MHRA registration is a required market-entry step for applicable in vitro diagnostic devices (IVDs); it is not product approval, certification, or endorsement. The route depends on where in the UK the device will be placed: Great Britain and Northern Ireland have different rules, registration systems, and conformity requirements.
What does MHRA registration mean for an IVD?
Registration means that the device and relevant party information are entered in the MHRA’s registration system. It is a regulatory requirement, not evidence that the MHRA has tested the device or confirmed that it meets the applicable safety and performance requirements.
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The MHRA states: “Registration of your devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement.” Registration therefore does not replace conformity assessment, a required certificate, or the applicable device marking.
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Do I need MHRA registration to sell an IVD in the UK?
First identify the territory where the IVD will be placed on the market. Great Britain means England, Wales, and Scotland. Northern Ireland follows a separate route; a GB registration alone should not be treated as satisfying Northern Ireland requirements.
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| Question | Great Britain | Northern Ireland |
|---|---|---|
| Applicable framework | UK Medical Devices Regulations 2002, as amended; specified CE-marking transitional routes remain available. | EU IVDR applies, and CE marking is required. |
| Registration baseline | All IVDs must be registered with the MHRA before they are placed on the market. | Requirements depend on factors including the manufacturer’s and authorised representative’s locations and the device class. The NI registration rules changed effective 28 May 2026. |
| Overseas manufacturer | Must appoint one UK responsible person for the GB registration route. | Must follow the applicable NI/EU actor and registration rules; a GB-only route may not be sufficient. |
| Registration system | MHRA registration, including the Devices Online Registration System (DORS). | Relevant actors have EUDAMED obligations; custom-made devices in NI continue to be registered on DORS. |
How do I register an IVD with the MHRA?
The responsible party depends on the manufacturer’s location. A GB-based manufacturer registers its devices. A manufacturer based outside the UK must appoint a single UK responsible person for the GB route. The responsible person needs written evidence that the manufacturer has authorised them to act on its behalf.
- Determine the destination territory. Decide whether the IVD will be placed on the market in Great Britain, Northern Ireland, or both. Do not assume one territory’s registration covers the other.
- Identify the responsible party and device route. For GB, establish whether the manufacturer is UK-based or needs a UK responsible person. For NI, check the location and role of the manufacturer and authorised representative, the device class, and the applicable NI/EU requirements.
- Complete the relevant registration. Use the applicable MHRA registration route for GB. For NI, establish which EUDAMED and, where relevant, DORS registrations apply to the device and parties involved.
- Meet conformity and marking requirements separately. Determine the applicable conformity route for the territory and device, and ensure the required marking and any required conformity assessment are in place. Registration itself does not establish conformity.
- Keep the record current. Report changes to registered information to the MHRA as they occur.
The required information, fees, and eligibility details can depend on the device and route. Consult the current MHRA instructions for the specific registration rather than relying on a general checklist to determine whether an individual IVD is eligible.
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What registration does not establish
- It does not mean the MHRA has accredited, certified, approved, or endorsed the IVD.
- It does not replace conformity assessment, a required certificate, or the relevant UKCA or CE marking route.
- It does not by itself establish that the device may be placed on every UK territory’s market.
How do CE-marked transitional routes work in Great Britain?
Great Britain continues to allow certain CE-marked IVDs to be placed on the market during defined transition periods. These allowances are separate from MHRA registration and have eligibility conditions; they should not be read as a blanket extension for every device or expired certificate.
- EU IVDD devices: Applicable CE-marked IVDs can generally be placed on the GB market until the earlier of the relevant certificate’s expiry or 30 June 2030.
- EU IVDR devices: Qualifying devices can generally be placed on the GB market through 30 June 2030.
Special rules apply to certain certificates extended under Article 110 of the EU IVDR. Among the conditions described by the MHRA, qualifying legacy devices must continue to comply with the IVDD, have no significant changes to design or intended purpose, and not present an unacceptable risk. Other quality-system, notified-body, and class-specific conditions and dates may also apply. Check the specific device’s status and current guidance before relying on a transition period.
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What is different about Northern Ireland?
EU IVDR applies in Northern Ireland, so its registration and conformity requirements cannot be inferred from the GB route. The applicable registration obligations depend on factors such as the operator’s role and location and the device’s class.
The MHRA guidance records that NI registration requirements changed effective 28 May 2026. It also states that four EUDAMED modules became mandatory from that date. Relevant actors include manufacturers, authorised representatives, importers, system or procedure-pack producers, and notified bodies; distributors are excluded from actor registration. Relevant actors placing devices on the NI/EU market must meet the applicable EUDAMED obligations. Custom-made devices in Northern Ireland remain registered on DORS.
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EU IVDR Article 110 transitional conditions also govern relevant legacy devices in Northern Ireland. The dates and required steps vary by device class and status, so a GB transition date should not be applied to an NI device without checking its specific route.
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- The intended destination: Great Britain, Northern Ireland, or both.
- The device’s classification and intended purpose.
- The manufacturer’s and, where relevant, authorised representative’s locations.
- The applicable conformity route, certificate status, and required device marking.
- The correct registration system and the party responsible for each registration.
- Whether a transitional provision applies, and whether every relevant condition and date is met.
These requirements and transition provisions can change. The MHRA guidance current as of 7 October 2026 is the appropriate starting point, but the relevant NI or extended-certificate guidance should be checked for the particular device. This overview does not determine the eligibility of an individual IVD.
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