Swissmedic announced they will implement the IVDR extension as outlined under EU Regulation 2024/1860: HERE
Note that:
Regulation 2024/1860 also introduces a gradual rollout of EUDAMED. However, due to the lapsed Swiss-EU Mutual Recognition Agreement for medical devices, Swissmedic does not have access to EUDAMED. Therefore, this requirement is not, and cannot, be applicable in Switzerland.
Due to lack of access to EUDAMED, Swissmedic is developing its own registration database called ‘swissdamed’. The Actor registration module is already available. The medical device registration module is expected to be available for voluntary use in 2025 and to become mandatory in 2026.
Switzerland will formally adopt the changes into the Ordinance on the In Vitro Diagnostic Medical Devices (IvDO) by the end of this year.
In the meantime, “Swissmedic is already going ahead with enforcement according to the EU amendment to avoid jeopardising the supply of in vitro diagnostic medical devices in Switzerland.”