The required marking depends on where you intend to sell the IVD. Great Britain (England, Scotland and Wales) has a UKCA route and accepts some qualifying CE-marked devices under transition arrangements. Northern Ireland follows the EU IVDR framework and requires CE marking. MHRA registration is a separate requirement for placing an IVD on the Great Britain market; a mark or registration alone does not establish that a device meets all applicable requirements.
First decide which market you are placing the IVD on
Great Britain (GB), Northern Ireland (NI) and the EU are distinct regulatory destinations. A route valid in one is not automatically valid in the others. The MHRA describes the UK medical-device framework in its official guidance, Regulating medical devices in the UK.
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| Destination | Main IVD framework and marking | Assessment-body consideration | Registration and post-market duties |
|---|---|---|---|
| Great Britain: England, Scotland and Wales | UK Medical Devices Regulations 2002, as amended; UKCA is available. Qualifying CE-marked devices may also be accepted during the applicable transition period. | For UKCA, use the relevant UK approved-body route when the device’s conformity-assessment route requires third-party assessment. For a CE route, use an EU-recognised notified body where third-party assessment is mandatory. | Register with the MHRA before placing an IVD on the GB market. GB vigilance and post-market surveillance (PMS) duties apply. |
| Northern Ireland | EU IVDR applies to IVDs; CE marking is required. If a UK body carries out mandatory third-party assessment for the NI route, the device carries CE plus UK(NI). | An EU-recognised notified body is needed for mandatory CE assessment intended to cover both NI and the EU. A UK-body assessment resulting in CE plus UK(NI) does not confer EU market access. | EU-aligned PMS requirements apply. MHRA registration arrangements should be checked against the current NI guidance for the specific device and operator. |
| European Union | EU IVDR applies; CE marking is required. | Use an EU-recognised notified body when third-party assessment is required. UK notified bodies are not recognised by the EU for this purpose. | EU IVDR PMS and vigilance obligations apply. Applicable EU economic-operator and database requirements depend on the circumstances. |
The MHRA’s Medical devices: conformity assessment and the UKCA mark guidance covers the GB route. Its Regulation of medical devices in Northern Ireland guidance explains the NI route. Body designations and scopes can change, so verify a body’s current designation before contracting.
How to choose a route for a specific IVD
Do not start with the mark. Establish the device’s intended purpose, classification, manufacturer location, certificate status and destination markets first. These facts determine the applicable legislation and whether self-declaration or third-party assessment is allowed.
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- Define the intended purpose and classify the device. The assessment route depends on the IVD type and class. Do not assume that a route used for another product in the portfolio also applies to this device.
- List every intended destination. Decide whether the product will be placed on the GB market, the NI market, the EU market, or some combination. Treat GB and NI separately.
- Identify the legal basis for each route. For GB, determine whether the device will follow UK MDR 2002 and UKCA or rely on an eligible CE transition route. For NI and the EU, assess the EU IVDR route and any applicable transition provisions.
- Confirm the assessment route and assessor. Check whether the class and conformity route require a third party. Select a UK-designated approved body for a UKCA route where required, or an EU-recognised notified body for mandatory CE assessment covering NI and/or the EU.
- Verify certificates and transition eligibility. Check the certificate’s scope and validity, the legislation under which it was issued, and whether the device meets the conditions for the relevant market’s transition arrangements.
- Complete registration and market-specific obligations before placement. For GB, register with the MHRA and, if the manufacturer is based outside the UK, appoint one UK responsible person for all its devices. Separately confirm the current NI and EU operator, registration and database requirements that apply to the product.
For the UKCA route, the manufacturer must complete the applicable conformity assessment and sign a declaration of conformity before applying the mark. Some routes can be self-declared; where third-party assessment is required, the appropriate UK approved body must be involved. If an approved body participated, its identification number must appear below the UKCA mark. The UKCA mark is for the GB market; UKCA alone is not recognised in NI.
MHRA registration is not a substitute for conformity assessment. The MHRA says all devices, including IVDs, custom-made devices and systems or procedure packs, must be registered before they are placed on the GB market. A manufacturer outside the UK must appoint a single UK responsible person for all its devices; that person performs specified tasks on the manufacturer’s behalf, including registration. Check the current MHRA registration guidance for required information, timing, fees and any device-specific exceptions.
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Can you still sell a CE-marked IVD in Great Britain?
Some CE-marked IVDs can be placed on the GB market under transition arrangements. The MHRA guidance distinguishes devices compliant with the current EU IVDR from legacy devices under the EU IVDD; the deadlines are not interchangeable.
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| CE basis for the device | GB acceptance stated in MHRA guidance | Qualification |
|---|---|---|
| EU IVDR-compliant IVD | Through 30 June 2030 | The device must qualify under the applicable transition arrangements and continue to meet the relevant requirements for its CE marking. |
| Legacy EU IVDD IVD | Until the sooner of the certificate’s expiry or 30 June 2030, where the relevant transition provisions apply | Eligibility depends on the device, certificate and transition conditions; this is not a blanket extension for every IVDD device. |
The MHRA also lists separate GB acceptance dates for certain general medical devices, but those dates do not establish an IVD deadline and should not be applied to an IVD. Transition eligibility can depend on factors such as whether notified-body assessment was required under the old and new legislation and whether the device was previously self-declared. Confirm eligibility for each device and certificate against the current MHRA guidance before relying on a transition date.
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What CE plus UK(NI) means
EU IVDR has applied in NI since 26 May 2022, and CE marking is required there. Where a UK-based body performs mandatory third-party conformity assessment for the NI route, the device must bear CE plus UK(NI). UK(NI) is never used alone, and the CE plus UK(NI) combination is not accepted on the EU market.
If a manufacturer wants one CE route to cover both NI and the EU, any mandatory third-party assessment must be performed by an EU-recognised notified body. The EU no longer recognises UK notified bodies for that purpose. A manufacturer targeting GB as well may need a separate UKCA route or qualifying CE transition basis in addition to its NI/EU route; the correct arrangement depends on product and certificate status.
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NI registration details require particular care. MHRA guidance has described registration for certain devices placed on the NI market through 27 May 2026. That stated date has passed as of 7 October 2026, and it does not by itself establish what registration duty applies now to every IVD or operator. Consult the current detailed MHRA registration guidance for the device’s class and the manufacturer, authorised representative and importer arrangements before placing it on the NI market.
Plan for surveillance and incident reporting after launch
Great Britain
Strengthened GB PMS measures came into force on 16 June 2025. They extend PMS duties to CE-marked devices placed on the GB market under transition provisions. Manufacturers need a system to gather and analyse information about device quality, performance and safety over its lifetime, record conclusions and take appropriate action. The MHRA also requires reporting of specified incidents involving a device and appropriate safety action where required. Use the MHRA’s current vigilance guidance to determine the reporting route and deadline for an incident type.
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Northern Ireland and the EU
EU PMS requirements apply in NI and the EU. The MHRA identifies the MORE portal for manufacturer adverse-incident reports in NI and the Yellow Card scheme for reports from the public and healthcare professionals. Confirm the current channel and deadline for the particular incident rather than treating all reports as having the same timing.
NI supply-disruption notifications
A separate Article 10a duty may apply to manufacturers based in NI or whose authorised representative is based there. If an anticipated interruption or discontinuation could foreseeably cause serious harm or a risk of serious harm, the MHRA says notification must be made at least six months in advance except in exceptional circumstances. Relevant direct customers and healthcare operators must also be notified. Assess whether this duty applies to the specific manufacturer and supply situation.
What to verify before market placement
- The intended purpose and IVD classification support the chosen conformity route.
- The route, mark and assessment body are valid for each destination, including whether third-party assessment is mandatory.
- Any CE transition claim is supported by the device’s applicable legislation, certificate status and transition eligibility.
- GB MHRA registration is complete before placement, and a non-UK manufacturer has appointed one UK responsible person for its devices.
- Current NI registration and operator requirements have been checked rather than inferred from a past transitional date.
- PMS, vigilance and any applicable NI supply-disruption notification processes are in place for the markets served.
This is a market-level overview, not a device-specific determination. The MHRA’s live guidance and the device’s classification, intended purpose, certificates and operator arrangements control the final route.
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