Voté au Parlement européen en avril 2017 puis publié le 5 mai au Journal officiel de l’Union européenne, le règlement européen 2017/745 sur les dispositifs médicaux (DM) introduit de nombreuses modifications pour toute la chaîne de fabrication et de distribution. Il vient remplacer les directives 90/385/CEE et 93/42/CEE et entrera en application en mai 2020.
Parmi les principales modifications concernant tout le secteur, Pascale Cousin, directrice des affaires technico-réglementaires du
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","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","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"]}