Market Access
Swiss Regulatory Framework
Switzerland previously participated in the European single market for medical devices under the Mutual Recognition Agreement (MRA). Since 26 May 2021, the MRA has not been updated for medical devices, resulting in a legally independent regulatory framework under the Swiss Medical Devices Ordinance (MedDO).
Key consequences of this regulatory independence include:
- Limited access to EU regulatory systems such as EUDAMED
- Reduced institutional cooperation in market surveillance
- Application of Swiss-specific regulatory requirements
Key measures include:
- Mandatory designation of the CH-REP (Article 51 MedDO)
- Independent registration requirements (Swissdamed)
- Direct reporting obligations to Swissmedic
Need support with Swiss market access?
Request CH-REP support →Registration Requirements
Under the MedDO, economic operators must register with Swissmedic via Swissdamed.
All Swiss-based economic operators must obtain a CHRN (Swiss Single Registration Number). For non-Swiss manufacturers, the CH-REP performs the registration on their behalf.
Swissdamed includes:
- Actors module: Registration of economic operators
- UDI devices module: Registration of devices with Unique Device Identifiers
UDI registration will become mandatory for devices placed on the Swiss market from 1 July 2026, with a transitional period until 31 December 2026.
Accurate and timely registration supports regulatory compliance and traceability.
