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Showing 5041–5050 of 53957 articles for “Art. R. 1334-29-2”
As part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examina…
The operator must ensure that the maintenance and quality controls required for the medical devices it operates are carried out. Maintenance is carried out either by the manufacturer or under his resp…
The Agence nationale de sécurité du médicament et des produits de santé submits to its control a sample of each batch of the substance which, if used separately from the medical device in which it is…
In application of Article L. 5212-1, the list of medical devices subject to compulsory maintenance, the list of medical devices subject to internal quality control and the list of medical devices subj…
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the d…
Where an in vitro diagnostic medical device forms an inseparable unit with a device which, if used separately, could be considered to be a medical device within the meaning of Article L. 5211-1 and wh…
…vitro diagnostic medical device with the essential requirements set out in Section 5 of this Chapter. He shall specify the principles for ensuring the quality of his production and guarantee that his…
…ese examinations and tests are carried out is agreed between the authorized body and the manufacturer. Where the type meets the essential requirements, the authorised body issues the applicant with an…
The Agency's inspectors shall carry out inspections as decided by the Agency's Director General, who shall issue a letter of assignment to the inspector in charge of the investigation. This letter spe…
On the basis of a contract that complies with good hospital pharmacy practice, the principles of which are laid down by order of the Minister for Health, and after obtaining the opinion of the regiona…
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