French Public Health CodeIn force
Subsection 1: Common provisions.
Article R5221-18
The provisions of articles R. 5211-25 to R. 5211-29 are applicable to in vitro diagnostic medical devices.
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Showing 9261–9270 of 67137 articles for “Art. L. 145-11 + Art. R. 145-1”
The provisions of articles R. 5211-25 to R. 5211-29 are applicable to in vitro diagnostic medical devices.
Advertising to the public for a 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 a medical device;2° Specify…
…nown as reactovigilance, is to monitor incidents and risks of incidents as defined in 1° of article R. 5222-2. It is carried out on all in vitro diagnostic medical devices after they have been placed…
…ums, objects or products of any kind or direct or indirect material advantages of any kind whatsoever.
…ent, an inter-hospital 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 o…
…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 list of designated inspectors is…
…using in vitro diagnostic 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 co…
…rise and process in computerised form the data contained in the medical file referred to in article L. 1112-1 which is collected, for each patient, by the practitioner in charge of the medical or medi…
…nsmitted by the doctor responsible for medical information under the conditions laid down inarticle R. 6113-8, the representative of the establishment or, for care activities jointly operated by a hea…
…ms 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 identify it, analyse its causes, mitigate or eliminate…
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