Webcast now available, featuring expert presenters Edward Nobrega, Principal Clinical Evaluation Scientist at Boston Scientific, Breda Kearney, Clinical Regulatory Lead at BSI, and Marcus Torr, Head of Post Market Surveys at Purdie Pascoe.
This article explores the role of post-market RWD/RWE in establishing sufficient clinical evidence for legacy devices transitioning to the MDR. It outlines key data sources, explains how off-label data can be captured and used, shares Notified Body perspectives and case study examples, and considers how post-market surveys can generate high-quality RWD. It concludes with practical guidance on integrating these data into an ongoing clinical evidence strategy.
With 2026 marking the Regulatory Affairs Professionals Society’s 50th anniversary, the atmosphere felt especially energised. Between packed auditoriums, poster sessions, and many conversations, one thing became increasingly clear: post-market evidence generation is entering a far more mature and strategically important phase.
He has extensive knowledge in the specific requirements surrounding PMCF surveys, having overseen over 600 surveys for several of the leading global Medical Device manufacturers across a variety device types. These surveys have been approved by several of the leading Notified Bodies and consist of both end user general surveys and high-quality patient specific surveys.
