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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2 month period.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.
An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.
Published 29 June 2020 Last updated 24 October 2022 +show all updates
R6R2107 Bone Marrow Collection Kits with Flexible Pre Filter and Inline Filters (Fresenius Kabi) has been added to the list of medical devices that are no longer covered by an exceptional use authorisation. Evolution Revision Tibia, CE-656477 Evolution Revision Tibia (manufacturer: MicroPort Scientific Ltd) has been added to the list of medical devices given exceptional use authorisations.Procedure Packs, XRD Gauze, Examination Gloves (Medical), Wound Care Dressings and Plain Swabs from the manufacturer Bunzl Healthcare have been added to the list of medical devices given exceptional use authorisations.Expiry dates for MUTARS Hip System and MUTARS Knee System (manufacturer: implantcast GmbH) and Catheters and other single use medical devices - Various (manufacturer: Vygon GmbH) has been modified as it because an extension has been issued.
Two listings have been added (Fukuda Denshi Co. Ltd and BioAccess, Inc). One has been placed in the list of medical devices that are no longer covered by an exceptional use authorisation (Fresenius Kabi Ltd).
Added 'Philips Image Guided Therapy Corporation' to the Open list.
Added - 'Smiths Medical ASD, Inc. Device/model name: DI-50, DI-100,DI-300: Level 1 Normothermic I.V. Fluid Administration Set intended for use with Level 1R H-1000, H-1025, H-1028, and H-1200 Fast Flow Fluid Warmers only' to the authorised list.
Added Rocket Medical PLC - R54411 IPC Dressing Pack and 1000ml Bottle Issue date: 25/08/2022 Expiry date: 25/02/2023 to Open List
'List of medical devices given exceptional use authorisations' - Removed certain entries following expiry'List of medical devices that are no longer covered by an exceptional use authorisation' - Added expired entries to this list.
New entry to 'List of medical devices given exceptional use authorisations' - Biosense Webster, Inc: Various catheters (for the diagnosis and treatment of cardiac arrhythmia). Also some entries given extensions to their initial expiry dates.
Updated 'Open List'.
Updated 'Open List'
Open and closed lists updated.
Devices moved to expired list:- DEU/004/2021/003 - Sensyne Health Group Limited - MagnifEye for special use with the COVID-19 Self-Test (Department of Health and Social Care) - For supply through NHS Test and Trace only-DEU/007/2021/001 - Sensyne Health Group Limited - MagnifEye
