Swissmedic Medical Devices Database Playground – Test Environment

Purpose of the Playground

The Playground serves as a safe, non-production sandbox for users of the Swissmedic e-Business portal (medical devices section). It enables manufacturers, authorised representatives, importers, and other economic operators to:

• Test registration workflows for devices, economic operators, and related data.
• Validate UDI-DI formats, XML/JSON structures, and file uploads.
• Simulate complete submission scenarios including attachments and declarations.
• Train staff and prepare for live registrations without risk of errors impacting the real database.

This test environment helps ensure smooth transition to mandatory registrations under the revised MedDO and reduces errors in the productive system. Playground - Swissmedic

Access and Requirements

• Portal Login: Access requires an existing e-Business account with medical devices module activated.
• Separate Environment: The Playground uses distinct credentials or a dedicated test profile to isolate it from production.
• No Real Data: All entries created in the Playground are temporary and deleted periodically; no data migrates to the live database.
• No Fees or Official Validity: Actions in the Playground have no regulatory effect and incur no charges.

Users should contact Swissmedic support if they need assistance activating test access or obtaining test credentials.

Key Features and Functionalities

• Device Registration Simulation: Practice entering device details, UDI, classification, intended purpose, and conformity assessment data.
• Economic Operator Profile Testing: Create and update mock CHRN-linked profiles.
• File Upload Validation: Test supported formats for certificates, declarations of conformity, labels, and vigilance reports.
• Error Checking: Receive immediate feedback on invalid fields, missing mandatory data, or format inconsistencies.
• Preview and Reports: View how submitted data would appear in the public register or internal reports.

The interface mirrors the production portal as closely as possible, including validation rules and mandatory fields.

Best Practices for Using the Playground

• Use realistic but fictional test data to mimic actual scenarios.
• Test edge cases (e.g., high-risk devices, multi-language labels, batch-managed products).
• Repeat workflows multiple times to build familiarity.
• Document any encountered issues and report them to Swissmedic for portal improvements.
• Combine Playground practice with review of official guidance documents and FAQs.

The Playground is especially valuable during initial implementation phases or when preparing for significant regulatory changes (e.g., new UDI modules or database enhancements).

This test environment supports high-quality, error-free registrations in the productive Swiss medical devices database, contributing to efficient market surveillance and patient safety. Detailed instructions, login guidance, test data examples, and support contacts are provided on the Swissmedic Playground page. Playground - Swissmedic