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Showing 7591–7600 of 15061 articles for “Art. 6 mars 2012”
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.
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 manufacturer may instruct his authorised representative to initiate the procedures mentioned in 1°, 2°, 4° and 5° of article R. 5221-19.
…aration of conformity, full quality assurance system; 4° EC type examination ; 5° EC verification ; 6° EC declaration of conformity, production quality assurance.
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…
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