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Minimum expectations for market authorization of continuous glucose monitoring devices in Europe—‘eCGM’ compliance status

Mathieu, Chantal; Irace, Concetta; Wilmot, Emma G.; Akra, Bassil; Del Prato, Stefano; Cuesta, Martin; Adolfsson, Peter; Klupa, Tomasz; Renard, Eric; Battelino, Tadej

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Authors

Chantal Mathieu

Concetta Irace

Dr EMMA WILMOT Emma.Wilmot@nottingham.ac.uk
Clinical Associate Professor in Diabetes and Endocrinology

Bassil Akra

Stefano Del Prato

Martin Cuesta

Peter Adolfsson

Tomasz Klupa

Eric Renard

Tadej Battelino



Contributors

Citation

Mathieu, C., Irace, C., Wilmot, E. G., Akra, B., Del Prato, S., Cuesta, M., Adolfsson, P., Klupa, T., Renard, E., & Battelino, T. (2024). Minimum expectations for market authorization of continuous glucose monitoring devices in Europe—‘eCGM’ compliance status. Diabetes, Obesity and Metabolism, https://doi.org/10.1111/dom.16153

Journal Article Type Note
Acceptance Date Dec 12, 2024
Online Publication Date Dec 26, 2024
Publication Date Dec 26, 2024
Deposit Date Jan 15, 2025
Publicly Available Date Jan 17, 2025
Journal Diabetes, Obesity and Metabolism
Print ISSN 1462-8902
Electronic ISSN 1463-1326
Publisher Wiley
Peer Reviewed Peer Reviewed
DOI https://doi.org/10.1111/dom.16153
Keywords CE marking, conformity assessment, continuous glucose monitoring, European Union, regulation, type 1 diabetes, type 2 diabetes
Public URL https://nottingham-repository.worktribe.com/output/44230459
Publisher URL https://dom-pubs.pericles-prod.literatumonline.com/doi/epdf/10.1111/dom.16153
Additional Information Received: 2024-10-24; Accepted: 2024-12-12; Published: 2024-12-26

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Publisher Licence URL
https://creativecommons.org/licenses/by-nc/4.0/

Copyright Statement
This is an open access article under the terms of the Creative Commons Attribution-Non-Commercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.





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