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Showing 6121–6130 of 24499 articles for “Art. 4 Dec 2013”
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…
The official veterinarians mentioned in 3° of article L. 5146-2, sworn in under the conditions defined in article R. 205-1 of the rural and maritime fishing code and authorised to investigate and reco…
…may act on the human body by means of an action ancillary to that of the device, before taking its decision, the authorised body obtains the opinion of the Agence nationale de sécurité du médicament…
…ith an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under the conditions descri…
…s, the dissemination of advertising which is manifestly contrary to the provisions of articles R. 5141-82 to R. 5141-88.
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…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 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…
…ilance.After analysing the information gathered, the Director General takes, where appropriate, the decisions provided for in Articles L. 5312-1 to L. 5312-3.
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