NEX is now a UKCA-marked Class I medical device in Great Britain. This is an important milestone for the company. More importantly, it formalises the responsibility that comes with developing technology to support decisions affecting patient safety.
NEX Health Intelligence
What UKCA Marking Means
UKCA marking means that NEX has completed the required conformity process for a Class I 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. The device has also been registered with the Medicines and Healthcare products Regulatory Agency before being placed on the Great Britain market (MHRA, 2026).
This provides hospitals with greater clarity about how NEX is intended to be used, its role within clinical workflows and the responsibilities that remain with clinical teams.
Building Around Patient Safety
NEX brings together clinical, microbiology and patient-movement data to support infection surveillance, outbreak investigation and earlier identification of infection risk.
These functions can inform decisions affecting patients. Safety therefore needs to be considered throughout the product lifecycle.
For NEX, this includes:
Defining the intended use and the 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 clear instructions, limitations and safety information to users.
This work creates a consistent record of how decisions have been made and how risks have been controlled.
Quality Control Continues After Deployment
Medical-device development continues after a product enters clinical use.
We monitor how NEX performs, review feedback and incidents, and use this evidence to update our risk controls and product processes. Post-market surveillance is an important part of maintaining safety and performance over time (MHRA, 2025).
Each new deployment also helps us understand how the system performs across different hospitals, workflows and patient populations.
“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
