Exceptional Use Authorisation

An exceptional use authorisation (EUA) allows non-UKCA/CE certified medical devices to be placed on the UK market when doing so in the interest of the protection of public health. EUAs are granted by the MHRA for a specified period and exempt manufacturers from certain regulatory requirements. The MHRA reviews each EUA application individually. EUAs are subject to specific conditions and require that the manufacturer demonstrate ongoing progress towards full conformity with the applicable regulations. An EUA is not an alternative route to the UK market.

Great Britain (England, Scotland and Wales)

In England, Scotland and Wales, the exemption applies under UK Medical Devices Regulations 2002:

• 12(5) for general medical devices;
• 26(3) for active implantable medical devices;
• 39(2) for in vitro diagnostic (IVD) devices.

These provisions exempt manufacturers from:

• Regulations 8, 22, or 34 (compliance with the essential requirements and IVD devices not ready for use);
• Regulations 10, 24, or 36 and 38 (CE/UKCA marking requirements).

To qualify for an EUA in Great Britain, manufacturers must provide justification that the exemption is needed in the interests of protection of health. This includes, for example, fulfilling an immediate patient or public health need or preventing disruptions in patient care.

Northern Ireland

In Northern Ireland, the EU Medical Devices Regulation (2017/745) (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) additionally apply alongside UK Medical Devices Regulation 2002, the Medical Devices (Northern Ireland Protocol) Regulations 2021 (SI 2021/905) and the Medical Devices (In Vitro Diagnostic Devices etc) (Amendment) Regulations 2024 (SI 2024/221). An EUA may be granted under:

• Article 59(1) of the EU MDR
• Article 54(1) of the EU IVDR

These provisions exempt manufacturers from:

• Article 52 of the EU MDR (applicable conformity assessment procedures for medical devices)
• Article 48 of the EU IVDR (applicable conformity assessment procedures for IVD medical devices)

As is the case for Great Britain, an EUA for Northern Ireland may be granted if use of the device is in the interest of the protection of public health or patient safety or health.

Requirements under EUA

Each EUA is granted for a limited time, with conditions to facilitate compliance with relevant medical devices legislation. Once granted, manufacturers must report monthly to the MHRA on supply figures, complaints, adverse events, and progress towards UKCA or CE certification (for EUAs granted for the Great Britain market); or CE certification (for EUAs granted for the Northern Ireland or whole UK market).

EUAs are typically only granted to enable supply of critical medical devices to government-funded health organisations such as the NHS, and within social care settings. An EUA will not typically be granted outside of these purposes (e.g., for commercial distribution to private healthcare providers).   

All other relevant regulatory requirements, including post-market surveillance and vigilance, still apply. For EUAs in Great Britain, a UK Responsible Person (UKRP) must be appointed for manufacturers based outside the UK. For EUAs in Northern Ireland, manufacturers based outside the EU or Northern Ireland should appoint an Authorised Representative.

How to Apply for an EUA in Great Britain and Northern Ireland 

Only the manufacturer of the device, or their UKRP, or Authorised Representative, can submit and support an EUA application. Applications from others, for example, importers, distributors, or end uses like hospitals, will not be accepted.  The person making the application for an EUA should contact the manufacturer to discuss whether they are willing to support submitting an EUA application. 

Applicants must demonstrate that the device meets the following conditions:    

• There is an immediate clinical need; and

For applications for Great Britain only:

• There are no alternative UKCA or CE-marked devices available on the market; or
• There is a disruption in supply of relevant UKCA or CE-marked devices.

For applications for the whole UK, or Northern Ireland only:

• There are no alternative CE-marked devices available on the market; or
• There is a shortage in supply of relevant CE-marked devices.

Applicants must also provide comprehensive evidence addressing the following criteria:

• Demand for the device e.g. evidence of a purchase order/enquiries from NHS or other government health organisation for the applicant to supply
• Justified reasons for the product not having a valid UKCA or CE mark
• An explanation/plan for addressing any essential requirements that are not currently met
• Evidence of ISO 13485 certification or equivalent
• Evidence of regulatory approval of the device within other jurisdictions - e.g., US FDA, TGA, etc
• Explanation of any alternative UKCA or CE marked products on the UK market and reasons why using these products would not be appropriate
• Evidence of adverse impact to public health if the device is not used
• Evidence of financial burden on the Trusts/NHS/DHSC if the device is not used
• Numbers of product likely to be supplied under the exemption, plus an indication of how widely used the product is
• Instructions for use, labelling plus relevant marketing material
• Clinical evidence supporting the intended use and performance of the device – e.g. clinical studies, literature etc
• A detailed plan on how the manufacturer will demonstrate compliance or withdrawal of the device from the market after the EUA expires, including a plan to gain or re-gain CE/UKCA marking and expected timeline

To apply for an EUA, please complete the Exceptional Use Authorization (EUA) application form and send additional documentation to  devices.exceptionaluse@mhra.gov.uk.

Assessment steps of EUA applications for Great Britain and Northern Ireland

Once an application is received, the MHRA will undertake an initial check to make sure that:

• the application is not related to an existing or previous compliance investigation
• the justification for an EUA application is in the interests of the protection of public health
• the application contains the required manufacturer and product information
• all other questions in the application form have been addressed

Once through initial checks, the MHRA prioritises applications based on public health needs. Following the initial check that all required information is supplied, the application will undergo a review process, as follows:

• A technical assessment by a Benefit Risk/Therapeutic Area Unit assessor
• A clinical assessment by a clinician
• A senior approving officer then considers the recommendation by assessors

Applicants should ensure their applications are comprehensive and should respond promptly to requests for additional information during the review process.

The MHRA considers several factors when deciding whether to grant an EUA, including:

• Why the device is not able to meet all regulatory requirements.
• Whether supply of the device is necessary to protect health and there are no viable UKCA/CE-marked alternatives (as applicable based on the scope of the application) on the UK market.
• Whether there is sufficient clinical, technical, and other relevant evidence to support the safe ongoing supply of the device.

If an EUA is granted, the applicant will be notified by an official letter, outlining the conditions that must be met during the EUA period.

Outcome reporting

All granted EUAs are published on GOV.UK and remain available for two months after expiration, showing:

• Manufacturer
• Device name
• EUA issue date
• EUA expiry date
• MHRA reference number

See List of medical devices given exceptional use authorisations for a list of manufacturers and their medical devices which have been granted an EUA by the MHRA. 

Applicants appearing on the list must not use the name of the MHRA, or any Crown Body, to show preference to their products, services, or research.

Complaints

Applicants who wish to complain about the process should email: devices.exceptionaluse@mhra.gov.uk

You must include a full summary of the complaint and any supporting information you consider relevant.

Reviews

If your application is unsuccessful, and you wish to appeal against this decision, please see MHRA’s Appeals Procedure (for medical devices)