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Showing 5021–5030 of 12393 articles for “Art. 7 avr. 2010”
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…
The bodies responsible for carrying out the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
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…
In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees…
I.-The approved bodies must comply with the following obligations: 1° The approved body, its director and the personnel responsible for carrying out the assessment and verification operations may not…
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…
As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with…
…body shall examine at least the aspects provided for in point 2.2 of Annex I to Regulation (EU) No 722/2012 of 8 August 2012 on specific requirements as regards the requirements laid down in Council…
If an accredited body ceases to fulfil the conditions or fails to meet the obligations mentioned in Article R. 5211-56, accreditation is suspended or withdrawn by the Director General of the Agence na…
Before examining the application for assessment, the approved body will ensure that the file includes in particular : - the general characteristics of the applicant, such as company name, name, addres…
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