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Showing 11361–11370 of 38939 articles for “Art. al. 4”
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-46 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
…s, the dissemination of advertising which is manifestly contrary to the provisions of articles R. 5141-82 to R. 5141-88.
…nce with the formal notice at the end of the period prescribed in application of II of Article R. 5145-2 and where the observations presented are not satisfactory, the Director General of the Agency m…
…l products, including the extemporaneous preparation of medicated feed provided for in article L. 5143-3, is carried out in accordance with good practice, the principles of which are defined, on a pro…
…of the EC declaration of conformity procedure referred to in the first paragraph of Article R. 5211-40 and the EC type-examination procedure referred to in the first paragraph of Article R. 5211-41, i…
The financial penalties and daily fines provided for in Article L. 5145-5 are recovered by the accounting officer of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et…
…the medicated feed extemporaneously in accordance with the good practices mentioned in article R. 5143-1. Medicated feed may only be prepared extemporaneously from a single medicated premix. However,…
…ith an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under the conditions descri…
As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, called a type, of the production envisaged in order that the b…
The CE marking may be affixed to a medical device only if it complies with the essential health and safety requirements referred to in Section 5 of this Chapter and has undergone the certification pro…
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