Periodic Safety Update Report (PSUR)

Overview

The PSUR is a periodic summary of post-market surveillance findings that must be prepared for Class IIa, IIb, and III devices. It replaces the simpler PMS report required for Class I devices. The PSUR must be made available to the NB (who reviews it during surveillance audits) and to Swissmedic on request.

When a PSUR is Required

• Class IIa: at least every 2 years
• Class IIb and III: at least every year

Content Requirements (MedDO Art. 72)

1. Device identification — name, models covered, intended purpose, indications
2. Conclusions from benefit-risk determination — updated based on PMS findings
3. Main findings from PMCF — summary of PMCF data since last PSUR
4. Volume of sales — number of devices placed on the market during the reporting period
5. Estimation of exposed population — number of patients exposed
6. Summary of post-market data — complaint data trends, vigilance reports, FSCAs, literature findings
7. Conclusions — whether the benefit-risk balance remains positive; any changes required to technical documentation, risk management, or labelling

Submission and Review

• The PSUR is submitted to the NB as part of routine surveillance activities
• The NB reviews the PSUR and may request additional information or updates to technical documentation
• Swissmedic may request the PSUR as part of market surveillance activities

Official Sources

• MedDO Art. 72 (SR 812.213)
• MDCG 2022-21 — PSUR template guidance

Disclaimer

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