Swissdamed – UDI Devices Module
As of Aug. 18, 2025, Swissmedic activated the UDI Devices module in the Swissdamed database, allowing voluntary registration of medical devices, IVDs, and kit/process packs (SPPs).
From July 1, 2026, however, registration will become mandatory for all products placed on the Swiss market.
There is also a short transition period until December 31, 2026 swissmedic.ch+2swissmedic.ch+2.
Important: If a product is involved in a “Field Safety Corrective Action” (FSCA), there is no transition: registration is immediate from July 1, 2026
For more info:
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank.html
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/produktregistrierung.html
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank.html
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/faq.html
eIFU (Electronic Operating Instructions)
On Aug. 8, 2025, Swissmedic implemented EU Regulation 2025/1234, extending the use of electronic instructions for use(eIFUs) to Switzerland as well, as long as they are intended for professionals.
Instructions for use intended for the general public (e.g., patients) must remain in paper form.
The link to eIFUs must be registered in the UDI database.
For more info:
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/anwendbare-rechtsakte-gemaess-eu-mdr/umsetzung-eu-durchfuehrungsverordnung-gebrauchsanweisungen.html
- https://medenvoyglobal.com/blog/new-eu-regulation-on-eifus-adopted-by-swissmedic/
- https://www.swiss-medtech.ch/en/news/eifu-regulation-switzerland
Traceability System (Swissdamed – Actor & Device Registration)
The Swissdamed system consists of two main parts:
- Actors Module (active from August 2024): register of economic operators (manufacturers, authorized representatives, assemblers).
- UDI Devices Module (activated from August 2025): register of devices and IVDs intended for the Swiss market.
You are prompted to create the economic profile (Actor) before starting device registration.
For more info:
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank.html
- https://medenvoyglobal.com/blog/swissmedic-rolls-out-new-swissdamed-udi-devices-module/
- https://cmcmedicaldevices.com/swissdamed-udi-devices-module-medical-device-registration-now-available/
Guidelines for SPP – Systems and Procedure Packs.
An information document was published in 2025 aligning Swiss regulations with EU regulations (MDR/IVDR) for SPPs. Those assembling and marketing these products are required to register within 3 months of first placing on the market. The obligation also includes post-market surveillance.
For more info:
Operational Summary (Table)
| Theme | Key Expiration | Obligated | Official links |
|---|---|---|---|
| UDI Devices (Swissdamed) | Mandatory as of 1/7/2026 | Manufacturers, representatives, assemblers | Link 1 and link 2 |
| eIFU (electronic) | Active as of 8/8/2025 | Manufacturers to be included UDI URL | Link 1 and link 2 |
| SPP | Registration within 3 months | SPP Assemblers | Link 1 |
Implications for Pharmacies, Importers and Wholesalers
Pharmacies: need to apply for registration only if they act as SPP assemblers; otherwise, especially in preparations, it is important to be ready on eIFU and ter compliance.
Importers: must be registered as “actor” in Swissdamed, linked to the imported devices, but cannot register the devices themselves; this is the prerogative of the manufacturer or authorized representative.
Wholesalers/Distributors: must ensure traceability and UDI alignment, but registration is left to the lead actor. Use of eIFU and participation in supervision is crucial.
Why get help?
These changes require proactive planning especially for importers, manufacturers and pharmacies involved in SPP tracking, surveillance or assembly. For technical or operational support, we can align your current procedures to ensure compliance.
Free consultation!