UK to fast-track FDA-cleared medical devices under new US collaboration
The MHRA plans reliance routes from 2027 for devices cleared via FDA 510(k), De Novo and PMA, which could speed UK access to neurotech.
The UK’s medicines regulator, the MHRA, announced closer collaboration with the US FDA on medical technologies and AI. Under planned reforms, devices cleared by the FDA through the 510(k), De Novo or PMA pathways would get faster access to the UK market via new “reliance” routes, expected to open in 2027 once legislation passes in 2026.
For neurotech companies, which usually seek FDA approval first, this could shorten the path to UK patients for devices from stimulators to brain-computer interfaces.
Learn more: Clinical trial pathway