Decision: Medical devices given exceptional use authorisations

List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

To ensure transparency around the supply of medical devices in the UK, we are now providing a list of manufacturers and devices granted an exceptional use application. We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2-month period.

Medical devices granted an exceptional use authorisation can be sold to the NHS and within the social care setting to ensure a continued supply of medical devices.

Exceptional use authorisations will be issued directly to the manufacturer of the medical device and normally do not allow for distributor sales.

We only consider applications where there is a clear clinical need and there is no available supply of CE marked or already derogated alternatives.

We publish an updated list weekly (if there are any changes to report) to reflect any new, withdrawn or expired applications.

Updates to list of medical devices given exceptional use authorisations, to add extension to reference number DEU/002/2026/002

Updated list of medical devices given exceptional use authorisations to latest version

Updated 'List of medical devices given exceptional use authorisations' & 'List of medical devices that are no longer covered by an exceptional use authorisation'

List of medical devices given exceptional use authorisations changes: Added Clinisys Inc: WinPath 2023.3, WinPath v5 and WinPath v7 Ammeded American Surgical Company LLC: Radiopaque Cotton Balls to extend to 20 February 2027 List of medical devices that are no longer covered by an exceptional use authorisiation Removed: ICU Medical Inc. ClearGuard HD Antimicrobial Cap (CGHD-100)