IVDR Clinical Studies explained: What regulators expect and why It matters
Representatives from notified bodies, a national ethics committee and a national competent authority will share their perspectives on the requirements for IVDR-compliant clinical studies. This session will help anticipate regulatory expectations, strengthen evidence strategies and support the future of precision oncology diagnostics.
Bringing an innovative diagnostic assay from research to clinical adoption is an exciting yet complex journey. Compliance with the In Vitro Diagnostic Regulation (IVDR) is a key step to ensure the safety, performance and reliability of in vitro diagnostic tests in Europe. Clinical performance studies play a central role in generating the evidence required for conformity assessment and CE marking.
Building on the first webinar in this series, 'Notified Bodies’ Roles and Perspectives on IVDR Clinical Performance Studies', this session moves further along the decision-making pathway from study design to conformity assessment and clinical uptake.
The session will be an insightful discussion on how to design clinical performance studies that meet regulatory expectations and support the successful adoption of innovative diagnostic tests in clinical practice.
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The event can be saved to the calendar by clicking here.
The zoom link will be open at 15:30 and can be found here.
Reach out to megan@thesynergist.org for any questions or inquiries.
- 27/04/2026 - 15:30 - 27/04/2026 - 16:30
- Kyle Galea
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Working Group