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Showing 7651–7660 of 15170 articles for “Art. 6 mars 2013”
Any person who sterilizes with a view to placing on the market CE-marked medical devices designed by their manufacturer to be sterilized before use or systems or kits referred to in Section 10 of this…
As part of the EC declaration of conformity procedure, production quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the…
Within the framework of the EC declaration of conformity procedure, product quality assurance, for class II a medical devices or class I medical devices, the provisions laid down in Article R. 5211-49…
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…
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