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 when the procurement was signed off. For years that status felt like background furniture, a settled fact that had 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 2022 with a phased transition. Great Britain, having left the EU, did not adopt the IVDR and has been charting its own course, with the Medicines and Healthcare products Regulatory Agency, the MHRA, at the helm. And now Great Britain is reshaping its own framework, with draft reforms that would move in vitro diagnostics to a four-class, risk-based system and lift the evidence and surveillance expectations that come with it.
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 right in the blast radius, because so many near-patient and self-tests are precisely 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 understand the direction of travel now 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 sets 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 could reach the market on the manufacturer's own declaration, with an approved body involved only for a short high-risk list. The IVDR inverted that logic. It is risk-based: tests are sorted into classes according to 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. The result was a step change in the burden of proof, applied from 2022 with a long, phased transition to avoid tipping products off the shelves overnight.
Great Britain took a different road. It did not adopt the IVDR. Instead 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 the day after Brexit. 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 the sooner of their certificate expiry or 30 June 2030. After that backstop, a device needs to meet the Great Britain route to stay on sale here.
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 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 draft reforms, framed as the Medical Devices (Amendment) Regulations 2026, that would reshape how in vitro diagnostics are regulated in Great Britain. I want to be careful with the language here, because certainty is not the same as ambition. These are proposals. They are the 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 of the proposals is a move to a four-class, risk-based system for in vitro diagnostics, Classes A to D, broadly aligning Great Britain with international frameworks and with the logic the EU already adopted. Class A covers the lowest-risk products, Class D the highest. The higher the class, the more likely it is that an independent approved body, rather than the manufacturer alone, must assess the device before it can be sold, and the more clinical evidence and post-market vigilance are expected to sit behind it. Alongside the classification change, the proposals raise expectations on the evidence a manufacturer must hold and on what happens once a device is in real-world use.
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 system 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 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. 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. It obliges manufacturers to collect and act on information about how their products actually perform, to investigate signals of drift, and to correct problems. 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. Vigilance duties expect users to report incidents and near-misses through the proper channels so that a pattern invisible in any single clinic becomes visible in aggregate. The strengthened regime raises the stakes on that reporting culture. 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 Great Britain market may quietly be withdrawn rather than reworked. That is not a hypothetical: the transition to stricter regimes elsewhere has already seen products leave shelves. If a test you rely on is unusual or supplied by 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. The days when reporting a dud lot felt optional are ending. Under strengthened surveillance, feeding problems back through the proper channels is part of running a compliant service, and building a simple, reliable route to do it is now core governance rather than good manners.
Why point-of-care feels this more than the core laboratory
A hospital core laboratory has an entire quality apparatus wrapped around its analysers: dedicated staff, accreditation to ISO 15189:2022, established relationships with manufacturers, and people whose job is to track regulatory change. Point-of-care testing frequently does not. It lives on wards, in clinics, in pharmacies and in patients' homes, run by people whose primary job is caring for the patient in front of them, not curating 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 widest precisely 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 clearly is telling you something.
- 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 proper reporting channels rather than dying in a local workaround. Treat post-market surveillance as a duty you take part in.
- 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. 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.
The rules are moving. Move with them, calmly.
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 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 a habit of feeding problems back into the system. That is not red tape. It is what it looks like to take your own results seriously. Start now, while the change is still direction of travel and not yet a deadline.