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Showing 3901–3910 of 12461 articles for “Art. legal committee”
The labelling of a medical device given to the end user or patient, the accompanying leaflet and any other information relating to its operation or use must include a version written in French.
The bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
The provisions of this Title apply to in vitro diagnostic medical devices as defined in Article L. 5221-1.
The provisions of Section 7 of Chapter I of Title I of this Book, with the exception of Article R. 5211-54, the second paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé : 1° of any modification likely to alter the conditions under which autho…
The approved body shall inform the other approved bodies in France or in the other Member States of the European Union or parties to the Agreement on the European Economic Area and which have been pub…
Where an in vitro diagnostic medical device forms an inseparable unit with a device which, if used separately, could be considered to be a medical device within the meaning of Article L. 5211-1 and wh…
The provisions of this Title do not apply to: 1° Instruments, apparatus, equipment, materials or other articles, including software, intended to be used for research purposes without pursuing medical…
The decisions taken by the approved bodies under the procedures referred to in sub-sections 4, 5 and 6 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods…
Registration of the company in the Trade and Companies Register is governed by articles R. 123-31 et seq. of the Commercial Code, subject to the provisions of this article. The joint representative re…
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