UK and US tighten regulatory ties on medtech and AI

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is stepping up collaboration with the US Food and Drug Administration (FDA) to speed access to new medical technologies and artificial intelligence tools, while aiming to improve patient safety and cut trade barriers.

MHRA chief executive Lawrence Tallon, speaking at the AdvaMed medtech conference in San Diego, outlined the agencies’ joint efforts to deepen regulatory harmonization. Mr Tallon described parallels with the FDA’s Total Product Life Cycle Advisory Program, saying the UK reforms will bring earlier and safer access to innovative devices.

He stressed that the MHRA and FDA are moving toward greater reciprocity and strategic alignment, with new reliance frameworks allowing FDA-cleared devices to reach the UK faster. The reforms are due to be legislated in 2026, with reliance routes opening the following year.