Northern Ireland Registration: EUDAMED for Standard Devices, MHRA for Custom-Made Devices

1. Key takeaways

Northern Ireland completed its registration switch on 28 May 2026: all medical devices except custom-made devices must be registered in EUDAMED before being placed on the EU and Northern Ireland markets, and MHRA registration is no longer required for them. Custom-made devices are outside the scope of EUDAMED and must still be registered with MHRA within 28 days of being placed on the Northern Ireland market. In addition, manufacturers established outside Northern Ireland and the EU must appoint an authorised representative established in the EU or Northern Ireland; manufacturers in Great Britain must also appoint such a representative. The result is a two-track system that a single company can straddle: the same manufacturer may hold EUDAMED registrations for its standard portfolio and MHRA registrations for its custom-made line, with different fees, different timelines and different registration operators. This article explains the switch, the two branches it creates, the single-account rule for DORS and the authorised representative requirements that determine who performs each registration.

2. Legal basis

• The Medical Devices (Northern Ireland Protocol) Regulations 2021 (SI 2021/905): made 26 July 2021, in force 27 July 2021; reg 7(1)–(4) (registration of custom-made devices), reg 7(2)(a) (the 28-day time limit), reg 7(5) (fees, adjusted by SI 2026/197 reg 5(2)(a) to £300).
• The Medical Devices (Fees Amendment) Regulations 2026 (SI 2026/197, in force 1 April 2026): reg 5(2)(a)–(f).
• Regulation (EU) 2017/745 and Regulation (EU) 2017/746: apply in Northern Ireland under the Windsor Framework, applicable from 26 May 2021.
• Official guidance: GOV.UK, Register medical devices to place on the market (the Registration for the Northern Ireland market section).

The legal architecture has three pillars. First, the EU regulations apply in Northern Ireland under the Windsor Framework, which is why EUDAMED — the EU’s database — becomes the registration venue for standard devices placed on the Northern Ireland market. Second, SI 2021/905 keeps custom-made devices on the MHRA track, because they have no EUDAMED route; its reg 7 sets the 28-day time limit and the fee power. Third, SI 2026/197 aligns the money: reg 5(2)(a)–(f) updates the Northern Ireland fee provisions so that custom-made device registration under the MHRA track carries the same £300 annual structure as the Great Britain route. Reading the three together explains why a manufacturer can face both systems at once, each with its own rules.

3. Expert insights

Insight 1: one switch, two branches. After 28 May 2026, registration duties for the Northern Ireland market split according to whether the device is custom-made: non-custom devices go through EUDAMED (free, centrally funded by the European Commission), while custom-made devices go through MHRA (charged, and now with the new annual maintenance fee). The same company therefore runs two product lines in two systems in parallel, and the accounting, timeline and responsible function differ on each track. Companies with mixed portfolios should map every product to its branch before the next placing, because using the wrong track — EUDAMED for a custom-made device, or MHRA for a standard one — does not satisfy the applicable duty.

Insight 2: a DORS account is still one is enough. The official guidance is explicit: only one DORS account is needed to cover both the Great Britain and Northern Ireland markets. This lowers the administrative cost of account management — one set of contacts, one fee status view, one audit trail — but it does not reduce the substantive obligations, which remain distinct for each market. In particular, the account’s GMDN category structure still drives the annual fee for the Great Britain and custom-made registrations, so the same consolidation logic applies even though the account now serves two regimes.

Insight 3: the authorised representative requirement applies to Great Britain manufacturers too. The official guidance records that manufacturers in Great Britain must appoint an authorised representative established in the EU or Northern Ireland to place devices on the Northern Ireland market. An authorised representative established in Northern Ireland can register custom-made devices with MHRA on the manufacturer’s behalf, whereas where the authorised representative is established in the EU, the manufacturer itself registers all of its custom-made devices. This detail decides who actually operates the registration — the same appointment decision on paper leads to different hands on the keyboard, and companies should choose the representative’s location with that operational consequence in mind.

4. Practical recommendations

GRZAN recommends maintaining a separate ledger for Northern Ireland business, kept distinct from the Great Britain ledger but sharing the same master data. Suggested fields include the placing status, the EUDAMED registration number (for non-custom devices) or the MHRA registration number (for custom-made devices), the authorised representative’s identity and location, and the 28-day countdown for custom-made devices. For custom-made devices, set a placing-day record point at the logistics release step so the 28-day clock starts from a documented date rather than an estimated one, and route the countdown to an owner who can complete the MHRA registration well inside the window. Review the ledger quarterly alongside the DORS account review, since the two views must stay consistent: a custom-made device registered late or missed in the ledger is exactly the kind of gap that surface checks of the account alone will not reveal.

5. Verification checklist

For any Northern Ireland placing, confirm each of the following items.

• □ The registration route for custom-made and non-custom-made devices has been distinguished
• □ Non-custom-made devices have completed EUDAMED registration
• □ Custom-made devices are planned for MHRA registration within 28 days of placing
• □ An authorised representative established in the EU or Northern Ireland has been appointed
• □ The single DORS account has been confirmed to cover Great Britain and Northern Ireland

Regulatory information verified as of 29 October 2026.

• Appointment of the UK responsible person (UKRP) and support for signing the letter of designation
• End-to-end MHRA registration (DORS) filing and account lifecycle management
• Device classification assessment, GMDN code selection and annual registration fee calculation
• Dual-pathway design for Great Britain and Northern Ireland, including the UK(NI) option
• Post-market surveillance (PMS) system setup, PMSR/PSUR preparation and vigilance report submission
• Emergency handling of serious adverse events and field safety corrective actions (FSCA)
• Monitoring of UK regulatory changes and compliance gap assessment

Working with GRZAN. GRZAN Global supports manufacturers entering the United Kingdom market with the full scope of UKRP and fee-budgeting services described above: designing dual-pathway registration for Great Britain and Northern Ireland, managing EUDAMED and MHRA registrations in parallel, coordinating authorised representative arrangements, and forecasting annual registration fees by GMDN category. For a consultation, contact us at info@grzanglobal.com.