Post-Market Overview
Overview
Once a medical device is on the Swiss market, the manufacturer's regulatory obligations continue throughout the device's lifetime. Post-market obligations include implementing a post-market surveillance (PMS) system, conducting periodic safety reviews, reporting serious incidents and field safety corrective actions, managing vigilance data, maintaining an accurate DAPI registration, and updating technical documentation based on post-market findings.
Key Post-Market Obligations
| Obligation | All Classes | Class IIa+ | Class III/Implantable |
|---|---|---|---|
| Post-market surveillance (PMS plan) | ✓ | ✓ | ✓ |
| PMS report (PMSR) | ✓ | – | – |
| Periodic Safety Update Report (PSUR) | – | ✓ | ✓ |
| PMCF plan and report | – | ✓ | ✓ |
| Vigilance reporting (serious incidents) | ✓ | ✓ | ✓ |
| FSCA notification to Swissmedic | ✓ | ✓ | ✓ |
| DAPI registration maintenance | ✓ | ✓ | ✓ |
| SSCP (publicly available) | – | – | ✓ |
Obligation to Update Technical Documentation
Post-market data must be used to update technical documentation — particularly the risk management file, clinical evaluation report, and GSPR compliance matrix. This is a continuous obligation, not a periodic one.
CH REP Post-Market Role
The CH REP is responsible for receiving and forwarding post-market information (complaints, vigilance reports, FSCAs) and for submitting vigilance reports to Swissmedic where the manufacturer has delegated this obligation. The CH REP is jointly and severally liable for post-market compliance.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.