Module 15 Presentations

10/04/2024

Periodic safety update report (PSUR)

PSUR frequency:

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Electronic submission: • Manufacturer submits PSUR to EUDAMED (in absence of EUDAMED submit to Notified Body per MDCG 2021-1)

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• Notified Body reviews, provides feedback • Made available to the Competent Authorities

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

25

Periodic safety update report (PSUR)

• MDCG 2022-21 GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR), December 2022 • Provides guidance and a template for writing a PSUR • The PSUR is a summary of the findings from PMS, PMCF and Clinical Evaluation • Two key objectives: • Identification and evaluation of changes of the benefit-risk profile • Information on preventative and corrective actions (CAPA) according to Article 83(4)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

26