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Showing 13401–13410 of 39711 articles for “Art. al. 3”
…s advertised, together with the characteristics and performance claimed in respect of that purpose; 3° The class of the medical device; 4° Where applicable, the name of the authorised body which carri…
For medical devices, the list of which is set by order of the Minister for Health on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé (Fr…
…er healthcare professionals working in one of the establishments mentioned in 4° of Article R. 5222-3 or in a blood transfusion establishment immediately report to the local reactovigilance correspond…
In an emergency, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the authorisation of an advertisement for a maximum period of three months.
…gal representative of health establishments, health cooperation groupings mentioned in article L. 6133-7 and cosmetic surgery establishments shall, after consulting the medical committee of the establ…
…ply when: 1° The second-hand medical device is sold to a medical device manufacturer, as defined in 3° of Article R. 5211-4, unless the latter expressly requests this from the reseller; 2° The second-…
Every manufacturer of medical devices, or its authorised representative, appoints a material vigilance correspondent and communicates his name to the Director General of the Agence nationale de sécuri…
The certificate is issued by the person responsible for transferring the second-hand medical device to the transferee.
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 declaration provided for in article L. 5221-3 is made by the manufacturer or his authorised representative, the importer, distributor or exporter of in vitro diagnostic medical devices. The same n…
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