In early May 2026, the EU4MEDTECH project was represented at the 9th World Conference on Research Integrity (WCRI 2026), held from May 3–6 at The Westin Bayshore Hotel in Vancouver, British Columbia, Canada. The WCRI brings together researchers, universities, research funders, publishers, and governments across all disciplines and career stages, making it one of the most prominent global forums for advancing responsible research practices. EU4MEDTECH team member Miro Vuković delivered a short presentation of findings from the project’s ongoing scoping review on evidence integrity in medical device regulatory science. The presentation, co-authored with Nensi Bralić, Ružica Bandić, Ana Marušić, and colleagues from the Department of Research in Biomedicine and Health at the University of Split School of Medicine, examined the methodological approaches used to generate and evaluate clinical and performance evidence for high-risk medical devices and in vitro diagnostics under the EU MDR (2017/745) and EU IVDR (2017/746) frameworks. Key findings presented at the congress included the practical limitations of randomized controlled trials in the medical device context, the growing regulatory role of real-world evidence and post-market registries, and the emergence of novel methodologies such as AI/software-as-a-medical-device validation, in silico modelling, and synthetic data generation. The presentation also highlighted persistent regulatory gaps — particularly regarding AI-based devices and paediatric populations — and called for a lifecycle-based, integrated evidence strategy linking pre-market investigation with mandatory post-market surveillance.
