Exceptional Use Authorisation (EUA) in the UK

What is an Exceptional Use Authorisation?

An Exceptional Use Authorisation (EUA) allows a medical device that does not have UKCA or CE certification to be placed on the UK market when doing so is in the interest of protecting public health. EUAs are issued by the Medicines and Healthcare products Regulatory Agency (MHRA) for a specified limited period and exempt manufacturers from certain regulatory requirements, provided that ongoing progress towards full regulatory conformity is demonstrated. An EUA is not an alternative route to standard market access.
Source: Exceptional Use Authorisation (gov.uk)

Legal Framework and Scope

In Great Britain (England, Scotland and Wales), EUAs operate under the UK Medical Devices Regulations 2002, with specific provisions:

• Regulation 12(5) for general medical devices;
• Regulation 26(3) for active implantable medical devices;
• Regulation 39(2) for in vitro diagnostic (IVD) devices.
  These provisions exempt manufacturers from certain essential requirements and marking requirements including UKCA/CE marking where justified by public health need.
  Source: Exceptional Use Authorisation (gov.uk)

In Northern Ireland, EU MDR (2017/745) and EU IVDR (2017/746) apply alongside UK regulations under the Northern Ireland Protocol, and EUAs may be granted under:

• Article 59(1) of the EU MDR;
• Article 54(1) of the EU IVDR.
  These likewise exempt manufacturers from applicable conformity assessment procedures when use of the device is essential for public health or patient safety.
  Source: Exceptional Use Authorisation (gov.uk)

Requirements for an EUA

To qualify for an EUA, manufacturers (or authorised representatives) must demonstrate that:

• There is an immediate clinical need or public health need for the device;
• No suitable UKCA or CE-marked alternatives are available, or there is a supply disruption of compliant devices (for Great Britain applications);
• There is sufficient technical and clinical evidence to support the safe ongoing supply;
• A plan for meeting unmet regulatory requirements is provided;
• Evidence such as ISO 13485 certification or equivalent may be required.
  Source: Exceptional Use Authorisation (gov.uk)

Operational Conditions and Reporting

EUAs are granted for a defined period with conditions to ensure compliance progression. Once granted, manufacturers must submit monthly reports to the MHRA covering:

• Supply figures;
• Complaints and adverse events;
• Progress towards UKCA or CE certification (for Great Britain) or CE certification (for Northern Ireland).
  EUAs are typically issued to allow supply of critical devices to government-funded health services like the NHS, not for general commercial distribution.
  Source: Exceptional Use Authorisation (gov.uk)

Application Process

Only the manufacturer, their UK Responsible Person (UKRP) (for Great Britain), or Authorised Representative (for Northern Ireland or whole UK) may submit an EUA application. Importers, distributors, or end users cannot apply directly. The application must include evidence of:

• Clinical need or lack of alternatives;
• Justification for non-certification;
• Explanation of unmet regulatory requirements;
• Instructions for use, labelling and marketing material;
• Evidence for safe use and projected supply volumes.
  Source: Exceptional Use Authorisation (gov.uk)

Outcome and Oversight

The MHRA assesses each EUA individually. Outcomes may include:

• Granting the EUA with defined conditions and duration;
• Refusal if requirements are not met;
• Monitoring and compliance oversight during the EUA period.
  Mechanisms for complaints and reviews are also part of the governance framework.
  Source: Exceptional Use Authorisation (gov.uk)

Practical Considerations

EUAs are especially relevant where critical medical devices are in short supply or unavailable in compliant form, such as in urgent or emergency health situations. The issuer expects applicants to show a clear public health benefit and feasible approach to regulatory compliance.
Source: Exceptional Use Authorisation (gov.uk)

Conclusion

The Exceptional Use Authorisation mechanism provides a limited, conditional pathway for placing essential but non-compliant medical devices on the UK market in justified public health circumstances, while preserving regulatory integrity and patient safety.
Source: Exceptional Use Authorisation (gov.uk)