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Showing 2051–2060 of 51062 articles for “Art. II-6°”
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I. - The articles R. 5211-13 to R. 5211-15, with the exception of its first paragraph, article R. 5211-18 and article R. 5211-18-1 are applicable in French Polynesia subject to the adaptations provide…
For medical devices other than those subject to clinical investigations, the certification procedures mentioned in Article R. 5211-14 are as follows: 1° The EC declaration of conformity ; 2° The EC de…
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.
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…
In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees…
The documents mentioned in article R. 5211-26 shall be presented by the manufacturer or his authorised representative at the request of the agents mentioned in article L. 5431-1.
In carrying out certification procedures, manufacturers and approved bodies shall take account of the available results of any assessment and verification operations which may have been carried out, p…
An order of the Minister for Health, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, specifies the conditions for applying th…
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