PMS Overview
Overview
Post-market surveillance (PMS) is the systematic, active process of collecting and analysing data from devices placed on the market to identify and address safety and performance issues. Under MedDO, PMS is not optional — it is a mandatory lifecycle obligation for all device classes.
PMS Plan
The PMS plan (required by MedDO Annex III para. 1) must cover:
- Methods and procedures for proactively collecting post-market data
- Data sources: complaint data, vigilance reports, published literature, clinical registries, post-market clinical follow-up, information from NBs
- Thresholds and criteria for triggering corrective action
- How PMS data feeds back into risk management and technical documentation
PMS Report vs PSUR
| Class | Required Document | Frequency |
|---|---|---|
| Class I | PMS report (PMSR) | When significant changes occur or when requested |
| Class IIa | Periodic Safety Update Report (PSUR) | At least every 2 years |
| Class IIb | PSUR | At least every year |
| Class III | PSUR | At least every year |
Data Sources for PMS
- Complaint records and complaint trending
- Vigilance report data (reported to Swissmedic and received from Swissmedic)
- Published peer-reviewed literature
- Post-market clinical follow-up (PMCF) data
- Clinical registry data
- Information from NBs and other competent authorities
- Equivalent device data (where applicable)
Feedback Loop
PMS data must be used to update: the risk management file; the clinical evaluation report; the GSPR compliance matrix; and where applicable the SSCP. This feedback loop is assessed during NB surveillance audits.
Official Sources
Disclaimer
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.