Navigating MHRA's 2025 Real-World Data Guidance for UK Clinical Trials

Medical Device Global Market Access

This episode unpacks the UK MHRA's updated May 20, 2025, guidance on employing Real-World Data (RWD) in clinical studies for regulatory approval. We discuss the scope, the critical emphasis on data quality, essential considerations for sponsors using RWD sources like EHRs and wearables, and how the MHRA is shaping the future of evidence generation for medical products. Key Questions: • What exactly is Real-World Data and how is it changing regulatory submissions? • According to the MHRA's 2025 update, what defines high-quality RWD for clinical studies? • What are the major advantages and potential pitfalls of integrating RWD into your development strategy? • Which specific data quality aspects must sponsors meticulously address in their RWD study protocols? • How are emerging digital health technologies influencing RWD collection and its regulatory acceptance? • What scrutiny can be expected from MHRA during inspections of clinical trials utilizing RWD? • When is it advisable to proactively seek scientific advice from the MHRA on your RWD plans? • How can leveraging RWD ultimately streamline the path to market for new medical innovations? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of Brazil’s ANVISA process—and 30 + other markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.