Work Package 3 will explore methods to obtain and combine best clinical and scientific real-world evidence on clinical performance of high-risk medical devices in daily practice (post-marketing phase, for example from registries). It will also investigate how Notified Bodies are applying conditions to certificates of conformity.
Objectives
To review and develop methods for aggregating clinical data from real-world sources and registries across the lifecycle of high-risk medical devices
To develop a web-based tool for the automated surveillance of reports relating to specific types of medical devices
To advise how post-market clinical evidence should be generated, based on an analysis of notified bodies’ practices in applying conditions to certificates of conformity
Tasks
More information coming soon
More information coming soon
More information coming soon
