IVD Regulation Is Changing: What POCT Teams Need to Know

Somewhere on your bench right now sits a device that a patient's care depends on, and behind it sits a certificate you have probably never read. A CE mark on a box, a declaration in a folder, a regulatory status you took on trust the day procurement was signed off. For years that status felt like background furniture, a settled fact with nothing to say to the person actually running the test. That comfortable assumption is ending. The rules that decide which in vitro diagnostic tests are allowed on the market, what evidence must stand behind them, and what happens after they are sold, are being rewritten on both sides of the Channel at the same time.

Europe has already moved. The European Union replaced its old In Vitro Diagnostic Directive with the far stricter In Vitro Diagnostic Regulation, the IVDR, which applied from 26 May 2022 with a long, phased transition that is still running today. Great Britain, having left the EU, did not adopt the IVDR and has been charting its own course under the Medicines and Healthcare products Regulatory Agency, the MHRA. Post-market surveillance here was already strengthened in June 2025, and the MHRA has now set out how it means to rebuild the pre-market rules too, including a move to a four-class, risk-based system for in vitro diagnostics.

Here is my thesis, and I want to state it plainly before the detail buries it. This is not abstract legal news happening to somebody else. Point-of-care testing sits close to the centre of it, because so many near-patient and self-tests are exactly the higher-risk products the new rules scrutinise most. The regime change will touch which devices you can buy, what evidence you are entitled to demand, what some of them cost, and what you personally are expected to do after a result looks wrong. The teams that read the change early will make better procurement and governance decisions than the ones who wait for a letter.

Two regimes, one Channel, and why the split matters

Start with what actually changed in Europe, because it set the reference point everyone else is now measured against. The old IVD Directive was a light-touch, list-based regime under which the large majority of in vitro diagnostics reached the market on the manufacturer's own declaration, with an independent body involved only for a short high-risk list. Estimates from across the sector put the share of IVDs that needed a notified body under the old Directive at around one in five. The IVDR inverted that logic. It is risk-based: tests are sorted into classes by the harm a wrong answer could do, and the higher the class, the more independent scrutiny and clinical evidence the manufacturer must produce before and after launch. Under the IVDR that same share is widely estimated at roughly four in five. That is not a tweak. It is a wholesale change in who has to prove what.

That transition is not a single switch but a staged one, and it is still in progress. Under the amended timetable, and provided they meet conditions including a compliant quality management system and a timely application to a notified body, legacy in vitro diagnostics keep their route to the EU market for a window that depends on class: to the end of 2027 for the highest-risk Class D, the end of 2028 for Class C, and the end of 2029 for Class B and sterile Class A. In other words, the stricter regime is not fully bedded in even in Europe yet, which is one reason its ripples are still reaching us.

Great Britain took a different road. It did not adopt the IVDR. It kept a version of the pre-existing arrangements while it worked out its own path, and it accepted, for a defined window, devices carrying the European CE mark so the supply of tests would not collapse overnight. That pragmatic bridge is not permanent. Under current arrangements, CE-marked in vitro diagnostics can continue to be placed on the Great Britain market until 30 June 2030, and for devices on older Directive certificates that acceptance runs only to the sooner of certificate expiry or that date. After that backstop, a device needs the Great Britain route to stay on sale here. One live caveat belongs here: in February 2026 the government opened a consultation on recognising CE-marked devices indefinitely, so even the 2030 date is not fixed. This is a moving target, and I will come back to what that means for how you buy.

The practical consequence of this two-regime world is one many POCT teams have not fully absorbed. The device on your bench may be legal here today on a European certificate that will one day expire, under a European regime that is not the one Great Britain is building. For a while, we are living in the overlap of two systems that are both still moving. That is precisely the situation in which assuming nothing has changed is the riskiest move of all.

What Great Britain is proposing, and how to read it honestly

The MHRA has published its roadmap for the future regime and the draft legislation to carry it, with a further statutory instrument due to introduce the new pre-market rules for in vitro diagnostics. I want to be careful with the language here, because ambition is not the same as certainty. Parts of this are proposals and draft dates. They are a clearly signalled direction of travel, not settled law, and the sensible reader treats them as a strong steer to prepare rather than a fixed calendar to obey.

The centrepiece is a move to a four-class, risk-based system for in vitro diagnostics, Classes A to D, broadly aligning Great Britain with the international framework and with the logic the EU already adopted. Class A covers the lowest-risk products and is largely self-declared; Class B adds a certified quality management system; Class C brings in independent assessment by an approved body; and Class D, the highest risk, adds the most scrutiny again. The higher the class, the more clinical evidence and post-market vigilance are expected to sit behind the device. Alongside classification, the reforms propose an international reliance scheme that would let approvals from trusted regulators abroad, with Australia, Canada and the United States named as comparable countries, support a faster Great Britain route. On the published draft timings, the pre-market changes are expected to be made in 2026 and to come into force around 2027, with a longer transition for in vitro diagnostics than for other devices. Treat those dates as indicative.

Do not let the tidy diagram flatten the point. The reason this matters for point-of-care is that near-patient and self-test products often land higher up the ladder than intuition suggests. A test whose result is read and acted upon immediately, without a laboratory professional between the sample and the decision, and sometimes by the patient themselves at home, carries a risk profile the classification takes seriously. Self-tests in particular attract elevated scrutiny under risk-based regimes, precisely because there is no expert intermediary to catch a misleading answer. If your service runs near-patient testing, a meaningful slice of your catalogue is likely to sit in the classes that will feel the reforms most.

The device on your bench may be legal here today on a European certificate that will one day expire, under a European regime that is not the one Great Britain is building. We are living in the overlap of two moving systems.

Post-market surveillance is already here, and it is not just for manufacturers

One part of the reform is not a proposal at all. It is live. Strengthened post-market surveillance requirements came into force in Great Britain on 16 June 2025, under regulations that amend the existing device rules. This is the piece I would draw a POCT team's attention to first, because it is real today and because it changes the relationship between the people who make devices and the people who use them.

Post-market surveillance is the discipline of watching how a device behaves once it is out in the world, on real benches, in real hands, with real patients, rather than only in the tidy conditions of a validation study. The strengthened regime obliges manufacturers to plan their surveillance in proportion to a device's risk, to collect and act on how their products actually perform, and to move faster when something goes wrong: a manufacturer must now report a serious incident to the MHRA within 15 days, down from the previous 30, and sooner still for a death or a serious threat to public health. That clock sits on the manufacturer, not the user. But surveillance is not a one-way street that runs only through the manufacturer. It depends on a feedback loop, and the near end of that loop is you.

When a device gives a result that does not fit the patient, when a lot behaves differently from the one before it, when a control keeps failing for no reason you can find, that is not merely a local nuisance to be worked around. It is a data point in a national safety system. The MHRA asks users to report incidents and near-misses through the Yellow Card scheme, so that a pattern invisible in any single clinic becomes visible in aggregate. A service that treats an odd result as something to shrug off is not just failing its own patient; it is withholding a signal that could protect thousands of others.

What the reforms will actually do to your bench

Strip away the legislative vocabulary and the reforms translate into four concrete pressures on a working POCT service. None of them is a reason to panic. All of them are reasons to pay attention.

Availability may shift. When the evidence and assessment burden rises, some manufacturers rationalise their portfolios. A niche assay, a low-volume product, or a device that would need costly re-certification to stay on the market may quietly be withdrawn rather than reworked. That is not hypothetical: the move to stricter rules in Europe caused real concern about products leaving shelves, which is part of why the IVDR transition had to be extended more than once. If a test you rely on is unusual or comes from a smaller manufacturer, its future availability is a fair question to ask now.

Cost may move. Independent assessment, larger clinical evidence packages and ongoing surveillance are not free, and some of that cost flows downstream into the price of consumables and cartridges. It will not be uniform, but a procurement plan that ignores the possibility of price movement on affected classes is planning with one eye shut.

Evidence expectations rise, in your favour. This is the part I would frame as an opportunity rather than a threat. A stricter regime means the manufacturer is expected to hold more and better performance evidence for the intended use, including near-patient and self-test contexts. That is evidence you are entitled to ask to see. The reforms make it more reasonable, not less, to demand the instructions for use, the performance claims and the intended-use statement in writing before you commit.

Surveillance becomes a duty, not a courtesy. Reporting a dud lot can no longer be treated as optional housekeeping. Under strengthened surveillance, feeding problems back through the proper channels is part of running a well-governed service, and building a simple, reliable route to do it is core governance rather than good manners.

Why point-of-care feels this more than the core laboratory

A hospital core laboratory usually has a quality function around its analysers: accredited to ISO 15189:2022, with staff who track manufacturer notices and regulatory change as part of the job. Point-of-care testing often does not have that same dedicated capacity. It lives on wards, in clinics, in pharmacies and in patients' homes, run by people whose first duty is the patient in front of them rather than a device register.

That is exactly why regulatory change lands harder here. The near-patient setting has the least regulatory slack and the least dedicated attention, yet it hosts many of the higher-risk products the reforms target most, and it is the setting where a self-test may be handed to a patient with no professional between them and a wrong number. The gap between the risk a device carries and the governance wrapped around it is often widest at the point of care. Closing that gap is not a compliance chore bolted on from outside. It is the same discipline that makes a result trustworthy in the first place, now with the force of an evolving rulebook behind it.

The near-patient setting has the least regulatory slack and the least dedicated attention, yet it hosts many of the higher-risk products the reforms target most. The gap between risk and governance is widest at the point of care.

What this means for your service

You cannot change the regulations, and you should not try to become a regulatory affairs department. What you can do is make regulatory status a routine, unglamorous part of how you buy and govern testing, so that when the rules bite you are already standing on the right side of them. In the order I would take them:

• Build a device register with regulatory status in it. For every test you run, record the manufacturer, the intended use, the regulatory route it is on today, and, where it is CE-marked, when that certificate expires. You cannot manage exposure to the 30 June 2030 backstop if you have never written the expiry dates down.
• Make regulatory status a procurement criterion, not an afterthought. Before you commit to a new device, ask the supplier in writing about its Great Britain regulatory status, its intended use for your specific setting, and its plan for the reforms. A supplier who cannot answer those questions clearly is worth a second look before you commit.
• Keep the evidence you are entitled to. Hold the current instructions for use, the intended-use statement and the performance claims for each device on file, and keep them current when a manufacturer updates them. Under a stricter regime this is your evidence too, not just theirs.
• Stand up a real vigilance route. Decide now who reports a suspected device problem, how, and to whom, so that an odd result, a bad lot or a recurring failure reaches the manufacturer and the MHRA rather than dying in a local workaround. Once the manufacturer is on a 15-day clock for serious incidents, your report is the signal that starts it, so a route that exists only in principle is not good enough.
• Watch for withdrawals and price moves on affected products. Flag the niche or single-source tests in your catalogue and ask about their future early, so a withdrawal is a planned transition rather than a scramble.
• Go to the source for current detail. Timelines and specifics will move as proposals become law, and the CE recognition consultation may change the 2030 picture again. The MHRA is the authoritative place for the current position, and I would check it rather than rely on any summary, including this one, for a date you intend to act on.

If you want help turning this into practice, our consultancy can review your device register and procurement approach against the direction of travel and help you build a proportionate governance system that will survive scrutiny. The resource library holds starting points you can adapt for registers, procurement questions and incident reporting, and our training gives near-patient teams the grounding in quality and governance that the new regime assumes. None of it requires you to become a lawyer. It requires you to stop treating regulatory status as background furniture.

Prepare before the change becomes a deadline

I am not writing this to alarm anyone. The reforms are, on balance, good: a stricter, risk-based regime with real post-market surveillance is how you make near-patient testing safer, not how you make it harder. The point is simply that the ground is shifting, and it is shifting under point-of-care testing more than almost anywhere. The teams that thrive will not be the ones with the biggest compliance budget. They will be the ones who wrote down what is on their bench, asked their suppliers the awkward questions early, and built the habit of feeding problems back into the system. That is not extra bureaucracy. It is what taking your own results seriously looks like in practice. Start now, while the change is still a signalled direction and not yet a deadline.

Sources and notes

This article is a plain-English orientation, not legal or regulatory advice, and the Great Britain reforms it describes include proposals and draft dates that will change as they pass into law. Where I give a date or a figure, it is drawn from the MHRA, the UK government, the European Commission or published sector analysis, listed below. The two headline percentages for notified-body scope under the IVDD and the IVDR are widely cited sector estimates rather than a single official count, so I have rounded them and labelled them approximate. For any date you intend to act on, check the MHRA for the current position.

1. MHRA and Department of Health and Social Care. Implementation of the future regulation of medical devices. Sets out the 2026 pre-market statutory instrument, IVD reclassification, the international reliance scheme, and the CE recognition consultation open 16 February to 10 April 2026.
2. MHRA. Regulating medical devices in the UK. States that CE-marked IVDs may be placed on the Great Britain market until the sooner of certificate expiry or 30 June 2030.
3. MHRA. Guidance on new medical devices post-market surveillance requirements. Strengthened post-market surveillance in force 16 June 2025, including the 15-day serious incident reporting timeline.
4. MHRA. Guidance on the regulation of IVD medical devices in Great Britain.
5. Emergo by UL. MHRA publishes draft statutory instrument for the future regulatory framework. Four-class A to D IVD system and the draft timings.
6. Burges Salmon. MHRA confirms international reliance routes, IVD changes and UDI approach. Australia, Canada and the USA as comparable regulator countries.
7. European Commission. In vitro diagnostics: transitional provisions. IVDR applied from 26 May 2022; amended legacy transition to end of 2027 (Class D), end of 2028 (Class C) and end of 2029 (Class B and sterile Class A) under Regulation (EU) 2024/1860.
8. IQVIA. Understanding in vitro diagnostic risk-based classification. On the shift in the share of IVDs requiring notified-body involvement from the IVDD to the IVDR.
9. International Organization for Standardization. ISO 15189:2022, Medical laboratories, requirements for quality and competence.