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There is no single marking route for every UK market. In Great Britain (England, Scotland and Wales), manufacturers can use the UKCA route under the Medical Devices Regulations 2002, as amended, or rely on eligible CE-marked devices during the applicable transition period. Northern Ireland follows the EU IVDR framework and requires CE marking. Manufacturers must also meet market-specific registration and post-market duties; a mark alone does not satisfy them.
Which rules apply in each market?
Great Britain (GB), Northern Ireland (NI) and the European Union (EU) are separate destinations for an in vitro diagnostic device (IVD). The route depends on where the device will be placed, its intended purpose and classification, whether third-party assessment is required, and the status of any certificate or transition eligibility.
| Destination | Main IVD framework and marking | Registration and assessment considerations |
|---|---|---|
| Great Britain (England, Scotland and Wales) | UK Medical Devices Regulations 2002, as amended; UKCA is available. Qualifying CE-marked devices may be accepted under transition arrangements. | Register with the MHRA before placing the IVD on the market. The applicable UKCA conformity-assessment route depends on the device and its classification. |
| Northern Ireland | EU IVDR applies; CE marking is required. If a UK body performs mandatory third-party assessment for the NI route, the mark is CE plus UK(NI). | Specific MHRA registration arrangements apply. Check the current guidance for the device and operator rather than assuming GB requirements apply. |
| European Union | EU IVDR applies; CE marking is required. | Use an EU-recognised notified body where third-party assessment is mandatory. UK(NI) alongside CE is not accepted for EU market access. |
The MHRA is responsible for regulating the UK medical-device market. Its guidance, “Regulating medical devices in the UK,” distinguishes the rules for GB, NI and the EU.
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- Identify every destination market. Decide whether the device is intended for GB, NI, the EU, or more than one of them. Do not treat “the UK” as one regulatory destination: UKCA is for the GB route, while NI follows the EU framework for IVDs.
- Confirm intended purpose and classification. Establish what the IVD is intended to do and its classification before choosing an assessment route. Requirements differ by device type and class, including whether self-declaration is available or third-party assessment is required.
- Identify the legislation and evidence basis for each market. For GB, determine whether the device will follow UKCA under the UK MDR 2002, as amended, or qualifies for CE acceptance under transition arrangements. For NI and the EU, assess against the applicable EU IVDR route.
- Check the assessor’s designation and geographic recognition. For UKCA, use the appropriate UK-designated approved body if the route requires third-party assessment. For mandatory CE assessment intended to cover NI and the EU, use an EU-recognised notified body.
- Confirm registration and post-market responsibilities. Complete the registration steps applicable to each destination and establish the required surveillance and incident-reporting processes before market placement.
A CE mark does not automatically establish that a device qualifies for GB transition acceptance, and UKCA does not substitute for CE marking in NI or the EU. Assess each device, certificate and market combination on its own facts.
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What does the UKCA route require in Great Britain?
IVDs fall under Part IV of the UK MDR 2002. A manufacturer using UKCA must demonstrate conformity through the applicable assessment route and sign a declaration of conformity before applying the mark. The route depends on the device type and class; some devices may be self-declared, while others require third-party assessment by a UK-designated approved body. If an approved body participated, its identification number must appear below the UKCA mark.
UKCA is a GB route, not a UK-wide marking. A UKCA-marked device is not accepted in NI on that mark alone. A manufacturer serving both GB and NI may therefore need distinct routes or dual marking, depending on the product’s assessment and status.
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Can a CE-marked IVD still be placed on the GB market?
Yes, if the device meets the relevant acceptance conditions. The MHRA guidance sets these GB deadlines for IVDs:
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| EU IVDD IVD | The sooner of the certificate’s expiry or 30 June 2030 | Applies where the relevant transition provisions apply. Eligibility and certificate status must be checked for the specific device. |
These are transition acceptance windows, not a general permission to use any CE-marked product in GB. The guidance identifies conditions and exclusions, including factors relating to legacy self-declared devices and whether notified-body assessment is required under the old and new legislation. Confirm the device’s eligibility, certificate validity and applicable transition conditions, and continue to meet the EU legislation relevant to its CE mark.
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What registration does the MHRA require?
For GB, all devices—including IVDs, custom-made devices, and systems or procedure packs—must be registered with the MHRA before they are placed on the market. Registration is a separate obligation from conformity assessment: it does not, by itself, demonstrate that the device meets the applicable requirements.
A manufacturer based outside the UK must appoint one UK responsible person for all its devices. The responsible person performs specified tasks on the manufacturer’s behalf, including registration. Consult the current MHRA registration guidance for the required information, timing, fees and device-specific exceptions.
NI has specific MHRA registration arrangements. The MHRA guidance refers to registration for certain devices placed on the NI market until 27 May 2026; that stated date has passed. It does not establish what applies after that date to every device and operator. Before placing an IVD on the NI market, check the current detailed MHRA registration guidance for the product’s class and the relevant manufacturer, authorised representative or other operator arrangement.
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EU IVDR has applied in NI since 26 May 2022, and CE marking is required there. When a UK-based body performs mandatory third-party conformity assessment for an NI route, the device must carry CE plus UK(NI). UK(NI) is not used on its own, and the CE plus UK(NI) combination is not accepted for the EU market.
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For a CE route intended 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. Check the body’s current designation and scope before contracting, as these can change. The MHRA’s “Approved bodies for medical devices” information can help identify UK bodies for routes where they are appropriate; it is not a substitute for checking EU recognition for a CE assessment.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What post-market duties apply after placement?
Great Britain
Strengthened GB post-market surveillance (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 must maintain a system to gather and analyse information on device quality, performance and safety over its lifetime, record conclusions and actions, report specified incidents to the MHRA, and take appropriate safety action where required.
Northern Ireland and the EU
EU PMS requirements apply in NI and the EU. For NI reporting, the MHRA identifies the MORE portal for manufacturer adverse-incident reports and the Yellow Card scheme for reports from the public and healthcare professionals. Confirm the current reporting route and deadline for the particular incident type.
A separate supply-disruption notification duty may apply to NI-based manufacturers and manufacturers whose authorised representative is based in NI. Under Article 10a, an anticipated interruption or discontinuation that could foreseeably create serious harm or a risk of serious harm must be notified at least six months in advance, except in exceptional circumstances; relevant direct customers and healthcare operators must also be notified. Determine whether the duty applies to the specific manufacturer and situation.
What to verify before placing an IVD on the market
- The intended purpose, classification and destination market or markets for the specific device.
- Whether the chosen route permits self-declaration or requires third-party conformity assessment.
- For GB CE acceptance, whether the device meets the applicable transition conditions and whether its certificate remains valid for that route.
- Whether each assessment body is appropriately designated and recognised for the intended market.
- Whether the necessary registration is complete and any UK responsible-person arrangement is in place.
- Whether PMS, vigilance reporting and any applicable NI supply-disruption notifications are established.
The MHRA’s live guidance should be checked at the point of decision because designations, registration details and guidance can change. The correct route cannot be determined from the mark alone; it depends on product-specific facts and the markets the manufacturer intends to serve.
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