The regulatory grey zone for digital health in the European Union has finally cleared. In a landmark move, the EU's Medical Device Coordination Group (MDCG) has issued the MDCG 2025-4 Guidance, a document that fundamentally reshapes the responsibilities for medical device software (MDSW) and Software as a Medical Device (SaMD) distributed through major online platforms.

MDCG 2025-4  Medical Device Software Apps on Online Platforms

This interview provides a strategic overview for navigating medical device clinical trials, highlighting the fundamental philosophical differences between the US FDA approach and the EU's Medical Device Regulation (MDR). It details how early choices like device classification based on intended use and risk and differing equivalence requirements significantly shape the process, alongside outlining the ongoing post-market data collection and reporting burden in the EU and the critical steps and challenges of trial execution, especially tight safety reporting timelines.

Navigating the Clinical Trials Gauntlet US FDA vs EU MDR in Medical Device Trials

Miloš Cigoj

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