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Showing 5111–5120 of 55767 articles for “Art. 6 §1”
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…
A custom-made device is any medical device manufactured specifically in accordance with the written prescription of a duly qualified practitioner, or any other person who is authorised to do so by vir…
…France and who carries out one of the activities mentioned in Article R. 5211-52 or Article R. 5211-67 must make a declaration to the Agence nationale de sécurité du médicament et des produits de sant…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail sends a warning to the company in question, together with the inspection report o…
Where the authorised body encounters difficulties in implementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicam…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform without delay of any incident or risk of incident defined in Article L. 5212-2:the Etabliss…
The Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé may require the communication of all information essential for checking the accuracy of the advertised c…
The Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé may require the communication of all information essential for checking the accuracy of the advertised c…
The provisions of article R. 6111-53 apply to the arrangements for informing and obtaining the consent of pregnant women who are offered the accommodation referred to in this section.
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