Insights for Clinical Trial Sponsors: Navigating IVDR 2017/746 and CTR 536/2014

As the regulatory landscape for clinical trials continues to evolve, sponsors must adapt to the complex requirements introduced by the In Vitro Diagnostic Regulation (IVDR 2017/746) and the Clinical Trials Regulation (CTR 536/2014). This presentation provides a practical overview of the key compliance obligations under both frameworks, with a focus on IVDR compliant clinical trials. We will explore the implications for compliance, and regulatory submissions, highlighting common challenges and operational impacts. Attendees will gain actionable insights to support efficient trial planning and ensure alignment with current EU regulatory expectations.