13. Non-standard routes to placing medical devices on the UK market

Last Updated on 06/11/2025 by Sarah Sarsby

Exceptional Use Authorisation: In this guidance MHRA outlines how manufacturers can apply for exceptional use authorisation (EUA) which allows non-UKCA/CE certified medical devices to be placed on the UK market when doing so in the interest of the protection of public health.  EUAs are granted for a limited time, with conditions to facilitate compliance with relevant medical devices legislation. Once granted, manufacturers must report monthly to the MHRA on supply figures, complaints, adverse events, and progress towards UKCA or CE certification (for EUAs granted for the Great Britain market); or CE certification (for EUAs granted for the Northern Ireland or whole UK market).