Medical devices given exceptional use authorisations
MHRA has issued exceptional use authorisations for medical devices. This decision document outlines the devices approved under this pathway and the regulatory criteria met.
📅 Effective / published: 2026-06-12
Manufacturers and sponsors placing medical devices on the the UK market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗