Who Decides What Evidence Is Enough? The Reality of Medical Device Regulation

European medical device regulation is designed to protect patients—but does the current system provide innovators with enough clarity to develop the technologies patients need? In this episode of Beyond Outcomes: Clinical Research Unfiltered, Andreas Beust speaks with Prof. Tom Melvin, whose career spans medicine, law, regulatory authorities, European policy, and academic research. Together, they unpack the complex architecture of the European medical device system: the responsibilities of competent authorities and notified bodies, the growing influence of MDCG guidance and ISO standards, and the continuing uncertainty surrounding clinical evidence requirements. The conversation also explores early regulatory advice, structured dialogue, randomized trials, registries and real-world evidence, orphan and paediatric devices, artificial intelligence, in-silico models, and the lessons Europe could learn from regulatory systems in the United States, Japan, and the United Kingdom. At the centre of the discussion is a difficult question: How can Europe demand rigorous evidence for high-risk technologies while creating a more proportionate and predictable pathway for the thousands of other medical devices patients and healthcare systems rely on?