A blood glucose meter, a CRP analyser and a lateral flow cartridge can each sit on the same reception desk, yet only one of them is doing anything resembling diagnostic decision-making without a laboratory in the loop. That gap between a simple device and a governed clinical service is where most point-of-care testing (POCT) deployments in GP and community settings either succeed quietly or fail publicly. The equipment is rarely the hard part; the regulatory and quality-assurance layer behind it is.
Point-of-Care Testing Is Regulated Twice Over
Every point-of-care testing device sold in the UK is a medical device in its own right and falls under the Medicines and Healthcare products Regulatory Agency (MHRA). Since the post-Brexit replacement of the CE mark, in-vitro diagnostic devices sold into the UK market must carry a UKCA mark, with manufacturers required to demonstrate clinical evidence, analytical performance and scientific validity before that mark is issued. That is the manufacturing-side regulation, and it is largely invisible to the clinic buying the device.
The second layer of regulation is the one clinics actually have to manage themselves: the MHRA’s own guidance on the management and use of point-of-care IVDs. That guidance does not stop at "buy an approved device." It expects a documented clinical need for introducing the test in the first place, involvement of the local hospital laboratory that would otherwise be doing the work, clear lines of accountability for who owns the result, and robust arrangements for training, quality assurance and incident reporting. A UKCA mark on the box answers none of those questions on its own.
ISO 15189 and ISO 22870: The Standards Behind the Device
Where the MHRA sets expectations, two ISO standards supply the mechanics for meeting them. ISO 15189 covers quality and competence in medical laboratories generally, and the MHRA recommends that any site providing a point-of-care testing service work towards accreditation against it. The current version places particular weight on staff training and competence, management of reagents and consumables, formal service agreements, and ongoing participation in external quality assessment.
ISO 22870 sits alongside it and is written specifically for testing performed outside a conventional laboratory — in GP surgeries, community clinics and ambulatory care settings. Together the two standards cover method performance verification (does this device actually give the right answer, on this site, in this operator’s hands), internal and external quality assurance, staff competency, and a mechanism for continuous improvement rather than a one-off sign-off.
Someone Has to Own It: The POCT Coordinator
None of the above runs itself, which is why functioning POCT services are built around a named coordinator role rather than a shared assumption that "the nurses will manage it." The coordinator’s remit typically spans selecting and evaluating instruments, running staff training and competency assessment, overseeing day-to-day quality control, resolving technical faults, keeping an equipment register, and acting as the link between the clinical team and the laboratory that ultimately carries clinical responsibility for the service. Larger deployments pair this role with a multidisciplinary POCT committee — laboratory staff, clinicians and nursing representatives — so that decisions about adding or retiring a test are not made by one person in isolation.
This is also where connectivity earns its place on the requirements list rather than the nice-to-have list. A device that produces a result nobody can trace back to a patient record is a governance liability, not a convenience — which is why current guidance treats an IT link between the point-of-care device and the main clinical or laboratory system as part of the deployment, not an optional upgrade.
Proving It Still Works: External Quality Assessment
A device that passed verification on installation day does not stay verified by default. External quality assessment (EQA) — sometimes called proficiency testing — is the ongoing check: a clinic tests a blind sample alongside every other participating site and compares results. ISO 22870 treats EQA enrolment as a standard expectation for point-of-care devices, not an optional extra, because it is the only routine mechanism that catches a drifting result, a reagent problem or a training gap before it reaches a patient. A credible EQA scheme circulates material at reasonable intervals and gives participants feedback they can actually act on, rather than a pass/fail stamp with no explanation.
What This Table Adds Up To
| Requirement | What it actually covers | Typically owned by |
|---|---|---|
| UKCA marking | Device-level safety and performance evidence, set by the manufacturer | MHRA / manufacturer |
| Documented clinical need | Why this test, at this site, instead of sending the sample to a lab | Clinical lead + laboratory |
| ISO 15189 / 22870 alignment | Verification, staff competence, consumables management, service agreements | POCT coordinator |
| External quality assessment | Ongoing proof the device still performs correctly on this site | POCT coordinator / laboratory |
| Results connectivity | Getting the result into the patient record reliably | Practice IT / laboratory systems |
The Implementation Question the 2014 Report Left Open
"Better Health for London" argued for shifting more care into primary and community settings — which, read literally, means more testing happening away from a hospital laboratory, not less. What that recommendation does not spell out is that near-patient testing only earns the trust it needs if the regulatory and quality layer travels with the device. A GP surgery or community clinic weighing up a point-of-care testing service is not really choosing between vendors; it is choosing whether it is ready to run something closer to a small laboratory than a piece of consulting-room kit — clinical need documented, ISO-aligned quality processes in place, a named coordinator accountable for it, and an EQA scheme confirming the results can still be trusted six months after installation. That is what deploying point-of-care diagnostics actually requires, and it is the same governance question — regardless of borough, practice size or which test is under discussion.