Swissmedic Rolls Out New Swissdamed UDI Devices Module

Swissmedic has unveiled a significant enhancement to the Swiss database for medical devices, Swissdamed, with the launch of its UDI Devices module, enabling the registration of medical devices—including in vitro diagnostics, systems, and procedure packs—on a voluntary basis.

What’s New? 

• UDI Devices Module Live 
  Swissdamed now supports the voluntary registration of medical devices, including in vitro diagnostics (IVD) and systems/procedure packs.

• Gradual Rollout Approach 
  The Actors module, used for registering economic operators (manufacturers, authorized representatives, assemblers), has been available since August 2024, with the device module being gradually rolled out, granting economic operators time to comply.

Compliance Timeline 

Note:  Swissmedic is aware of the further postponement of the applicability of the device registration obligation in the EU and is closely monitoring the development of the corresponding timelines. 

Why It Matters 

• Enhanced Transparency and Oversight of devices on the Swiss market 
  Swissdamed offers public access to critical data on medical devices and their responsible economic operators fostering transparency in Switzerland’s healthcare system. 

• Regulatory Alignment with Europe but with Swiss-specific requirements 
  While Swissdamed aligns its data structure with Europe’s EUDAMED system, there is currently no interface or synchronization between the two databases. As a result, operators must actively upload their data to Swissdamed since Swissmedic does not facilitate automated transfers.  

• Despite a large overlap in data to be included in EUDAMED and Swissdamed there are distinct differences as well.
  • Swissdamed specific data elements
    • Swiss market status
    • Swiss single registration number (CHRN)
    • Swiss authorised representative
    • Versioning of records
  • Eudamed specific elements:
    • Clinical investigations, performance studies
    • Certificate information
    • Market status in EU member states
    • Member state of placing on the EU market
    • Device substatus (recalls, field safety corrective actions)
    • Reprocessed single use
    • Versioning of records
  • Common data elements swissdamed – EUDAMED:
    • Basic UDI-DI Data
      • Basic UDI-DI/EUDAMED DI, issuing entitiess
        • Applicable Regulation
        • Kits, SPP. special device type
        • Medical purpose
        • Risk class
        • Device model/name
        • Device Characteristics
        • Single registration number (SRN)
        • Presence of tissue and cells/derivatives
      • UDI-DI Data
        • UDI-DI/EUDAMD ID, unit of use DI, type of UDI-PI. direct marketing DI, secondary UDI-DI, package UDI-DI issuing entity
        • Device name, trade name, reference/catalogue number
        • Product description
        • Nomenclature code
        • Intended purpose
        • Storage/handling warnings/contraindictions
        • Information on sterilization, reuse, single use
        • List of substances
        • Clinical sizes
        • Quantity
        • Product original manufacturer

• If you have already registered devices in EUDAMED using an XML file compatible with EUDAMED’s XSD schema version 3.0.16, that same file can be reused in Swissdamed, as Swissmedic accepts XMLs compliant with EUDAMED specifications. Note: If your devices were entered into EUDAMED manually through the portal, you will first need to generate an XML file in order to complete voluntary registration in Swissdamed. A manual entry option may become available at a later stage. 

Available Guidance Documents and Playground 

Swissmedic has provided a suite of updated guidance materials accompanying the launch, including: 

• Actor Module User Guide 

• UDI Devices Module User Guide 

• Quick Guide for registration in the UDI Devices Module 

• Quick Guide for public search for actors and devices 

• Swissdamed Business Rules 

• Data dictionary UDI Devices: in progress. 

Availability of Playground for the swissdamed UDI Devices module is planned for the end of 2025. This test environment enables economic operators to further familiarise themselves with the functions and requirements of the module. 

What This Means for You 

If you’re involved in manufacturing or assembly of medical devices or system or procedure packs for Switzerland, you should: 

1. Register Yourself: Ensure your economic operator details are live in the Swissdamed Actors Module (if not already). If you are a foreign manufacturer placing devices on the Swiss market, you cannot register directly in Swissdamed as the economic operator. Instead, you must appoint a Swiss Authorised Representative (CH-REP). The CH-REP is responsible for registering in the Actors Module and obtaining a Swiss Single Registration Number (CHRN) on your behalf. 

2. Prepare for UDI Registration: Even though it’s voluntary now, planning ahead for the July 2026 deadline is wise. 

3. Review Updated Guidance: Swissmedic’s new user guides and agreements will help you navigate technical and procedural requirements. 

4. Stay Alert for Vigilance Obligations: Devices involved in serious incidents or corrective action reporting must be registered without delay, starting 1 July 2026. 

Final Thoughts on the New Swissdamed UDI Devices Module

Swissmedic’s integration of the UDI Devices module marks a significant step toward consistency and visibility in Switzerland’s medical device regulations. As transition timelines draw near, staying informed and proactive is more important than ever for all economic operators involved. 

How MedEnvoy Can Support 

MedEnvoy provides end-to-end Swissdamed compliance services to help manufacturers navigate registration efficiently and without disruption: 

• Swiss Authorized Representative (CH-REP): Acting as your official Swiss representative and ensuring regulatory responsibilities are met. 

• Actor & Device Registration Management: Handling CHRN applications and uploading device data in Swissdamed on your behalf. 

• Data Preparation & Alignment: Converting and validating EUDAMED datasets for Swissdamed, ensuring technical compatibility (XML, XSD schema). 

• Vigilance Compliance: Ensuring devices subject to incident reporting are registered on time (mandatory from 1 July 2026, without transition). 

• Ongoing Monitoring: Keeping you updated on Swissmedic announcements, evolving requirements, and future module rollouts. 

MedEnvoy offers expert regulatory support to manufacturers in navigating Swissmedic requirements. Our expertise ensures that your registration meets the applicable swissdamed standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support.