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
| Reference | Description |
|---|---|
| Medical Devices Act 2021 | Enabling powers for Approved for Use |
| MHRA: Innovation office | MHRA's innovation support |
Consider expanding this section to include:
Key application requirements
To apply for an Approved for Use designation, manufacturers should provide: Preliminary safety and performance data (even if not yet complete) Clinical evidence of unmet need or public health urgency Quality Management System certification or evidence of conformity with ISO 13485 Proposed conditions of use and monitoring requirements Commitment to complete full conformity assessment within a defined timeframe
Expected timelines and conditions
Approved for Use designations are typically time-limited (e.g., 12–24 months) and conditional on: Providing periodic updates to MHRA on safety and performance Completing full conformity assessment and obtaining UKCA marking before designation expires Agreeing to enhanced post-market surveillance Maintaining transparent communication with MHRA
Approved for Use vs. Exceptional Use Authorisation (EUA)
While both mechanisms support early access, they differ: Approved for Use: for innovative devices with unmet clinical need; intended for planned market access EUA: emergency mechanism for acute supply shortages or public health crises