Module 16 2024

18/10/2024

Summary

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Summary

• MDCG 2022-21 provides useful guidance and templates for manufacturers.

• PSURs are intended for the manufacturer first, Notified Body and Competent Authority second.

• Imperative that manufacturers establish device specific PMS Plans – the ‘inputs’.

• PSUR documents the current (at a given time) safety and performance of a device(s).

• Compiles information from PMS activities to ensure the benefit/risk is favourable.

• PSUR for Class IIb implantable and Class III devices assessed by Notified Body and thereafter uploaded to EUDAMED.

• PSURs need to be created as of the Date of Application (DoA) of the MDR (May 2021), irrespective of the delay of EUDAMED.

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