Episode Description
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