The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced new steps to reinforce its collaboration with the US Food and Drug Administration (FDA). The move aims to encourage innovation, maintain patient safety, and improve access to medical technologies across both markets.
The announcement was made during the AdvaMed conference in San Diego, where the MHRA highlighted its ongoing commitment to working closely with trusted regulators such as the FDA. Strengthened cooperation is expected to support greater regulatory alignment and reduce barriers for manufacturers looking to introduce new technologies internationally.
Addition of AI in healthcare for faster UK market access
A new National Commission on the Regulation of AI in Healthcare has also been launched. The Commission brings together UK and US experts to explore how artificial intelligence can be used safely and transparently in healthcare. Its work is expected to contribute to global discussions on the responsible use of AI in medical technology.
In addition, the MHRA confirmed plans to introduce international reliance routes that would allow devices already approved by trusted authorities, including the FDA, to access the UK market more efficiently. This approach seeks to combine faster regulatory pathways with the same level of safety oversight.
Next steps for manufacturers under the evolving UK framework
The upcoming UK medical device framework is anticipated to be implemented in 2026, with the reliance routes available from 2027. These developments signal the UK’s intention to build a more connected and innovation-friendly regulatory environment.
Stakeholders should follow these developments closely, as the increased cooperation between the MHRA and FDA may simplify future market access strategies and strengthen international recognition of conformity assessments.
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References:
UK Government (2025), Patients to benefit as UK and US regulators forge new collaboration on medical technologies and AI. Retrieved on 23/10/2025.
Meric Gonul
Regulatory Intelligence & Innovation
24/10/2025