Article R5211-57-1
The General Director of the Agence nationale de sécurité du médicament et des produits de santé regularly checks that the authorised body has the required skills and up-to-date knowledge of the medica…
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Showing 3801–3810 of 13190 articles for “Art. professional status not enough”
The General Director of the Agence nationale de sécurité du médicament et des produits de santé regularly checks that the authorised body has the required skills and up-to-date knowledge of the medica…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…
The approved body may require the manufacturer to provide any information and to carry out any test or assessment necessary for it to carry out the verifications for which it is responsible.
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have be…
…enting Regulation (EU) No 920/2013 of 24 September 2013 on the designation and monitoring of bodies notified under Council Directive 90/385/EEC concerning active implantable medical devices and Counci…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of any change likely to alter the conditions under which authorisation ha…
…ector and the personnel responsible for carrying out the assessment and verification operations may not be the designer, manufacturer, supplier, installer or user of the devices they inspect, nor the…
The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) shall carry out surveillance and ongoing monitoring of…
The provisions of this Title apply to the medical devices defined in Article L. 5211-1. These devices are intended to be used for the purposes of: 1° the diagnosis, prevention, control, treatment or a…
The decisions taken by the approved bodies under the procedures referred to in subsections 5, 6, 8 and 9 of section 6 of this chapter are valid for five years. They may be renewed for five-year period…
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