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