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 directly with Swissmedic before relying on these dates for compliance planning — transitional dates have been amended in the past and may be updated. Swissmedic publishes updates on its website and in official Fedlex records.
swissdamed Registration
swissdamed device registration is mandatory from 1 July 2026 for all devices/systems/procedure packs placed on the Swiss market. A transitional period to register existing market devices runs to 31 December 2026; devices subject to serious-incident/FSCA/trend reporting must register immediately with no transitional period. Legal basis: amendment to the Swiss IVD Ordinance of 20 November 2024 (AS 2024 742).
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.