Decision

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
182 FebruaryMarch 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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2 month period.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An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.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 182 FebruaryMarch 2022 + show all updates

  1. 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'

  2. Weekly update

  3. 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.

  4. Additions to open and closed EUA lists

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

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

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

  8. 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

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

  10. 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.

  11. Updated this weeks Devices Exceptional Use authorisations

  12. Updated expiry dates

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

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

  15. Updated open and closed list

  16. Updates Devices Exceptional Use authorisations lists

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  36. Updated Exceptional Use list

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

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

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

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

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

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

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

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

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

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

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

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

  49. 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.

  50. Updated the list with new additions and expired authorisations

  51. Updated HTML attachment with new entries.

  52. Updated HTML attachment

  53. Updated list of medical devices given exceptional use authorisations

  54. updated list of medical devices given exceptional use authorisations

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

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

  57. First published.