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A free scan shows the junk files, broken settings and background clutter dragging Windows down - then fixes them in one click.Free scan · Windows 10 & 11Before importing an in vitro diagnostic (IVD) device into the UK, first identify whether it is destined for Great Britain (England, Scotland or Wales) or Northern Ireland. The regulatory route, acceptable marking and importer obligations differ. Then confirm that the product is an IVD, document its intended purpose, and verify the relevant conformity and registration requirements before it is placed on the market.
Use the checklist below to identify what to verify. Whether a particular device qualifies for a route or transition depends on its documentation and circumstances; the device’s manufacturer, intended purpose and conformity evidence must be checked.
Start by choosing Great Britain or Northern Ireland
The UK does not have one uniform IVD market-entry route. MHRA guidance describes separate requirements for Great Britain and Northern Ireland. Use the destination of the device—not simply the location of your business—to determine which column applies.
| Check | Great Britain | Northern Ireland |
|---|---|---|
| Core framework | Part IV of the UK Medical Devices Regulations 2002, as amended. | EU In Vitro Diagnostic Medical Devices Regulation (IVDR) applies. |
| Market marking | UKCA is the Great Britain route. Some CE-marked devices may remain eligible under specific transition arrangements. | CE marking is required. CE UKNI applies when a UK notified body performs mandatory third-party assessment. UKCA alone is not recognised. |
| Device registration | IVDs must be registered with MHRA before placement on the Great Britain market. | Confirm applicable device-registration requirements for the device and operator. |
| Importer step | A Great Britain-based importer tells the manufacturer or UK Responsible Person of its intention to import; that party submits the importer’s details to MHRA. | The importer must meet EU IVDR importer duties, including applicable identification and database requirements. |
| Database timing | The applicable MHRA device-registration requirement applies before placement. | MHRA guidance states that EUDAMED actor registration for Northern Ireland importers is required from 28 May 2026. |
These routes and dates reflect MHRA guidance available on 7 October 2026. Check the current regulator guidance and the device’s own evidence before relying on a specific route.
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Confirm what the product is and what it is intended to do
Establish whether it meets the IVD definition
Do not assume that a product is an IVD because it is used in a laboratory or produces health-related information. Confirm that it falls within the applicable IVD definition and identify the regulatory framework for its destination.
Record the manufacturer’s intended purpose
Obtain and retain the manufacturer’s stated intended purpose. It informs the regulatory route and risk classification, so do not substitute a reseller’s product description or your own assumptions. If the intended purpose or product status is unclear, resolve that question before selecting a conformity route.
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Identify your role and the responsible parties
Map the supply chain
Record where the manufacturer and your business are established, where the device will first be placed on the market, and whether your business is importing or only distributing. A distributor that does not import for the Great Britain market is not required to register as an importer under the relevant MHRA guidance; do not assume that label applies if your actual role is different.
Verify the UK Responsible Person where required
An overseas manufacturer placing a device on the Great Britain market must appoint a single UK Responsible Person for its devices to carry out specified tasks, including registration. Verify who has been appointed and what responsibilities they have. The importer is not a substitute for the manufacturer’s representative.
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Verify registration and conformity evidence for the destination
For Great Britain, check registration and importer notification
Before Great Britain market placement, verify that the IVD is registered with MHRA. If you are a Great Britain-based importer, notify the manufacturer or UK Responsible Person of your intention to import. Under MHRA’s stated process, that party submits your details to MHRA; keep a record of the notification and confirm that the submission has been made.
For Northern Ireland, check importer and database status
Confirm that you can meet the EU IVDR importer duties applicable to your role. MHRA guidance states that Northern Ireland importers must register as actors in EUDAMED from 28 May 2026. Check the relevant actor-registration status and any applicable device-registration requirement before placement.
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Inspect the conformity route and the mark
For either destination, review the manufacturer’s conformity documentation against the applicable framework and intended purpose. Confirm that any required third-party assessment has been carried out by the appropriate body and that the device bears a mark accepted in its destination market. For Northern Ireland, CE UKNI is relevant when a UK notified body performs mandatory third-party assessment; UKCA by itself is not accepted there.
Check transition eligibility rather than relying on a deadline alone
MHRA guidance states that EU IVDD-compliant IVDs may be placed on the Great Britain market until the sooner of the certificate’s expiry or 30 June 2030, and EU IVDR-compliant IVDs until 30 June 2030. These are conditional transition routes, not blanket extensions. Before relying on one, check the device’s declaration, certificate status and eligibility under the applicable arrangements.
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Review labels, accompanying documents and handling arrangements
Check Northern Ireland importer information
For Northern Ireland, verify that the importer’s name, registered trade name or trademark, place of business and contact address accompany the device. MHRA guidance allows this information to appear on the device, its packaging, the instructions for use or an accompanying document.
Check the complete device pack
Confirm that the device is correctly marked and accompanied by the instructions and declaration required for its route. Check UDI information where applicable, and make sure the documents, product identity and device supplied are consistent. Follow the manufacturer’s storage and transport requirements so that handling does not depart from its instructions.
Set up traceability and escalation
Maintain the complaint and non-conforming-device records required for your role, with a clear process for escalating issues to the manufacturer or other responsible party. Keep the registration, conformity, importer-identification and shipment records needed to show what was checked and which device or supply they relate to.
Do not use exceptional authorisation as an importer shortcut
If exceptional use authorisation is relevant, an importer cannot submit the application. MHRA guidance assigns the application to the manufacturer, UK Responsible Person or Authorised Representative. Other regulatory requirements continue to apply.
Quick Recap
Pre-import release checklist
- Destination: Great Britain or Northern Ireland is recorded for the planned placement.
- Product: IVD status and manufacturer-stated intended purpose are documented.
- Roles: Manufacturer, importer, distributor and any UK Responsible Person are identified.
- Route: Applicable framework, conformity evidence and accepted market marking are verified.
- Registration: Device and actor requirements for the destination are checked, including the Great Britain importer notification chain or Northern Ireland EUDAMED actor status as applicable.
- Documents and operations: Labels, instructions, declaration, applicable UDI information, handling arrangements, records and escalation contacts are in place.
- Transition: If relying on a transition, device-specific eligibility and certificate status are verified rather than inferred from the end date.
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