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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:
Extended Transition Periods Based on Risk Classification
High-Risk Device Categories (Notified Body Review Required):
- Class D (Very High Risk): Extended until December 2027
- Class C (High Risk): Extended until December 2028
- Class B (Increased Risk) and Class A Sterile: Extended until December 2029
Extended Transitional Periods for IVD Devices
Legacy Device Certificates
- Certificates issued between May 25, 2017, and May 25, 2022, remain valid through December 31, 2027
- Removal of end-of-sale deadline to preserve supply chain integrity and prevent waste of safe medical devices
Strategic Changes for Healthcare Institutions
In-House In vitro Diagnostic Devices / Laboratory-developed Tests (LDTs):
- Deadline extended to December 31, 2030 for demonstrating that the devices manufactured and used in house cannot be replaced by comparable CE-marked IVD devices commercially available on the market.
Streamlined Implementation Measures
Professional Supply Chain Considerations:
- Permanent simplification of labeling requirements for professional-use devices to ensure supply chain continuity for Swiss IVD market.
Timelines for mandatory Medical Device Registration in SWISSDAMED (Swiss database on Medical Devices):
- Implementation date set for July 1, 2026, six months after the planned obligation to register in EUDAMED.
Impact Assessment
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.
About Veranex
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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