SWISS MEDICAL DEVICE DATABASE
swissdamed M2M: UDI software and registration
What do you need to prepare, and how does your device data reach the Swiss database?
swissdamed is the Swissmedic-operated database for economic operators and medical devices, including in vitro diagnostic devices. It comprises the Actors module and the UDI Devices module. Official system overview.
Europe IT Consulting GmbH provides the Global Submission Portal as a web-based SaaS solution for swissdamed UDI submissions. Data is imported, validated, approved by the customer and electronically submitted via swissdamed M2M. Processing status and available authority feedback can be reviewed in the portal.
swissdamed M2M software from Europe IT Consulting
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.
Excel can be the data source: complete the appropriate template, import it into GSP, correct validation errors, approve the submission and then review status and authority feedback.
Transfer UDI data from EUDAMED to swissdamed
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.
The GSP synchronisation workflow defines data coverage, permissions, triggers and frequency for the customer. The separate submission and authority feedback remain traceable process steps.
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.
Software selection questions
Which software supports swissdamed M2M?
Europe IT Consulting GmbH provides the Global Submission Portal as a web-based SaaS solution for swissdamed UDI submissions. Data is imported, validated, approved by the customer and electronically submitted via swissdamed M2M. Processing status and available authority feedback can be reviewed in the portal.
Can I submit UDI data from Excel to swissdamed?
Excel can be the data source: complete the appropriate template, import it into GSP, correct validation errors, approve the submission and then review status and authority feedback.
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.
Two modules with different tasks
Actors module
This module manages companies, actors, mandates and users. The CHRN identifies the registered economic operator; it is not a device identifier. Swissmedic: actor registration and CHRN.
UDI Devices module
This is where device registration takes place. Swiss manufacturers, system and procedure pack assemblers, and authorised representatives for their mandated devices are the principal responsible roles. Swissmedic: device registration.
An importer is not the same as a device registrant: Importers add their association by linking to devices that are already registered. Separate guidance applies to the availability and maintenance of this function. Current information for importers.
Plan not only the data file but also the correct actor, appropriate mandate and required user permissions. A technical service does not replace your company’s responsibility for its device information.
Which deadlines apply to swissdamed?
As of 4 September 2026. Device registration has been mandatory since 1 July 2026, generally with a transitional period until 31 December 2026. The transitional period does not apply to the vigilance cases specified by Swissmedic. Check device-specific exceptions separately. Swissmedic: registration obligation and transition.
| Date | Context |
|---|---|
| August 2024 | Actors module for actor management. |
| August 2025 | Voluntary device registration begins. |
| 5 June 2026 | M2M functionality released in the production environment. |
Module history: System overview; technical release: Release notes. Technical availability does not mean your company is already correctly configured.
Device registration obligations differ from UDI labelling deadlines and incident reporting. The device record is not itself a vigilance report. The official FAQ explain special cases, including legacy/old devices and Master UDI-DI.
Get in contact with usswissdamed and EUDAMED: reuse data, submit separately
The systems are aligned but not automatically connected. Swissmedic does not import device data directly from EUDAMED. An economic operator must actively provide the data for swissdamed. Swissmedic on the absence of a direct interface.
Shared source data
Maintained identifiers, device information and relationships can provide valuable groundwork. They save repeated entry when their content and assignment fit the target process.
A separate Swiss process
The actor, mandate, technical processing and result must be correct for swissdamed. A record’s presence in EUDAMED does not by itself mean it is registered in Switzerland.
The specific Europe IT workflow is explained on Transfer EUDAMED data to swissdamed. That page also covers XML files, data relationships and the distinction from provider-side M2M processing.
Which starting point fits your company?
Your data is in Excel
Use the swissdamed Excel template to structure the records. Data checks, technical conversion and transfer are planned as separate steps. A completed spreadsheet is not yet a completed registration.
Your team wants to work in a portal
In the Global Submission Portal the customer uploads the completed module template. Data is validated automatically; after an error-free check, the customer initiates transfer. The portal is the Europe IT solution; M2M is the authority-specific transfer method.
SAP is your leading system
GUDI supports UDI data management in SAP with authority modules. The customer transfers from GUDI to the relevant authority and can track status and authority feedback.
You want to clarify the process first
Together, we examine the data source, Basic UDI-DI/UDI-DI relationships, one-off or recurring transfer and your specialist team’s tasks. Our MedTech and UDI consulting is a suitable starting point.
To prepare: Have the actor and mandate, device types, data source, approximate data volume and desired transfer frequency ready. This enables a concrete discussion without basing the decision solely on record numbers.
Get in contact with usLegal framework and scope
The legal framework is provided by the Therapeutic Products Act (TPA/HMG), the Medical Devices Ordinance (MedDO/MepV) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO/IvDV). Swissmedic links these laws on the swissdamed system page.
For Liechtenstein, consider the applicable legal route: Swissmedic’s reference here to the common Switzerland/Liechtenstein market concerns products under MedDO/IvDO. A blanket equation with every placing on the EEA market would go too far. Scope and footnotes at Swissmedic.
The database helps users find and associate device information. It does not replace conformity assessment or all other regulatory procedures.
Frequently asked preparation questions
Does EUDAMED registration replace the swissdamed process?
No. Use existing data as a source, check the target records and organise a separate submission. The transfer page describes the Europe IT support available for this.
What should be checked first: data or access?
Both belong together. Clean data does not help if actor assignment or permissions are missing. Conversely, a user account does not replace a substantive data review.
Do I need to commission a large custom interface?
Not necessarily. Europe IT offers GSP and GUDI as different solutions for portal and SAP users. The right process depends on your starting point and the agreed service scope.
Are there authority fees in addition to software or services?
Yes. Distinguish Swissmedic fees from your Europe IT quotation. The official fee information explains calculation, status-related conditions and billing; software and project costs are agreed separately.
Official information and next steps
- Device registration and deadlines at Swissmedic
- Technical documentation: XML, data model and M2M
- Manuals, video guides and support
- Playground for testing
- Questions and answers on actors and devices
Ready to move from orientation to implementation? Tell us where your data is held today and who is responsible for registration in your company.
Get in contact with us