Le dispositif médical à la recherche d’un nouveau cadre juridique

Abstract : From artificial heart to bandage through implants, corrective lenses, wheelchairs or radiology devices, the concept of medical device covers a wide range of products having in common their medical purpose and their action which is not obtained by pharmacological, immunological or metabolic means. Medical devices were regulated in the 1990s by directives based on the principles of the new approach (definition of essential requirements and reference to technical harmonization, important role for professional actors and limited role for public authorities, evaluation of the conformity of products by notified bodies and absence of marketing authorization). Despite the advantages of their flexibility, these directives have only partially succeeded in guaranteeing the safety of medical devices, as underlined in the circumstances of PIP implants scandal: limited clinical evaluation, information and traceability of products, limited control by and on notified bodies, lack of coordination between authorities, etc. To strengthen the safety of European medical devices, rather than transposing the legal framework of medicinal products or American medical devices, a custom-made legal framework, adapted to their varying level of risk, is to be considered. This is what the upcoming regulations put forward.
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Déborah Eskenazy. Le dispositif médical à la recherche d’un nouveau cadre juridique. Droit. Université du Droit et de la Santé - Lille II, 2016. Français. ⟨NNT : 2016LIL20014⟩. ⟨tel-01461616⟩

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