MedTech Europe Diabetes Sector Group’s position on quality standards for diabetes technology

The MedTech Europe Diabetes Sector Group is dedicated to improving access for people with T1 and T2 diabetes to safe, accurate, and high-performing medical technologies across Europe.

We acknowledge the ongoing discussions within the diabetes community and among standardisation bodies regarding quality standards for continuous glucose monitoring (CGM) technologies. Innovation in CGM and other medical devices has transformed diabetes management, benefiting people with diabetes, care teams, and health systems alike. The CE marking system under the EU regulatory framework (EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)) ensures the safety and performance of these technologies, providing a solid foundation for considering additional quality standards.

To deliver real value, such standards must be evidence-based, consistent with existing regulations, foster continued innovation, and ensure inclusive, transparent, and coordinated stakeholder engagement.

Read the Diabetes Sector Group’s full position below.