Before importing an in vitro diagnostic (IVD) device, decide whether it will be placed on the Great Britain or Northern Ireland market. The rules differ, and the right route depends on the device’s intended purpose, conformity evidence and the roles of the businesses in its supply chain. Use the checks below before placing an order or arranging market access; an unnamed device’s classification or eligibility cannot be determined without its product documents.
1. Decide where the device will be placed on the market
“The UK” is not one IVD regulatory route. Great Britain means England, Scotland and Wales; Northern Ireland follows a different framework. Record the intended destination, where the manufacturer and your business are established, and whether your business will import the device or only distribute it. The Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for medical devices and IVDs in Northern Ireland, as well as the relevant UK regulator.
| Check | Great Britain | Northern Ireland |
|---|---|---|
| Core IVD framework | Part IV of the UK Medical Devices Regulations 2002, as amended | EU In Vitro Diagnostic Medical Devices Regulation (IVDR) |
| Market marking | UKCA route; certain CE-marked IVDs may qualify under transition provisions | CE, or CE UKNI where a UK notified body carries out mandatory third-party assessment; UKCA alone is not accepted |
| Device/operator registration and importer action | IVD registration with MHRA before placement; a Great Britain-based importer notifies the manufacturer or UK Responsible Person of its intention to import, and that party submits the importer’s details to MHRA | EU IVDR importer duties apply; Northern Ireland importer EUDAMED actor registration has been required from 28 May 2026 |
| Evidence to check | Intended purpose, classification, conformity route, declaration or certificate, and any transition eligibility | CE conformity, declaration, importer identification, labeling and instructions, UDI where applicable, and EUDAMED actor status |
This comparison reflects MHRA guidance on UK regulation, Northern Ireland regulation, conformity and registration, current to 7 October 2026. Check the current guidance and the device’s own evidence before relying on a route.
2. Confirm that the product is an IVD and document its intended purpose
Do not decide the regulatory route from a product’s marketing name alone. Check whether the product meets the IVD definition and retain the manufacturer’s stated intended purpose, including what it detects or measures and how the result is intended to be used. The applicable requirements and conformity assessment depend in part on that purpose and the device’s risk classification.
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- Obtain the manufacturer’s intended-purpose statement and the device’s classification rationale.
- Check that the product documents describe the same device and use as the one being imported.
- Identify which destination’s rules apply before assessing conformity evidence; Great Britain uses Part IV of the UK Medical Devices Regulations 2002, as amended, while Northern Ireland follows the EU IVDR.
3. Confirm who is the importer and who carries each regulatory responsibility
Map the actual supply chain rather than assuming that every distributor is an importer. For Great Britain, MHRA guidance distinguishes a Great Britain-based business importing a device for the Great Britain market from a distributor that does not import it for that market. A distributor in the latter position is not required under that guidance to register as an importer.
If an overseas manufacturer places a device on the Great Britain market, check that it has appointed a single UK Responsible Person for its devices and establish what that person is responsible for. The UK Responsible Person’s role is not replaced simply because a separate business imports the product.
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For Northern Ireland, identify the importer under the EU IVDR and confirm that it can meet the importer duties that apply to the device and transaction. MHRA guidance states that EUDAMED registration of Northern Ireland importers is required from 28 May 2026. As that date has passed, verify the importer’s actor registration and any applicable device registration before placement.
4. Verify the conformity route, mark and any transition eligibility
For the intended destination, review the manufacturer’s declaration of conformity and any required certificate, including whether an approved body or notified body must be involved. Match the documents and mark to the actual device and route; a mark by itself does not establish that the device is eligible for sale in that market.
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In Great Britain, UKCA is the relevant marking route, but MHRA guidance provides conditional transition routes for some CE-marked devices. In particular, EU IVDD-compliant IVDs may be placed on the Great Britain market until the sooner of certificate expiry or 30 June 2030; EU IVDR-compliant IVDs may be placed there until 30 June 2030. These are not blanket permissions. Before relying on either date, verify the device’s declaration, certificate status and eligibility under the applicable transition provisions.
In Northern Ireland, confirm the applicable CE route. Where a UK notified body performs mandatory third-party assessment, the device must carry CE UKNI as applicable; UKCA alone is not recognised on the Northern Ireland market. Check that the conformity documents support the mark and route shown on the device.
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5. Inspect labeling, instructions, traceability and handling arrangements
Before accepting a shipment, compare the device, its packaging and accompanying documents with the requirements for the destination. For Northern Ireland, the importer’s name, registered trade name or trademark, place of business and contact address must accompany the device. That information may appear on the device, packaging, instructions for use or an accompanying document.
- Check that the required market mark, manufacturer details and importer identification are present for the destination.
- Confirm that the required instructions and declaration accompany the device, where applicable, and that the documentation matches the product supplied.
- Check UDI and other traceability details where applicable, and make sure your records can identify the device and relevant supply-chain parties.
- Follow the manufacturer’s storage and transport conditions; establish how complaints, suspected non-conforming devices and escalation to the manufacturer or regulator will be recorded and handled.
6. Treat exceptional use as a separate route, not an importer workaround
If exceptional use authorisation may be relevant, the importer cannot submit the application. The manufacturer, UK Responsible Person or Authorised Representative must apply, and other regulatory requirements continue to apply. Do not use exceptional use as a substitute for confirming the ordinary market-access route.
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Before you commit to the import
- Write down the destination market and the roles and locations of the manufacturer, importer and any distributor.
- Obtain the intended-purpose statement, classification rationale and conformity documents for the exact IVD.
- Confirm the destination-specific registration, marking and importer obligations with the responsible parties and regulator guidance.
- Check that the labels, instructions, traceability information and handling arrangements are ready for the shipment.
MHRA guidance on regulation, conformity, registration and Northern Ireland requirements is time-sensitive. Recheck the current documents and the device’s eligibility before placement; the rules and transition dates stated here reflect guidance available on 7 October 2026.
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