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How the EU intends to secure a tighter grip on clinical trials

This article was originally published in Clinica

Executive Summary

Clinical trials will be one of the areas most impacted by the proposed changes to the Medical Devices Directive (MDD). The draft review just sent to stakeholders by the European Commission services - still subject to change - introduces numerous clauses intended to tighten up this area that will ensure that companies are far more actively responsible in assessing the validity of their trials, that clinical investigations are subject to closer scrutiny by the authorities as well as performed more often than at present in preference to literature reviews.

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