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Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This strategic alignment ensures regulatory equivalence with EU IVD regulations (2017/746 EC, IVDR) while providing manufacturers extended transition periods. Here are the essential modifications affecting your IVD device strategy:
High-Risk Device Categories (Notified Body Review Required):
In-House In vitro Diagnostic Devices / Laboratory-developed Tests (LDTs):
Professional Supply Chain Considerations:
Timelines for mandatory Medical Device Registration in SWISSDAMED (Swiss database on Medical Devices):
These modifications demonstrate Switzerland’s commitment to maintaining robust regulatory oversight while providing practical transition periods for industry stakeholders. Alignment with EU regulations ensures continued market access while supporting innovation and patient safety.
With over 20 years of commitment and expertise in In Vitro Diagnostics (IVDs), Veranex delivers exceptional assistance tailored to the quality, regulatory, clinical and market access requirements for IVD devices, enabling businesses to confidently achieve regulatory compliance.
For detailed guidance on compliance requirements or strategic planning assistance, contact our regulatory affairs team.
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