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On August 18, 2025, Swissmedic announced the launch of the new UDI Devices module in the swissdamed database. This development is a key milestone in enhancing transparency and regulatory oversight in the Swiss medical device market.

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What is changing?

The new module enables the registration of:

Medical devices
In vitro diagnostic medical devices (IVDs)
Systems and procedure packs.

Key Timelines

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Voluntary registration is available starting August 18, 2025.
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Mandatory registration will take effect on July 1, 2026.
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A six-month transition period applies, but devices subject to vigilance reporting must be registered by July 1, 2026 without transition.
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This requirement applies to Swiss manufacturers, authorized representatives, and assemblers of systems and procedure packs.
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Why is this important?

The swissdamed database aligns closely with the EU’s EUDAMED but is tailored to Swiss regulatory needs. With this new module, regulators, healthcare professionals, and patients will benefit from greater transparency about the devices placed on the Swiss market.

For manufacturers and economic operators, early registration will help ensure a smooth transition before the mandatory deadline and reduce risks of non-compliance.

Supporting documentation

Swissmedic has published a comprehensive set of documents to support stakeholders in navigating the new registration process:

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User Guide for Actors (BW630_40_001e_HB) – explains company registration, role management, and assignment of CHRN numbers.
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Business Rules (BW630_40_002e_PU) – defines valid data submission conditions, aligned with EUDAMED standards but adapted for Switzerland.
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Quick Guide for Actors and Devices (BW630_40_808e_PU) – instructions for public searches of registered actors and devices.
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Quick Guide for UDI Registration (BW630_40_809e_PU) – step-by-step instructions for uploading and registering UDIs.
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UDI Devices Module User Guide (BW630_40_841e_HB) – detailed instructions for uploading, validating, updating, and managing UDIs.
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Privacy Notice and Terms of Use (BW630_40_870e_WL) – outlines data processing practices and user rights.
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Service Agreement (BW630_40_871e_WL) – legal framework for using swissdamed, including responsibilities and conditions.
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A full overview of the published documents can be found on the Swissmedic overview page for medical devices.

How Qserve can support you

With regulatory landscapes evolving rapidly, understanding how these changes impact your business is crucial.

That’s where Qserve InSight comes in. Our Regulatory Intelligence service keeps you updated on global changes, helping your organization stay compliant, competitive, and prepared for upcoming requirements such as swissdamed registration.

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New Updates to IVD Classification Guidance Document MDCG 2020-16 r3 - Clarify Guidance for Self-Testing and Specimen Receptacle Devices