End of MedDO transitional provisions — CE-marked devices must be notified or registered in swissdamed
2026-12-31 — End of MedDO transitional provisions — CE-marked devices must be notified or registered in swissdamed
Switzerland's Medical Devices Ordinance (MedDO), which aligns with EU MDR/IVDR, includes transitional provisions for devices bearing CE marks under legacy MDD/AIMD directives. However, these transitional periods are tied to — and generally co-terminus with — the EU MDR/IVDR transition periods.
Manufacturers placing CE-marked devices on the Swiss market must:
- Ensure their device is notified or registered in the swissdamed database.
- Hold a valid CE certificate under EU MDR (or MDD/AIMD during the applicable transitional period).
- Have a CH REP (Swiss Authorised Representative) registered with Swissmedic.
As EU MDR transition periods end (Class IIb implantable: December 2027; others: December 2028), Swiss market access requirements tighten in parallel. Monitor Swissmedic announcements for Switzerland-specific transitional arrangement dates, which may differ slightly from EU timelines.
Verify the current transitional provisions and applicable deadlines directly with Swissmedic, as these are subject to update.
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