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Showing 7501–7510 of 14533 articles for “Art. 6 avr. 2005”
As part of the EC declaration of conformity procedure, production quality assurance, for active implantable medical devices or medical devices in class IIb or class III, the manufacturer submits an ap…
As part of the 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 fi…
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…
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture,…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-46 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
As part of the procedure 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…
As part of the procedure for the EC declaration of conformity, product quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessm…
…l 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 manufac…
The in vitro diagnostic medical devices referred to in Article L. 5221-5 may be exempted from conformity assessment procedures only if the procedure corresponding to the category of device does not in…
The provisions of articles R. 5211-25 to R. 5211-29 are applicable to in vitro diagnostic medical devices.
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