Article R5211-33
…table medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the manufacturer shall follow the following procedures: 1° EC declaration o…
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Showing 3841–3850 of 66606 articles for “Art. 1186 al. 2 and 3”
…table medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the manufacturer shall follow the following procedures: 1° EC declaration o…
…ocedures: 1° Declaration relating to medical devices to be the subject of clinical investigations ; 2° EC declaration of conformity ; 3° EC type-examination ; 4° EC verification ; 5° Declaration relat…
…table medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the manufacturer follows the following procedures: 1° For class I medical d…
Critical care is carried out in the following two ways: 1° Adult critical care; 2° Paediatric critical care.
…likely to 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…
…agreement, access to: a) A medical imaging centre on site allowing cerebral explorations by scanner and MRI to be carried out within a timeframe compatible with the imperatives of care safety, twenty-…
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…
…e 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 their state of health per…
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…
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