Article R5211-25
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…
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Showing 3791–3800 of 12461 articles for “Art. legal committee”
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…
…the importer, distributor or exporter of in vitro diagnostic medical devices. The same natural or legal person may declare several activities. The manufacturer or its authorised representative is no…
…on the European Economic Area, with a view to placing it on the market; 9° Importer: any natural or legal person established in a Member State of the European Union or party to the Agreement on the Eu…
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.
On pain of being unenforceable against third parties, the legal representative of the company must notify the president of each council of the order to which it belongs, by any means that provides pro…
…pursuant to Article L. 6223-1, including those formed by way of merger, demerger or a change in the legal form of the company.
A company operating a medical biology laboratory is formed under the suspensive condition of its registration on the roll of the Order of Physicians, where at least one medical biologist holds a fract…
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