Critical Updates for Medical Device Manufacturers and Healthcare Institutions: Switzerland Aligns with EU IVDR Transitions

Written by Heather Antonovich | Jan 17, 2025 5:28:45 PM

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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