The European Diabetes Forum has published a call to action highlighting the growing role of Continuous Glucose Monitoring (CGM) devices in diabetes care and the need to ensure their safety and performance across Europe.
According to the Forum, CGMs are increasingly used by people living with diabetes, enabling more personalised disease management and supporting improved glycaemic control, which can reduce the risk of complications.
As uptake grows and new manufacturers enter the European market, real-time glucose monitoring is becoming a core component of daily diabetes management for both patients and healthcare professionals.
What the diabetes community is calling for — key points
- EU-wide, CGM-specific safety, accuracy, and performance standards
- Harmonised clinical evidence and study requirements to ensure comparability
- Greater transparency and stronger oversight in device approval
- Regulatory action to guarantee patient access only to safe, reliable CGMs
Besides tracking glucose changes in response to food, medication and physical activity, alerts are provided when hypoglycemia or hyperglycemia are imminent, allowing immediate intervention.
Many CGM devices can be connected to insulin pumps leading to automated insulin delivery. False sensor values can thus harm by missing impending hypo- or hyperglycemia or misleading insulin delivery in automated insulin delivery systems. Having only reliable CGMs in clinical practice is thus of the utmost importance.
The primary legislation applicable to CGM devices in the EU market is the Medical Devices Regulation (MDR) which mandates that devices must meet General Safety and Performance Requirements to demonstrate an acceptable benefit–risk profile with lifecycle risk management.
Notified Bodies are appointed to evaluate CGMs. Whereas the Medical Device Coordination Group provides templates and guidance for medical devices generally, and harmonised ISO standards could provide technical detail, no specific guidance nor standards describe specific quality standards for CGM systems for manufacturers, leaving the Notified Bodies only with the evidence and claims submitted by manufacturers.
This system thus provides no clear standard setting for the level of safety and performance required and makes evaluation of CGMs entering the EU market untransparent. It is also difficult to compare the devices already on the market based on their supporting studies, as different study designs and procedures are used for different CGM systems.
Moreover, no minimum quality requirements in terms of methodology and representativeness of the populations investigated in the studies are prespecified.
This lack of regulatory guidance on CGM quality criteria holds a potential risk for PwD and their medical teams as lack of standardisation might affect therapeutic decisions and perceived glycaemic management.
Although most CGMs currently available in Europe are safe and preformant, reports have raised concerns about safety and quality of recently approved devices due to lack of reliable data.
In 2022, in an Italian region, a publicly procured CE-marked CGM device was recalled due to its poor accuracy at low and high glucose levels. As a result, 20,000 PwD had to return to using finger pricking.
In 2024, British diabetologists raised concerns about the lack of published evidence of the CE-marked hybrid closed loop system available in England and other countries, with significant concerns around sensor accuracy leading to glycaemic instability, and in some cases hospitalisation.
The US has adopted specific accuracy and performance standards for CGM devices–such as but not limited to – the FDA-approved integrated CGM (iCGM) requirement 21CFR862.1355. Nevertheless, issues reported in the MAUDE database and recent FDA warning letters to an iCGM system manufacturer suggest even more robust accuracy and performance standards are required for patient safety.
Such standards are being discussed by several European bodies represented in the International Federation of Clinical Chemistry (IFCC) working group on CGM.
Pending consensus among stakeholders, interim solutions that have been defined in the EU, UK and peer approved, alongside the iCGM recommendations, can serve as a guidance.
Harmonised CGM-specific EU standards would improve patient safety and outcomes, streamline Notified Body assessments, and reduce regulatory burden for manufacturers.
Centralising and standardising the approval process would further accelerate access to innovation and ensure consistent evaluation across EU Member States, thus also ensuring that only devices meeting safety and performance standards are marketed in Europe.
CGM devices contribute to more personalised and effective diabetes care.
However, it is crucial to ensure that PwD have access to safe and high-quality CGMs.
We call upon the European Commission to consider our concerns and take appropriate measures to uphold the rights and ensure continued safety of PwD.
10.02.2026.
