Content PSUR/Report

Title Page

Summary and Applicable Guidelines

Abbreviations

1. INTRODUCTION
2. WORLDWIDE STATUS OF THE DEVICE
(including classification, CE and Marketing history)
3. HUMAN USE AND POSSIBLE EXPOSURES (intended/non-intended)
(With characteristics of population using the device and application frequency)
4. POST MARKET SURVEILLANCE
(Volume of sales, estimated size to be evaluation, feedbacks)
5. PSU DATA
5.1. Findings in Clinical Evaluation
5.2. Findings from clinical studies (completed/ongoing), PM studies, literatures
(published/unpublished)
(cumulative exposures, interval exposures, post experiences)
5.3. Findings in Post Market Surveillance
(complaints, incidents, FSCA, errors, service reports, observations and CAPA)
5.4. Materiovigilance
(reported AE/ADE/SAE, signals and signal analysis)
5.5. In-house findings
(Changes, incidents, CAPA)
6. DATA EVALUATION
6.1. Evaluation of PSU data
6.2. Risk mitigation, Risk control & CAPA (rationale and descriptions)
6.3. Issues addressed and Issues to be addressed in next PSUR
7. TREND ANALYSIS
8. BENEFIT-RISK BALANCE
9. OVERALL CONCLUSION
(include recommendations & considerations)
10. PSUR INTERVALS AND NEXT UPDATE