Article R5212-1
The purpose of materiovigilance is to monitor incidents or risks of incidents resulting from the use of medical devices which are defined in article L. 5211-1 and come under this title by virtue of ar…
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Showing 2551–2560 of 52210 articles for “Art. 2332-1°”
The purpose of materiovigilance is to monitor incidents or risks of incidents resulting from the use of medical devices which are defined in article L. 5211-1 and come under this title by virtue of ar…
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…
The following is punishable by the fine laid down for fifth class offences: 1° For a health establishment, an inter-hospital syndicate, a health cooperation group or an association mentioned in articl…
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…
The following is punishable by a fifth-class fine: 1° For a healthcare establishment, an interhospital syndicate, a health cooperation grouping using in vitro diagnostic medical devices or a blood tra…
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…
On 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 re…
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…
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