MEDDEV 2.7/1 révision 4 et Réglement Européen : une révolution au royaume de l’évaluation clinique ?
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MEDDEV 2.7/1 révision 4 et Réglement Européen : une révolution au royaume de l’évaluation clinique ?
En parallèle du nouveau règlement (EU MDR), la publication en juin 2016 du guide MEDDEV 2.7/1 révision 4 n’aura échappé à personne. Celle-ci réitère l’essentiel des exigences de la directive européenne 93/42 amendée 2007/47, mais s’aligne aussi sur le projet de règlement européen (proposition de février 2016). S'agit-il d'une ...
Apr 10, 2017
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