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

Medicines Healthcare Products Regulatory Agency

August 28
11:33 2020

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.

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An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.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 28 August 2020 +show all updates
  1. Updated the list with new additions and expired authorisations

  2. Updated HTML attachment with new entries.

  3. Updated HTML attachment

  4. Updated list of medical devices given exceptional use authorisations

  5. updated list of medical devices given exceptional use authorisations

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

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

  8. First published.

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