Description: The MDR tells us that PMCF must confirm the safety and performance of a medical device throughout its expected lifetime. Similarly, PSURs need to continue to be generated even when a product is no longer placed on the market until there is sufficient data within them to cover the expected lifetime.
But how does one define the expected lifetime, particularly for implantables and capital equipment?
This session will review the varying guidance that exists and the considerations to be used. It will then move on to a discussion of real-world examples. Industry speakers will share how they have done this in their organizations and the sort of Notified Body feedback received (if any), and how they addressed those issues.
Learning Objectives:
Understand the complexity of estimating the expected lifetime for a medical device, as well as the potential consequences.
Learn what guidance exists and what factors should be considered in defining the expected lifetime
Learn from real-world examples how one might address the challenges of estimating the expected lifetime