Regulatory Update

Swissmedic launches swissdamed UDI playground

The swissdamed UDI Playground, launched in November 2025, gives economic operators a free testing environment to practise UDI XML uploads and data validation before the swissdamed UDI Devices module becomes mandatory. Registered companies can test versioning, onboarding, and UDI registration workflows. Swissmedic also provides a 13-page guide explaining access, actor registration, XML upload steps, and validation rules.

Published on:
December 2, 2025

The swissdamed UDI Playground 2025 is now officially available, offering registered economic operators a dedicated testing environment to prepare for the swissdamed UDI Devices module. Launched on 27 November 2025, the Playground allows users to practise XML uploads, test UDI data validation, and understand swissdamed business rules in a realistic, risk-free setting. This early access environment is designed to help manufacturers, importers, and authorised representatives adapt smoothly ahead of future mandatory use.

Key Features of the swissdamed UDI Playground

The Playground allows all economic operators registered in the swissdamed production environment to test the UDI Devices module before full implementation. It simulates real workflows, supports XML file uploads, and checks entries against the module’s validation and business rules. The environment is free of charge and includes structured opportunities for users to provide feedback after each release cycle. This makes it a valuable preparatory tool for organisations expecting swissdamed UDI requirements.

What Economic Operators Can Practise

Users can explore core UDI functionality in advance, including:

  • Access and setup for companies not yet formally registered
  • Actor registration and user onboarding
  • Uploading UDI datasets via XML
  • UDI versioning and change control
  • Completing UDI registrations
  • Understanding swissdamed validation and error logic

This hands-on experience helps organisations build internal competence long before the production module becomes mandatory.

Swissmedic’s 13-Page User Guide

Swissmedic has published a comprehensive 13-page user guide that explains how to access the Playground, manage actors and users, upload and correct UDI XML files, and finalise UDI records. The guide is designed for practical use and supports both new and experienced regulatory teams navigating swissdamed’s structure and rules.

Impact on Manufacturers and Other Economic Operators

The Playground enables early system familiarisation, reducing the risk of implementation delays when swissdamed UDI registration becomes mandatory. Operators can test UDI data structures, identify gaps in master data, and align internal processes before real submissions. This staged approach improves regulatory readiness and minimises compliance risks.

Recommended Actions to Prepare

  • Register your organisation in swissdamed if not yet completed
  • Download and review Swissmedic’s user guide
  • Test XML UDI uploads using representative product datasets
  • Validate that your internal UDI master data matches swissdamed rules
  • Collect feedback from internal testers and adjust documentation
  • Plan for integration with future production-level requirements

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