To check an in vitro diagnostic medical device (IVD) for Great Britain, search the MHRA’s Public Access Registration Database (PARD) using the legal manufacturer and the exact product name and identifiers, then compare the entry with the product label and packaging. A register entry shows registration; it does not mean the MHRA has approved or endorsed the device. Northern Ireland has a different route: from 28 May 2026, non-custom-made devices are registered in EUDAMED, while custom-made devices remain with the MHRA.
First identify where the device will be sold
The correct register depends on the intended market. Great Britain (GB) means England, Scotland and Wales; Northern Ireland (NI) has separate arrangements.
| Device and market | Register to check | What applies |
|---|---|---|
| IVD intended for Great Britain | MHRA Public Access Registration Database (PARD) | IVDs must be registered with the MHRA before they are placed on the GB market. |
| Non-custom-made IVD intended for Northern Ireland | EUDAMED | From 28 May 2026, this group must be registered in EUDAMED before placement; MHRA registration is no longer required for these devices. |
| Custom-made device intended for Northern Ireland | MHRA | Custom-made devices remain subject to MHRA registration, within 28 days of being made available in NI. |
| IVD undergoing performance evaluation in Great Britain | MHRA | Registration is required by the time the study commences; the study’s regulatory route and declaration also matter. |
The MHRA’s GB registration guidance was last updated on 20 July 2026. Because registration routes and transitional rules can change, confirm the current guidance for the device and market you have in mind.
How to check a Great Britain IVD in PARD
- Open the official MHRA registration guidance. Go to Register medical devices to place on the market and follow its link to PARD. Starting from the guidance helps ensure you reach the official register rather than an unofficial database.
- Read the device label and packaging. Note the legal manufacturer’s name and address, exact brand or trade name, model or version, catalogue or reference number, and UDI-DI if one is shown. Do not rely on a retailer’s shortened product name.
- Search for the manufacturer and product. Look for the legal manufacturer and the exact device identity. Compare the result with the model, catalogue/reference number and other identifiers on the device or its packaging. A similar manufacturer or product name alone is not a reliable match.
- Check whether the record is for the relevant legal entity and device. MHRA guidance describes registering devices under the legal manufacturer’s organisation. If a record appears under a parent company, represented manufacturer or different organisation, do not assume it covers the product without confirmation.
- Resolve missing or conflicting details. If the public record does not show an identifier you need, or you cannot confidently match the entry, ask the manufacturer or supplier for clarification and supporting evidence. MHRA says registered information must be accurate and up to date and that it may request supporting technical documentation.
What a registration result does—and does not—show
A matching entry indicates that the device has a registration record in the relevant system. It is not a general finding about the device’s safety, effectiveness, or compliance with every requirement for sale.
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“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.”
This is the MHRA’s wording in its registration guidance. Do not describe an IVD as “MHRA approved” just because it appears in PARD. Registration is separate from conformity assessment, applicable market markings and other legal requirements.
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What to do if you cannot find the device
An unsuccessful search is a reason to investigate, not by itself a definitive legal determination about a particular product or sale. Check the spelling, legal manufacturer, model/version and catalogue or reference number; consider whether the record may be under a parent company or represented manufacturer; and make sure you are checking the register for the intended market. If the mismatch remains material, ask the supplier or manufacturer to explain and provide evidence, and contact the MHRA where appropriate.
For a GB sale, the MHRA says IVDs must be registered before placement on the market. A non-UK manufacturer must appoint a UK Responsible Person, who assumes registration responsibilities. Separate transition provisions can apply to certain IVDs relying on extended EU IVDD certificates or declarations; dates vary by device group and market, so do not infer a product’s status from a general certificate end date.
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Check the product information as well as the register
MHRA consumer guidance advises checking whether the product carries 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, but they do not replace searching the correct register or matching the exact device. If you are concerned about a device, you can report it through the MHRA’s Yellow Card scheme; consult a healthcare professional for advice about using a test or interpreting its result.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Manufacturer and supplier responsibilities can affect the record
For GB, the legal manufacturer is responsible for registration, and a non-UK manufacturer must appoint a UK Responsible Person. For NI non-custom-made devices placed on the NI or EU market from 28 May 2026, the registration route is EUDAMED; a GB-based manufacturer supplying NI still needs an EU- or NI-based Authorised Representative. These roles are distinct, so a supplier’s name or address is not necessarily the legal manufacturer shown in a registration record.
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