Prof. Tom Melvin on clinical evidence, MDR complexity, notified bodies, real-world data, AI, and building a more scientific European regulatory system.
In this episode, Andreas and Tom discuss:
Tom’s unusual career journey from hospital medicine and law into medical device regulation
How clinical experience and legal training shape regulatory decision-making
The roles of competent authorities, notified bodies, the European Commission, and other regulatory actors
Why the European medical device system can be difficult even for experienced insiders to navigate
The legal and practical importance of MDCG guidance documents
How ISO standards interact with the Medical Device Regulation
Why technology-specific clinical evidence requirements remain unclear
Whether the MDR has actually improved the quality of clinical evidence
Why intended purpose and product claims determine the evidence a manufacturer needs
The limitations of equivalence-based approaches
Why European developers lack early scientific and regulatory advice
The potential—and limitations—of structured dialogue with notified bodies
How fragmented decision-making can produce inconsistent expectations
Why high-risk implants may require a more rigorous and centralized evidence pathway
The role of randomized controlled trials in medical device development
How registries and real-world evidence can support long-term device evaluation
Why post-market evidence should not compensate for inadequate pre-market planning
The regulatory challenges surrounding orphan and paediatric devices
How Europe can balance patient access, innovation, and evidence requirements
The difficulties of regulating AI-enabled and continuously evolving technologies
The potential role of in-silico models and synthetic evidence
What Europe can learn from the FDA, PMDA, and MHRA
Why clinical validation alone is not enough for successful implementation in healthcare
Tom’s proposal for a more proportionate system: rigorous oversight for a limited number of high-risk devices and clearer pathways for lower- and medium-risk products