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Showing 4421–4430 of 13190 articles for “Art. professional status not enough”
For Class IIa devices, the authorized body must, as part of the assessment of the quality system, assess the technical documentation for at least one representative sample of each device subcategory i…
…ith the essential requirements and indicate, where applicable, the essential requirements that have not been fully met, together with the reasons for this. This declaration must be attached to class I…
…e technical documentation drawn up in application of the EC declaration of conformity procedure and not with an EC type certificate, and with the essential requirements applicable to them. Similarly,…
…pliers or subcontractors to check the manufacturing processes. The decision of the approved body is notified to the manufacturer. It contains the conclusions of the inspection and a reasoned assessmen…
…iers or subcontractors to check the manufacturing processes. The decision of the authorised body is notified to the manufacturer. It contains the conclusions of the inspection and a reasoned assessmen…
In the event of disagreement on the application of the classification rules between the manufacturer of an in vitro diagnostic medical device and an authorised body involved in the conformity assessme…
…technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided that they are not used on sample…
…cturers shall follow the following procedures: 1° For in vitro diagnostic medical devices which are not included in the lists established by the order mentioned in Article R. 5221-6, the EC declaratio…
…conformity assessment procedures only if the procedure corresponding to the category of device does not involve the intervention of an authorised body. Establishments providing care which manufacture…
The provisions of articles R. 5211-25 to R. 5211-29 are applicable to in vitro diagnostic medical devices.
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