Medical devices given exceptional use authorisations during the COVID-19 pandemic

Updated List of medical devices given exceptional use authorisations.

Extensions issued for: DEU/010/2023/002 - 7 August 2025 DEU/002/2024/002 - 7 August 2025

Joerns Healthcare Inc: Dolphin Fluid Immersion Simulation System (DEU/011/2023/002) - Extension issued to 27 August 2025

Added to open list: EBR Systems, Inc/EBR Systems (UK) Ltd - DEU/012/2024/001 Modified DEU/004/2022/003 - extension issued Removed from closed list: DEU/006/2024/001

OBP Medical corporation and Covidien LLC/Medtronic Ltd added to the open list.

Extensions issued for: DEU/010/2023/002 - AxiomTM Total Blood Typing Solution/Gene Titan™ Multi-Channel Instrument System DEU/002/2024/002 - Integrated Analysis Package (IAP) software

Amended issue extensions to BIRR BioSciences products and Medgyn Word Bartholin Catheter and Medgyn Amniohook

Updated extension condition for Medgyn International Inc

Changed to make small amends to products in exceptional use authorisations lists.

Changed to update exceptional use lists.

Added 'Greiner Bio-One GmbH - DEU/012/2024/003' to List of medical devices given exceptional use authorisations

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 authorisation.

Updated open list

Updated Open and Closed lists

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 & List of medical devices that are no longer covered by an exceptional use authorisation.

The list of medical devices given exceptional use authorisations has been updated to include Extra Corporeal Membrane Oxygenation (ECMO) items produced by Getinge.

The list of medical devices given exceptional use authorisations has been updated to state to indicate that the extension is granted exclusively to the 'Bolus Cable’ product.

List of medical devices given exceptional use authorisations has been updated to include new expiry date for BD BodyGuard Accessory Products - Bolus Cable.

'List of medical devices given exceptional use authorisations' and 'List of medical devices that are no longer covered by an exceptional use authorisation' have been updated.

The List of medical devices given exceptional use authorisations has been updated to include new expiry dates.

'List of medical devices given exceptional use authorisations' and 'List of medical devices that are no longer covered by an exceptional use authorisation' have been updated.

Updated Open and Closed lists.

Open and closed lists have been updated.

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

Updated open & closed lists.

Added 'S.A.L.F. S.p.A. Laboratorio Farmacologico (aka S.A.L.F.) - Servator M ' to Open list. Moved 'UnifAI - Covid-19 Digital Reader ' to the Closed list.

List of medical devices given exceptional use authorisations updated to include DEU/005/2022/006, DEU/005/2022/006, DEU/012/2022/013, DEU/002/2021/001 and remove DEU/008/2022/002, DEU/007/2022/003, DEU/008/2022/005, DEU/010/2022/003, DEU/010/2022/004, DEU/010/2022/006. Extension issued to DEU/012/2022/015. List of medical devices that are no longer covered by an exceptional use authorisation updated to include DEU/008/2022/002 and DEU/007/2022/003, and remove DEU/003/2022/001, DEU/005/2022/006 and DEU/002/2021/001.

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

Added HeartWave Inc (Medtronic Ltd) HVAD Controller to the New medical devices given exceptional use authorisations list.

New medical devices given exceptional use authorisations added. Rocket Medical Plc - R54411 IPC Dressing Pack and 1000ml Bottle extension issued.

Removed the following from Open List: DEU/010/2022/003 - ESCO Medical Technologies UAB (IVF Synergy) - CultureCoin DEU/003/2022/001 - Hunter Scientific Ltd - Pure Sperm Wash DEU/005/2022/006 - Smiths Medical ASD, Inc.

List of medical devices given exceptional use authorisations updated to include Biosense Webster Inc - SOUNDSTAR eco 8F Diagnostic Catheter and Abbott Diagnostics Scarborough Inc - COVID-19 Swab Transport Tube Accessory Pack (Catalogue code 190-010). ESCO Medical Technologies UAB (IVF Synergy) - CultureCoin, Hunter Scientific Ltd - Pure Sperm Wash and Smiths Medical ASD, Inc. - 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 were added to 'no longer covered by an exceptional use authorisation' list.

List of medical devices given exceptional use authorisations updated to include Medtronic Ltd - CapSure Epicardial Lead Model 4968. Extension issued until 31 July 2023 to Biosense Webster Inc - Various catheters and Bunzl Healthcare - Gauntlet Range Sterile Nitrile Examination Gloves (Medical). Extension issued until 1 August 2023 to Terumo Medical Corporation - FemoSealTM and Angio-SealTM Vascular Closure Devices. CryoLife Europa, Ltd – BioGlue and Cooper Surgical, Inc. - Fetal Pillow, FP-010 were added to 'no longer covered by an exceptional use authorisation' list.

Products were added to the open list from Rocket Medical plc and products were removed from Mercedes AMG HPP/UCL Hospital Trust UCL Ventura CPAP and Perspectum Ltd. Extensions were issued to Bunzl Healthcare and Gas Arc Ltd. A products was removed from the closed list from NVT GmbH (Biosensors International).

Updated changes to the open list of medical devices given EUAs

Update to 'List of medical devices given exceptional use authorisations'

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

'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™ for special use with the Rapid COVID-19 (Antigen) Self-test (Zhejiang Orient Gene Biotech) - For supply through NHS Test and Trace only - DEU/009/2021/001 - Sensyne Health Group Limited - MagnifEye™ for special use with the Rapid COVID-19 (Antigen) Self-test (Acon) - For supply through NHS Test and Trace only - DEU/001/2022/002 - Sensyne Health Group Limited - MagnifEye™ for special use with the Rapid COVID-19 (Antigen) Self-test (SureScreen) - For supply through NHS Test and Trace only - DEU/008/2021/002 - Becton, Dickinson & Company - BD Vacutainer® SST™ Blood Collection Tubes (#367986) and BD Vacutainer® K2 EDTA (K2E) 7.2mg Blood Collection Tubes (#367861) Modification (extension issued) to - DEU/012/2020/006 - Perspectum Ltd - Coverscan MD

Changes made to Open and Closed lists.

Medtronic Ltd added to exceptional list

Open and Closed lists updated

Updated open & closed lists.

Added Hunter Scientific Ltd Pure Sperm Wash to list. Modified closure dates for entries of Venus Medtech and Medtronic Ltd as extensions have been issued.

Added to open list.

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

Weekly update

The device manufactured by Zhejiang Orient Gene Biotech was moved from the list of existing EUAs to the list of expired EUAs because its EUA has expired.

Additions to open and closed EUA lists

Open list updated. Added: - DEU/010/2021/003 - DEU/011/2021/002 - DEU/001/2022/001 Modified expiry date for - DEU/012/2020/003

Updated to reflect two Devices Exceptional Use authorisations have expired

Updated list of medical devices given exceptional use authorisations and list of medical devices that are no longer covered by an exceptional use authorisation.

LeMaitre – Xenosure Biologic Patch moved to 'no longer covered by an EUA'; Medline Scientific - Oropharyngeal Swab expiry date extended to 31/03/2022; Mercedes AMG HPP/UCL Hospital Trust - UCL Ventura CPAP expiry date to 14/07/2022 ; Venus Medtech (Hangzhou) Inc. - TRANSCATHETER PULMONARY VALVE & TRANSCATHETER VALVE DELIVERY SYSTEMS expiry date extended to 14/03/2022

New entry to open list - 'Christoph Miethke GmbH & Co. KG, M.scio - Telemetric Sensor Reservoir' and removal of entries from closed list.

New entries and edits to both 'List of medical devices given exceptional use authorisations' and 'List of medical devices that are no longer covered by an exceptional use authorisation' HTML links.

Updated this weeks Devices Exceptional Use authorisations

Updated expiry dates

Extensions issued for DEU/012/2020/003, DEU/005/2021/001 and DEU/005/2021/002

An updated list of devices with exceptional use authorisations as well as those no longer covered.

Updated open and closed list

Updates Devices Exceptional Use authorisations lists

Updated list of medical devices given exceptional use authorisations and list of medical devices that are no longer covered by an exceptional use authorisation

An updated list of devices with exceptional use authorisations as well as those no longer covered.

Updated list of devices that have received an exceptional use authorisation as well as those no longer covered.

Updated list of devices with exceptional use authorisations as well as those no longer covered

Updated the list of medical devices with exceptional use authorisations.

Updated lists of medical devices with an exceptional use authorisation as well as those no longer covered

Updated lists of devices with an exceptional use authorisation as well as those no longer covered.

An updated list of devices with exceptional use authorisations as well as those no longer covered.

Updated lists of devices with exceptional use authorisations as well as those no longer covered

Updated the list of medical devices given exceptional use authorisations during the COVID-19 pandemic

Updated list of devices with an exceptional use authorisation as well as those no longer covered.

Updated lists of devices with exceptional use authorisation as well as those no longer covered.

Updated lists of devices with exceptional use authorisations as well as those no longer covered.

Updated lists of devices with an exceptional use authorisation as well as those no longer covered

Updated list of devices granted an exceptional use authorisation as well as those no longer covered.

An updated list of devices no longer covered by an exceptional use authorisation.

Updated lists of devices with an exceptional use authorisation as well as those no longer covered

Updated list of devices with exceptional use authorisations during the COVID-19 pandemic

Updated lists of devices with exceptional use authorisations and those no longer covered

Updated Exceptional Use list

Updated lists of those devices with an exceptional use authorisation as well as those no longer covered

Updated the list of those devices with an exceptional use authorisation as well as those no longer covered

Updated lists of devices covered by exceptional use derogations as well as those no longer covered.

Updated lists of devices that have received exceptional use authorisations and those that are no longer covered

Updated list of devices that have received exceptional use authorisations as well as those who are no longer covered.

Updated devices with an exceptional use derogation, as well as those no longer covered

Updated the lists of devices with exceptional use applications as well as those no longer covered.

Updated lists of devices with exceptional use authorisations and those who are no longer covered.

Updated the lists of devices with exceptional use authorisations for use during the COVID-19 pandemic as well as those no longer authorised

Updated the lists of medical devices given exceptional use authorisations, as well as those that are no longer covered.

Updated the lists of medical devices given exceptional use authorisations and the list of devices no longer covered.

Added a new list of medical devices that are no longer covered by an exceptional use authorisation

Removed exemptions for manufacturers Danameco, Guangzhou Fuzelong Hygiene Material Co.,Ltd, Sterilab Services and Fortress Diagnostics and added a new listing for MED-EL UK Ltd.

Updated the list with new additions and expired authorisations

Updated HTML attachment with new entries.

Updated HTML attachment

Updated list of medical devices given exceptional use authorisations

updated list of medical devices given exceptional use authorisations

A new device has been added to the list - Sterilab Services

New devices have been added and several have been removed.

First published.