Legacy Devices & Transitional Provisions
Overview
MedDO (SR 812.213) entered into force on 26 May 2021, replacing the predecessor Swiss MDD/AIMDD-implementing ordinance. Transitional provisions allowed continued market access for a defined period for devices certified under predecessor legislation.
Key Transitional Dates
| Event | Date |
|---|---|
| MedDO entry into force | 26 May 2021 |
| Last date to place on market under MDD/AIMDD certificates | 26 May 2024 (general devices) |
| End of sell-off period | 26 May 2025 (general devices) |
| Implantable Class III/IIb special rules | Earlier phased dates apply |
Always verify current transitional dates with Swissmedic — these dates have been subject to amendment and align with EU MDR transitional provisions.
Post-Transition Obligations
PMS and vigilance obligations under MedDO apply to all devices regardless of transitional certification status. CH REP obligations apply immediately regardless of which ordinance the conformity was certified under.
Devices Without Valid Certificates
If an MDD/AIMDD NB certificate expired during transition without MDR/MedDO renewal, the device cannot be newly placed on the Swiss market. New conformity assessment is required.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.