As of July 1, 2026, the registration of UDI (Unique Device Identification) data for medical devices and procedure packs in the national database swissdamed has become mandatory in Switzerland, with a transitional period until December 31, 2026, for MDR/IVDR-compliant devices already placed on the market. For devices involved in serious incidents or Field Safety Corrective Actions (FSCA), registration must be immediate starting July 1, 2026, with no transition periods.

To support Swiss manufacturers and authorized representatives in fulfilling this new obligation, Swissmedic has updated the operational documentation for the swissdamed UDI module, publishing, among other things, the “swissdamed User Guide – UDI Devices Module” (Version 4.0, valid from July 7, 2026) and the “Swissdamed UDI Data Dictionary,” providing clarifications on both regulatory aspects and technical data transmission methods.

New features in the User Guide: Focus on Legacy Devices

Version 4.0 of the operational guide introduces a new chapter dedicated to legacy devices, i.e., those placed on the market under previous European directives MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC), which continue to benefit from the transitional provisions provided by the regulations.

The document clarifies several particularly relevant operational aspects:

• Registration Obligation: Legacy devices placed on the market under former European directives (MDD, AIMDD, and IVDD) remain subject to registration obligations according to the applicable transitional period timelines. However, compliance is not required if the exact same product is already registered as an MDR/IVDR-compliant device, unless vigilance cases (incidents or FSCA) exclusive to the legacy version arise.
• Links between Legacy Devices and MDR/IVDR Devices: the guide introduces the possibility of establishing a link between a legacy device and the corresponding MDR/IVDR-compliant device. This link reflects the regulatory continuity of the same product through the transition from former directives to MDR/IVDR regulations and is displayed in swissdamed in the details view of both devices.
• Transition from Legacy to MDR: in the event that a legacy device has already been registered in swissdamed and the same device becomes EU-MDR compliant, the MDR device requires a new registration with a Basic UDI-DI and a UDI-DI in swissdamed, due to the change in applicable legislation.
• Identifiers for Legacy Devices: for legacy devices, the device identifiers EUDAMED DI (the equivalent of the Basic UDI-DI) and EUDAMED ID (the equivalent of the UDI-DI in cases where no UDI-DI has been assigned) must be used in swissdamed.

Updating the UDI Data Dictionary: interoperability and technical requirements

The “Swissdamed UDI Data Dictionary” refers to version 2.27.0 of the “EUDAMED UDI Devices Data Dictionary” to foster interoperability between the two systems while maintaining the specificities of the Swiss database.

The document defines the technical structure of the data to be transmitted to swissdamed and specifies, in the “Attributes” sheet, the properties of each information element:

• Level of mandatory requirement (Occurence);
• Public visibility (Public Access Flag);
• Possibility of update (Updateable);
• Applicability to different regulatory scenarios (MDR, IVDR, and legacy regulations).

Furthermore, data transmission methods via XML file upload and Machine-to-Machine (M2M) interfaces based on REST API are described, including JSON attribute mapping, facilitating the integration of manufacturers’ IT systems with the national database.

Operational implications for manufacturers

For manufacturers placing medical devices on the Swiss market, the introduction of the registration obligation in swissdamed entails managing a national registration system distinct from EUDAMED. The obligation applies to both Swiss manufacturers and foreign manufacturers operating in Switzerland through a Swiss Authorized Representative (CH-REP), who handles device registration on behalf of the manufacturer according to the mandate granted.

Although the development of swissdamed by Swissmedic was based on the EUDAMED model and the related Data Dictionary was aligned with the European one, allowing economic operators to reuse most of the information on devices already prepared for EUDAMED, it remains necessary to manage distinct registration processes in the two systems.

This situation leads to an increase in administrative and operational tasks, making it essential to ensure the consistency, updating, and correct management of UDI data and recorded information, particularly for manufacturers marketing devices in both the Swiss and European Union markets.

>>> To support companies in managing UDI requirements, Complife offers a software solution for the bulk uploading and management of data intended for swissdamed and EUDAMED, aimed at simplifying registration processes and reducing operational times.

SOURCES:

• BW630_40_841e_HB Handbook – swissdamed User Guide UDI Devices Module, Version 4.0, valida dal 7 luglio 2026.
• BW630_40_001e_PU swissdamed UDI Data Dictionary