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Showing 7191–7200 of 14413 articles for “Art. 6 Dec 1977”
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.
…he devices it has produced and which have been put into service on French territory, as well as the declarations and documentation relating to these devices.
…ied cases, on the premises of suppliers or subcontractors to check the manufacturing processes. The decision of the authorised body is notified to the manufacturer. It contains the conclusions of the…
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 Director General of the Agence nationale de sécurité du médicament et des produits de santé the declarations of conformity and technical documentation which he has drawn up as part of the procedur…
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…
…vestigations and custom-made devices, the manufacturer shall follow the following procedures: 1° EC declaration of conformity, full quality assurance system ; 2° EC type examination, combined with EC…
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…
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