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Showing 8721–8730 of 18871 articles for “Art. CA Douai 12-7-2018 n° 18/00485”
As part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examina…
…cond paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211-64, are applicable to authorised bodies for in vitro diagnostic medical devices.
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé : 1° of any modification likely to alter the conditions under which autho…
…ea and which have been published in the Official Journal of the European Union: 1° All suspended or cancelled certificates ; 2° On request, of all decisions taken under the procedures defined in this…
…ction 6 of this chapter are valid for five years. They may be renewed for five-year periods on application submitted at a time contractually agreed between the manufacturer and the body. For duly just…
Continuous monitoring is carried out in health establishments comprising one or, exceptionally, several units, if the size of the establishment justifies it, organised to care for patients who, due to…
The implementation of home haemodialysis, as defined in article R. 6123-66, is managed by a healthcare establishment, which holds an authorisation to treat chronic renal failure by means of extrarenal…
The continuous surveillance unit may operate in a health care establishment that has neither a resuscitation unit nor an intensive care unit if it has signed an agreement specifying the conditions for…
The managing health care establishment provides appropriate training for the patient and the third party who will assist him, either in a haemodialysis centre, in a medical dialysis unit or in an inde…
The provisions of article R. 6152-73 are applicable to assistants.
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