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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2 month period.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An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.
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
Changes made to Open and Closed lists.
Medtronic Ltd added to exceptional list
Open and Closed lists updated
Updated open & closed lists.
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.
Added to open list.
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'
Weekly update
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.
