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Showing 8991–9000 of 34678 articles for “Art. CE 27-3-2020 n° 428234”
…f presentation of the declaration are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health…
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…
…ete to enable, as appropriate, the general public to understand the intended use of the medical device and professionals to appreciate the characteristics and performance of the medical device. Quotat…
…ing the medical committee of the establishment mentioned inarticle L. 6144-2 or the medical conference of the establishment mentioned inarticle L. 6111-2, lay down the written procedure by which the d…
The exercise of material vigilance may involve, in addition to the communication by the manufacturer of the documents mentioned in Article R. 5211-26, access to data in the pre-clinical experimental f…
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…
The provisions of Section 7 of Chapter I of Title I of this Book, with the exception of Article R. 5211-54, the second paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211…
The approved body shall inform the other approved bodies in France or in the other Member States of the European Union or parties to the Agreement on the European Economic Area and which have been pub…
Each user department of a medical device on the list provided for in Article R. 5212-36 completes the information mentioned in Article R. 5212-38 by recording:-the date of use ;the identification of t…
…vision of a healthcare professional, records all the data relating to the dispensing of medical devices on the list provided for in Article R. 5212-36. This record includes the following information:-…
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