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Showing 5011–5020 of 12493 articles for “Art. 7 févr. 2019”
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…
…isation procedure shall be conducted in accordance with the conditions laid down in paragraphs 2 to 7 of Article 3 of Implementing Regulation (EU) No 920/2013.Authorisation shall be granted taking int…
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…
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 bodies responsible for implementing 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…
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…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé : 1° of any modification likely to alter the conditions under which autho…
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…
The decisions taken by the approved bodies under the procedures referred to in sub-sections 4, 5 and 6 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods…
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