Before importing an in vitro diagnostic (IVD) device into the UK, decide whether it is for Great Britain (England, Scotland and Wales) or Northern Ireland. The applicable rules differ: Great Britain uses Part IV of the UK Medical Devices Regulations 2002, as amended, while EU IVDR applies in Northern Ireland. Then confirm the product’s intended purpose, the businesses’ roles in the supply chain, and the conformity, registration and labeling requirements for that destination. The deadlines below reflect MHRA guidance current on 7 October 2026; verify the device’s specific eligibility before relying on a transition route.
1. Which UK market will the device enter?
Choose the destination before assessing conformity or placing an order. A device intended for Great Britain follows a different regulatory route from one intended for Northern Ireland.
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| Check | Great Britain | Northern Ireland |
|---|---|---|
| Core IVD rules | Part IV of the UK Medical Devices Regulations 2002, as amended | EU IVDR |
| Market marking | UKCA route; some CE-marked devices remain eligible under transition provisions | CE, or CE UKNI when applicable; UKCA alone is not accepted |
| Device registration | IVD registration with MHRA is required before placement on the Great Britain market | Check the applicable device-registration requirements for the device and operator |
| Importer registration or notification | A Great Britain-based importer notifies the manufacturer or UK Responsible Person, who submits the importer’s details to MHRA | Importers must meet EU IVDR importer duties; EUDAMED actor registration has applied since 28 May 2026 |
| Evidence to check | Intended purpose, classification, conformity route, declaration or certificate, and any transition eligibility | CE conformity, declaration, importer details, labeling and instructions, UDI where applicable, and EUDAMED actor status |
MHRA is the competent authority for medical devices and IVDs in Northern Ireland. If your supply chain serves both markets, assess and document each route separately rather than treating “UK compliant” as a single status.
2. Is the product an IVD, and what is its intended purpose?
Confirm that the product meets the IVD definition under the rules applicable to its destination. Record the manufacturer’s stated intended purpose and use that wording as the starting point for the regulatory assessment. Intended purpose and risk classification affect the applicable conformity route; do not infer a route from a product’s name, marketing description or appearance alone.
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For a specific device, review its technical and regulatory documents and current requirements. The information here cannot establish the classification or eligibility of an unnamed product.
3. Who is importing, and who is responsible for each obligation?
Map the supply chain before shipment. Record where the manufacturer and importer are established, which business will place the device on the market, and whether your business is actually importing or only distributing it. Duties differ by role and destination.
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- Great Britain importer: A business importing a device for placement on the Great Britain market must inform the relevant manufacturer or UK Responsible Person of its intention to import. That party submits the importer’s details to MHRA. A distributor that does not import for the Great Britain market is not required to register as an importer under this guidance.
- UK Responsible Person: An overseas manufacturer placing a device on the Great Britain market must appoint a single UK Responsible Person for its devices. Verify the appointment and the representative’s specified responsibilities, including registration; the importer does not replace this role.
- Northern Ireland importer: Meet the importer duties under EU MDR/IVDR that apply to the device and operator, including the relevant identification and database requirements.
4. Is the device registered and is the conformity route valid?
Great Britain
Check that the IVD is registered with MHRA before it is placed on the Great Britain market. Confirm the applicable UK MDR conformity route, whether an approved body must be involved, and that the declaration and any required certificate support the route and device.
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UKCA is the Great Britain marking route, but MHRA guidance allows some CE-marked devices to remain eligible under specific transition provisions. The stated transition dates are not blanket permission:
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- EU IVDD-compliant IVDs: MHRA guidance states they may be placed on the Great Britain market until the earlier of the certificate’s expiry or 30 June 2030.
- EU IVDR-compliant IVDs: MHRA guidance states they may be placed on the Great Britain market until 30 June 2030.
Before relying on either route, verify the device’s declaration, certificate status and eligibility against the current MHRA requirements. Do not assume that a CE mark by itself establishes eligibility.
Northern Ireland
Verify conformity under EU IVDR and the correct marking for Northern Ireland. CE marking is required. If a UK notified body performs mandatory third-party assessment, the device must carry CE UKNI; UKCA alone is not recognized in Northern Ireland.
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Check the applicable device-registration requirements as well as the importer’s database status. MHRA guidance states that EUDAMED registration of Northern Ireland importers is required from 28 May 2026, a date that has passed as of 7 October 2026.
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Check the final device and accompanying materials for the destination market, not just the supplier’s general product file.
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- For Northern Ireland, ensure the importer’s name, registered trade name or trademark, place of business and contact address accompany the device. The information may appear on the device, its packaging, the instructions or an accompanying document.
- Confirm the required marking, instructions and declaration are present and consistent with the conformity route. Check UDI where applicable.
- Follow the manufacturer’s storage and transport requirements so that handling during import does not compromise the device.
- Set up required records for complaints and non-conforming devices, with a clear process for escalation.
6. Is exceptional-use authorization being mistaken for an import route?
If exceptional use authorization is relevant, the application must be made by the manufacturer, UK Responsible Person or Authorised Representative. An importer cannot submit it, and authorization does not remove other applicable regulatory requirements.
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