Continuous Glucose Monitoring Systems in Europe: Regulatory Landscape and Certification Process Challenges Under MDR 2017/745.

AIMS: 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.

METHODS

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 Conformité Européenne certification process.

RESULTS

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- and post-marketing collection of medical device information, have limited access to critical evidence for Notified Bodies and delayed strengthening of post-market surveillance.

CONCLUSIONS

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-marketing period.