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 2531–2540 of 52210 articles for “Art. al. 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…
…s 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 articles R. 5211-1 to R. 5211-3. It is carried out on me…
…cal 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 all in vitro diagnostic medical devices after they hav…
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…
…gence 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 publ…
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…
…e 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 medico-…
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