iTechGuides is reader-supported. When you buy through links on our site, we may earn an affiliate commission. As an Amazon Associate I earn from qualifying purchases. Learn more
To check an in vitro diagnostic medical device (IVD) for sale in the UK, first identify where it is intended to be sold. In Great Britain—England, Scotland and Wales—search the MHRA’s Public Access Registration Database (PARD), reached from the MHRA registration guidance. For Northern Ireland, non-custom-made devices have used EUDAMED since 28 May 2026; custom-made devices remain registered with the MHRA. Match the record against the product’s legal manufacturer and exact identifiers: a similar name is not enough. An entry is evidence of registration, not MHRA approval or endorsement.
Choose the register for the intended market
The UK does not have one register for every IVD in every part of the country. Great Britain (GB) and Northern Ireland (NI) have different routes, and the applicable route can also depend on whether a device is custom-made or undergoing performance evaluation.
| Device and market | Register or route | What to know |
|---|---|---|
| IVD intended for Great Britain | MHRA Public Access Registration Database (PARD), via the MHRA registration guidance | IVDs must be registered with the MHRA before they are placed on the GB 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 NI. |
| IVD undergoing performance evaluation in Great Britain | MHRA registration | The IVD must be registered by the time the study commences; the study-specific declaration and applicable regulatory route also matter. |
The MHRA’s NI guidance explains the jurisdictional change and exceptions: regulating medical devices in the UK. Great Britain-based manufacturers supplying NI also need an EU- or NI-based Authorised Representative.
Recommended Free Tools
How to check a product record
- Confirm the destination market. Decide whether the device is intended for England, Scotland or Wales, or for Northern Ireland. For a GB IVD, start at the MHRA’s registration guidance and follow its PARD link. For a non-custom-made NI device, use EUDAMED; for a custom-made NI device, check the MHRA route.
- Read the product 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 present. These are among the product identity fields described in the MHRA’s Device Registration Reference Guide.
- Search the relevant register. In PARD, search using the legal manufacturer and exact device name or identifiers. If the record does not show every identifier, do not treat a close name match as proof that it is the same device.
- Compare the record with the item offered. Check that the manufacturer and product identity correspond to the label, packaging and instructions. Where the listing is unclear, ask the supplier or manufacturer to identify the exact record and provide supporting evidence.
- Check related market-facing information. Look for the applicable CE, UKCA or CE UKNI marking and the manufacturer’s address on the device or packaging. MHRA’s consumer guidance on using medical devices safely describes these checks. They complement, but do not replace, checking the correct register.
What an MHRA registration does—and does not—show
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 by the MHRA.” A matching PARD entry therefore shows that a registration record exists; it does not by itself establish MHRA approval, the device’s safety or effectiveness, or compliance with every other requirement for placing it on the market. Do not describe a product as “MHRA approved” solely because it appears in the database.
#1 Best Overall
- FDA-Approved & Clinically Trusted: The only oral fluid HIV self-test capable to detect both HIV-1 and HIV-2 antibodies. The same trusted test used by healthcare providers. Approved for use in individuals 14 years of age and older
- Quick & Easy Results in 20 Minutes: Just three simple steps and 20 minutes to know your HIV status, no lab visit or waiting required. Contact the OraSure support call center for confidential expert assistance and guidance if needed. FSA/HSA Eligible
- Pain-Free Oral Swab Testing: Uses a gentle gum swab; no needles, no discomfort, and no mess. Each kit includes: 1 OraQuick test device and vial, 1 Test Stand, 1 "HIV, Testing & Me" educational booklet, 1 instructional guide
- Confidential & Convenient At-Home Testing: Perform your test anytime, anywhere, with complete privacy. No appointments, waiting rooms, or follow-up visits. Ideal for individuals seeking discreet, self-directed HIV testing
- Sustainable & Reliable: Rebranded from OraQuick In-Home HIV Test with eco-friendly packaging; same trusted accuracy and performance as before.
Registration is distinct from conformity assessment and applicable conformity markings. The MHRA’s UK medical-device regulatory guidance sets out the wider regulatory context.
If you cannot find an exact match
An unsuccessful search is a reason to investigate, not by itself a definitive legal finding about a particular product or sale. Before drawing a conclusion, check for spelling variations, the legal manufacturer rather than only a consumer-facing brand, a parent company or represented manufacturer, and whether you searched the register for the actual destination market.
Rank #2
- Quick Results: Learn your blood type in just a couple of minutes with this easy-to-use testing kit
- Simple Interpretation: Easily understand your blood type group with clear and straightforward results
- Permanent Record: Keep as a permanent record of your blood type on the durable card for your records or safekeeping
- Reliable Accuracy: Offers a reliable and accurate way to learn your blood type using proven testing technology
- Convenient Home Use: Can be used conveniently at home without the need for laboratory visits
- Ask the supplier or manufacturer to confirm the relevant legal manufacturer, exact model or version, and registration record.
- If the discrepancy remains material, contact the MHRA or seek appropriate regulatory advice. MHRA guidance says registration information must be accurate and up to date, and supporting technical documentation may be requested.
- If you have concerns about a device, follow the MHRA’s Yellow Card route for reporting a problem with a medicine or medical device. For questions about your own care or a test result, consult a healthcare professional.
Allow for device-specific rules and changes
Some IVDs are subject to transitional arrangements, including devices relying on extended EU IVDD certificates or declarations. Their conditions and end dates vary by device group; MHRA guidance gives dates for certain groups through 2027, 2028 or 2029. Do not assume that one certificate date applies to every IVD. Check the device’s classification and circumstances against current MHRA guidance on medical-device regulation in the UK.
Quick wins for a faster PC:
Repair Windows errors before they cause bigger problemsFix Now →Scan for outdated or missing drivers - takes under a minuteDriver Scan →The MHRA’s registration guidance was last updated on 20 July 2026, and its Northern Ireland guidance on 11 June 2026. Because register status and regulatory rules can change, verify the live record and current guidance when making a purchasing, supply or compliance decision.
Quick Recap
Best Value
- Tests for 5 STDs: An easy-to-use 5-Panel STD test with simple, fast, and private results. Simple HealthKit's 5-Panel STD Test screens for 5 STDs / STIs: Chlamydia, Gonorrhea, Trichomoniasis, HCV & Syphilis.
- Fast, Simple, Private: Getting tested has never been easier. Collect a urine & blood sample from the privacy of your home and send it to our lab for testing. Once the sample is received by our lab, your online results are typically available within 3 - 5 days.
- Free Follow-Up Care: Lab processing is included with your test purchase. If you receive a positive or abnormal test result, follow-up care is included. No extra charge. No hidden fees. It's that simple.
- Physician Approved, HSA / FSA Eligible, Test Intended for 18+ Only: Not Available in NY. Lab is CLIA Certified and CAP Accredited. Results delivered through a HIPAA-compliant portal.
- Fast, Simple, Private: Getting tested has never been easier. Collect a urine & blood sample from home and send it to our lab for testing. Once the sample is received by our lab, your online results are typically available within 3 - 5 days.
Rank #4
- FAST & EASY RESULTS IN 1 MINUTE – Simple at-home testing with clear results in as little as 60 seconds. No lab visits, no appointments, no waiting.
- PRIVATE & CONFIDENTIAL AT-HOME TESTING – Test in the comfort of your home with privacy and control from start to finish.
- OVER 99% ACCURATE - Clinically proven to deliver highly accurate results, giving you confidence in your test outcome.
- MORE ACCURATE THAN ORAL TESTS - Designed to provide greater confidence and clarity compared to oral fluid HIV tests.
- SATISFACTION GUARANTEED - If you experience any issues with your test, contact INSTI directly and we will resolve it quickly.
Rank #3
- BD Veritor System offers test assays that can be used to process samples provided to the lab in an appropriate transport medium
- The first CLIA-waived Digital Immunoassay (DIA), a new category of diagnostic tests where the assay and instrument work together to combine advances in detection particles, optical image recognition and interpretation algorithms to improve accuracy
- Advanced Particle Technology enhances sensitivity by using a proprietary process to produce highly stable modified colloidal metal particles, helping improve test performance
Product prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on Amazon at the time of purchase will apply.
