How to Publish Your UDI Data to Swissdamed with ACKOMAS

Swissdamed at a Glance: Official Facts

• Registration mandatory since 1 July 2026 for the devices, systems and procedure packs concerned, with a transition period until 31 December 2026. Some vigilance situations, however, require immediate registration from 1 July 2026.
• No automatic synchronisation with EUDAMED: the operators concerned must actively register their data in Swissdamed. Data already prepared for EUDAMED can nevertheless be largely reused.
• Several submission modes are available: entry through the user interface, XML import in the EUDAMED GET DEVICE / POST DEVICE formats, and automated machine-to-machine exchange through a REST API in JSON format.
• Swissdamed largely follows the logic of EUDAMED, to keep the Swiss and European frameworks as equivalent as possible and to reduce the burden on economic operators.

Sources: Swissmedic, mandatory registration notice, Swissdamed technical documentation and UDI Devices FAQ, consulted in October 2026.

Swissdamed in Your Regulatory Landscape

A definition first. The Basic UDI-DI is the primary identifier of a device model: it structures, at regulatory level, the devices that share common characteristics. The UDI-DI identifies a specific device within that structure.

Swissdamed was developed in close alignment with the principles and structure of EUDAMED, which makes it possible to reuse a large part of the data prepared for the European system. There is, however, no direct synchronisation between the two databases: registration in Swissdamed must be carried out separately.

For regulatory teams already managing EUDAMED, GUDID or other international databases, Swissdamed is therefore one more regulatory destination to maintain, with its own rules and its own transmission channel. A data point changed in one database but not updated in another can create an inconsistency between the regulatory information published.

ACKOMAS lets you manage your Swissdamed UDI data according to the rules of that database, from import to submission. Two publication paths can be used, depending on how your company, and the party responsible for registration in Swissdamed, are organised.

Path 1: Publish Directly to Swissdamed Through an Automated Connection

Swissdamed allows direct machine-to-machine data exchange through a REST API in JSON format. Swissmedic recommends M2M in particular for operators with the necessary IT expertise, or working with an experienced provider.

With ACKOMAS, when the party registered in Swissdamed holds the necessary rights and uses the automated connection, validated data can be sent directly to Swissdamed, with no manual handling of an XML file.

1. Prepare your data. Enter your Basic UDI-DI and UDI-DI data in the ACKOMAS Swissdamed Excel template, or send it to the platform by API.
2. Import and check your data in ACKOMAS. Your data is automatically validated, registered and stored. Each import produces a line-by-line report: created, updated, unchanged or in error. A rejected line shows what to correct before anything is sent to the regulator. Beyond format and structure checks, the AI built into the platform can also flag values that look inconsistent and explain why. The final decision stays with your team.
3. Publish. Once the data is registered and validated in ACKOMAS, it is sent to Swissdamed through the automated connection. Nothing is published without explicit user validation.
4. Track the result of the submission. ACKOMAS retrieves the result of the exchange, so you can follow its status and the technical information attached to the transmission to Swissdamed. The synchronisation status, the available technical information and the exchange history remain accessible in ACKOMAS.

Path 2: Generate the XML File for the Party Responsible for Submission

This path suits, in particular, manufacturers established outside Switzerland whose device registration in Swissdamed is carried out by their Swiss authorised representative, under the applicable mandate. Swissmedic provides that Swiss manufacturers register their devices, and that authorised representatives register the devices covered by their mandates.

ACKOMAS then prepares the file in line with Swissdamed’s technical requirements, so that it can be handed to the party responsible for submitting it.

1. Prepare your data. Enter your Basic UDI-DI and UDI-DI data in the ACKOMAS Swissdamed Excel template, or send it by API.
2. Import the data into ACKOMAS. It is automatically validated, registered and stored, with the same line-by-line report as in Path 1, so that any errors or inconsistencies are identified before the file is generated.
3. Generate the submission file. ACKOMAS produces the Swissdamed-compatible XML file from your validated data. Swissdamed accepts files in the EUDAMED GET DEVICE and POST DEVICE formats. You never build or edit the XML by hand.
4. Hand the file to the party responsible for submission. Your authorised representative, or the party concerned, uploads the file to Swissdamed. The system then runs the checks that apply to the file and the data submitted, and returns the result of the submission. The generated file and its history remain stored in ACKOMAS.

After Publication: Proof and Traceability

Publishing the data does not close the process. Being able to find what was sent, when, by whom and through which process matters just as much. For each Swissdamed submission, ACKOMAS retains:

• the status and result of each submission, with their timestamp;
• the generated submission files and the associated technical information, when available;
• the history of updates and modifications;
• exportable audit trails for internal review or audits.

When an attribute changes, the update follows the same governed process: check, validation, transmission and traceability.

Swissdamed Among Your Regulatory Databases

Swissdamed is one destination among several. Whether you work on a single regulatory database today or across several markets, the discipline is the same: structured data, controlled changes and complete traceability of each transmission.

ACKOMAS supports EUDAMED, GUDID, Swissdamed, SFDA, AusUDID and other regulatory databases, each according to its own rules, data structures and submission channels. The aim is to let regulatory teams maintain a controlled dataset and adapt it to the specific requirements of each database, rather than running separate processes and files for each market.

If you manage device data for Switzerland alongside other markets, it all starts with structured governance. Contact our team, or explore the ACKOMAS solution.