swissdamed: linking of UDIs

swissdamed · Importers · UDI data

swissdamed: Link up to 1,000 device codes to an importer in a single operation

News · Updated: 19 October 2026

A key next step is now available in swissdamed for importers of medical devices and in vitro diagnostic devices: Since 1 October 2026, they have been able to link their actor registration to the devices they place on the Swiss market, provided those devices have already been registered.

The linking obligation also covers systems and procedure packs. For larger portfolios, a bulk linking function supports up to 1,000 UDI-DI or EUDAMED ID codes per operation. A complete code list, the appropriate user permissions and prior device registration are essential.

Two deadlines to plan for now

Important: The later linking deadline does not extend the device registration deadline. From 1 April 2027, Swissmedic will no longer accept any delay between placing an imported device on the market and linking it in swissdamed. Until that date, Swissmedic will not take enforcement measures solely because a link is missing.

Immediate device registration is required in certain vigilance cases. The standard transitional period therefore does not apply to every situation.

What needs to be in place before linking?

• Existing device record: The relevant record must already be registered in swissdamed. Registration in EUDAMED alone is not sufficient for this step.
• Correct market status: The device must have the status “On the market” in swissdamed.
• Appropriate permissions: The user needs the “UDI Linker” profile for the relevant importer. If the user has access to several importers, the correct actor must be selected.
• Up-to-date actor details: Devices are linked to the importer using its CHRN. The importer’s contact details in the Actors module must be kept up to date.

Bulk linking: How the process works

Start at “My UDIs” → “UDI Linking” → “Bulk link UDI-DIs”. Then complete these four steps:

1. Enter the code list
   Enter up to 1,000 UDI-DI or EUDAMED ID codes in the text field as a space-separated list.
2. Check the list
   Click “Check” to see which codes are found and can be linked.
3. Review the results
   Review both linkable and non-linkable entries. Use “Edit list” to correct the input; result lists can be copied.
4. Confirm the links
   The links are created only when you click “Link UDI-DIs”. You can then review the linked devices under “UDI Linking”.

Which entries can prevent linking?

swissdamed displays codes that cannot be linked together with the reason. The guide lists the following cases:

• No UDI-DI or EUDAMED ID was found for the code.
• According to the validation rule, the record was not registered by a foreign manufacturer.
• The device has the market status “No longer placed on the market”.
• The code exists under two different issuing entities.
• The same code was entered twice in the input list.

The quality of the source list is therefore a practical success factor: Duplicates, missing registrations and unclear device identifiers should be resolved before linking.

Take legacy devices and existing links into account

Existing links can be searched and reviewed. If a link needs to be removed, use “Unlink UDI-DIs”. Multiple entries can be selected for this step as well. Swissmedic does not charge a fee for importer linking itself.

What companies should prepare now

• Reconcile your portfolio: Match the devices you place on the market to the required UDI-DIs or EUDAMED IDs.
• Clarify registration status: Work with manufacturers and Swiss authorised representatives to address missing records or incorrect market statuses.
• Set up user permissions: Check the responsible users and the “UDI Linker” profile for the correct importer.
• Carry out linking with appropriate checks: Check the lists, confirm eligible links and reconcile the results with your own portfolio.