MHRA updates medical-device exceptional use authorisation lists

What Changed

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its medical-device exceptional use authorisation publication on 2 October 2026. The update records an extension for open-list reference DEU/002/2026/001.

It also records the removal of DEU/011/2025/005 from the closed list. The stated explanation is that the derogation closed following a return to conformity within the derogation period. This is not presented as a new removal from the open list.

Who Is Affected

The update concerns the relevant authorisation holders and NHS or social care organisations monitoring supply of the affected devices. However, the supplied latest update does not identify the manufacturers or devices associated with either reference.

MHRA states that exceptionally authorised devices can be sold to the NHS and within social care settings to maintain supply. Authorisations are issued directly to manufacturers and normally do not permit distributor sales.

Regulatory and Technical Implications

MHRA considers applications only where there is a clear clinical need and no available supply of CE-marked or already derogated alternatives. The latest entry does not announce a change to that general approach.

The publication separately lists recently expired, withdrawn or cancelled authorisations for a two-month period. Removal from that closed list should therefore not, by itself, be interpreted as the grant of a new exceptional use authorisation.

Manufacturer Actions

A practical follow-up for affected manufacturers is to match the references against their authorisation documents and current list entries. The revised expiry date and authorisation-specific conditions for DEU/002/2026/001 cannot be established from the supplied summary.

Supply planning should distinguish the publication’s general explanation from each device’s specific authorisation scope. These are editorial follow-up recommendations: the update does not announce a new application obligation or compliance deadline.

Confirmed Dates

The publication was first issued on 29 June 2020 and last updated on 2 October 2026. No revised expiry date is supplied for the latest extension. MHRA says it updates the list weekly when there are changes to report.

Official Source

MHRA’s GOV.UK publication, “Medical devices given exceptional use authorisations,” links to separate HTML lists for devices covered by authorisations and those no longer covered.

https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations