Article R5211-23-2
Before applying for the issue of the EC design examination certificate or EC type examination certificate referred to in Articles R. 5211-40 and R. 5211-41 respectively, manufacturers of medical devic…
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Showing 8861–8870 of 31891 articles for “Art. Cass. ass. plén. 17-5-2002 n° 488 P”
Before applying for the issue of the EC design examination certificate or EC type examination certificate referred to in Articles R. 5211-40 and R. 5211-41 respectively, manufacturers of medical devic…
The manufacturer is required to update the risk analysis and management system referred to in Article R. 5211-23-2 by analysing all elements relating to the medical devices he manufactures and taking…
…erally recognised state of the art, in such a way that, when used in accordance with their intended purpose and under the conditions laid down for that purpose, they do not compromise, directly or ind…
Medical devices and active implantable medical devices manufactured from non-viable tissues of animal origin or non-viable products derived from tissues of animal origin, falling within the scope defi…
The conditions for implementing the essential requirements defined in this section are specified, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produ…
The provisions of article R. 5211-21 are applicable to in vitro diagnostic medical devices.
In order to comply with the requirements relating to design and manufacture, in vitro diagnostic medical devices are designed, manufactured and packaged in such a way as to meet the following objectiv…
…a seven-member Executive Board, which he chairs and which includes, in addition to himself : 1° The president of the establishment's medical commission, vice-president ; 2° The chairman of the nursing…
The centre's accounting officer is the Receiver General of Finances for Paris.
The centre has a social committee. It comprises : 1° The director of the establishment, represented, where applicable, by the director of social life and integration ; 2° The heads of the establishmen…
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