Continuous Glucose Monitoring Systems in Europe: Regulatory Landscape and Certification Process Challenges Under MDR...

Area of Science:

• Medical device regulation
• Diabetes technology
• Regulatory affairs

Background:

• Continuous glucose monitoring (CGM) systems are crucial for diabetes management.
• The European Medical Device Regulation (MDR) 2017/745 governs the certification of medical devices, including CGMs.
• Ensuring the reliability and safety of CGMs under the new MDR framework is critical.

Purpose of the Study:

• To analyze the CGM certification process under the MDR 2017/745.
• To identify potential issues impacting CGM device reliability after market introduction.
• To assess the effectiveness of current regulatory checks and balances.

Main Methods:

• Detailed review of the MDR 2017/745 using European Commission information portals.
• Assessment of current implementation status of key regulatory functions.
• Examination of gaps in accuracy and safety assurance for CGM devices.
• Identification of delays impacting transparency and efficacy of the Conformité Européenne (CE) certification process.

Main Results:

• Key MDR elements remain unimplemented, causing delays for manufacturers and Notified Bodies.
• Delayed implementation of the European Databank on Medical Devices (EUDAMED) hinders data access and post-market surveillance.
• Limited transparency and efficacy in the CE certification process for CGMs.

Conclusions:

• The current CGM conformity assessment under MDR 2017/745 restricts access to essential clinical evidence.
• Additional regulatory checks and balances are needed to enhance transparency before CE marking.
• Improved post-marketing traceability of CGM devices is required to ensure ongoing safety and effectiveness.