Swissmedic Updates swissdamed Actors User Guide: What Manufacturers and Authorised Representatives Should Know

Swissmedic has published version 2.0 of the “swissdamed User Guide Actors”, introducing updates and clarifications for economic operators using the Swiss medical device database platform, swissdamed. The updated handbook became valid on 10 May 2026.

The document provides detailed operational guidance for manufacturers, authorised representatives (ARs), importers, and system/procedure pack producers managing registrations and user access within swissdamed.

Key Updates in Version 2.0

According to the change history, version 2.0 mainly introduces adjustments related to Switzerland’s migration from CH-LOGIN to AGOV Login, the new federal authentication system.

Swissmedic confirms that:

• AGOV will progressively replace CH-LOGIN;

• Existing CH-LOGIN accounts can be upgraded to AGOV accounts;

• Existing authorisations and permissions will remain valid after migration.

This is particularly relevant for manufacturers and ARs that rely on multiple users and distributed regulatory teams to maintain Swiss registrations and UDI-related activities.

Clarification of User Roles and Permissions

The handbook also provides detailed clarification on the different user profiles available within swissdamed, including:

• Company Admin

• Actor Admin

• Mandate Admin

• UDI Editor

• Viewer roles

The distinction between company-level permissions and actor-level permissions is important operationally, especially for organisations managing several legal entities or external regulatory service providers.

Swissmedic also recommends maintaining at least two active Actor Admins as a fail-safe mechanism to avoid access disruptions.

Impact on Manufacturers

For manufacturers placing devices on the Swiss market, several practical points stand out:

1. Company Verification Remains Mandatory

Before an actor can be registered and obtain a Swiss Single Registration Number (CHRN), the company itself must first be registered and verified through a postal verification process.

This means manufacturers should factor in additional lead times when onboarding new Swiss entities or subsidiaries.

2. Periodic Data Validation Requirements

The guide reiterates that economic operators must periodically confirm the accuracy of their registered data in line with:

• Article 31(5) MDR

• Article 28(5) IVDR

Swissmedic states that actor validation reminders will be issued:

• 12 months after initial registration;

• Then every two years thereafter.

Manufacturers should ensure internal regulatory ownership for maintaining actor data accuracy to avoid administrative issues.

3. Mandate Transfer Functionality

One of the more operationally significant functionalities described in the guide is the ability to transfer mandates between authorised representatives directly within swissdamed.

According to the handbook:

• mandate transfers include associated registered devices;

• both ARs must already be registered in swissdamed;

• transfers require approval from the new AR before the specified transfer date.

This could simplify transitions when manufacturers change Swiss Authorised Representatives, particularly for larger portfolios.

Increased Operational Maturity of swissdamed

The updated handbook reflects the continued maturation of the swissdamed ecosystem, especially around:

• user governance;

• access control;

• mandate lifecycle management;

• actor data maintenance.

While the document does not introduce new regulatory obligations, it provides clearer operational expectations for companies interacting with the Swiss registration environment.

Manufacturers and authorised representatives operating in Switzerland should review their internal user management processes and ensure alignment with the updated guidance.

Read the full document below.