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Showing 7961–7970 of 19750 articles for “Art. CE 25-5-1988 n° 81512”
In order to comply with the essential requirements relating to design and manufacture, medical devices, other than active implantable devices, must be designed, manufactured and packaged in such a way…
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…
…nt system referred to in Article R. 5211-23-2 by analysing all elements relating to the medical devices he manufactures and taking account of public information relating to similar medical devices. Th…
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…
…uirements defined in this section are specified, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health…
The provisions of article R. 5211-21 are applicable to in vitro diagnostic medical devices.
…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 objectives: 1° To…
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…
…ch includes, in addition to himself : 1° The president of the establishment's medical commission, vice-president ; 2° The chairman of the nursing, re-education and medico-technical care committee; 3°…
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