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Showing 6971–6980 of 62891 articles for “Art. 440 al. 1 to 4”
…dical devices or medical devices in class IIb or class III, the manufacturer submits an application to the authorised body for assessment of this quality system, which includes technical documentation…
…he 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 final inspecti…
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…
…the medical devices with an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under…
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 the EC declaration of conformity, a full quality assurance system, the manufacturer must submit to an approved body for verification the quality system which he has set up for the design, manufact…
…duct quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessment of the quality system relating to the final inspection and the…
The medical file referred to in article R. 1112-2 must include:identification of the medical device: name, serial or batch number, name of the manufacturer or its authorised representative; - date of…
Doctors and dental surgeons who use medical devices on the list provided for in Article R. 5212-36, who carry out their activity outside a health or cosmetic surgery establishment, record the data nec…
Standby duty is paid at least once a year.
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