Regulatory perspectives on post-market evidence generation schemes for high-risk medical devices: a systematic review

Abstract

Introduction: The new European Medical Device Regulation has raised the bar for the clinical evaluation of medical devices to gain marketing authorization by Notified Bodies (NBs) regarding certificates of conformity in Europe. Restrictions applied for High-risk medical devices (HRMD) may require further evidence generation. Some other jurisdictions apply similar schemes that may be useful to the European Union. This systematic review focused on extracting lessons from similar schemes worldwide to the European context. Methods: A systematic review of peer-reviewed and gray literature was performed based on ‘Device approval’ and ‘conditional approval’ keywords. Databases such as Medline, Embase, and WoS retrieved documents assessed with the AMSTAR-2 checklist. A descriptive and narrative analysis was conducted detailed in CRD42023431233–PROSPERO. Results: We obtained eight documents where conditional approvals for High-risk medical devices in the United States of America, China, and Canada were subject to generate further evidence. In Europe, NBs impose restrictions or limitations to certificates of conformity instead. Conclusion: Further development of policies, supporting access to HRMD subject to further evidence generation, would help Europe in further defining the appropriate situations for the application of determined regulatory routes, to enhance access to HRMD with promising evidence and further evidence development. Registration: PROSPERO (CRD42023431233).