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Showing 4051–4060 of 13190 articles for “Art. professional status not enough”
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…
…technical documentation drawn up in application of the EC declaration of conformity procedure, and not with an EC type certificate, and with the essential requirements applicable to them. In the same…
Where the conformity certification procedure applied by a manufacturer involves the intervention of an authorized body, the manufacturer may apply to the body of his choice within the framework of the…
The content and methods of presentation of the declaration are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order o…
…r legal person may declare several activities. The manufacturer or its authorised representative is not required to declare itself as an importer or distributor for the in vitro diagnostic medical dev…
…a sample; 2° Specimen receptacle, any in vitro diagnostic medical device, whether vacuum-formed or not, primarily intended by its manufacturer to receive directly the specimen from the human body and…
Manufacturers who place in vitro diagnostic medical devices on the French market and who do not have their registered office on the territory of a Member State of the European Union or a party to the…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé is notified of any changes to the information contained in the declaration.
The definitions given in 1°, 3°, 4° and 5° of Article R. 5211-4 are applicable to in vitro diagnostic medical devices.
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