The launch of the Swissdamed UDI Devices Module marks a critical milestone for the regulatory landscape of medical devices in Switzerland. With this module now operational, manufacturers, authorised representatives, and system or procedure pack assemblers must adapt to a transparent, digital-first era of device registration and management on the Swiss market.
What is Swissdamed?
Swissdamed (Swiss Database on Medical Devices) is the national database established by Swissmedic to align Switzerland’s regulatory system with international requirements. The system is split into two main modules:
- Actors Module – for registration and management of economic operators (manufacturers, authorised representatives, and importers).
- UDI Devices Module – for registration and management of devices, now fully operational.
Additionally, two public search functions allow anyone to look up registered actors and devices.
Who Can Register Devices?
Only certain economic operators can register devices in Swissdamed. These include:
- Manufacturers
- Authorised Representatives
- Persons assembling systems or procedure packs (SPPs)
To upload and manage UDIs (Unique Device Identifiers), users must hold the “UDI Editor” profile. This ensures that only authorised individuals within an organisation can perform device registrations.
How Does Device Registration Work?
At this stage, UDI registration is only possible via XML upload. Two automatic validation checks take place during the upload process:
- Technical Validation – Verifies the XML structure against the applicable EUDAMED data exchange format.
- Business Rules Validation – Ensures compliance with Swissmedic’s device registration rules.
If successful, the UDIs are uploaded as “drafts” and must then be assigned a market status before becoming publicly accessible.
Market Status Options
- On the market – Device is actively placed on the Swiss market.
- No longer placed on the market – Device has been withdrawn but remains publicly visible.
- Draft – Device uploaded but not yet finalised (not visible to the public, no fees incurred).
This functionality ensures that Swissmedic and stakeholders have a clear view of the lifecycle of a device on the market.
While the module is already live, Swissmedic has set July 2026 as the mandatory compliance deadline. From that date forward, all devices intended for the Swiss market must be registered in Swissdamed.
Equivalence with EU Procedure
To reduce regulatory complexity, Swissdamed has been designed to mirror the structure and business logic of the European Union’s EUDAMED database. However, an important difference remains: Swissdamed does not interface with EUDAMED. This means Swiss-specific device data must be uploaded separately, as there is no automated transfer or synchronization from EU systems. Both Swiss and international device suppliers are therefore responsible for keeping their Swissdamed records current and aligned with their active device portfolio.
Key Features of the UDI Devices Module
- Versioning – Each update creates a new version of the UDI, ensuring traceability.
- Mandate Transfers – If a Swiss authorised representative mandate changes, associated UDIs are transferred automatically.
- Draft Deletion – Unfinalized draft UDIs can be deleted by the UDI Editor.
- Public Transparency – Once the market status is set, UDIs become visible in the public search portal.
Why This Matters for Manufacturers
The Swissdamed UDI Devices Module strengthens post-market surveillance and ensures alignment with EU MDR principles, even though Switzerland is not part of the EU regulatory framework. For manufacturers, this means:
- Enhanced regulatory oversight and accountability.
- Increased transparency for healthcare providers and patients.
- A streamlined digital process for compliance with Swiss market requirements.
Next Steps for Economic Operators
Manufacturers and authorised representatives should ensure that:
- They have registered in the Actors Module.
- They assign appropriate user rights, including “UDI Editor.”
- Their device data (UDI-DIs and Basic UDI-DIs) is formatted according to EUDAMED’s XML standards before upload.
- They regularly update market status to reflect device availability.
Swissmedic has also indicated that registration may result in fees in the future, meaning economic operators should plan for potential cost implications.
How can OMC Medical help?
At OMC Medical, we specialize in supporting manufacturers with device registrations in Switzerland. With the Swissdamed UDI Devices Module now live, our team can assist you with:
- Swiss Authorised Representative services – ensuring compliance with Swiss regulatory requirements.
- Actors Module registration – setting up your company profile and user access in Swissdamed.
- UDI Devices Module support – preparing XML files, uploading UDIs, and managing validations.
- Market status management – assisting with correct assignment of “On the market” or “No longer placed” statuses.
- Strategic compliance planning – helping you complete registrations well ahead of July 2026 to avoid delays or penalties.
Our goal is to ensure that your devices remain fully compliant, visible in the Swiss market, and aligned with regulatory expectations.
