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 talk will cover the definition of real-world data (RWD) and how it can be leveraged to generate clinical evidence for medical device software in pre- and post-market settings. It will show how well-designed real-world evidence (RWE) studies complement traditional trials by demonstrating performance in diverse populations and environments, supporting regulatory submissions, and enabling continuous safety and effectiveness monitoring. Key topics include 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 AI- and ML-based systems. This talk will outline regulatory expectations under MDR, define acceptable RWE and explain how manufacturers can design studies meeting the required methodological and statistical rigor. Key opportunities (e.g. performance across diverse populations) and challenges (e.g. data quality, bias, 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

This talk will detail a case study on leveraging RWD to address the rigorous clinical evidence requirements of MDR. After a major algorithm change, a Class IIb medical device app faced the challenge of demonstrating safety and performance. A Post-Market Clinical Follow-up (PMCF) was pursued, using in-app real-world data instead of a traditional clinical trial. The journey, challenges, and key lessons will be shared, offering an honest account of how regulatory acceptance was achieved for this data-driven strategy.