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

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To review and develop methods for aggregating clinical data from real-world sources and registries across the lifecycle of high-risk medical devices

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To develop a web-based tool for the automated surveillance of reports relating to specific types of medical devices

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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