Module 16 2024

17/10/2024

Summary

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Summary

• The manufacturer must establish a post-market surveillance system within their QMS

• The manufacturer must have device specific post-market surveillance plans

• The manufacturer must collect and analyse real world data to support their devices performance, safety and benefit claims for the lifecycle/time of the device

• The manufacturer must take appropriate corrective/preventative action when necessary

• The manufacturer must report the findings of their post-market surveillance (PMS report, PSUR, vigilance as applicable) • Post-market surveillance data must be fed back into the risk evaluation and clinical evaluation to support the benefit/risk determination

• The manufacturer must have agreements with economic operators to manage complaints and vigilance

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