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. 2025 Mar;27(3):1025-1031.
doi: 10.1111/dom.16153. Epub 2024 Dec 26.

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

Chantal Mathieu  1 , Concetta Irace  2 , Emma G Wilmot  3   4 , Bassil Akra  5 , Stefano Del Prato  6 , Martin Cuesta  7 , Peter Adolfsson  8   9 , Tomasz Klupa  10 , Eric Renard  11 , Tadej Battelino  12   13
Affiliations

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

Chantal Mathieu et al. Diabetes Obes Metab. 2025 Mar.
No abstract available

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

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Conflict of interest statement

CM serves or has served on the advisory panel for Dexcom, Medtronic and Insulet. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for CM from Medtronic; CM serves or has served on the speakers bureau for Medtronic. Financial compensation for these activities has been received by KU Leuven. CM is the president of EASD. All external support of EASD is to be found on www.easd.org. CI has provided advisory board services for Roche Diabetes Care Italy, Abbott, Ascensia and Senseonics and has received speaker fees from Roche Diabetes Care Italy, Abbott and Ascensia. EGW has received personal fees from Abbott, Dexcom, Embecta, Insulet, Medtronic, Roche, Sinocare and Ypsomed and research support from Abbott, Embecta and Insulet. BA has participated in EU Medical Device Regulation and has represented Notified Bodies at EU Level. SDP has served as president of EASD/European Foundation for the Study of Diabetes (EFSD) (2020–2022) and is the president of the European Diabetes Forum and of the Menarini Foundation; he has served as an advisor for Abbott. PA has received honoraria for speaking engagements from Dexcom, Insulet, Medtronic, Nordic InfuCare, Rubin Medical and Tandem and is on an advisory board for Insulet, Medtronic and Roche. PA has received an unrestricted grant from Rubin Medical, Sweden, which is a reseller of Tandem insulin pumps. TK has received research support from Medtronic; participated in advisory boards for Medtronic, Dexcom and Ascencia; and received speaker honoraria from Medtronic, Dexcom, Abbott and Ascencia. ER declares consultant/speaker fees from Abbott, Dexcom, Medtronic and Roche and research support from Abbott, Dexcom and Roche. TB has served on advisory panels for Medtronic, Abbott and Indigo Diabetes and received honoraria for participating on the speaker's bureau of Medtronic, Abbott, Dexcom and Roche. TB's Institution has received research grant support from Abbott, Medtronic, the Slovenian Research and Innovation Agency, the National Institutes of Health and the European Union.

Figures

FIGURE 1
FIGURE 1
Minimum accuracy and performance requirements for safeguarding people with diabetes when using CGM systems. The figure illustrates the proposed minimum requirements for conformity assessment and CE marking of CGM devices within the EU and EFTA regions. *CGM data privacy and cybersecurity safeguards must meet European data protection laws. All clinical data from studies submitted for conformity assessment and CE marking must be fully disclosed on the product label at the point of marketing. CGM, continuous glucose monitoring; EU, European Union; EFTA, European Free Trade Association.
See this image and copyright information in PMC

References

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