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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2-month period.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We publish an updated list weekly (if there are any changes to report) to reflect any new, withdrawn or expired applications.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 this page
Published 29 June 2020 Last updated 27 December 2024 +show all updates
Changed expiry date for BioAccess Inc listing in List of medical devices given exceptional use authorisations
DEU/012/2023/002 & DEU/004/2023/003 moved to 'List of medical devices that are no longer covered by an exceptional use authorisation'.DEU/011/2022/007 & DEU/012/2022/024 - extensions issued.
Extension issued for XVIVO (non-ischemic hypothermic perfusion) NIHP - (DEU/001/2024/001)
Removed DEU/002/2021/001 (Numed Inc) & DEU/001/2024/001 (Inspire Medical Systems, Inc.) from Open list.Added DEU/001/2024/001 (Inspire Medical Systems, Inc.) to Closed list.
Integra Lifesciences Ltd: NeuroBalloon (DEU/011/2022/002)Expiry date extension issued - 1 April 2025
Updated Becton Dickinson U.K. Limited BD BodyGuard Blous Cable, Closure date to 31st January.
Updated 'Open list' entry for 'The Heartware HVAD (model number 1104) System (DEU/012/2022/006)' to reflect Expiry Date of 19 March 2025.
Updated 'List of medical devices given exceptional use authorisations':- DEU/006/2024/001 - Extension issued to 20 December 2024- DEU/012/2022/006 - Extension issued to 19 February 2025
Added the following to the 'List of medical devices given exceptional use authorisations':- Dolphin Fluid Immersion Simulation System- AxiomTM Total Blood Typing Solution/Gene Titan Multi-Channel Instrument System- Integrated Analysis Package (IAP) software
Changed made to expiry dates (extended) of BIRR Biosciences products and BD Bodycomm.
Updated 'Open' List of medical devices given exceptional use authorisations. No changes to 'Expired' list.
Updated the close date of OMC Medical on behalf of Edare Inc Wireless Automated hearing Test System WAHTS AC1.
Extension issued for DEU/009/2022/005 on the list of medical devices given exceptional use authorisations. DEU/011/2023/005 removed from the list of medical devices that are no longer covered by an exceptional use authorisation.
Updated 'List of medical devices given exceptional use authorisations' & 'List of medical devices that are no longer covered by an exceptional use authorisation'.
Updated list of medical devices given exceptional use authorisations
Updated list of medical devices given exceptional use authorisations
Updated list of medical devices given exceptional use authorisations and list of medical devices that are no longer covered by an exceptional use authorisation
Updated list of medical devices given exceptional use authorisations
Updated List of medical devices given exceptional use authorisations and List of medical devices that are no longer covered by an exceptional use authorisatio
