Module 16 2022

9/2/2022

Ramifications of PSURs once available • Purpose of the creation of the PSUR: “post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.” • After the PSUR is uploaded to EUDAMED, the document will need to be reviewed by the Notified Body. For Class III and Implantable devices, this review needs to await approval. In addition, the review of the Notified Body of the PSUR will in addition be shared with the Competent Authority. • This is done to increase transparency and availability of the safety and performance information in Europe. • PSURs are not intended to be shared with other stakeholders: this role is fulfilled by the Summary of Safety and Clinical Performance (SSCP).

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© NAMSA 2021

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Ramifications of PSURs once available • PSURs will become available for Competent Authorities in the EU: they are able to compare this information with safety and performance data that can be obtained from other parts of EUDAMED: vigilance information, trend reports, incidents, etc. • In addition, parts of the EUDAMED will now also become available for the Notified Bodies that will use this database for their surveillance assessments at manufacturers. • It is therefore important to be aware that much more information about your device is now available and can be tracked.

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© NAMSA 2021

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