EU Guide: Risk Management Concepts and Terminology & MDR/IVDR Application of ISO 14971
14 August 2024
EU Commission Publishes Draft of New IVDR Common Specifications for Public Feedback
19 August 2024Overview
Swissmedic announced they will implement the IVDR extension as outlined under EU Regulation 2024/1860: HERE
Note that:
- Switzerland will “base its enforcement on the relevant EU interpretation documents”.
- The labeling requirements for IVD non-self-test devices have long been simplified in Switzerland, to allow the Swiss Authorized Representative (CH-REP) to be identified on either the label or in a document accompanying the device. This will continue to be the case, even after changes from Regulation 2024/1860 are implemented. See the Further Reading section below for an overview of the CH-REP labeling requirements.
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.
Timing
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.”
