Module 16 2022

9/2/2022

Key Takeaways • Although the content of PSURs are clearly explained in the MDR, how to put this into practice is not. • PSURs are intended for the manufacturer first, Notified Body and Competent Authority second. • PSURs will need to be created as of the Date of Application (DoA) of the MDR (May 2021), irrespective of the delay of EUDAMED. • PSURs for Implantable devices and Class III are challenging due to limited availability of information. • Presently no formal guidance on PSURs via MDCG document are in place (draft copy in existence but due to delays in publishing likely to be significant changes when it is published).

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© NAMSA 2021

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© NAMSA 2021

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