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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.

Published 29 June 2020

Last updated 111 NovemberFebruary 20202021 — see all updates
From:
Medicines and Healthcare products Regulatory Agency

Documents

List of medical devices given exceptional use authorisations

HTML

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 withdrawn or cancelled authorisations for a 2 month period.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An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.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 111 NovemberFebruary 20202021 + show all updates

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

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

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

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

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

  6. Updated Exceptional Use list

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

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

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

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

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

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

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

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

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

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

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

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

  19. 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.

  20. Updated the list with new additions and expired authorisations

  21. Updated HTML attachment with new entries.

  22. Updated HTML attachment

  23. Updated list of medical devices given exceptional use authorisations

  24. updated list of medical devices given exceptional use authorisations

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

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

  27. First published.

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