Swissmedic publishes updated swissdamed Playground User Guide
Swissmedic has published Version 3.0 of the swissdamed User Guide – Playground, describing how manufacturers, authorised representatives and other eligible users can use the playground environment to test actor registration and UDI management before working in the production system.
The updated handbook explains how users can register actors, onboard users, upload and manage UDI data, test market status changes and access Machine-to-Machine (M2M) functionality within the simulated environment.
What is the swissdamed Playground?
According to Swissmedic, the swissdamed Playground is a simulated environment that enables users to perform trial uploads and validation of UDI data before using the production UDI Devices module.
The playground validates whether submitted data complies with swissdamed specifications and also provides users with access to newly developed functionalities before they are released in the production system. Activities performed in the playground do not affect the production environment, actor registrations are specific to the playground, and no registration fees apply.
Main topics covered in the updated guide
The handbook provides instructions covering several areas of the playground environment, including:
Actor registration;
User onboarding and permission management;
UDI registration via XML;
Market status management;
UDI versioning;
Deletion of draft UDIs;
Discarding registered UDIs;
Machine-to-Machine (M2M) registration;
Manual UDI management using the online editor.
Changes introduced in Version 3.0
According to the document's change history, Version 3.0 introduces several updates, including:
Removal of the chapter covering the transfer of UDIs by transferring a mandate;
Updates to the chapter on Upload UDIs via XML;
Updates to the Online editor – Create / manage UDIs manually section.
Impact for medical device manufacturers
The updated handbook is relevant for manufacturers, authorised representatives and organisations responsible for UDI registration in Switzerland that use the swissdamed platform.
The document provides practical guidance for testing UDI registration workflows before submitting data in the production environment, including actor registration, user permission management, UDI uploads, market status changes and manual or Machine-to-Machine (M2M) registration processes. As the playground mirrors key functionalities of the production system without affecting live data or generating registration fees, it can be used to prepare organisations for operational use of the swissdamed UDI Devices module.
Next steps
Manufacturers intending to use the swissdamed UDI Devices module can use the updated playground guide to familiarise themselves with the registration process and validate UDI submissions before working in the production environment. Swissmedic notes that the playground also serves as a preview of functionalities that may be introduced into the production system in the future.
