{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T04:41:22Z","timestamp":1792384882444,"version":"4.4.0"},"reference-count":43,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To analyze the certification process for continuous glucose monitoring (CGM) systems in Europe under the applicable Medical Device Regulation (MDR) 2017\/745 and to highlight potential issues that may impact the reliability of CGM devices following introduction to the market.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We undertook a detailed review of MDR 2017\/745 using publicly available European Commission information portals to assess the current implementation status. Specifically, we examined where checks and balances intended to ensure the accuracy and safety of CGM devices were not in place and identify where delays in implementation of key functions may reduce transparency and efficacy of the Conformit\u00e9 Europ\u00e9enne certification process.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Key elements of the MDR have not been implemented, creating inertia for manufacturers and the Notified Bodies that undertake conformity assessments. Delays in implementing the European Databank on Medical Devices (EUDAMED), which was designed to harmonize pre\u2010 and post\u2010marketing collection of medical device information, have limited access to critical evidence for Notified Bodies and delayed strengthening of post\u2010market surveillance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The current process of CGM Conformity Assessment under MDR 2017\/745 limits access to regulatory submissions of clinical evidence reports, reference methodologies and other documentation necessary for CGM devices to be assessed as safe, accurate and effective in the populations of people with diabetes in whom they may be used. Additional checks and balances are required to increase transparency of the conformity assessment process prior to CE marking, and improve the traceability of CGM devices in the post\u2010marketing period.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.71202","type":"journal-article","created":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T02:35:32Z","timestamp":1786674932000},"page":"10081-10092","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Continuous Glucose Monitoring Systems in Europe: Regulatory Landscape and Certification Process Challenges Under\n                    <scp>MDR<\/scp>\n                    2017\/745"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5182-5473","authenticated-orcid":false,"given":"Concetta","family":"Irace","sequence":"first","affiliation":[{"name":"Department of Health Science University Magna Gr\u00e6cia  Catanzaro Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bassil","family":"Akra","sequence":"additional","affiliation":[{"name":"AKRA TEAM GmbH  Landsberg am Lech Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,13]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2025.112277"},{"key":"e_1_2_12_3_1","unstructured":"\u201cIDF Diabetes Atlas 11th Edition \u201d2025 accessed 17 Oct 2025 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