A new publication in The Lancet Regional Health – Europe highlights the urgent need for clear, harmonised quality and performance standards for continuous glucose monitoring (CGM) devices. CGMs are essential tools for people living with diabetes, supporting safer, more personalised care. This paper, co-authored by IDF Europe Chair Prof. Tadej Battelino, highlights gaps in EU regulation and calls for harmonised CGM-specific EU standards to improve patient safety and outcomes, streamline Notified Body assessments, and reduce regulatory burden for manufacturers, further accelerating access to innovation and ensure consistent evaluation across EU.
IDF Europe has long advocated for stronger oversight under the EU Medical Devices Regulation to ensure CGMs are safe, reliable and fit for purpose. This publication reinforces the need for EU-wide action to safeguard patient safety while supporting innovation.
