562-P: Navigating Regulatory Challenges for Diabetes Devices—A Comparative Analysis of EU and U.S. Frameworks

Résumé fourni par la source

Introduction and Objective: The growing prevalence of diabetes presents major public health and economic challenges, driving the need for innovative medical devices. However, navigating the regulatory frameworks of the European Union (EU) and the United States (US) is complex, requiring substantial resources and expertise. Methods: Using qualitative research methods, including case studies and semi-structured interviews, we identified differences and similarities between the EU and US risk classifications. The findings were used to design flowcharts that guide the classification of diabetes-related medical devices. Results: Our research revealed that while both the EU and the US classify medical devices based on risk, their approaches differ: the EU employs a rule-based system, whereas the US uses a code-based system. We compared specific cases (Fig.) and developed flowcharts illustrating similarities and discrepancies between the two jurisdictions, offering insights into strategic regulatory compliance and identifying potential synergies to manufacturers. Conclusion: The significant differences in US and EU medical device risk classifications reflect their distinct regulatory approaches, highlighting the need for early strategy clarification and comprehensive classification tools. A streamlined strategy across jurisdictions can better facilitate innovation in diabetes care, improving outcomes for those living with diabetes. Disclosure S. Hossmann: None. C. Malonzo Marty: Other Relationship; Siemens Healthcare Diagnostics, Eli Lilly and Company. Employee; Hylomorph AG. Consultant; Evido Denmark, FlenHealth Belgium. D. Brandt: None. L. Heinemann: Consultant; Dexcom, Inc., Roche Diabetes Care. Board Member; Lifecare. Stock/Shareholder; Science Consulting in Diabetes GmbH, Profil Institut für Stoffwechselforschung GmbH, diateam GmbH. Consultant; Indigo. M. Rothenbühler: None. Funding The work is supported by the Diabetes Center Berne.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.