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MHRA registration is a required market-entry step for in vitro diagnostic devices (IVDs) placed on the market in Great Britain, but it is not product approval. It does not certify, accredit or endorse a device, and it does not replace the conformity assessment and marking requirements that apply to the device. Northern Ireland follows a separate route, so a registration that covers Great Britain should not be assumed to satisfy Northern Ireland requirements.
What MHRA registration does—and does not—mean
Registration records the IVD and relevant party information with the regulator. The MHRA’s guidance states: “Registration of your devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement.”
In practical terms, a registration entry is not evidence that the MHRA has tested the device, assessed its safety or performance, or confirmed that it meets the legal requirements for its intended purpose. Those obligations sit alongside registration and depend on the applicable conformity route and the market where the device will be supplied.
Do I need MHRA registration to sell an IVD in the UK?
First identify the territory: Great Britain means England, Wales and Scotland; Northern Ireland has a distinct regulatory route. The MHRA says all medical devices, including IVDs, must be registered before placement on the Great Britain market. Northern Ireland requirements depend on the relevant manufacturer or authorised representative and the device’s classification and status.
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| Question | Great Britain | Northern Ireland |
|---|---|---|
| Primary framework | UK Medical Devices Regulations 2002, as amended; specified CE transitional routes remain available. | EU In Vitro Diagnostic Medical Devices Regulation (IVDR) applies, and CE marking is required. |
| Registration baseline | All IVDs must be registered with the MHRA before placement on the market. | Requirements depend on factors including manufacturer and authorised-representative location and device class. NI registration rules changed effective 28 May 2026. |
| Relevant registration system | MHRA registration through DORS. | Relevant actors have EUDAMED obligations; custom-made devices in Northern Ireland continue to be registered on DORS. |
| Key distinction | Registration is separate from conformity assessment and marking. | Do not assume that meeting the Great Britain route alone fulfils Northern Ireland requirements. |
These are separate territorial requirements, not two names for one UK-wide registration. If a device will be supplied in both territories, assess each route separately.
Who is responsible for Great Britain registration?
Manufacturer based in Great Britain
A GB-based manufacturer registers its devices with the MHRA. Registration must be in place before the devices are placed on the GB market.
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Manufacturer based outside the UK
An overseas manufacturer must appoint one UK responsible person for the Great Britain route. That person can register devices and act on the manufacturer’s behalf, and must hold written evidence of that authority. Appointment of a responsible person does not itself establish that a device has met its conformity or marking requirements.
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Apply the NI and EU actor-registration rules that match the operator’s role and the device. The MHRA guidance says four EUDAMED modules became mandatory on 28 May 2026. Relevant actors include manufacturers, authorised representatives, importers, system or procedure-pack producers, and notified bodies; distributors are excluded from actor registration. Custom-made devices in Northern Ireland remain registered on DORS.
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Registration is separate from conformity assessment and marking
For Great Britain, determine the applicable conformity route under the UK Medical Devices Regulations 2002, as amended, or whether the device qualifies for a permitted CE-marking transition. For Northern Ireland, EU IVDR applies and CE marking is required, subject to applicable transition provisions. In either territory, registration does not replace the relevant conformity assessment, evidence, declaration or marking obligations.
The correct route depends on more than the device name. Check the intended purpose and classification, the manufacturer’s and authorised representative’s locations, the target territory, the applicable mark and conformity route, the responsible registration actor, and any certificate or transitional status. A device-specific determination may require reviewing the detailed MHRA and EU requirements; registration alone cannot settle eligibility.
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How long can certain CE-marked IVDs be placed on the Great Britain market?
Great Britain has transitional acceptance routes for specified CE-marked IVDs. The general dates in MHRA guidance are not a blanket extension for every device or an alternative to registration.
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- EU IVDD-compliant IVDs: the general limit is the earlier of the certificate’s expiry date or 30 June 2030.
Special rules apply to certain legacy certificates extended under Article 110 of the EU IVDR. Among the conditions described by the MHRA, qualifying devices must continue to comply with the IVDD, have no significant change to design or intended purpose, and present no unacceptable risk. Further quality-system, notified-body and class-specific conditions and dates also apply. An expired certificate is not automatically valid for continued use. Northern Ireland applies EU IVDR transition rules, with dates and steps that differ by device class and status.
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What happens after registration?
Keep the information supplied to the MHRA current. The MHRA says changes to registered information must be reported as they occur. Registration is therefore an ongoing administrative responsibility, not a one-time confirmation that the device remains compliant or eligible for a particular market route.
Regulatory requirements, transition periods and EUDAMED implementation can change. For an operational decision, consult the current MHRA guidance for the relevant territory and the specific section covering the device’s class, certificate and transition status.
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