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Master Thesis

Évolution du cadre juridique de la mise sur le marché des dispositifs médicaux dans l'Union Européenne

Abstract : The aim of this thesis is to make an inventory of the regulation of medical devices in France and in the European Union and analyze its evolution to allow to illustrate the contributions of future regulation and highlighting its foreseeable impact. The initial legal framework for the placing on the market of medical devices is being laid by Directive 93/42/EEC. To be placed on the market a medical device must obtain the CE marking which guarantees compliance with the essential requirements of Annex I, the conformity assessment procedure depending on the risk class of the device. Despite the contributions of Directive 2007/47/EC, in particular concerning the clinical evaluation and post-marketing surveillance, the European Commission considered that the regulation of medical devices should be thoroughly revised. The aim of the recast of these directives is to provide a simplified regulatory framework which encourages innovation and competitiveness, and ensuring a high level of security. This has led in 2012 to the publication of the proposal for a Regulation of the European Parliament and of the Council on Medical Devices. The main measures are the establishment of a joint assessment procedure for notified bodies, better control for clinical investigations, the creation of a European database for vigilance and market surveillance, definition of roles and obligations of economic operators, the creation of MDCG and the establishment of a unique European identifier system. This regulation will lead to a major but necessary disruption of the medical devices market impacting economic operators, notified bodies and competent authorities for better patient safety.
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Master Thesis
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Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Friday, January 16, 2015 - 3:05:39 PM
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  • HAL Id : dumas-01104312, version 1



Célia Chadirac. Évolution du cadre juridique de la mise sur le marché des dispositifs médicaux dans l'Union Européenne. Sciences pharmaceutiques. 2014. ⟨dumas-01104312⟩



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