Module 15 2022

19/05/2022

Periodic safety update report (PSUR)

• Article 86 periodic safety update report

Electronic submission: • Manufacturer submits PSUR to EUDAMED • Notified Body reviews, provides feedback • Available to the Competent Authorities

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The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

25

Periodic safety update report (PSUR)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

26

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