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 8141–8150 of 20314 articles for “Art. CAA Paris 28-5-2013 n° 12PA03642”
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…
Medical devices must be designed and manufactured, taking into account the generally recognised state of the art, in such a way that, when used in accordance with their intended purpose and under the…
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…
For the application of this section, orders issued by the Minister for Health, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, shall spe…
The Director manages the establishment's affairs other than those which fall within the remit of the Board of Directors mentioned in article R. 6147-95. The Director is assisted by a seven-member Exec…
The centre's accounting officer is the Receiver General of Finances for Paris.
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