Module 16 2024

18/10/2024

Ramifications of PSURs once available

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Ramifications of PSURs once available

• 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.

• The Notified Body review of the PSUR will also be shared with the Competent Authority (CA).

• Purpose is 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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