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Showing 7061–7070 of 38200 articles for “Art. R. 210-6”
…heck the manufacturing processes. The decision of the authorised body is notified to the manufacturer. It contains the conclusions of the inspection and a reasoned assessment.In all cases, the approve…
…c medical devices which are not included in the lists established by the order mentioned in Article R. 5221-6, the EC declaration of conformity; in the case of devices intended for self-diagnosis, the…
…vided for in Article L. 5221-5 are subject to the provisions of the first two paragraphs of Article R. 5221-28.
The provisions of articles R. 5211-25 to R. 5211-29 are applicable to in vitro diagnostic medical devices.
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…
…his authorised representative to initiate the procedures mentioned in 1°, 2°, 4° and 5° of article R. 5221-19.
The conformity of in vitro diagnostic medical devices with the essential health and safety requirements is assessed by carrying out one or more of the following procedures: 1° The procedure applicable…
…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…
…et des produits de santé, specifies the conditions for applying the procedures defined in Articles R. 5221-23 to R. 5221-28.
…le L. 1234-2 or article L. 1243-6 of the present code or of the activity mentioned in 8° of article R. 6122-25 and which combines the transplantation of organs or parts of organs, tissues or vasculari…
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