A database organized around two modules
The swissdamed platform is based on two separate modules.
The first, “Actors,” has been operational since August 2024 and allows for the registration of economic operators, including:
- manufacturers based in Switzerland;
- Swiss representatives (CH-REP);
- system integrators and related services.
The second module, “UDI Devices,” has been available since August 2025 and allows for the registration of medical devices, in vitro diagnostic medical devices, as well as systems and kits.
This architecture largely follows the principles implemented in EUDAMED, while serving as a standalone database administered by Swissmedic.
The CHRN: The Regulatory Identifier for Economic Operators
Registration in the “Actors” module results in the assignment of a CHRN (Swiss Single Registration Number).
This unique identifier allows Swissmedic to identify each economic operator registered in the Swiss market. It is the equivalent of the SRN (Single Registration Number) used in the European Union.
The CHRN must be used in communications with Swissmedic and in certain regulatory procedures related to market surveillance or pharmacovigilance.
Depending on the activities carried out, a single entity may have several separate CHRNs when it assumes different regulatory roles.
For manufacturers based outside Switzerland, obtaining a CHRN is generally handled through their Swiss representative when required by regulation.
Device registration will be mandatory as of July 1, 2026
Currently optional, the registration of devices in the “UDI Devices” module will become mandatory as of July 1, 2026.
This requirement will apply to:
- medical devices;
- in vitro diagnostic medical devices;
- systems and supplies.
Swissmedic is providing for a transition period through December 31, 2026, to allow economic operators to complete the registration of their product portfolios.
However, this transition period will not apply to devices used in vigilance activities. Thus, products covered by:
- a serious incident;
- a field safety corrective action (FSCA);
- a fashion statement;
must be entered into swissdamed without delay.
What data will need to be recorded?
Device registration is based on the principles of the UDI system and requires the submission of a set of regulatory data related to the product.
The information that must be provided includes, in particular:
- the UDI-DI;
- information about the manufacturer;
- the details of the Swiss representative, when required;
- the risk class;
- the applicable certificates of conformity;
- information regarding the marketing of the device.
To minimize the administrative burden on manufacturers already involved in European regulatory processes, Swissmedic is establishing import mechanisms that use formats compatible with those of EUDAMED.
It should be noted, however, that no automatic synchronization between EUDAMED and swissdamed is currently planned. Operators therefore remain responsible for ensuring that the data in both systems are consistent.
Fees for Registrations
Swissmedic has also published the fee schedule for swissdamed.
Administrative fees are charged for:
- the registration of economic operators and the assignment of a CHRN;
- certain registration changes;
- Registering devices in the “UDI Devices” module.
This change introduces a new budgetary component that manufacturers and authorized representatives will need to incorporate into their regulatory activities.
For companies with a large portfolio of devices, it will be particularly important to anticipate the costs associated with product registration and regulatory data management.
What are the implications for manufacturers?
The gradual implementation of swissdamed represents a major shift in the Swiss regulatory landscape.
Manufacturers marketing devices in Switzerland should take the following preparatory steps immediately:
- verify that the relevant operators are registered in the “Actors” module;
- obtain or confirm their CHRN;
- consolidate the UDI data for their devices;
- identify discrepancies between EUDAMED data and Swiss requirements;
- estimate the costs associated with fees;
- adapt internal procedures for managing regulatory data and pharmacovigilance.
Foreign manufacturers will need to pay particular attention to coordinating with their Swiss authorized representative to ensure that registrations are compliant and that data is kept up to date throughout the devices’ lifecycle.
For more information: https://www.swissmedic.ch/swissmedic/en/home/medical-devices