Periodic Safety Update Report (PSUR)

MDR Reference: Article 86; Annex III
BPG Rev.4 Reference: Section 7.2 (pp. 90-92)
Document Code: AIII-PSUR
Responsible Party: CRO
Service Mode: Write only

Applicability

• Required for: Class IIa, IIb, and III devices
• Update frequency (per Article 86):
  • Class IIa: at least every 2 years
  • Class IIb / Class III: at least annually
• Class I devices: PMS Report per Article 85 (not PSUR)

Requirements Checklist

Content (per Article 86 and Annex III)

• [ ] Summary of PMS data analysis for the reporting period
• [ ] Conclusions from benefit-risk assessment based on PMS data
• [ ] Main findings from PMCF activities
• [ ] Volume of sales data (units sold) and estimation of usage population
• [ ] Summary of complaints (categorised by type and frequency)
• [ ] Serious incidents and FSCAs reported during period
• [ ] Trend analysis against PMS Plan indicators and thresholds
• [ ] Actions taken as result of PMS findings (CAPAs, design changes, labelling updates)
• [ ] Conclusions and recommendations:
  • [ ] Risk-benefit ratio remains acceptable
  • [ ] Actions to optimise safety and performance
  • [ ] Any necessary updates to TD (CER, RMR, IFU, GSPR, etc.)
• [ ] Reference to PMCF evaluation report findings
• [ ] Updates to SSCP triggered (if applicable)

Lifecycle Integration

• [ ] PSUR conclusions reflected in next CER update
• [ ] PSUR findings feed back into risk management file
• [ ] PSUR triggers PMS Plan updates where needed
• [ ] Alignment with SSCP annual review
• [ ] Alignment with NB surveillance schedule

Submission

• [ ] Uploaded to EUDAMED (when functional)
• [ ] Available to NB for assessment
• [ ] In absence of EUDAMED: follow NB-specific submission arrangements (per MDCG 2021-1)

Key Regulatory References

• MDR (EU) 2017/745, Article 86 (PSUR)
• MDR (EU) 2017/745, Annex III (PMS documentation)
• MDR (EU) 2017/745, Article 87 (Vigilance reporting)
• MDCG 2022-21: Guidance on PSUR (including end of obligation to update)
• MDCG 2021-1: EUDAMED interim arrangements
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 7.2

Common Pitfalls (from BPG Rev.4)

• PSUR update frequency not per MDR Article 86 requirements
• Incomplete trend analysis or missing connection to PMS Plan indicators
• Benefits section is a re-statement of CER rather than analysis of new post-market data
• Actions taken not clearly linked to specific PMS findings
• Serious incident analysis lacking root cause investigation
• PSUR not aligned with PMCF report and SSCP updates

Dependency

PSUR is a Phase 5 (post-certification lifecycle) deliverable:

• Depends on PMS Plan (defines data collection scope)
• Incorporates PMCF Report findings
• Triggers updates to CER, RMR, IFU, SSCP
• Feeds into NB annual surveillance review