Module 15 Presentations

10/04/2024

Periodic safety update report (PSUR)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

27

Periodic safety update report (PSUR)

Key considerations • Provide a clear executive summary • Grouping of devices in one PSUR is permitted when duly justified • When grouping devices, a ‘leading device’ should be defined to which the PSUR reference number is attached • Volumes of sales must be broken down to allow sufficient analysis and identification of trends. Trends may be related to device types, variants, models, versions, user groups, individual users, healthcare facilities, etc. • The guidance advocates the use of IMDRF Adverse Event Terminology (AET) for reporting of serious incidents. IMDRF terminology may need to be integrated into the manufactures complaints management system.

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The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

28