Minimum expectations for market authorization of continuous glucose monitoring devices in Europe-'eCGM' compliance status

Diabetes Obes Metab. 2024 Dec 26. doi: 10.1111/dom.16153. Online ahead of print.

Chantal Mathieu¹, Concetta Irace², Emma G Wilmot^{3

4}, Bassil Akra⁵, Stefano Del Prato⁶, Martin Cuesta⁷, Peter Adolfsson^{8

9}, Tomasz Klupa¹⁰, Eric Renard¹¹, Tadej Battelino^{12

13}

¹ Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium.
² Department of Health Science, University Magna Græcia, Catanzaro, Italy.
³ University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.
⁴ University of Nottingham, Nottingham, UK.
⁵ AKRA TEAM GmbH, Landsberg am Lech, Germany.
⁶ Interdisciplinary Research Center "Health Science" of the Sant'Anna School of Advanced Studies, Pisa, Italy.
⁷ Endocrinology and Nutrition Service, Hospital Clínico San Carlos, Madrid, Spain.
⁸ Department of Diabetes, Högsbo Hospital, Gothenburg, Sweden.
⁹ Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.
¹⁰ Department of Metabolic Diseases, Jagiellonian University Medical College, Krakow, Poland.
¹¹ Department of Endocrinology and Diabetology, Montpellier University Hospital, Montpellier, France.
¹² Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
¹³ University Medical Centre Ljubljana, Ljubljana, Slovenia.

No abstract available

Keywords: CE marking; European Union; conformity assessment; continuous glucose monitoring; regulation; type 1 diabetes; type 2 diabetes.

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