Swissmedic Updates swissdamed Business Rules – Key Changes for Device Manufacturers in 2026
Swissmedic has published Version 3.0 of its technical document on swissdamed business rules, now in effect as of 20 January 2026. The update introduces additional requirements and adaptations that impact the way device and legacy device data must be submitted to the Swiss database (swissdamed).
While the structure of the swissdamed system remains closely aligned with EUDAMED, the document highlights key differences and Swiss-specific constraints that manufacturers must account for.
Key Takeaways for Manufacturers
1. Certain Devices Now Explicitly Restricted
Devices under AIMDD are by default considered implantable and active. These attributes are mandatory when submitting under AIMDD.
Reprocessing of single-use devices is explicitly prohibited in Switzerland and Liechtenstein, and such devices cannot be uploaded to swissdamed.
Devices with special device types (e.g. software, orthopedic) under AIMDD must follow specific limitations.
2. Mandatory Fields Expanded for UDI Submissions
When registering a UDI-DI, the following fields are now mandatory under MDR/IVDR:
Type of UDI-PI
Base quantity of the device
Device model or device name
Risk class, implantability, and active status
For software, appropriate classification under MDR_SOFTWARE or IVDR_SOFTWARE is required when the UDI-PI indicates software identification.
3. Enhanced Substance Reporting Rules
For devices containing CMR or endocrine disrupting substances, submission must include type, name, language, and optionally EC# or CAS#.
Substances considered medicinal products or derived from human blood/plasma can only be submitted if specific flags are enabled in the Basic UDI-DI.
4. Legacy Devices: Special Constraints
Swissmedic provides specific formatting rules for EUDAMED DI and EUDAMED ID, depending on whether a UDI-DI was previously assigned.
Several attributes cannot be submitted for legacy devices (e.g., Direct Marking DI, quantity of device, endocrine substances, etc.) depending on the legislation (MDD, AIMDD, IVDD).
5. Market Status Enforcement
Uploaded UDI-DIs that remain in draft status for over 30 days without being set as “on the market” are automatically deleted from swissdamed, along with associated Basic UDI-DIs.
What This Means for You
If you manufacture, import, or are the Swiss Authorised Representative for a device intended for the Swiss market, you must:
Ensure alignment with the latest swissdamed structure and mandatory fields.
Avoid submitting prohibited attributes for legacy devices.
Review your UDI-DI and Basic UDI-DI data structure, especially around packaging, clinical size, and implantability.
Use the correct EMDN nomenclature (leaf code only) and ensure consistency with MDR rules.
This version also reinforces the regulatory independence of Switzerland from the EU system—Swiss-specific rules now diverge further from EUDAMED in key technical areas.
Access the full technical document below.
