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Showing 4261–4270 of 10372 articles for “Art. CE 28-9-2021 n° 439145”
As part of the procedure for the EC declaration of conformity, product quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessm…
Authorisation may only be granted if the holder has access, on site or by agreement, to medical biology tests and labile blood products within a timeframe that is compatible with the safety of treatme…
…cine structures mentioned in article R. 6123-1, including via telehealth. This round-the-clock service may be shared by several authorised sites. In this case, an agreement is drawn up between the aut…
…tivity under medical imaging in neuroradiology, category A, may only be granted if the holder has access to a neurosurgery unit, where applicable by agreement. Authorisation for interventional activit…
…ing in neuroradiology are practised in two categories: 1° Category A comprising solely the performance of mechanical thrombectomy and associated diagnostic procedures in the context of acute ischaemic…
…roradiology, category B. The agreement provides in particular for the sharing of professional practices and the arrangements for connecting information systems, in particular to enable images to be sh…
For interventional neuroradiology treatment of cancerous lesions, the holder of the authorisation to carry out interventional neuroradiology activity must hold the authorisation mentioned in 18° of ar…
Interventional procedures under medical imaging in neuroradiology concern diagnostic and therapeutic procedures relating to the cervico-cerebral and medullo-spinal region and which are performed by en…
Authorisation may only be granted if the holder has a vascular neurology intensive care unit, as referred to in article R. 6123-34-1, on site twenty-four hours a day, seven days a week, and an intensi…
…forecast for the first year. The annual activity mentioned in this article is established by reference to certain procedures mentioned in article R. 6123-107. II - In the event of an exceptional and t…
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