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.
RAPS members can access the full article on the RAPS Regulatory Focus website at the following link: The impact of the EU IVDR on clinical trials
Citation Bogaert P, Paulussen A. The impact of the EU IVDR on clinical trials. Regulatory Focus. Published online 8 March 2024. https://www.raps.org/News-and-Articles/News-Articles/2024/3/The-impact-of-the-EU-IVDR-on-clinical-trials
Connect with European and international regulatory affairs
Additionally, Pieter Bogaert will be presenting at RAPS EU on May 8th, 2024, on CTA with Devices: State of Play for non-CE Marked Diagnostic Tests in European Clinical Trials in Berlin. Don’t miss this valuable opportunity to connect with Pieter and gain further insights into regulatory developments.
 Mark your calendars and join us for this enlightening event!