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Showing 4301–4310 of 62496 articles for “Art. Cass. 3e civ. 19 December 1983 · Cass. 3e civ. 2 October 2002 · Cass. 3e civ. 3 May 2006”
For medical devices to be subject to clinical investigations, the manufacturer must comply with the provisions of Title II of Book I of Part I of this Code.
…de medical device on the market, the manufacturer shall follow the procedure defined in Article R. 5211-51. The Director General of the Agence nationale de sécurité du médicament et des produits de sa…
…he manufacturer shall draw up a declaration containing the information referred to in Articles R. 1123-37 to R. 1123-41 and certifying that the medical device concerned complies with the essential req…
…l follow the following procedures: 1° EC declaration of conformity, full quality assurance system ; 2° EC type examination, combined with EC verification; 3° EC type-examination, combined with EC decl…
The manufacturer may instruct his authorised representative to initiate the following procedures: 1° Declaration relating to medical devices to be the subject of clinical investigations ; 2° EC declar…
…ollows the following procedures: 1° For class I medical devices, the EC declaration of conformity ; 2° For class II medical devices a choice of : a) the EC declaration of conformity, complete quality…
Critical care is carried out in the following two ways: 1° Adult critical care; 2° Paediatric critical care.
…present one or more acute failures directly threatening the vital or functional prognosis and which may require the use of one or more methods of substitution.
I. - Authorisation for entries 1° and 2° under the adult critical care modality may only be granted if the holder has at his disposal twenty-four hours a day, every day of the year: a) On site, full-t…
I.-The 4° adult critical care authorisation may only be granted if the holder has an on-site medical unit dedicated to vascular neurology activities. II.-The holder has on-site access, or access under…
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