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Does MHRA registration mean an IVD is approved?
No. Registration records a device and relevant party information with the regulator; it does not show that the MHRA tested, certified or endorsed the device. 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 is separate from the requirements for conformity assessment and product marking. A registered device must still meet the conformity rules that apply to its territory and route. In Great Britain, that may mean UK MDR 2002, as amended, and the applicable UK conformity route, or a qualifying CE-marked transitional route. In Northern Ireland, the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) applies and CE marking is required.
Where are you placing the IVD on the market?
“The UK” is not one registration route for IVDs. Great Britain comprises England, Wales and Scotland; Northern Ireland follows a distinct framework. The MHRA’s guidance, checked on 7 October 2026, describes these territorial differences:
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| Question | Great Britain: England, Wales and Scotland | Northern Ireland |
|---|---|---|
| Main framework | UK MDR 2002, as amended. Specified CE-marked transitional routes remain available. | EU IVDR applies; CE marking is required. |
| Registration baseline | All IVDs must be registered with the MHRA before being placed on the market. | Requirements depend on factors including manufacturer and authorised-representative location and device class. 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; GB-only registration should not be assumed sufficient. |
| Database | MHRA registration, using 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?
For Great Britain, the manufacturer is responsible for the registration. A manufacturer based outside the UK must appoint a single UK responsible person (UKRP), who can register devices and act on the manufacturer’s behalf. The UKRP needs written evidence of its authority.
- Identify the market. Establish whether the device will be placed on the market in Great Britain, Northern Ireland or both. Do not treat a GB registration as a substitute for NI/EU obligations.
- Confirm the device and conformity route. Determine the device’s classification, intended purpose, applicable conformity requirements and whether a transitional route is available. Registration alone does not settle these questions.
- Identify the responsible party. For the GB route, a UK-based manufacturer registers its devices. An overseas manufacturer appoints one UKRP and gives it written authority.
- Use the applicable registration route. GB registration is handled through the MHRA registration system, DORS. For NI, determine which MHRA and EUDAMED requirements apply to the manufacturer, representative, importer or other relevant actor and to the device.
- Keep the information current. The MHRA says changes to registered information must be reported as they occur.
The MHRA requires applicable devices to be registered before they are placed on the GB market. Its general guidance states that this includes IVDs, custom-made devices, and systems or procedure packs.
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What registration and database obligations apply in Northern Ireland?
EU IVDR applies in Northern Ireland, so the GB registration route cannot be applied wholesale. Registration requirements depend on details such as the manufacturer’s and authorised representative’s locations and the device class. Manufacturers and other operators should check the current NI-specific requirements for their role and product rather than infer them from a GB registration.
The MHRA says four EUDAMED modules became mandatory from 28 May 2026. 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 registration obligations. Custom-made devices in Northern Ireland remain registered on DORS.
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Can a CE-marked IVD use a transition period in Great Britain?
In some cases. A transition period is a time-limited route for eligible devices; it is not MHRA registration and does not remove the obligation to register applicable IVDs in Great Britain. The general dates in MHRA guidance are:
- EU IVDD devices: applicable CE-marked devices can generally be placed on the GB market until the earlier of the certificate’s expiry or 30 June 2030.
- EU IVDR devices: qualifying devices can generally be placed on the GB market through 30 June 2030.
These dates do not make every expired certificate usable or establish eligibility for a particular product. Special rules apply to certain certificates extended under EU IVDR Article 110. For qualifying legacy devices, MHRA guidance identifies conditions including continued compliance with IVDD, no significant change to design or intended purpose, and no unacceptable risk, alongside other quality-system, notified-body and class-specific conditions. Northern Ireland has its own application of EU IVDR Article 110 transition conditions, with dates and steps that vary by device class and status.
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What should a manufacturer check before placing an IVD on the market?
Before relying on a registration or transitional route, confirm the complete route for the device and territory. The relevant checks include:
- Whether the destination is Great Britain, Northern Ireland or both.
- The device’s classification and intended purpose.
- The manufacturer’s and, where relevant, authorised representative’s location.
- The applicable conformity assessment and marking requirements.
- Which party must register, and whether the applicable database is DORS, EUDAMED or both for relevant obligations.
- Whether a certificate is valid or a specific transitional provision applies, including its conditions and deadline.
MHRA registration guidance and NI/EUDAMED requirements can change. The dates and rules above reflect MHRA/GOV.UK guidance checked on 7 October 2026; this general explanation does not determine eligibility for a particular IVD.
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