliance with the provisions relating to the composition, prescription and adminis…
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.
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…
…to a malfunction or ageing of the device provided that maintenance or calibration is not possible; 3° Have properties making it possible to guarantee the characteristics and performances mentioned in…
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…
…aking his investigations : 1° Certify, in accordance with the procedures defined in Article R. 5211-38 , that the device in question complies with the essential requirements, with the sole exception o…
…grammes and proposing the approval of the groups designated in the first paragraph of article L. 5143-6.
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