For Great Britain (England, Scotland and Wales), check the MHRA’s Public Access Registration Database (PARD), reached from the agency’s medical-device registration guidance. Match the legal manufacturer and the exact in vitro diagnostic (IVD) device—not just a similar brand name. For Northern Ireland, the route depends on device type: since 28 May 2026, non-custom-made IVDs use EUDAMED, while custom-made devices remain registered with the MHRA.
Choose the register for the market where the IVD will be sold
The UK does not have one registration search for every market and device circumstance. Start by identifying whether the intended market is Great Britain or Northern Ireland, and whether the device is custom-made.
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| Situation | Register to check | What applies |
|---|---|---|
| IVD intended for Great Britain | MHRA guidance links to PARD | IVDs must be registered with the MHRA before they are placed on the Great Britain market. |
| Non-custom-made IVD intended for Northern Ireland | EUDAMED | Since 28 May 2026, this group must be registered in EUDAMED before placement; MHRA registration is no longer required for it. |
| Custom-made device intended for Northern Ireland | MHRA | Custom-made devices remain subject to MHRA registration, within 28 days of being made available in Northern Ireland. |
| IVD undergoing performance evaluation in Great Britain | MHRA | Registration is required by the time the study commences; the study’s declaration and applicable regulatory route also matter. |
The MHRA’s Northern Ireland guidance was last updated on 11 June 2026. Great Britain-based manufacturers supplying Northern Ireland still need an EU- or Northern Ireland-based Authorised Representative. These rules are not interchangeable with the Great Britain route.
How to check an IVD in the Great Britain register
- Confirm the intended market. If the product is for England, Scotland or Wales, use the MHRA route. Open the agency’s “Register medical devices to place on the market” guidance and follow its link to the Public Access Registration Database (PARD).
- Copy the identifiers from the product. Record the legal manufacturer’s name and address, the exact brand or trade name, model or version, catalogue or reference number, and UDI-DI if one is shown. The MHRA’s April 2026 Device Registration Reference Guide describes product fields including these identifiers and says devices must be added to the legal manufacturer’s organisation.
- Search and compare the full identity. Compare the register entry against the product label, packaging and instructions. A shared brand, partial name or similar model is not enough to establish that the record is for the product in hand.
- Resolve missing or conflicting details. A public record may not show every identifier you have. Do not infer a match from an approximate name; ask the manufacturer or supplier to clarify the record and provide supporting evidence. The MHRA requires registration information to remain accurate and up to date and may request supporting technical documentation.
- Interpret the result narrowly. A matching entry indicates a registration record in the relevant system. It does not by itself establish compliance with every requirement for placing the device on the market.
What MHRA registration does—and does not—tell you
The MHRA’s registration guidance states: “Registration of your devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA.” An IVD with an MHRA registration entry should therefore not be described as “MHRA approved” on that basis alone.
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Registration is one regulatory obligation. It is separate from conformity assessment and applicable market-facing requirements, including conformity markings. The MHRA’s guidance for patients on medical devices advises checking the applicable CE, UKCA or CE UKNI marking and whether the manufacturer’s address appears on the product or packaging. These are useful additional checks, not substitutes for searching the correct register.
If you cannot find a matching record
An unsuccessful search is a reason to investigate, not by itself a definitive legal determination about a specific product or sale. Before drawing a conclusion:
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- Check the spelling of the legal manufacturer and product name.
- Check the exact model, version, catalogue or reference number, and any UDI-DI.
- Ask whether the device is registered under a parent company or represented manufacturer.
- Confirm that you searched the register for the actual intended market; Northern Ireland and Great Britain have different routes.
- Ask the supplier or manufacturer to identify the applicable record and explain any mismatch. If the issue remains material, seek confirmation from the MHRA.
In Great Britain, a non-UK manufacturer must appoint a UK Responsible Person, who assumes registration responsibilities. Device-specific transitional provisions may also apply to certain IVDs relying on extended EU IVDD certificates or declarations. The MHRA’s IVD legislation guidance gives different end dates for certain device groups through 2027, 2028 or 2029; those dates and conditions depend on classification and market, so do not apply one certificate date to all IVDs.
What to do if you have a safety concern
If a device seems questionable, the MHRA’s patient guidance provides the Yellow Card reporting route. Consult a healthcare professional as appropriate, particularly before making decisions about diagnosis or treatment based on a test result.
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