It is not complexity or price that defines a medical device's class, but rather the potential clinical risk to the patient in case of malfunction.
Higher class means tougher checks and longer certification timelines.
The continuous glucose monitoring system falls under class IIb, a moderate to high risk category. This device is in prolonged contact with the body and monitors critical physiological functions, so any malfunction or error could place the patient in immediate danger.
As an active medical device, the CGM system impacts treatment adjustment decisions, which is why it requires mandatory certification by a notified body and a comprehensive clinical evaluation.
That is why obtaining certification for a CGM system is a rather lengthy and resource‑intensive process, with no room for compromise.
MLC is deeply committed to its responsibility and approaches each stage of CGM Flystat certification with the utmost rigour, fully aware that the safety and health of end‑users depend on the excellence of our work.
