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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
309 DecemberJanuary 20222023 — 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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2 month period.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.

An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.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 309 DecemberJanuary 20222023 + show all updates

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

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

  3. 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.

  4. 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.

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

  6. 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

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

  8. 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.

  9. 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).

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

  11. 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.

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

  13. '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.

  14. 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.

  15. Updated 'Open List'.

  16. Updated 'Open List'

  17. Open and closed lists updated.

  18. 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

  19. Changes made to Open and Closed lists.

  20. Medtronic Ltd added to exceptional list

  21. Open and Closed lists updated

  22. Updated open & closed lists.

  23. 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.

  24. Added to open list.

  25. 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'

  26. Weekly update

  27. 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.

  28. Additions to open and closed EUA lists

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

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

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

  32. 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

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

  34. 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.

  35. Updated this weeks Devices Exceptional Use authorisations

  36. Updated expiry dates

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

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

  39. Updated open and closed list

  40. Updates Devices Exceptional Use authorisations lists

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  60. Updated Exceptional Use list

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

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

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

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

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

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

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

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

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

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

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

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

  73. 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.

  74. Updated the list with new additions and expired authorisations

  75. Updated HTML attachment with new entries.

  76. Updated HTML attachment

  77. Updated list of medical devices given exceptional use authorisations

  78. updated list of medical devices given exceptional use authorisations

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

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

  81. First published.