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 active surveillance, incident reporting, periodic safety reporting, and maintaining the DAPI registration.
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.