Annex III — Technical Documentation on Post-Market Surveillance (PMS)
Source: EU MDR 2017/745 Annex III | OJ L 117, 5.5.2017
PMS Documentation System
PMS Plan (Article 84)
Manufacturers shall establish, document and implement a PMS plan covering:
- Proactive and reactive methods for collecting post-market data
- Methods for evaluating collected data
- Appropriate indicators and threshold values
- Relevant databases and data sources
Data Sources:
- Reports of serious incidents and field safety corrective actions
- Records of non-serious incidents and complaints from economic operators, users and patients
- Literature reviews (scientific literature, clinical databases)
- Data from similar devices
- EUDAMED database information
PMS Report (Article 85) — Class I Devices
- Updated at least every 2 years
- Shall be incorporated into the technical documentation
Periodic Safety Update Report (PSUR) (Article 86) — Class IIa/IIb/III Devices
| Device Class | PSUR Update Frequency |
|---|---|
| Class IIa | At least every 2 years |
| Class IIb | At least annually |
| Class III | At least annually |
PSUR Content:
- Conclusions regarding the device and its intended purpose
- Main findings and conclusions
- Assessment of the benefit-risk ratio
- Sales volume estimates
- Estimated frequency of device use (where feasible)
Relationship with Clinical Evaluation
PMS data shall feed back into:
- Updates to the Clinical Evaluation Report (CER)
- Adjustments to the Post-Market Clinical Follow-up (PMCF) plan
- Updates to risk management documentation