MHRA CEO Highlights Risk-Proportionate Regulation for AI & Medical Devices
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is taking lessons from the European Union’s experience with MDR and IVDR to create a smarter, risk-proportionate regulatory framework. MHRA CEO Lawrence Tallon shared insights on this approach during the 2025 Medtech Conference, emphasizing innovation and patient safety.
How MHRA is Adapting from EU Regulatory Challenges
Tallon highlighted that the EU’s MDR and IVDR faced challenges because notified bodies were overwhelmed, causing delays in product approvals. "Anytime you introduce complex new legislation or new regulations, you can have somewhat unintended consequences," he said. In keeping with its risk-based methodology, the MHRA has implemented a self-declaration procedure for Class B IVDs in order to prevent such delays. This makes it possible to access markets more quickly without risking security. Tallon stated, “There are certain things where we clearly need full scrutiny, but other things can have calibrated oversight based on risk.”
Risk-Proportionate Clinical Trial Oversight
A recent study in the British Journal of Clinical Pharmacology evaluated MHRA’s risk-proportionate approach in clinical trials. By adjusting regulatory scrutiny to trial risk, the agency reduced the average approval time from 91 days to 41 days, illustrating the benefits of smart, proportionate regulation.
Collaboration with the FDA and Global Alignment
MHRA also draws lessons from the US Food and Drug Administration (FDA). Tallon emphasized that both agencies share philosophical alignment, including adopting regulatory standards and leveraging data insights. He noted the UK’s NHS healthcare data can complement FDA efforts in evaluating emerging technologies.
Regulating AI with a Risk-Based Approach
Because AI deviates from established regulatory frameworks intended for static medications, it poses special difficulties. "AI is fundamentally challenging this whole regulatory paradigm," emphasised Tallon. Rethinking regulations for the AI era requires a lot of innovative thinking.
In order to provide guidance for a new AI regulatory framework anticipated next year, the UK government established the National Commission into the Regulation of AI in Healthcare, which brings together experts, regulators, clinicians, and patient advocates. In contrast to a single high barrier, Tallon clarified, the goal is to establish a proportionate barrier to market entry along with strong post-market monitoring.
Balancing Innovation and Patient Safety
A consistent theme in Tallon’s discussion was balancing innovation with safety. MHRA’s risk-proportionate approach ensures that regulations are adaptable, effective, and scalable, allowing patients timely access to new technologies while maintaining rigorous safety standards.
At Elexes, we guide medical device and digital health organizations through evolving regulatory requirements. Contact us today to learn how Elexes can help your organization achieve compliance while accelerating innovation.
To read more about the news, you can go to the official link below:
MHRA driving risk-proportionate regulation for AI and medical devices
