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Showing 2111–2120 of 54342 articles for “Art. 1186 al. 2–3”
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.
For the purposes of placing a custom-made 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 sécur…
As part of the procedure applicable to medical devices undergoing clinical investigations, the manufacturer shall draw up a declaration containing the information referred to in Articles R. 1123-37 to…
For the purposes of placing active implantable medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the manufacturer shall follow the…
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…
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