Swissdamed: Device Registration Requirement Updates

Swissmedic has recently expanded its Swissdamed device registration “Questions and answers” section with three new entries to clarify key technical and regulatory issues.

Key Technical Guidelines

1. XML File Formatting for Device Data Upload

Swissmedic now confirms that the Swissdamed device registration data for Swissdamed can be uploaded as XML, using the EUDAMED standard “GET DEVICE” or “POST DEVICE” format.

2. EUDAMED Data Migration – Whose Responsibility?

Swissmedic clarifies that economic operators themselves are responsible for migrating any device data from EUDAMED to Swissdamed. There is currently no automated interface or synchronization between the two databases.  

3. Accepted UDI Issuing Entities

Swissdamed now officially recognizes four issuing organisations for Unique Device Identifiers (UDI):
• GS1 AISBL
• Health Industry Business Communications Council (HIBCC)
• ICCBBA
• IFA GmbH (Informationsstelle für Arzneispezialitäten)

What This Means

• Uniform XML Standard
  Aligning Swissdamed device registration XML requirements with EUDAMED ensures streamlined cross-border filings and reduces redundant work for manufacturers.
• No Swissmedic-Led Migration
  Economic operators must proactively export their data from EUDAMED and upload it manually to Swissdamed—Swissmedic won’t facilitate data transfer.
• Clear UDI Issuer Framework
  The explicit listing of four accepted entities offers clarity and compliance assurance for UDI registrants.

What’s Next?

• Economic operators planning device registrations should start planning for device registrations using Swissdamed.
• Stay tuned for upcoming deadlines: voluntary device registration is slated for 2025, with full mandatory UDI submission by 1 July 2026 under Swiss regulation

How Can We Support?

We can support manufacturers with smooth and compliant Swissdamed registration by managing XML formatting, UDI verification, and device data uploads.

If you have questions or need expert support to ensure continued compliance within the Swissdamed registration process – MedEnvoy is here to help. We simplify regulatory complexity, helping you stay focused on innovation and patient outcomes. 

We encourage you to reach out to our regulatory experts here.