Lifecycle of a Medical Device
Overview
The Swiss regulatory lifecycle follows a defined sequence from initial product definition to post-market monitoring. Understanding this sequence helps manufacturers and CH REPs plan regulatory activities effectively.
Stage 1 — Device Definition and Classification
Define the intended purpose by reviewing labelling, instructions for use, promotional materials, and technical claims. Determine whether the device falls under MedDO (medical devices: Classes I–III) or IVDO (in vitro diagnostics: List A, List B, Self-test, General). Classification drives all subsequent requirements. → How Classification Works
Stage 2 — General Safety and Performance Requirements (GSPRs)
Systematic assessment against MedDO Annex I requirements. Map each GSPR to harmonised standards and document compliance evidence. → GSPR Overview
Stage 3 — Technical Documentation
Compile Annex II (general technical doc) and Annex III (PMS documentation). Includes device description, GSPR compliance, risk management, and clinical evaluation. → Technical Documentation Overview
Stage 4 — Conformity Assessment
Complete the class-appropriate conformity assessment (Annex IV for Class I; NB-assessed routes for Class IIa+). Issue Declaration of Conformity. → Conformity Assessment Overview
Stage 5 — Swissmedic Registration
Notify or register the device in DAPI before (or within 30 days of) market placement. → Registration Overview
Stage 6 — Market Placement and Labelling
Place the device on the market with compliant labelling (including DE/FR/IT). Apply UDI. → Labelling Requirements
Stage 7 — Post-Market Surveillance
Active PMS system — monitor complaints, vigilance data, literature, and PMCF data. Update technical documentation as required. → PMS Overview
Stage 8 — Vigilance and FSCA
Report serious incidents to Swissmedic via eVigilance. Implement and notify FSCAs. → Vigilance Reporting
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
Expand Stage 5 description: "Notify or register the device in DAPI before (or within 30 days of) market placement. For Class I devices, notification suffices (subject to MRA status). For Class IIa and higher, full registration with NB documentation is required before market placement."