Module 15 Presentations

10/04/2024

Periodic safety update report (PSUR)

Key considerations • PSURs are required throughout the lifetime of the device as defined by the manufacturer • A PSUR is no longer required to be updated when the last manufactured device of the device model has been placed on the market and the intended lifetime of that (individual) device; i.e., the overall lifetime of the device (model), has been achieved. Note: Shelf-life must be taken into consideration. • The benefit-risk profile of the device and its position within the state-of-the-art must be re-evaluated with clear links to the clinical evaluation and risk evaluation. • The risk evaluation must be used determine the on-going acceptability of hazards considering real-world occurrence levels from PMS data.

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The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

29

Notified Body expectations

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

30