PSUR

The Periodic Safety Update Report (PSUR) is a mandatory reporting requirement under EU MDR Article 86 for Class IIb, Class III, and implantable devices. It provides a comprehensive summary of post-market surveillance (PMS) data and serves as a critical tool for notified bodies to monitor the ongoing safety and performance of medical devices after CE marking.

EU MDR Article 86 requirements:
Manufacturers of Class IIb, Class III, and implantable devices must:
- Prepare PSURs summarizing the results and conclusions of post-market surveillance analyses
- Submit PSURs to their notified body according to defined timelines
- Update risk management and benefit-risk analysis based on PSUR findings
- Make PSURs available to competent authorities upon request

PSUR reporting frequency:
- Class IIa - PMS report (not PSUR) when technical documentation is updated
- Class IIb - PSUR every 2 years
- Class III - PSUR annually
- Implantable devices - PSUR annually (regardless of class)

The reporting period starts from the date of the first CE certificate under EU MDR for that device.

PSUR content requirements:
A comprehensive PSUR must include:

1. Device identification
- Commercial name, model numbers, UDI-DI
- Basic UDI-DI for device families
- Classification and applicable regulations
- Intended purpose and indications for use

2. Volume of sales and clinical use
- Number of devices sold/distributed by market
- Estimated number of patients exposed
- Device population at risk (for implantables)

3. Post-market surveillance data summary
- Complaints received (type, frequency, severity)
- Returns, repairs, and warranty claims
- Field safety corrective actions (FSCAs)
- Vigilance reports (incidents, serious incidents, trends)
- PMCF data collected during the reporting period
- Literature review findings
- Data from registries and clinical studies

4. Volume of vigilance data
- Number of incident reports submitted to authorities
- Breakdown by incident type and severity
- Trend analysis and statistical evaluation
- Comparison to previous reporting periods

5. Risk-benefit analysis update
- Evaluation of known risks and benefits
- Identification of new or increased risks
- Assessment of residual risks
- Overall benefit-risk determination and conclusion
- Comparison with alternative treatments/devices

6. Conclusions and actions
- Overall assessment of device safety and performance
- Corrective and preventive actions (CAPA) implemented or planned
- Updates to risk management file
- Changes to instructions for use or labeling
- Implications for clinical evaluation report updates

PSUR vs PMS report:
| Aspect | PSUR | PMS Report |
|--------|------|------------|
| Devices | Class IIb, III, Implantable | All classes |
| Frequency | Annual or biennial | Variable by class |
| Submitted to | Notified body (mandatory) | Part of technical documentation |
| Format | Structured per Article 86 | Flexible format |
| Focus | Safety and risk-benefit | Broader performance data |

Integration with other post-market activities:
The PSUR integrates data from:
- PMS system - Complaint handling, trend analysis, market data
- PMCF activities - Clinical follow-up studies and registries
- Vigilance system - Incident reporting and FSCAs
- Risk management - Ongoing risk assessment updates
- Clinical evaluation - CER updates with new clinical data

Notified body review:
After receiving the PSUR, the notified body will:
- Review the report for completeness and adequacy
- Evaluate whether PMS activities are appropriate for the device risk
- Assess whether risk-benefit ratio remains favorable
- Determine if additional actions are needed
- May request additional information or clarification
- Consider PSUR findings during surveillance audits

Common PSUR deficiencies:
- Insufficient data analysis (data collection without interpretation)
- Incomplete vigilance data or missing trend analysis
- Inadequate risk-benefit evaluation or outdated comparisons
- Missing PMCF data or failure to reference PMCF evaluation report
- No conclusions or action plans
- Late submission to notified body
- Inconsistencies with other post-market documentation

PSUR and certificate renewal:
PSURs play a critical role in maintaining CE marking:
- Notified bodies review PSURs as part of ongoing surveillance
- Negative PSUR findings may trigger special audits
- Certificate renewal requires demonstration of adequate PMS, including PSURs
- Failure to submit PSURs may result in certificate suspension or withdrawal

Timeline considerations:
- First PSUR is due 1 year (Class III/implantable) or 2 years (Class IIb) after first CE certificate
- Manufacturers should establish internal timelines 3-6 months before submission to allow data compilation and analysis
- Late submissions may constitute a breach of MDR obligations
- Changes in device classification may change PSUR frequency requirements

The PSUR is a critical regulatory document that demonstrates a manufacturer's ongoing commitment to monitoring device safety and taking appropriate action to protect patients. It provides transparency to notified bodies and competent authorities about the real-world performance of medical devices and serves as an early warning system for emerging safety issues.