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Showing 7391–7400 of 18228 articles for “Art. 5° ter”
…s: 1° To have chemical, physical and biological properties which enable them to guarantee the characteristics and performance referred to in Article R. 5211-21, to reduce as far as possible the risks…
…alysis and management system, defined by the manufacturer for each medical device, evaluates the latter according to criteria relating to the need to use tissues or products derived from animal origin…
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…
…d attested by a certificate of conformity in accordance with the legislative provisions of this chapter.A secondary and undesirable effect is permissible only if it presents an acceptable risk in rela…
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…
…al 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.
…jectives: 1° To have chemical and physical properties which make it possible to guarantee the characteristics and performance referred to in Article R. 5221-15 and to reduce as far as possible the ris…
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…
…ial Life and Integration; 4° The head of the supervisory staff of the establishment's social units; 5° A member of the medical, pharmaceutical, odontological and midwifery professions appointed by the…
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