Exceptional Use Authorisations (EUA)
The Exceptional Use Authorisation mechanism is a UK-specific provision. It has no direct equivalent in the pre-Brexit EU MDR framework.
What is an Exceptional Use Authorisation?
An Exceptional Use Authorisation (EUA) is a regulatory mechanism by which MHRA can authorise the use of a medical device that has not completed the standard conformity assessment process (and therefore does not bear the UKCA or CE mark) in exceptional circumstances.
EUAs may be appropriate when:
- There is a public health emergency or significant unmet need that cannot be met by existing authorised devices
- The device represents a potentially life-saving technology where the risk of not using it outweighs the risk of using an unevaluated device
- There are supply chain disruptions affecting availability of UKCA-marked equivalents
The COVID-19 precedent
The COVID-19 pandemic demonstrated the EUA mechanism in practice. MHRA used exceptional access provisions to:
- Authorise the use of COVID-19 rapid antigen tests before they had completed full conformity assessment
- Facilitate access to ventilators manufactured under emergency conditions
- Streamline access to personal protective equipment (PPE) during supply shortages
The experience of COVID-19 has informed MHRA's thinking on how to balance regulatory rigour with the need for rapid access in emergencies.
How EUAs are issued
EUAs are issued by MHRA on a case-by-case basis. Manufacturers seeking an EUA must:
- Contact MHRA to discuss the exceptional circumstances
- Provide available safety and performance data (even if incomplete compared to a full conformity assessment package)
- Demonstrate that the clinical need cannot be met by an available, authorised device
- Agree to provide additional data and to complete full conformity assessment as soon as practicable
EUAs are time-limited and subject to conditions.
Official references
| Reference | Description |
|---|---|
| UK MDR 2002 | Exceptional circumstances provisions |
| MHRA: Exceptional use of medical devices | MHRA guidance on EUAs |