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Showing 4891–4900 of 53949 articles for “Art. R 224-2”
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…
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…
As part of the EC declaration of conformity procedure, the manufacturer shall draw up technical documentation making it possible to assess the conformity of the in vitro diagnostic medical device with…
I.-External quality control of medical devices is carried out by bodies accredited for this purpose by the Comité français d'accréditation or by any other accreditation body which is a signatory to a…
As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, known as the type, of the production envisaged in order that t…
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