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

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

From:
Medicines and Healthcare products Regulatory Agency
Published
29 June 2020
Last updated
122 JuneJuly 2024 — See all updates

Documents

List of medical devices given exceptional use authorisations

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

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Details

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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2-month period.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We publish an updated list weekly (if there are any changes to report) to reflect any new, withdrawn or expired applications.

Published 29 June 2020
Last updated 122 JuneJuly 2024 + show all updates

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

  2. Updated list of medical devices given exceptional use authorisations

  3. Updated list of medical devices given exceptional use authorisations

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

  5. Updated list of medical devices given exceptional use authorisations

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

  7. Updated open list

  8. Updated Open and Closed lists

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

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

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

  12. 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.

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

  14. '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.

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

  16. '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.

  17. Updated Open and Closed lists.

  18. Open and closed lists have been updated.

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

  20. Updated open & closed lists.

  21. 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.

  22. 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.

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

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

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

  26. 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.

  27. 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.

  28. 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.

  29. 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).

  30. Updated changes to the open list of medical devices given EUAs

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

  32. 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.

  33. 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.

  34. List of medical devices given exceptional use authorisations updated to include ESCO Medical Technologies UAB

  35. 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

  36. Added to Open list - Flowonix Medical Inc & CliniMed Ltd. Amended Surescreen Diagnostics (extension issued). Removed from Closed list - Chalice Medical & Metronic Ltd

  37. 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.

  38. 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).

  39. Added 'Philips Image Guided Therapy Corporation' to the Open list.

  40. 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.

  41. Added Rocket Medical PLC - R54411 IPC Dressing Pack and 1000ml Bottle – Issue date: 25/08/2022 – Expiry date: 25/02/2023 to Open List

  42. '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.

  43. 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.

  44. Updated 'Open List'.

  45. Updated 'Open List'

  46. Open and closed lists updated.

  47. 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

  48. Changes made to Open and Closed lists.

  49. Medtronic Ltd added to exceptional list

  50. Open and Closed lists updated

  51. Updated open & closed lists.

  52. 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.

  53. Added to open list.

  54. 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'

  55. Weekly update

  56. 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.

  57. Additions to open and closed EUA lists

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

  59. Updated to reflect two Devices Exceptional Use authorisations have expired

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

  61. 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

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

  63. 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.

  64. Updated this weeks Devices Exceptional Use authorisations

  65. Updated expiry dates

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

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

  68. Updated open and closed list

  69. Updates Devices Exceptional Use authorisations lists

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

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

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

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

  74. Updated the list of medical devices with exceptional use authorisations.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  89. Updated Exceptional Use list

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

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

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

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

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

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

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

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

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

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

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

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

  102. 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.

  103. Updated the list with new additions and expired authorisations

  104. Updated HTML attachment with new entries.

  105. Updated HTML attachment

  106. Updated list of medical devices given exceptional use authorisations

  107. updated list of medical devices given exceptional use authorisations

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

  109. New devices have been added and several have been removed.

  110. First published.