Article R5211-38
As part of the procedure applicable to medical devices undergoing clinical investigations, the manufacturer shall draw up a declaration containing the information referred to in Articles R. 1123-37 to…
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Showing 7851–7860 of 15170 articles for “Art. 6 mars 2013”
As part of the procedure applicable to medical devices undergoing clinical investigations, the manufacturer shall draw up a declaration containing the information referred to in Articles R. 1123-37 to…
Implantable medical devices, active implantable medical devices and class III devices must be subject to clinical investigations, unless the use of existing clinical data can be duly justified.
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the d…
…consult the competent authorities within the meaning of Article 4(1)(40) of Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 or, where applicable, within the…
…ding resulting from the decreeD. 214-187-1n° 2014-87 of 30 January 2014D. 214-188 and D. 214-195no. 2013-687 of 25 July 2013D. 214-202-1n° 2014-87 of 30 January 2014D. 214-206-1 and D. 214-206-2n° 201…
In the light of the certificate provided by the couple or the unmarried woman of the pre-implantation diagnosis, one of the practitioners of the multidisciplinary clinical-biological medical team obta…
…y issue in compliance with the provisions of this section and Article 129 of Regulation (EU) No 575/2013 of 26 June 2013. The conditions for application of this article are specified by order of the M…
[Provisions declared unconstitutional by Constitutional Council decision no. 2004-492 DC of 2 March 2004.] [Provisions declared unconstitutional by Constitutional Council decision no. 2004-492 DC of 2…
…livre Ier à l'exception des articles R. 133-1, R. 133-2 (4°) et R. 135-1 à R. 135-4;L'article R. 136-1 est applicable dans sa rédaction résultant du décret n° 2021-1369 du 20 octobre 2021;L'articles…
I. - This paragraph applies, subject to the conditions laid down in Article 6 of Directive 2002/14/EC of 11 March 2002:1° To one or more AIFs managed by the same management company which, either separ…
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