Background

Swissmedic has launched a new online database called swissdamed:

Scroll down for the latest information on the UDI/Device registration module in swissdamed. This article starts with an overview of the Actor registration module (first step in the overall process).

Actor Module

How to Access the Actor Module

Actor registration is only applicable to Swiss-based operators, i.e., non-Swiss companies cannot register themselves as an Actor in swissdamed.

Transferring Mandates

Swissmedic has published new information regarding what happens when you transfer Swiss Authorized Representatives (AR). The full steps are available in the Actors User Guide (starting page 27).

High-level: the outgoing Swiss AR will submit a transfer request in swissdamed. Then, the new incoming Swiss AR can approve or reject the request in their swissdamed account. Once approved, the manufacturer (and all its registered devices) will be transferred to the new Swiss AR, on the transfer date.

Fee to Register Actors

Swissmedic charges a flat fee of CHF 200 per Actor registration request.

Deadline to Register

The swissdamed Actor module became mandatory starting 6 August 2024. Any Actors registered using the old process, were automatically rolled into swissdamed once it went live.  

Actor Module Resources (scroll down for Device Module Resources)

UDI/Devices Module

How to Access the UDI/Devices Module

Registration in swissdamed is required for all medical devices, IVDs, and system/procedure packs being marketed in Switzerland, i.e., by both Swiss and non-Swiss companies.

Non-Swiss manufacturers: Devices may be registered in two ways:

Under Option 1, the Swiss AR must receive all of the device information to complete this step. They may charge additional fees for their time and support. Under Option 2, once you have been granted access, you have control over the process.

Any devices registered for your company will be associated with your “Mandate ID”, which is what is issued to non-Swiss manufacturers instead of a Swiss Single Registration Number (“CHRN”).

Swiss manufacturers: Will automatically have access to the device registration module after completing the Actor registration. Therefore, if you have already registered as an Actor, this new module is now available when you log into your swissdamed account.

EUDAMED vs swissdamed Information Required

All of the Basic UDI-DI and UDI-DI details are the same for both EUDAMED and swissdamed. However, there are some market-specific differences to consider. See image below.

How to Register Devices

Currently, devices can only be registered by XML upload.

If you already used an XML file to register in EUDAMED, you can reuse that file for swissdamed. This is because Swissmedic accepts XMLs that comply with EUDAMED specifications.

If you entered your devices into EUDAMED manually (one by one through the portal), then an XML file will need to be generated for voluntary swissdamed registration.

The User Guide notes that “UDI registration is currently only possible via XML upload”, indicating that manual entry may be possible in the future.

What is an XML file for EUDAMED/swissdamed registration?

An XML file is a structured text file; essentially, a kind of digital form that computers can easily read. Instead of typing information into the registration portal by hand, the XML file is a ready-made package of your device details, arranged in the exact format the system requires.

What do Excel files have to do with XML?

You may have seen EUDAMED Excel files mentioned or advertised by support companies. However, neither EUDAMED nor swissdamed allow Excel file upload. So then, why are these Excel files provided in the first place?

It is because writing XML code directly would be too technical for most companies. Therefore, it is easier to start with a human-readable tool like Excel. Then, once the data is entered in Excel, a software tool can be used to convert it into XML format.

In other words, Excel is the human-friendly workspace, and XML is the computer-ready version that EUDAMED/swissdamed accepts.

Future Versions of the UDI/Devices Module

This first published version of swissdamed has some limitations. As discussed above, it 1) only allows registration of MDR/IVDR devices and systems/procedure packs, and 2) must be submitted via XML upload.

A future version will be published that also allows legacy device and Master UDI-DI registration. Therefore, companies with only legacy devices, or a mix of Regulation and legacy devices, may need to wait for an updated version to be published. Further, companies with a small number of UDI-DIs may want to wait, and see if manual entry will be possible in the future.

Fee to Register Devices

Swissmedic has confirmed there will be a charge levied. However, they have not disclosed the amount as of yet. Per one of their FAQ items:

Device registration fee (scroll down to bottom of page)

“Swissmedic levies fees for the licences, controls and services that it provides (Art. 65 TPA). After the registration obligation enters into force, a one-time fee will be charged for registering devices in swissdamed. Additional information will be available at a later time.”

Deadline to Register

The swissdamed UDI/Device registration module is currently voluntary. It does not become mandatory until 1 July 2026, followed by a 6-month transition period.

While companies are encouraged to start registering in the voluntary system, especially those with a high volume of products, it is not yet legally required.

In the meantime, companies should follow the current registration requirements. Currently, only a subset of devices require registration in Switzerland:

Our Swiss Registration Requirements guide is linked in the Resources section below.

Importers Linking to Imported Devices

Swiss Importers are obligated to link themselves to the devices they place on the Swiss market, same as required for Europe and EUDAMED. However, Swissmedic notes that the “link function for importers is not available at this time“. And that they will “announce the introduction and mandatory use of the link function when it becomes available“.

Device Module Resources (scroll up for Actor Module Resources)

swissdamed Public Database

How to Find Your Company & Devices

The process is simple: