Article R5222-1
The purpose of vigilance of in vitro diagnostic medical devices, known as reactovigilance, is to monitor incidents and risks of incidents as defined in 1° of article R. 5222-2. It is carried out on al…
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Showing 5241–5250 of 59199 articles for “Art. 1845 to 1870-1”
The purpose of vigilance of in vitro diagnostic medical devices, known as reactovigilance, is to monitor incidents and risks of incidents as defined in 1° of article R. 5222-2. It is carried out on al…
Advertising to the public for an in vitro diagnostic medical device: 1° Is designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as an in v…
…spital syndicate, a health cooperation group or an association mentioned in article R. 5212-12, not to appoint a local material vigilance correspondent or not to communicate the name of this local cor…
The equipment and services referred to in article L. 5232-3 may only be supplied by service providers and equipment distributors who have competent staff according to the type of equipment or service…
Designation as an inspector of the Agence nationale de sécurité du médicament et des produits de santé, as provided for in Article L. 5313-1, is the subject of a decision by the Director General.The l…
…iagnostic medical devices or a blood transfusion establishment mentioned in article R. 5222-10, not to appoint a reactovigilance correspondent or not to communicate the name of this correspondent to t…
In order to analyse their medical activity, public and private health care institutions shall, in accordance with the conditions laid down in this section, summarise and process in computerised form t…
…the basis of and within the limits of the data supplied by practitioners and transmitted by the doctor responsible for medical information under the conditions laid down inarticle R. 6113-8, the repr…
Each health care organisation has access, at the request of its representative, to information concerning it, derived from the data it has transmitted in application ofarticle R. 6113-10, which is hel…
The management of risks associated with healthcare aims to prevent the occurrence of undesirable events associated with healthcare as defined in article R. 1413-66-1 and, if such an event occurs, to i…
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