B1: Leverage real-world data for your clinical development

13:15-13:40 Ghazaleh Gouya Lechner: Real-world data – how to use them for generating clinical evidence pre- and post market

This presentation will talk about the definition of RWD, and on how real-world data (RWD) can be leveraged to generate clinical evidence for medical device software in both pre-market and post-market settings. It will outline how well-designed real-world evidence (RWE) studies can complement traditional clinical investigations by demonstrating performance across diverse populations and clinical environments, supporting regulatory submissions, and enabling continuous monitoring of safety and effectiveness. Key topics will include opportunities and challenges in study design, data quality, and the legal and ethical framework for using RWD.

13:40-14:05 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.

14:05-14:30 Katarzyna Malenczyk: Driving Clinical Development with RWD: Lessons from mySugr's PMCF Plan