Annual reports & Periodic Safety Update Report (PSUR)
Regulatory basis - MDR Art. 85 / IVDR Art. 80. The PSUR is required for higher-risk device classes and must be submitted to the notified body via EUDAMED. MDCG 2022-21 provides detailed guidance on PSUR content and format.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
PMS report vs. PSUR — the key distinction
Lower-risk devices require a PMS report — a summary of PMS findings with no fixed submission cycle or standardised format. Higher-risk devices require a Periodic Safety Update Report (PSUR) — a more structured, periodically submitted document with defined content requirements under MDR Art. 85.
| Document | Required for | Submitted to |
|---|---|---|
| PMS report | Class I, IIa (MDR); Class A, B (IVDR) | Held in technical documentation; reviewed by NB at surveillance (Class IIa/B) |
| PSUR | Class IIb implantable, III/AIMD (MDR); Class C, D (IVDR) | Submitted to NB via EUDAMED |
PSUR — required content (MDR Art. 85 / MDCG 2022-21)
A compliant PSUR must contain:
1. Device identification
- Device name and trade name
- Basic UDI-DI
- ARTG/EUDAMED registration reference
- Certificate number(s) and notified body
- Intended purpose (as CE marked)
2. Production and distribution data
- Cumulative number of devices placed on the EU market since CE marking
- Estimated number of devices currently in use
- Geographic distribution (EU markets)
- Number of devices placed on market in the reporting period
3. Summary of PMS activities and results
A structured summary of all PMS data collected in the reporting period:
| Data source | Key questions to address |
|---|---|
| Complaints | How many? What types? Any trends? Any serious incidents? |
| Vigilance | All reportable events listed; actions taken |
| Literature | Key publications; any new safety or performance signals? |
| PMCF results | Key findings from PMCF studies, registries, or surveys in the period |
| Registry data | National implant registry or disease registry data (if applicable) |
| EUDAMED / competitor device data | FSCAs or vigilance data for comparable devices |
4. Conclusions from PMS data
Based on the PMS data:
- Do the clinical data confirm the benefit-risk is positive?
- Have any new risks been identified?
- Is the device performing as expected in the intended population?
- Are there any signals suggesting the clinical evaluation or IFU needs updating?
5. Benefit-risk analysis
An updated benefit-risk analysis based on accumulated post-market evidence. Must be consistent with the CER / performance evaluation report. If new evidence changes the benefit-risk conclusion, the CER must be updated and the notified body informed.
6. PMCF / PMPF plan and evaluation report reference
Reference to the current PMCF/PMPF plan and the most recent evaluation report findings.
7. Conclusion on the need for preventive or corrective action
Explicit conclusion: is any change to the device, labelling, clinical strategy, or vigilance approach needed?
PSUR frequency
| Device class | PSUR frequency |
|---|---|
| MDR Class IIb (implantable) | At minimum every 2 years |
| MDR Class III / AIMD | At minimum annually |
| IVDR Class C | At minimum every 2 years |
| IVDR Class D | At minimum annually |
The notified body may require more frequent PSURs — for example, annually for a Class IIb implantable where post-market evidence is still maturing.
PSUR submission — via EUDAMED
The PSUR is submitted to the notified body through EUDAMED. The notified body reviews the PSUR as part of its ongoing surveillance of the manufacturer's products. The PSUR review may:
- Be a desk review (documentation only)
- Trigger a targeted site audit if the NB has concerns arising from the PSUR content
- Result in a request for a PSUR update or supplementary data
PSUR findings are factored into the NB's decision on whether to renew the CE certificate at the next renewal cycle.
PMCF / PMPF integration with the PSUR
The PSUR cannot be completed without the PMCF evaluation report (MDR) or PMPF evaluation report (IVDR). These must be current and consistent with the PSUR:
- PMCF/PMPF data is a key input to the PSUR's PMS summary section
- The PMCF/PMPF conclusions must be reflected in the PSUR benefit-risk analysis
- If PMCF/PMPF has identified new risks, the PSUR must address how those risks are being managed
Common PSUR deficiencies
| Deficiency | Issue |
|---|---|
| PMS data not properly analysed | Raw complaint numbers listed without analysis or trend assessment |
| Benefit-risk not updated | PSUR concludes benefit-risk is positive without referencing the accumulated evidence |
| PMCF findings not integrated | PMCF evaluation report exists but is not referenced or reflected in the PSUR |
| Production data missing | No data on volumes placed on market or estimated devices in use |
| PSUR not updated annually | Only produced for NB renewal, not on the required annual cycle |
| Inconsistency with CER | PSUR safety conclusions differ from those in the CER without explanation |
Related pages
- PMS requirements by class
- Distribution records
- Post-market data in technical documentation
- PMCF plan and evaluation report
Official references
| Reference | Description |
|---|---|
| MDR Art. 85 | PSUR requirements |
| IVDR Art. 80 | IVDR PSUR requirements |
| MDR Annex III | Post-market technical documentation |
| MDCG 2022-21 | PSUR guidance and template |
| MDCG 2020-7 | PMCF plan and evaluation report |