Post-Market Risk Management Excellence: What Notified Bodies Actually Want to See

Navigating Notified Body expectations for post-market surveillance (PMS) documentation is one of the hardest parts of maintaining EU MDR compliance—especially with the Proposed Targeted Revision reinforcing the need for well-designed PMS strategies.

This session cuts through the ambiguity by showing what reviewers actually care about and how to focus effort where it matters. Attendees will learn to distinguish truly critical elements from “nice-to-have” content, reducing the risk of non-conformities, delays, and endless document rework.

We will also unpack the connections between PMS and risk management, with concrete examples of how PMCF plans, PSURs, and SSCP updates should feed into and strengthen the risk management file across the product lifecycle. Participants will see how to recognize and respond to SSCP triggers in a way that demonstrates control, satisfies regulatory scrutiny, and avoids over-burdening teams.

By the end of the session, attendees will have a practical picture of current and future NB expectations for PMS, and a clearer roadmap for building documentation that is both compliant and efficient.