Questions and answers

• If an error page appears when logging in, click again on the "Login" button at the top right of the menu.
• If the problem persists, delete your browser history, close the internet tab and reopen swissdamed or contact the swissdamed support team via Support swissdamed (swissmedic.ch)

Log in with your CH-LOGIN account. Go to the “Companies” tab and click on the “Register new company” button in the top right corner. Search for your company and confirm the company details. A letter with the validation code will be sent to the company’s address. After entering the validation code, your company is registered.

Wait for at least one week after registering the company, then contact the swissdamed support team via Support swissdamed (swissmedic.ch)

Contact the swissdamed support team via Support swissdamed (swissmedic.ch) with the following details: company name, first name, last name and e-mail address of the designated company admin.

• If your company was registered via Zefix, the details of your company are synchronised automatically with Zefix. Therefore, the data in Zefix first has to be updated before the new data can be viewed in swissdamed.
• If your company was registered manually, or if you have declined the automatic synchronisation with Zefix, you can modify the company details under “Actor management” in the “Registered companies” tab by clicking on the pencil icon. For changes regarding the company name, please contact the swissdamed support team via Support swissdamed (swissmedic.ch)

If your company is registered and validated, the company is shown under “Actor management” in the “Registered companies” tab. Click on the “+” button next to the company to create a new actor request.

The submitted actor registration request can be found under “Actor management” in the “Actor registration request” tab.

Upon approval of the registration request, you will receive a confirmation e-mail containing your CHRN.

Under “Actor management” in the “Registered actors” tab. The data for the highlighted actors has to be validated. To do so, open and check your actor registration request details (pencil icon on the right below “Actions”) and update and validate the data if necessary.

Under “Actor management” in the “Registered actors” tab, open the actor registration details (pencil icon on the right below “Actions”) and make the desired changes.

This means either that your actor's data was automatically changed by the system by synchronisation with Zefix, or that your actor has not been updated for 365 days or 720 days. You must therefore make sure that your actor's data is up to date and confirm accordingly.

As actor admin, open the detailed view for a registered actor and click on the “Inactivate actor” button at the top right of the mandate. In the pop-up, confirm that the actor will be inactivated.

Contact the swissdamed support team via Support swissdamed (swissmedic.ch).

Following a review by Swissmedic, the reactivation can be carried out subject to a fee. The registration of an economic operator can be reactivated if the linked UID entry for the company in Zefix has the status "active" or "in liquidation".

Once the economic operator (CHRN) has been reactivated, its status changes to "Action needed". The CHRN data for the operator must therefore be validated and confirmed within six months.

According to Art. 4 Para. 2 of FeeO-Swissmedic (SR 812.214.5) fees will be charged on a time and material basis and invoiced separately if the registration of an economic operator is reactivated.

In order to register a new mandate, you need to be logged-in as actor admin. In “Registered actors” choose the authorised representative (AR) for whom you want to register a mandate. Open the actor and go to the mandate tab (or click on the “Go to mandates” on the right of the AR in the “Registered actors” overview). Click on the “Register a new mandate” button.

Choose the authorised representative (AR) for whom you want to update a mandate in the “Actor management”. Open the actor details and then open the mandate you want to update (pencil icon on the right below “Actions”).

As mandate admin, open the detailed view for a registered mandate and click on the “Inactivate mandate” button at the top right of the mandate. In the pop-up, confirm that the mandate will be inactivated and cannot be reactivated.

The mandates already reported were not imported into swissdamed due to a partial lack of data quality and different data information. Therefore, already reported mandates and new mandates must be entered in swissdamed.

The recording of mandates in swissdamed is not yet mandatory. However, Swissmedic can already request the publication of the mandate via Art. 51 para. 3 TPLRO in conjunction with Art. 11 para. 3 EU MDR.

In connection with the «Devices» module, so-called «Regulation Devices» (MDR and IVDR) can be uploaded as an XML file in EUDAMED format on a voluntary basis from 2025. However, in preparation for this, it is advisable to include the mandates in swissdamed as soon as possible, as the products will be directly linked to the mandates afterwards.

Check all your e-mail folders. If the e-mail cannot be found, please repeat the user invitation process.

The company admin can invite new users to the company by clicking the respective action button on the company overview page. This will open a view where the admin has to enter the personal data and the company role (admin or viewer) to be assigned to the user.

• You have to be logged in as company admin. In the “Registered companies” tab, click on the pencil icon in the “Action” column on the right of the company to access the “Manage users” tab
• There is an action button at the end of the row that opens a pop-up window with the name and e-mail address of the selected user and the new role that can be assigned (admin if currently a viewer, or viewer if currently an admin).
• Click on the “Change permission” button.

The UDIs of "old devices" do not have to be registered in swissdamed. However, even for "old devices" serious incidents, field safety corrective action or trends (vigilance) shall be reported to Swissmedic.

• Starting 1 July 2026, UDIs for products, systems and procedure packs shall be registered in the swissdamed UDI module:

- if they were placed on the market in Switzerland from 26 November 2017 and met the requirements of the EU MDR or EU IVDR (in accordance with Article 22a of the MedDO of 17 October 2001)

or

- if they were placed on the market in Switzerland since 26 May 2021 (in the case of medical devices) or 26 May 2022 (in the case of in vitro diagnostics).

• Registrations shall be in accordance with Article 17 para. 5 MedDO and Article 16 para. 5 IvDO.

Yes. UDIs for products that have to be reported to Swissmedic due to a serious incident, a field safety corrective action or a trend (vigilance) are subject to immediate registration from 1 July 2026. In these cases, no transitional period applies.

"Old devices" are exempt from the UDI registration in swissdamed. However, even for "old devices" serious incidents, field safety corrective action or trends (vigilance) shall be reported to Swissmedic.

Manufacturers (including manufacturers of systems and procedure packs) and their authorised representatives are able to register UDIs in swissdamed as soon as they themselves are registered as “economic operators” in swissdamed.

During 2025 it will become possible to voluntarily register the UDIs of certain products in swissdamed. This applies to "regulation devices" (MDR and IVDR devices), which are to be uploaded in the EUDAMED format via XML files.

The registration obligation for the UDIs of all products, systems and procedure packs applies from 1 July 2026, with a transitional period until 31 December 2026.

No. The requirement to register UDIs in swissdamed does not replace the requirement of notification for medical devices, IVDs and devitalised human tissue.

In swissdamed, only the EMDN nomenclature will be used.

An overview of the EMDN codes can be found here: European Medical Device Nomenclature (EMDN).