Article R5211-31
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…
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Showing 2351–2360 of 57851 articles for “Art. Cass. 3e Civ. 3-2-1988 n° 86-16.158”
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…
For the purposes of placing medical devices other than active implantable medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the man…
Critical care is carried out in the following two ways: 1° Adult critical care; 2° Paediatric critical care.
The critical care activity consists of the management of patients who present or are likely to present one or more acute failures directly threatening the vital or functional prognosis and which may r…
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…
I. - Authorisation for 3° under the adult critical care modality may only be granted if the holder has a medical unit on site dedicated to cardiology activities. II.- The holder has, on site or by agr…
I. - The holder of the authorisation provides round-the-clock care, every day of the year, for the reception, diagnostic and therapeutic management, monitoring and transfer of patients as soon as thei…
Notwithstanding article R. 8293-2, when the seconded employee is employed by a temporary employment undertaking established outside France, the declaration is made by the undertaking using the seconde…
The employer or, where applicable, the user undertaking of a temporary employee on secondment shall inform the union of funds mentioned in article R. 8291-2 within twenty-four hours of any change rela…
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