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

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

From:
Medicines and Healthcare products Regulatory Agency
Published
29 June 2020
Last updated
2112 SeptemberOctober 2022 — See all updates

Documents

List of medical devices given exceptional use authorisations

HTML

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

HTML

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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2 month period.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.

An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.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 2112 SeptemberOctober 2022 + show all updates

  1. 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).

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

  3. 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.

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

  5. '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.

  6. 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.

  7. Updated 'Open List'.

  8. Updated 'Open List'

  9. Open and closed lists updated.

  10. 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

  11. Changes made to Open and Closed lists.

  12. Medtronic Ltd added to exceptional list

  13. Open and Closed lists updated

  14. Updated open & closed lists.

  15. 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.

  16. Added to open list.

  17. 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'

  18. Weekly update

  19. 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.

  20. Additions to open and closed EUA lists

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

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

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

  24. 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

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

  26. 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.

  27. Updated this weeks Devices Exceptional Use authorisations

  28. Updated expiry dates

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

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

  31. Updated open and closed list

  32. Updates Devices Exceptional Use authorisations lists

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  52. Updated Exceptional Use list

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

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

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

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

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

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

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

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

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

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

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

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

  65. 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.

  66. Updated the list with new additions and expired authorisations

  67. Updated HTML attachment with new entries.

  68. Updated HTML attachment

  69. Updated list of medical devices given exceptional use authorisations

  70. updated list of medical devices given exceptional use authorisations

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

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

  73. First published.