The Impact of EU IVDR on Clinical Trials

Anne Paulussen and Pieter Bogaert, Senior Consultants IVD - Regulatory Affairs at QbD Group

Clinical

Regulatory Affairs

In Vitro Diagnostics

Sunday, 24 March 2024

The Impact of EU IVDR on Clinical Trials | QbD Group

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We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Bogaert and Anne Paulussen, recently featured in RAPS Regulatory Focus. Titled “The impact of the EU IVDR on clinical trials,” this article delves into the implications of Regulation (EU) 2017/746 or the in vitro diagnostic medical device regulation (IVDR) on the landscape of clinical trials.

Published online on March 8, 2024, this article offers a comprehensive analysis of how the EU IVDR is reshaping the regulatory environment surrounding clinical trials. Pieter and Anne bring their expertise and understanding of regulatory affairs to explore the challenges and opportunities that arise from this significant regulatory change.

We invite you to delve into this article and gain valuable insights into navigating the ever-evolving regulatory landscape of clinical trials in the EU.

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