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Showing 6541–6550 of 57142 articles for “Art. Loi 2019-744 of 19-7-2019”
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…
…ecisions 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 periods on…
…ns mentioned in Article R. 5211-56, accreditation is suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after the head of the bo…
…the approved body will ensure that the file includes in particular : - the general characteristics of the applicant, such as company name, name, address, legal status ; - a precise description of the…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall decide on the application within seven months of the date of receipt of the complete file. Failing…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
…mplementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicament et des produits de santé for specific recommendati…
…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 sécurité du médicament et des produits de santé p…
As part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examina…
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…
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