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Showing 6941–6950 of 38200 articles for “Art. R. 210-6”
…er 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 declaration of conformity…
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.
…m-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 sécurité du médicament et des produits d…
…heck the manufacturing processes. The decision of the authorised body is notified to the manufacturer. It contains the conclusions of the inspection and a reasoned assessment. In all cases, the approv…
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…
…et des produits de santé, specifies the conditions for applying the procedures defined in Articles R. 5211-37 to R. 5211-52.
The manufacturer or his authorised representative shall, for a period of at least five years and, in the case of implantable devices, at least fifteen years after the last copy of the product has been…
…evices with 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 condition…
For the purposes of placing active implantable medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the manufacturer shall follow the…
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