Beyond the CE Mark: A Call to Action for Minimum CGM Accuracy Standards in Central and Eastern European Nations

Tomasz Klupa; Silvija Canecki-Varžić; Adriana Ilavská; Andrej Janež; Sanja Klobučar; Mladen Krnić; Tatjana Milenkovic; Peter Novodvorský; Martin Prázný; Marko Šimunović; Jan Šoupal; Anca Pantea Stoian; Agnieszka Szadkowska; Tsvetelina Tankova; Tadej Battelino

doi:10.1111/dom.71344

September 14, 2026Diabetes Obesity and Metabolism

Beyond the CE Mark: A Call to Action for Minimum CGM Accuracy Standards in Central and Eastern European Nations

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Key Points

To advocate for establishing standardized minimum analytical and clinical accuracy thresholds for continuous glucose monitoring (CGM) systems beyond standard CE mark approval in Central and Eastern Europe.
Expert consensus and policy perspective formulated by leading diabetes clinicians and professional society leaders across Central and Eastern European nations.
Evaluation of regulatory standards, reimbursement pathways, and clinical performance benchmarks for commercial continuous glucose monitoring devices.
Basic CE marking certifies conformity to European safety directives but does not guarantee the rigorous clinical accuracy necessary for safe, automated, or intensive insulin dosing decisions.
Regional adoption of standardized minimum accuracy metrics—such as mean absolute relative difference thresholds—is urged across national health systems to ensure patient safety and equitable care.

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Implication

Expert consensus demonstrates the need for rigorous continuous glucose monitor accuracy standards in diabetes, highlighting regulatory gaps beyond standard European CE marking.

Abstract

T.K.'s institution received a beneficiary from Medtronic and Ypsomed/MyLife. T.K. received consulting fees from Medtronic, Dexcom, Abbott, Eli Lilly, Novo Nordisk and Sanofi, and honoraria from Medtronic, Dexcom, Abbott, Eli Lilly, Novo Nordisk, Sanofi, Krka, Servier, Astra Zeneca and Boehringer Ingelheim. T.K. received support for attending meetings/travel from Novo Nordisk and Sanofi, participated on a data safety or advisory board for Medtronic, Eli Lilly, Novo Nordisk, Sanofi and Dexcom and has stock or stock options with Eli Lilly. A.I.'s institution received grants or grants from Boehringer Ingelheim, Pfizer, Sanaclis, Eli Lilly, Egis, KRKA, Servier, Abbott, Sanofi-Aventis, Novo Nordisk, Novartis and Bayer, consulting fees from Novo Nordisk, Novartis, Boehringer Ingelheim, Eli Lilly, Egis, Abbott and Sanofi-aventis and honoraria from Novo Nordisk, Novartis, Boehringer Ingelheim, Pfizer, Eli Lilly, Egis, KRKA, Servier, Abbott and Sanofi-aventis. A.I. is the president of the Slovak Diabetes Society (unpaid) and is part of the Categorization Committee for Medical Devices Ministry of Health.

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Klupa et al. (2026) studied this question.

synapsesocial.com/papers/6aabb61e5f706d05830e4981 https://doi.org/10.1111/dom.71344

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Beyond the CE Mark: A Call to Action for Minimum CGM Accuracy Standards in Central and Eastern European Nations

Key Points

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Beyond the CE Mark: A Call to Action for Minimum CGM Accuracy Standards in Central and Eastern European Nations

Key Points

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Implication

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