Module 15 2022

19/05/2022

The Periodic Safety Update Report (PSUR)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

23

Periodic safety update report (PSUR)

• Article 86 periodic safety update report • Applies to Class IIa, IIb and III devices, including custom made devices

• Summarises the results and conclusions of the post-market surveillance data including a rationale and description of any corrective or preventative action taken (PMS report) • Required for the lifetime of the medical device • Sets out: • The conclusion of the benefit-risk determination • The main findings of the PMCF • The volume of sales, estimate of the size and characteristics of the population using the device, and where practical, the usage frequency

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

24

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