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Showing 7241–7250 of 14914 articles for “Art. 6 mars 1996”
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…
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…
As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with…
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…
Files and correspondence relating to certification procedures are drawn up in French or in a language of a Member State of the European Union or party to the Agreement on the European Economic Area ac…
The manufacturer may instruct his authorised representative to initiate the following procedures: 1° Declaration relating to medical devices to be the subject of clinical investigations ; 2° EC declar…
For the purposes of placing medical devices other than active implantable medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the man…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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