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Approved for Use designations

What is an Approved for Use designation?​

MHRA has powers under the Medical Devices Act 2021 to designate certain devices or categories of device as "Approved for Use" — a mechanism that can facilitate rapid access to innovative or urgently needed devices while a fuller regulatory assessment is completed.

This mechanism is intended to complement, rather than replace, the standard UKCA / CE conformity assessment pathway.

Relationship to the reform programme​

The "Approved for Use" concept is part of MHRA's broader reform programme and is still being developed. MHRA has signalled its intention to use this mechanism to support innovation and rapid patient access, particularly for:

  • Novel breakthrough technologies
  • Devices addressing unmet clinical needs
  • Devices where the standard pathway would result in unacceptable delays to patient access

Current status​

As of May 2026, the formal Approved for Use designation mechanism has not yet been fully operationalised in published guidance. Monitor MHRA's innovation hub and the What's New section for implementation details.

Official references​

ReferenceDescription
Medical Devices Act 2021Enabling powers for Approved for Use
MHRA: Innovation officeMHRA's innovation support