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Showing 6801–6810 of 47092 articles for “Art. L. 311-4”
A manufacturer and importer of veterinary medicinal products mentioned in 1° and 2° of article R. 5142-1 has one or more quality control departments. This department or these departments are placed un…
As part of the EC declaration of conformity procedure, production quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the…
In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees…
As part of the EC declaration of conformity procedure, production quality assurance, for active implantable medical devices or medical devices in class IIb or class III, the manufacturer submits an ap…
As part of the EC declaration of conformity procedure, product quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the fi…
As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, called a type, of the production envisaged in order that the b…
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…
In an emergency, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may suspend, for a maximum period of three months, the dissemina…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-46 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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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