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MHRA updates exceptional use authorisation lists for medical devices again

🇬🇧 MHRA · Tue 27 Oct 2026

The UK regulator revised both its open and closed device exemption lists on 27 October 2026, continuing a run of near-weekly changes through the year.

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its "Medical devices given exceptional use authorisations" page on 27 October 2026. The entry says both the list of devices currently given exceptional use authorisations and the list of devices no longer covered by one were revised. The note does not say which manufacturers or devices changed.

The page, first published on 29 June 2020, names manufacturers and their devices granted an exemption by MHRA. It also includes manufacturers whose exemption has expired or been cancelled. Its change log shows frequent edits in 2026, mostly extensions to existing authorisations, new entries and moves from the open list to the closed one.

Recent entries show the pattern. On 9 October the agency recorded an extension for the modified BD BodyGuard Accessory Products "Bolus Cable". On 2 October it noted an extension for DEU/002/2026/001. It also removed DEU/011/2025/005 from the closed list, saying the derogation had closed after a return to conformity within the derogation period. Andocor NV received an extension on 28 September.

Earlier in the year, MHRA added UK Health Security Agency to the open list (29 May) and Medlogical Innovations' ProFocal System (13 March). On 24 August it added Clinisys WinPath 2023.3, WinPath v5 and WinPath v7. It also extended American Surgical Company's radiopaque cotton balls to 20 February 2027. In mid-August three further authorisations were extended to February 2027.

What it means for your team

  • Manufacturers, importers and distributors of devices on either list should check their current status and expiry dates on the live page, because the 27 October changes are not itemised.
  • Healthcare providers relying on exempted devices should watch for expiry or closure, since entries move to the closed list when authorisations lapse or derogations end.
  • Teams should record reference numbers (DEU/xxx/year/xxx format) and extension dates, which the agency has been changing often, in their regulatory trackers.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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