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Showing 7791–7800 of 68083 articles for “Art. R 581-65 and R 581-65-1”
If the quality control has led to the reporting of a risk of incident as provided for in Article R. 5212-31, the operator shall notify the Director General of the Agence nationale de sécurité du médic…
In the case of external quality control, the return to conformity of the devices is certified by the compliant results of a second quality control carried out on the device in accordance with the prov…
I.-Local materiovigilance correspondents are responsible for: 1° Forwarding without delay, with the exception of the reports mentioned in b, to the Director General of the Agence nationale de sécurité…
At the operator's request, the accredited bodies carry out the inspections in accordance with the specific provisions set out in Articles R. 5212-27 and R. 5212-27-1. Each external quality control giv…
The operator must ensure that the maintenance and quality controls required for the medical devices it operates are carried out. Maintenance is carried out either by the manufacturer or under his resp…
I.-For the medical devices mentioned in article R. 5212-26, the operator is required :1° Keep a regularly updated inventory of the devices it operates, mentioning for each of them the common and comme…
The Agence nationale de sécurité du médicament et des produits de santé submits to its control a sample of each batch of the substance which, if used separately from the medical device in which it is…
In application of Article L. 5212-1, the list of medical devices subject to compulsory maintenance, the list of medical devices subject to internal quality control and the list of medical devices subj…
For the devices mentioned in Article R. 5212-26, with the exception of those used during exposure to ionising radiation, subject to internal or external quality control, the Director General of the Ag…
When informed of one of the events mentioned in Article L. 5212-2, the Director of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Med…
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