swissdamed: How Europe IT Consulting Supports UDI Registration in Switzerland
With swissdamed, Swissmedic is systematically expanding the national database for medical devices and in vitro diagnostics. For manufacturers, Swiss Authorised Representatives and other economic operators, this means that UDI and product data must be registered and maintained in swissdamed in a structured manner in the future.
Key dates: The registration obligation applies from 1 July 2026, with a transition period until 31 December 2026.
Using Existing EUDAMED Data as a Basis
As swissdamed is closely aligned with EUDAMED from a regulatory and data perspective, EUDAMED data that has already been prepared can often serve as a starting point. Important: There is no automatic synchronisation between the two systems. The data must be actively uploaded or transmitted to swissdamed.
Europe IT Consulting offers several implementation options for this purpose – tailored to different system landscapes and data volumes.
Solution 1 – SAP Add-On: Extension for Existing EUDAMED Customers
Customers already using the EUDAMED UDI Add-On in SAP GUI can benefit from a dedicated swissdamed extension. Products can be marked directly as swissdamed-relevant and supplemented with Switzerland-specific information, such as the CHRN or the responsible Swiss economic operator.
The technical transmission to swissdamed is then carried out via a transmission service provided by Europe IT Consulting. Existing EUDAMED data can therefore be reused as much as possible; only the additional regulatory requirements specific to Switzerland need to be added.
Suitable for: Customers who already manage their UDI data centrally in SAP.
Solution 2 – GUDI Add-On Based on Fiori: Modern Interface for Global UDI Management
For companies pursuing a global UDI approach, the Fiori-based GUDI Add-On offers a modern, web-based alternative. Here as well, products relevant for swissdamed can be specifically identified, prepared and transmitted in a structured manner.
GUDI is designed for customers who want to manage UDI data not only for EUDAMED, but also for multiple authorities and markets from one central platform in the future.
Suitable for: Customers with an international product portfolio and a need for a future-proof UDI platform.
Solution 3 – Global Submission Portal: swissdamed Plugin for Excel-Based Processes
Customers without SAP integration or with Excel-based workflows can submit swissdamed data via a dedicated plugin in the Global Submission Portal. The process is fully structured and transparent:
- Upload of the swissdamed Excel file in the portal
- Automatic validation and plausibility checks
- Correction of errors or warnings
- Preparation of the submission
- Technical transmission to swissdamed
- Tracking of the submission status
Suitable for: Customers who do not require a direct SAP connection, but want a traceable and technically secure process.
Solution 4 – XML Upload: Pragmatic Option for Small Product Portfolios
For customers with only a few products, a one-time XML upload may be the most efficient solution. Swissmedic supports the EUDAMED format “GET DEVICE” / “POST DEVICE” as an accepted transmission method.
Europe IT Consulting supports the entire process – from data preparation and review through to the execution of the upload. This service is billed on a time and material basis as consulting support.
Suitable for: Customers with a manageable product scope who are looking for an uncomplicated one-time solution.
Technical Requirement: Access Credentials for M2M Connectivity
Regardless of the chosen approach, the customer must either be registered as a manufacturer in Switzerland or have a Swiss Authorised Representative.
For the technical machine-to-machine connection, Client ID and Client Secret are also required. Swissmedic uses an OAuth2 Client Credentials Flow for this purpose; the access credentials are actor- or mandate-specific. Europe IT Consulting supports the setup process – however, the provision of the access credentials remains the responsibility of the customer or the Swiss Authorised Representative.
Conclusion: Choose the Right Approach for swissdamed Now
swissdamed will become an integral part of regulatory product data management for many market participants. As the deadline is approaching and there is no automatic synchronisation with EUDAMED, it is advisable to clarify at an early stage which technical and organisational approach is the best fit.
Europe IT Consulting supports customers throughout the entire process – from the use of existing EUDAMED data through to the technical transmission to swissdamed. Contact us to jointly determine the most suitable approach for your company.
We will gladly prepare a quote for you if you fill out the form below.
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