Swissmedic Updates swissdamed User Guide for the UDI Devices Module
Swissmedic has updated its handbook “swissdamed User Guide UDI Devices Module”, version 4.0, valid from 7 July 2026.
The user guide explains how manufacturers, including persons who assemble systems or procedure packs, and authorised representatives can upload, register and manage Unique Device Identifiers (UDIs) in swissdamed.
According to the document, swissdamed is structured around two modules and two public search sites: the Actors Module, the UDI Devices Module, a public search function for actors and a public search function for UDIs.
UDI Registration in swissdamed
The guide clarifies that users must have the “UDI Editor” user profile to register UDIs in swissdamed.
Only manufacturers, authorised representatives, or persons who assemble systems or procedure packs can register UDIs. Authorised representatives must register UDIs at mandate level.
UDIs can be uploaded through:
XML upload via “UDI Management” or “UDI Uploads”;
XML upload via a registered actor or mandate;
Machine-to-Machine registration;
manual entry through the online editor.
The guide also explains that XML files are validated against the applicable EUDAMED data exchange format definition, and that failed uploads do not result in UDIs being uploaded.
Market Status and Public Visibility
Swissmedic explains that UDIs are only considered registered and publicly accessible once a market status has been assigned in swissdamed.
UDIs without a market status are stored as drafts in the UDI Management tab and are not publicly visible. The UDI Editor can assign a market status to UDI-DIs and Package UDI-DIs.
The market status can be set to:
On the market;
No longer placed on the market.
The guide also notes that draft UDIs do not cause fees and that draft elements are automatically deleted 30 days after the last update, with a reminder email sent after 20 days.
Updates, Versioning and Discarding UDIs
The user guide explains that UDIs can be updated by uploading an updated XML file, subject to non-updatable fields and applicable business rules. When a UDI is updated, a new version is created.
Version history is available for UDIs with an assigned market status. Draft UDIs do not have versions.
The guide also includes instructions for deleting draft UDIs and discarding registered UDI-DIs where incorrect data cannot be corrected through an update because of business rules. Discarded UDIs are deleted from the system, are no longer visible in public search and can be newly registered.
Master UDI-DI and Legacy Devices
Version 4.0 of the guide adds a chapter on legacy devices.
The guide also addresses Master UDI-DI requirements for certain highly individualised devices, including contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
Swissmedic states that contact lenses must be registered in swissdamed with the Master UDI-DI starting 9 November 2026. Spectacle frames, spectacle lenses and ready-to-wear reading spectacles must be registered with the Master UDI-DI starting 1 November 2028.
For legacy devices, the guide explains that devices placed on the market under the former European Directives may continue to be placed on the market or put into service during the applicable transitional period. Like regulation devices, legacy devices are subject to the registration obligation in swissdamed.
The guide also describes the use of EUDAMED DI and EUDAMED ID for legacy device registration and the possibility of linking legacy devices with regulation devices to reflect regulatory continuity.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers placing products on the Swiss market, the updated guide reinforces the importance of preparing for device registration and UDI data management in swissdamed.
Manufacturers and authorised representatives should pay particular attention to:
assigning the correct user roles, including the UDI Editor profile;
preparing UDI data for XML upload, M2M registration or manual entry;
validating data against applicable formats and business rules;
assigning market status so that UDIs are considered registered and publicly visible;
managing draft UDIs before automatic deletion;
maintaining version control for updated UDI records;
understanding Master UDI-DI requirements and applicable timelines;
assessing registration obligations for legacy devices;
linking legacy and regulation devices where applicable.
For manufacturers with products transitioning from legacy legislation to MDR or IVDR-aligned requirements, the new legacy device chapter is particularly relevant. It clarifies when legacy devices must be registered, when they may not need separate registration and how regulatory continuity can be reflected in swissdamed.
