Swissmedic has announced the release of the Swissdamed UDI Devices Playground, an online tool designed to assist medical device stakeholders in navigating Unique Device Identification (UDI) requirements. This tool aims to support clinical, quality, and regulatory professionals in ensuring compliance with UDI-related provisions under Swiss and European medical device regulations.
What changed?
Swissmedic has launched the Swissdamed Playground as of November 27, 2025. This platform replicates critical components of the official Swissdamed UDI system, offering manufacturers, importers, and other users a controlled environment to test different functionalities. The module allows participants to upload, validate, and review UDI data in compliance with the Medical Device Ordinance (MedDO). By simulating real-case scenarios, users can familiarize themselves with UDI submission protocols before interacting with the live system.
Who is affected?
This initiative specifically targets stakeholders in the medical device industry who are responsible for ensuring device traceability and regulatory compliance. Key groups include:
- Manufacturers based in Switzerland or exporting to the Swiss market.
- Authorized representatives, importers, and distributors.
- Quality assurance and regulatory compliance teams managing UDI submissions.
The Swissdamed Playground is particularly beneficial for organizations preparing for Swiss-specific UDI requirements or aligning their processes with broader EU regulatory frameworks under the MDR/IVDR.
Why does this matter?
Compliance with UDI regulations plays a critical role in enhancing patient safety by improving traceability of medical devices. Swissmedic’s provision of a testing environment helps stakeholders identify and resolve potential data submission issues proactively. This participation reduces the risk of delayed approvals and ensures smoother operation within regulatory workflows. The playground also serves as an educational tool, helping teams understand optimal practices for UDI data management.
FAQ
1. What is the Swissdamed UDI system?
The Swissdamed UDI system is a standardized framework under Swissmedic’s jurisdiction for managing Unique Device Identifier data for medical devices distributed within Switzerland. It aligns with global UDI practices.
2. How can users access the playground?
Access to the playground requires registration through official Swissmedic channels. Detailed instructions are available on the Swissmedic website.
3. Is the playground mandatory for manufacturers?
Participation in the playground is not mandatory but is strongly recommended for stakeholders who aim to optimize compliance processes prior to using the live system.
Conclusion
The release of the Swissdamed Playground marks a significant step forward in simplifying UDI compliance for the Swiss medical device community. All relevant stakeholders are encouraged to utilize this tool to streamline their regulatory workflows and enhance device traceability standards. For further details regarding account setup and integration, visit Swissmedic’s official page.
Disclaimer
The information presented here is intended for general guidance only. It does not constitute legal or regulatory advice. Stakeholders are encouraged to consult appropriate legal or compliance professionals for specific advice related to Swiss UDI requirements.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissdamed-playground.html