From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".

Аннотация

Both the US Food and Drug Administration (FDA) and European Medical Device Regulation maintain the authority to require post-market surveillance for novel, high-risk medical devices. Yet, the current post-market surveillance system has several limitations. In their systematic review, Hoogervorst and colleagues highlight opportunities for improvement in the European medical device registries for the cardiovascular and orthopedic fields by standardised reporting of structural and methodological ch