Today Swissmedic announced that the Swiss Actor Registration Module will become mandatory starting 6 August 2024.

Swissmedic also updated their general swissdamed overview page. It estimates the Medical Device Registration Module to be available starting sometime in 2025.

Background

Due to the lapsed Mutual Recognition Agreement for medical devices, Swissmedic does not have access to the new EUDAMED platform. As a result, Swissmedic developed its own registration system.

It originally consisted of emailing Swissmedic of required notifications and only applied to a limited number of devices. Meanwhile, Swissmedic has been developing their own version of EUDAMED, called ‘swissdamed’. It will consist of an Actor and UDI/Device registration modules, mirrored after EUDAMED. Under the new system, it is expected that all devices will require registration.

Overview of Today’s Announcement

The Actor Registration Module will go-live Tuesday, 6 August 2024.

Until Friday, 26 July 2024, companies should continue to follow the current process. This consists of completing a PDF Swiss Single Registration Number (CHRN) application form and emailing it to Swissmedic.

As of 6 August 2024, registration must be submitted through swissdamed. Note that a link to the swissdamed Actor registration module is not yet available. Neither yet, are any user manuals on the new process.

Impact to Swiss Economic Operators

Already Registered

Those who have already registered will be rolled into the new system. They will not need to take significant additional action. Swissmedic will contact active registrants (by letter) with further details, e.g., to verify their data post-migration.  

Not Yet Registered

If you have not yet registered for a Swiss Single Registration Number (CHRN), there will be a ~1 week gap period where Actor registrations are not possible (27 July 2024 – 5 August 2024). Therefore, you should submit via the PDF form by 26 July, or wait to submit via the swissdamed platform starting 6 August.

Impact to non-Swiss Manufacturers

To date, only Swiss-based Economic Operators require registration in Switzerland. Therefore, the impact to non-Swiss manufacturers should be minimal. Their Swiss Authorized Representatives and Importers will carry the action to verify their data has been correctly migrated.

This is detailed in Swissmedic’s FAQ ‘Who needs a CHRN?’. Casus will advise if anything changes in this regard.

“Pursuant to Art. 55, para. 1 MedDO / Art. 48 para. 1 IvDO, the registration requirement applies to Swiss manufacturers (based in Switzerland) or to the authorised representative (based in Switzerland) of the foreign manufacturer and to the importer (based in Switzerland). The foreign manufacturer/producer is not required to register in Switzerland but must appoint an authorised representative (within the deadlines stated in Art. 104a MedDO / Art. 86 IvDO for manufacturers in the EU/EEA).

The authorised representative…and/or the importer must in turn register with Swissmedic pursuant to Art. 55, para. 1 MedDO / Art. 48 para. 1 IvDO. This is subject to a deadline of three months after they have first placed medical devices or in-vitro diagnostics on the market.

Owing to the revision of the applicable legislation for medical devices and in vitro diagnostic medical devices on 18 October 2022, economic operators based in Liechtenstein must now also register with Swissmedic.”

Further Information

Once the new system is live, Casus will provide an overview of the process. In the meantime, the below resources may be of interest:

• Swiss Single Registration Numbers (CHRN): Process, Fees & Timing (current process)
• Swiss Medical Device & IVD Registration: Process, Fees, & Timing (current process)
• Swiss Authorized Representative (CH-REP): Overview of Requirements & Role
• Swiss Requirements for System/Procedure Pack Producers
• Swiss Authorized Representative Labeling Requirements