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 We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2 month period.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An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.
Updated List of medical devices given exceptional use authorisations and List of medical devices that are no longer covered by an exceptional use authorisation.
Updated open list
Updated Open and Closed lists
Updated List of medical devices given exceptional use authorisations and List of medical devices that are no longer covered by an exceptional use authorisation.
Updated List of medical devices given exceptional use authorisations & List of medical devices that are no longer covered by an exceptional use authorisation.
The list of medical devices given exceptional use authorisations has been updated to include Extra Corporeal Membrane Oxygenation (ECMO) items produced by Getinge.
The list of medical devices given exceptional use authorisations has been updated to state to indicate that the extension is granted exclusively to the 'Bolus Cable product.
List of medical devices given exceptional use authorisations has been updated to include new expiry date for BD BodyGuard Accessory Products - Bolus Cable.
'List of medical devices given exceptional use authorisations' and'List of medical devices that are no longer covered by an exceptional use authorisation' have been updated.
The List of medical devices given exceptional use authorisations has been updated to include new expiry dates.
'List of medical devices given exceptional use authorisations' and'List of medical devices that are no longer covered by an exceptional use authorisation' have been updated.
Updated Open and Closed lists.
Open and closed lists have been updated.
Updated: 'List of medical devices given exceptional use authorisations' &'List of medical devices that are no longer covered by an exceptional use authorisation'
Updated open & closed lists.
Added 'S.A.L.F. S.p.A. Laboratorio Farmacologico (aka S.A.L.F.) - Servator M ' to Open list. Moved 'UnifAI - Covid-19 Digital Reader ' to the Closed list.
List of medical devices given exceptional use authorisations updated to include DEU/005/2022/006, DEU/005/2022/006, DEU/012/2022/013, DEU/002/2021/001 and remove DEU/008/2022/002, DEU/007/2022/003, DEU/008/2022/005, DEU/010/2022/003, DEU/010/2022/004, DEU/010/2022/006. Extension issued to DEU/012/2022/015.List of medical devices that are no longer covered by an exceptional use authorisation updated to include DEU/008/2022/002 and DEU/007/2022/003, and remove DEU/003/2022/001, DEU/005/2022/006 and DEU/002/2021/001.
Updated 'List of medical devices that are no longer covered by an exceptional use authorisation'
Added HeartWave Inc (Medtronic Ltd) HVAD Controller to the New medical devices given exceptional use authorisations list.
