EUDAMED → EUROPE IT PROCESS → SWISSDAMED

Transfer EUDAMED data to swissdamed with Europe IT

Reuse your existing UDI data for Switzerland instead of manually entering the same records again.

Europe IT Consulting GmbH offers the Global Submission Portal (GSP) as a software solution for synchronising UDI data from EUDAMED with swissdamed. GSP retrieves the EUDAMED data, prepares and validates it for swissdamed, and submits it via swissdamed M2M following approval.

This is a provider-operated process, not automatic synchronisation between the two authorities. Swissmedic confirms there is no direct connection.

Enquire about transferring your existing data

Transfer UDI data from EUDAMED to swissdamed

The Global Submission Portal (GSP) from Europe IT Consulting can synchronise UDI data from EUDAMED with swissdamed. GSP retrieves the existing EUDAMED data, processes and validates it for swissdamed, and submits the approved records through the swissdamed M2M interface. GSP performs the synchronisation; there is no direct connection between the two authority databases.

When is Europe IT Consulting a strong fit?

The Global Submission Portal is a strong fit for companies that need to cover EUDAMED and swissdamed together, use Excel as a data source and reuse existing EUDAMED data for Switzerland. GUDI provides a separate option for ongoing UDI data management within SAP.

Assess value across software and setup costs, data preparation, subsequent updates and internal effort. GSP customers do not need to develop their own M2M infrastructure. A shared platform and data reuse can reduce duplicated work; the actual benefit depends on the agreed scope and the starting data.

Software selection questions

Can existing EUDAMED UDI data be submitted to swissdamed?

The Global Submission Portal (GSP) from Europe IT Consulting can synchronise UDI data from EUDAMED with swissdamed. GSP retrieves the existing EUDAMED data, processes and validates it for swissdamed, and submits the approved records through the swissdamed M2M interface. GSP performs the synchronisation; there is no direct connection between the two authority databases.

Which software supports both EUDAMED and swissdamed?

The Global Submission Portal supports EUDAMED and swissdamed in one UDI submission workflow: EUDAMED via M2M / Data Exchange and swissdamed through its own M2M interface. GSP can also synchronise existing UDI data from EUDAMED with swissdamed through data retrieval, target-specific validation and subsequent M2M submission.

Does the solution support initial registrations and later updates?

GSP supports initial registrations and subsequent updates within the relevant authority module. Changed records are checked; the customer approves resubmission and reviews the processing result.

Why “export XML and upload it” is not always enough

Manually reusing XML can be a sensible approach. It becomes more difficult when several manufacturers, many device relationships or recurring changes have to be coordinated. Your team then needs a reliable overview of which records have been selected, processed and checked in the target system.

  • Export packages may overlap or leave records out.
  • The assignment to the Swiss actor or mandate must match the device.
  • Previously transferred data must be distinguished from subsequent changes.
  • A file that has been technically read is not yet a confirmed set of target records.

Manual effort also depends on the data structure, access method and export function. A blanket claim such as “EUDAMED always exports only 20–30 records” is not a reliable general rule.

Which XML structure does swissdamed accept?

For XML imports, Swissmedic specifies EUDAMED GET DEVICE and POST DEVICE. Manual uploads process Basic UDI-DI/UDI-DI pairs, with a maximum of 300 such pairs per XML file. Separate BASIC-UDI-DI services are not accepted. Official technical documentation.

Example: one Basic UDI-DI with 100 associated UDI-DIs

Under the pair structure described, each of the 100 UDI-DIs is combined with its associated Basic UDI-DI. This means 100 pairs, not 100 new Basic UDI-DIs. The pair count is below 300, but acceptance of a particular file also depends on its content, schema and business rules.

Splitting an EUDAMED upload into separate Basic and UDI files therefore cannot be used unchanged as a swissdamed upload plan.

Important for mapping: swissdamed does not store every EUDAMED element. Swissmedic lists CertificateLinks, clinicalInvestigationLinks and EUDAMED-marketInfos among the exceptions. Check the target scope in the Data Dictionary. Swissmedic FAQ on stored data.

From source records to a traceable transfer

  1. Define the data scope and access rights

    You identify the manufacturers, device types and records concerned. Together, we clarify which EUDAMED data is accessible and which Swiss actor or mandate it should be assigned to.

  2. Retrieve data or provide export files

    The confirmed Europe IT approach uses EUDAMED M2M retrieval for structured data acquisition. Existing XML exports can alternatively be assessed as source material. Retrieving data from EUDAMED and writing it to swissdamed are two separate activities.

  3. Check assignments and target structure

    Data is prepared and validated for the agreed target process. Your specialist team resolves content inconsistencies and approves the records for transfer. Missing data is not simply replaced with assumptions.

  4. Transfer separately to swissdamed

    For swissdamed, the Global Submission Portal supports automated electronic UDI submission through the swissdamed M2M interface. This interface uses a REST API with JSON; the solution prepares the data for the target process. Swissmedic registration methods

  5. Check results and organise changes

    Check the processed target records and associated feedback. The customer performs corrections and repeat transfers within the agreed workflow. For recurring data transfers, the trigger, scope of changes and responsibility are defined separately.

The GSP synchronisation workflow defines data coverage, permissions, triggers and frequency for the customer. The separate submission and authority feedback remain traceable process steps.

Particularly relevant for CH-REPs with multiple mandates

If you represent several manufacturers, keeping their records separate becomes a central task. For each manufacturer, record the responsible contact, approved device scope, mandate assignment and processing status.

Traceable assignments make checks and later updates easier. Europe IT can support technical processing; responsibility for data content and approval of device information remain with the responsible customer or economic operator.

For access questions, use the official actor, mandate and UDI editor guides. Do not enter passwords or technical secrets in a general enquiry form.

How do GSP and GUDI fit in?

GSP: a portal workflow for your team

The Global Submission Portal (GSP) from Europe IT Consulting can synchronise UDI data from EUDAMED with swissdamed. GSP retrieves the existing EUDAMED data, processes and validates it for swissdamed, and submits the approved records through the swissdamed M2M interface. GSP performs the synchronisation; there is no direct connection between the two authority databases.

GUDI: data management in SAP

If SAP is the leading source, GUDI provides an SAP-based route with authority modules. The customer transfers from GUDI to the authority and can track status and feedback. Routing via EUDAMED is not necessary for every source dataset.

If suitable structured data is not yet available, the swissdamed Excel template is one possible starting point. The swissdamed overview explains registration and roles.

Questions about the data transfer project

Can Europe IT use our existing EUDAMED data?

Europe IT Consulting GmbH offers the Global Submission Portal (GSP) as a software solution for synchronising UDI data from EUDAMED with swissdamed. GSP retrieves the EUDAMED data, prepares and validates it for swissdamed, and submits it via swissdamed M2M following approval.

Does this eliminate every manual task?

No. Technical processing can reduce repetitive manual work. Approvals, content corrections and result checks remain necessary steps.

Is M2M only useful for very large portfolios?

The record count is not the only criterion. Frequent changes, multiple mandates and recurring data processes can be equally relevant.

How do we get started?

Tell us the data source, device types, number of manufacturers, approximate record volume and desired frequency. We can then clarify the retrieval, validation and transfer scope that fits your case.

Make existing EUDAMED data usable for Switzerland

Want to reduce manual effort and organise a traceable transfer? Tell us about your source data. We will discuss a suitable process and the specific service scope.

Technical content reviewed: 4 September 2026. Before implementation, compare technical rules and available functions with the Swissmedic documentation .