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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2 month period.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An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.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 19 December 2022 +show all updates
List of medical devices given exceptional use authorisations updated to include CliniMed Ltd Appeel - Sterile Range, Liquid Barrier Film Range and CliniSorb Activated Charcoal Dressing. Extension issued until 30 June 2023 to COVID-19 Self-Test to detect infection in asymptomatic individuals, SARS-CoV-2 Antigen Rapid Test Cassette and UnifAI Digital Reader for COVID-19 LFDs.
Becton, Dickinson & Company - BD PosiFlush XS and BD PosiFlush SP added to the list. List of medical devices that are no longer covered by an exceptional use authorisation was updated.
List of medical devices given exceptional use authorisations updated to include ESCO Medical Technologies UAB
Smiths Medical ASD, Inc. 4900 Pulsator Loss of Resistance Syringe - added to 'no longer covered by an exceptional use authorisation' list. Becton, Dickinson & Company BD BodyComm - extension issued until 31 May 2023
Added to Open list - Flowonix Medical Inc & CliniMed Ltd. Amended Surescreen Diagnostics (extension issued). Removed from Closed list - Chalice Medical & Metronic Ltd
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
