NEX is now a UKCA-marked Class I medical device in Great Britain. For us, this matters for a simple reason: NEX supports decisions that can affect patient safety. That brings responsibility.
NEX Health Intelligence
What UKCA Marking Means
UKCA marking confirms that NEX has completed the required conformity process for a medical device under the UK Medical Devices Regulations 2002.
As the manufacturer, we have defined the device’s intended use, completed the relevant conformity assessment and signed a Declaration of Conformity.
This gives hospitals clearer assurance about how NEX is intended to be used and the role it plays within clinical workflows. NEX supports decision-making; clinical judgement remains central.
Safety at Our Core
NEX brings together clinical, microbiology and patient-movement data to support infection surveillance, outbreak investigation and the earlier identification of infection risk.
Because these functions can inform decisions affecting patients, safety must be considered throughout the product lifecycle. In practice, this means:
Defining the intended use and boundaries of the system.
Identifying foreseeable hazards and assessing their potential impact.
Introducing controls to reduce clinical, technical and operational risks.
Testing that these controls work as intended.
Reviewing product changes through documented quality processes.
Providing users with clear instructions, limitations and safety information.
Together, these processes create a consistent record of how decisions have been made and how risks have been controlled.
Safety Does Not Stop at Deployment
UKCA marking is not the end of the work.
We continue to monitor how NEX performs, review feedback and incidents, and use this evidence to strengthen our risk controls and product processes. Post-market surveillance is an important part of maintaining safety and performance over time (MHRA, 2025).
Each deployment also helps us understand how the system performs across different hospitals, workflows and patient populations. That learning feeds back into how we build, test and improve NEX.
“Becoming a medical device is important because it formalises the responsibility that comes with building software for clinical use. Clearly, patient safety depends on defined intended use, disciplined risk management, effective quality control and learning from how the product performs in practice.”
Chang Ho Yoon, Chief Medical Officer of NEX Health Intelligence
