MHRA Updates Medical Device Registration Guidance in October 2026: Great Britain Still Requires Device-by-Device Registration, Northern Ireland Moves to EUDAMED

MHRA Updates Medical Device Registration Guidance in October 2026: Great Britain Still Requires Device-by-Device Registration, Northern Ireland Moves to EUDAMED

Published: 17 October 2026, 13:30 | Category: Registration and Market Access

On 16 October 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on registering medical devices to place on the market. The update confirms that the Great Britain market still requires MHRA registration before placing devices on the market, to be handled by a UK Responsible Person. The Northern Ireland market has been handled through EUDAMED since 28 May 2026, with no MHRA registration required, except for custom-made devices. The guidance also notes that former authorized representatives that did not convert their role to a UK Responsible Person by 30 March 2026 have had their registration system accounts closed.

Sources: UK Government (GOV.UK) — MHRA: Register medical devices to place on the market: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market (16 October 2026); UK Government (GOV.UK) — Regulation of medical devices in Northern Ireland: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr; European Commission — EUDAMED roadmap: https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en

The update focuses on a very specific point

At first glance, the change is routine maintenance of a guidance page. In practice, it makes two points clearer. First, the registration routes for Great Britain (England, Wales and Scotland) and Northern Ireland are now fully separate. Second, after separation, the applicable entities, timelines and systems are different for each market.

Great Britain: registration before placing on the market

The guidance reiterates that all medical devices, including in vitro diagnostic devices (IVDs), custom-made devices, systems and procedure packs, must be registered with the MHRA before being placed on the Great Britain market. The situations requiring registration are listed item by item:

• Class I, IIa, IIb and III devices manufactured and sold, rented, lent or gifted;
• Devices of the same classes refurbished or relabeled under the manufacturer's own name;
• Systems or procedure packs containing at least one medical device;
• Custom-made devices;
• In-house IVDs;
• IVDs undergoing performance evaluation.

Where the manufacturer is outside the United Kingdom, it must designate a UK Responsible Person, who is responsible for the registration. This requirement is unchanged, but its implication is clear: overseas companies cannot open an account and register by themselves; the registration action is tied to the UK-based entity.

A deadline that has passed but still affects account status

The guidance includes a reminder: if a former Great Britain authorized representative did not update its role to a UK Responsible Person before 30 March 2026, its registration system (DORS) account is now closed.

In practice, this carries more weight than the wording suggests. In the past, many overseas manufacturers used an authorized representative to manage registration. After the role name changed to UK Responsible Person, some companies updated contracts but did not update the role in the system. Once an account is closed, new device registrations and changes to registration information cannot be made, even though the devices may still be on the market. The guidance also states elsewhere that any change to registration information may attract a statutory fee per application.

Northern Ireland follows a different route

From 28 May 2026, all medical devices other than custom-made devices must be registered in EUDAMED before being placed on the EU and Northern Ireland markets. From that date, MHRA registration is no longer required for the Northern Ireland market.

Custom-made devices are the exception. They must still be registered with the MHRA within 28 days after being placed on the Northern Ireland market, regardless of the manufacturer's country. If a Northern Ireland-based authorized representative is appointed, it may register on the manufacturer's behalf. If an EU-based authorized representative is appointed, the manufacturer must complete all custom-made device registrations itself.

Two further boundary points are easily confused: a Great Britain manufacturer selling devices into Northern Ireland still needs an authorized representative established in the EU or Northern Ireland; a manufacturer established outside Northern Ireland or the EU also needs such a representative.

Three determination points that are often overlooked

Placing on the market versus putting into service. The guidance defines placing on the market as the first making available of a device for use or distribution on the UK market, whether or not for payment. Putting into service is the stage at which the device reaches the final user. Where a device is only put into service without market distribution, for example hospital in-house manufacture for own use, MHRA registration is encouraged rather than mandatory. Where both occur, registration is mandatory.

Discontinuation. Once a device is discontinued and no longer placed on the market, registration is no longer required, but post-market surveillance and vigilance obligations for devices already placed on the market continue. Discontinuation does not terminate obligations.

The nature of registration. The guidance makes clear that MHRA registration does not constitute any form of recognition, certification, approval or endorsement. Companies must not make claims on that basis and must not use the MHRA logo on packaging, instructions for use, promotional materials or test certificates.

Sources and applicability note

Sources: UK Government (GOV.UK) — Register medical devices to place on the market, page updated 16 October 2026: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market; UK Government (GOV.UK) — Regulation of medical devices in Northern Ireland: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr; European Commission — EUDAMED roadmap (EUDAMED rollout schedule): https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en

Verification scope and access date: This review checked the full text of the above MHRA registration guidance, the Northern Ireland medical device regulation guidance, and the EUDAMED schedule document cited in the guidance. The access date was 17 October 2026. The dates, scope of application and entity requirements in this article are taken from the original text of those pages.

Applicability note: This article is an interpretation of public guidance issued by the UK regulator. It does not constitute a conclusion or commitment regarding any specific product, company or registration application. Registration obligations depend on device classification, the manner of placing on the market and actual commercial arrangements. Specific determinations should be based on the original MHRA text and current legislation. The guidance may change with subsequent official updates.

AIMEILI Regulatory Interpretation

The update confirms that the UK no longer operates a single registration logic. For Great Britain, MHRA registration remains a pre-market administrative requirement at device level and is not a conformity assessment or approval. The UK Responsible Person is both the account holder and the regulatory interface; an overseas manufacturer cannot bypass this requirement by self-registering. For Northern Ireland, most devices now follow the EU route through EUDAMED, while custom-made devices remain subject to a specific MHRA registration within 28 days. This means regulatory affairs teams need to maintain two separate market-access maps for the same UK footprint.

The DORS account closure point is operationally significant. A closed account can block new registrations and variations even while devices remain on the market. Companies should therefore audit legacy authorized representative arrangements, verify the current DORS account status and role designation, and ensure that contracts, system records and regulatory contacts are aligned with the UK Responsible Person appointment. The distinction between placing on the market and putting into service also affects whether registration is mandatory or encouraged, and discontinuation does not end post-market surveillance or vigilance duties. Finally, because MHRA registration is not an endorsement, all labelling, instructions, promotional materials and certificates should be checked for prohibited MHRA logo use or implied approval claims.

Business Impact

• Manufacturers: Review UK market access arrangements, confirm that a valid UK Responsible Person is appointed for Great Britain, verify DORS account access and role status, and update contracts and internal records where legacy authorized representative arrangements remain. For Northern Ireland, confirm EUDAMED actor and device data, and check whether a Northern Ireland or EU authorized representative is required.
• Distributors: Before accepting or supplying devices, verify that the relevant registration route has been completed, that the UK Responsible Person or authorized representative is correctly identified, and that product documentation does not imply MHRA approval or use the MHRA logo.
• CROs and regulatory affairs teams: Update regulatory intelligence and client questionnaires, build a device inventory covering Great Britain and Northern Ireland separately, identify custom-made devices and IVDs with special requirements, and prepare remediation plans for closed accounts or missing variations.
• Compliance and commercial planning: Budget for potential statutory fees for registration changes, align post-market surveillance and vigilance resources with continued obligations after discontinuation, and avoid market access delays caused by administrative registration gaps.