B1: Leverage real-world data for your clinical development

13:15-13:35 Ghazaleh Gouya Lechner: Real-world data – how to use them for generating clinical evidence pre- and post market

13:40-14:00 Camille Petri: The Notified Body’s Perspective on Using Real-World Evidence for Clinical Evaluation of Medical Device Software

From a Notified Body’s perspective, RWE can play a valuable role in the clinical evaluation of medical device software - particularly for AI and machine learning-based systems. This talk will outline regulatory expectations under MDR, clarify what constitutes acceptable RWE, and explain how manufacturers can design real-world studies that meet the methodological and statistical rigour required for regulatory submissions. Key opportunities (e.g. performance across diverse populations, post-market clinical follow-up) and challenges (e.g. data quality, bias, and traceability) will be examined through the lens of regulatory compliance and clinical robustness.

14:05-14:25 tba