Module 15 Presentations

10/04/2024

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

• The PSUR summarises the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan (Article 84) tighter with a rationale and description of any preventative and corrective actions taken. • Applies to Class IIa, IIb and III devices, including custom made devices • Throughout the lifetime of the device concerned the PSUR shall set 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