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Showing 6111–6120 of 24448 articles for “Art. 4 Dec 2018”
…ied cases, on the premises of suppliers or subcontractors to check the manufacturing processes. The decision of the authorised body is notified to the manufacturer. It contains the conclusions of the…
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…
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…
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