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Showing 9801–9810 of 29733 articles for “Art. CE 8-4-2022 n° 447694”
The establishments referred to in article R. 5142-1 shall take all necessary measures to ensure that veterinary medicinal products are transported and delivered under conditions which guarantee their…
…manufacture and deliver comply with the characteristics to which they must conform and that the necessary controls have been carried out. Manufacturers of veterinary medicinal products which are the…
…R. 5142-1 has one or more quality control departments. This department or these departments are placed under the authority of a suitably qualified person who is hierarchically independent of the othe…
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, product quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the fi…
…ticle R. 205-1 of the rural and maritime fishing code and authorised to investigate and record offences provided for and punished by the provisions of title III of book II of the same code, are also a…
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. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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