MHRA and US FDA Forge New Collaboration on Medical Technologies and AI

10th October 2025

MHRA and US FDA Forge New Collaboration on Medical Technologies and AI

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) have deepened their collaboration to advance regulatory harmonisation and expedite patient access to innovative medical technologies. Key initiatives include:

• National AI Commission: The MHRA has launched the National Commission on the Regulation of AI in Healthcare, incorporating expertise from both the UK and the US to shape safe and transparent AI integration in healthcare systems.

• International Reliance Routes: New frameworks have been established to recognise and accept medical device approvals from trusted regulators like the FDA, facilitating quicker market access for UK patients.

• Regulatory Alignment: The MHRA's ongoing medical technology reforms aim to align closely with FDA practices, promoting mutual recognition and reducing regulatory duplication.

These efforts are part of a broader strategy to foster a globally harmonised regulatory environment, ensuring that patients benefit from the latest medical innovations more swiftly and safely.

Link: Patients to benefit as UK and US regulators forge new collaboration on medical technologies and AI

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