UK MHRA Updates Exceptional Use Authorisation Lists in October 2026: EUAs Address Public Health Gaps Only, Not an Alternative Route into the UK Market

On 27 October 2026 the UK Medicines and Healthcare products Regulatory Agency (MHRA) refreshed two lists at the same time: the list of devices holding an Exceptional Use Authorisation (EUA) and the list of devices that no longer benefit from such an authorisation. The list page was first published on 29 June 2020; this update did not change the rules themselves, only the lists.

What changed in and around October

The most recent changes are concentrated in September and October. On 9 October, an extension was granted for BD's BodyGuard accessory product, the Bolus Cable. On 2 October two records were processed: DEU/002/2026/001 was granted an extension, while DEU/011/2025/005 was moved to the closed list on the grounds that conformity had been restored during the exemption period. On 28 September Andocor NV received an extension, and on 11 September a further extension was added for DEU/002/2026/002.

August saw denser activity. On 24 August, Clinisys's WinPath 2023.3, WinPath v5 and v7 were added, and the authorisation for American Surgical's radiopaque cotton balls was extended to 20 February 2027. On 14 August, three authorisations were extended to 6 February 2027 and 13 February 2027 respectively. On 31 July, mypen 2 was extended and ClearGuard HD was moved from the open list to the closed list.

What kind of authorisation an EUA is

MHRA guidance is explicit: an Exceptional Use Authorisation allows devices that do not hold UKCA or CE certification to be placed on the UK market, provided that doing so serves the interests of protecting public health. Authorisations are issued by the MHRA after case-by-case review, are time-limited, exempt manufacturers from certain regulatory requirements, carry specific conditions, and require the manufacturer to demonstrate that it is continuing to work towards full regulatory conformity. One statement in the guidance is worth remembering: an EUA is not an alternative route to the UK market.

Scope of application

The scope falls into two parts. In England, Scotland and Wales, under the UK Medical Devices Regulations 2002, general devices fall under Regulation 12(5), active implantable devices under Regulation 26(3) and in vitro diagnostic devices under Regulation 39(2); the exemption concerns essential requirements conformity and the provisions relating to UKCA/CE marking. Northern Ireland is handled separately under Article 59(1) of the EU MDR and Article 54(1) of the EU IVDR, where the exemption concerns the corresponding conformity assessment procedures.

Conditions for obtaining an EUA

Applicants must demonstrate an urgent clinical need and that no alternative UKCA/CE-certified product is available on the market, or that the supply of such products has been disrupted. The MHRA also explains where such authorisations are typically directed: generally they are used only to supply the NHS and other government-funded healthcare providers and social care settings, and are normally not granted for commercial distribution to private healthcare providers.

The documentation requirements are extensive. They include evidence of purchasing intent or orders from the NHS or another public body; a justified reason why the product lacks valid certification; an explanation of how outstanding essential requirements will be met; an ISO 13485 or equivalent certificate; regulatory approvals in other jurisdictions (such as the US FDA or Australia's TGA); an explanation of why existing certified alternatives are not suitable; evidence of the public health and financial impact of not supplying the device; the projected supply quantity and scope of use; instructions for use and labelling; clinical evidence supporting the intended purpose and performance; and a detailed plan and timeline for achieving compliance or withdrawing the device from the market when the authorisation expires.

Authorisation does not mean unrestricted market access

Authorisations are granted for a fixed period, and the conditions are set out in a formal notification letter. Holders must report monthly to the MHRA on supply volumes, complaints, adverse events and progress towards UKCA/CE certification (or, for Northern Ireland or UK-wide authorisations, progress towards CE certification). Manufacturers established outside the UK must appoint a UK Responsible Person (UKRP) for England, Scotland and Wales scenarios, and an authorised representative for Northern Ireland scenarios.

There are also restrictions on who may apply. Only the manufacturer itself, its UKRP or its authorised representative may submit and support an application; applications submitted by importers, distributors or user organisations such as hospitals are not accepted. Granted authorisations are published on GOV.UK, listing the manufacturer, device name, issue date, expiry date and MHRA reference number, and the record remains on the list for two months after expiry.

The two lists should be read together

The open list contains authorisations that currently remain in force; the closed list contains those that have lapsed or been withdrawn. A record moving from open to closed does not necessarily indicate a problem; it may be exactly the outcome the regulator wants to see, namely that the company restored conformity during the exemption period and the exemption has therefore come to a natural end. Conversely, repeated "extension" entries are the real signal worth watching, because they show that the company has not yet completed certification and is relying on short-term renewals to maintain supply.

Sources and scope of verification

Sources: MHRA list page, "Medical devices given exceptional use authorisations", https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations, first published 29 June 2020, last updated 27 October 2026; MHRA guidance, "Exceptional Use Authorisation", https://www.gov.uk/guidance/exceptional-use-authorisation, published 31 March 2025.

Verification scope and access date: both pages were accessed on 29 October 2026, and the update log on the list page (including the change notes from 31 July 2026 to 27 October 2026) and the guidance text on scope, legal basis, application conditions and post-authorisation obligations were checked. The individual device detail files within the list were not opened one by one.

Applicability note: this article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. The specific authorisation status, duration and conditions are governed by the official MHRA lists and the formal notification letter, and the information may change with subsequent official updates.

AIMEILI regulatory interpretation

The October 2026 list update reinforces a point that is frequently misunderstood in industry practice: an EUA is a public health safeguard mechanism, not a market access pathway. The MHRA's wording is unambiguous, and the structure of the regime supports it. An EUA is granted case by case, for a defined period, against evidence of an urgent clinical need and an absence of certified alternatives, and is normally confined to supply to the NHS and other publicly funded providers. It does not confer UKCA or CE marking, does not create a presumption of conformity, and does not remove the obligation to progress towards full certification.

Three features of the regime are particularly important for regulatory strategy. First, the applicant is restricted to the manufacturer, its UKRP or its authorised representative; distributors and importers cannot apply, which means the compliance burden and the regulatory relationship sit with the manufacturer. Second, the reporting obligations are ongoing and substantive: monthly reporting on supply volumes, complaints, adverse events and certification progress turns the authorisation into a supervised transitional arrangement rather than a static permission. Third, the movement of records between the open and closed lists is itself informative. Closure following restoration of conformity is a successful exit, whereas serial extensions indicate a certification programme that is behind schedule and a supply arrangement that remains dependent on regulatory forbearance.

The August entries also show the range of products involved, from laboratory information systems such as Clinisys WinPath to consumables such as American Surgical's radiopaque cotton balls, which underlines that EUAs are not confined to a single device category and are assessed on the basis of clinical need rather than product type.

Business impact

• Do not build a UK market entry plan on an EUA. Companies without UKCA or CE certification should treat the EUA as a contingency for genuinely unmet public health need, and should plan certification as the primary route. Commercial distribution, particularly to private providers, is unlikely to be supported.
• Budget for the evidentiary burden. Applications require NHS or public body purchase intent, justification for the absence of certification, a remediation plan, ISO 13485 evidence, other regulators' approvals, clinical evidence and a withdrawal or compliance timeline. This is a substantial dossier, not a short notification.
• Appoint the correct UK entity. Non-UK manufacturers need a UKRP for England, Scotland and Wales, and an authorised representative for Northern Ireland. Importers and distributors cannot substitute for these roles in the application process.
• Operationalise monthly reporting. Supply volumes, complaints, adverse events and certification progress must be reported monthly. Companies should build this into quality management system processes and pharmacovigilance or post-market surveillance workflows from day one.
• Monitor the lists as a competitive and risk signal. Repeated extensions for a given manufacturer suggest certification delays and potential supply continuity risk. Movement to the closed list after conformity is restored indicates a manufacturer that has completed the transition and may now compete on a fully certified basis.
• Manage timelines around expiry. Authorisations are time-limited and records remain published for two months after expiry. Companies should plan certification milestones and, where necessary, extension requests well before expiry, and should have a documented exit or withdrawal plan as required by the authorisation conditions.

Sources

• Medicines and Healthcare products Regulatory Agency (MHRA), 2026-10-27
• Medicines and Healthcare products Regulatory Agency (MHRA), 2025-03-31