Swiss Registration Requirements
Due to larger political issues, the Switzerland-EU Mutual Recognition Agreement has lapsed for medical devices and IVDs. As a result, Swissmedic no longer has Competent Authority access to EUDAMED.
Therefore, Swissmedic has developed its own medical device registration database, called ‘swissdamed’. It consists of two modules and mirrors EUDAMED:
- Economic Operators (manufacturers, system/procedure pack producers, authorized representatives, importers) – mandatory starting August 6, 2024
- Medical Devices and IVDs – mandatory starting July 1, 2026, followed by a 6-month transition period:
Manufacturer Registration Requirements
Like Europe, Switzerland requires the registration of economic operators, e.g., manufacturers and system/procedure pack producers.
However, unlike the EU MDR/IVDR, which requires that all manufacturers and system/procedure pack producers register as ‘Actors’ in EUDAMED, Swissmedic only requires Swiss manufacturers and system/procedure pack producers to register as actors and obtain a Swiss Single Registration Number (CHRN).
Instead, the Swiss Authorized Representative (AR) registers the foreign manufacturer within their swissdamed account. Then, the non-Swiss manufacturer is assigned a Mandate ID and is included in the ‘swissdamed’ public database under the Swiss AR’s Actor registration.
Device Registration Requirements
The swissdamed UDI/Device module became mandatory on 1 July 2026, followed by a six-month transition period. Therefore, the final deadline for devices to be registered is 31 December 2026. After this date, any device new to the Swiss market must be registered prior to marketing.
Manufacturers may register their devices directly into swissdamed, i.e., it is not mandatory for their Swiss AR to complete this registration. Any manufacturers who wish to register directly, must request system access from their Swiss AR. There are multiple steps to this process:
- Swiss AR must invite individual users
- Users must accept the invitation, which requires creation of a Swiss AGOV account
- Swiss AR must then modify the user’s profile to allow them registration editing access
There are three different ways to register in swissdamed:
- Machine-to-Machine (best for extensive number of devices, who regularly add/discard product codes)
- XML upload (best for companies that have already registered their devices in EUDAMED)*
- Manual entry (best for companies with a small number of product codes)
*If your devices are already registered in EUDAMED, please refer to the EUDAMED user manual for instructions on how to download your registration data as an XML file. This downloaded XML file can then be easily uploaded to swissdamed, requiring you only to update the status from “draft” to “on the market”. The registration is not considered complete until the device status is “on the market”.
Custom-Made Devices
Custom-made devices (CMDs) are exempt from being registered in swissdamed. Instead, these must be registered with Swissmedic directly, using the official notification form for CMDs. The registration can be made by the manufacturer, authorized representative (CH-REP), importer, or distributor in Switzerland. Registration must be completed before making the device available on the market.
Device Registration Fees
Swissmedic charges CHF 200 for the first device per year and CHF 20 for each additional device, up to a maximum of CHF 10,000 per year per manufacturer / person who assembles systems or procedure packs (no additional costs for 492 devices or more per year).
Each individual device registration (e.g., per UDI-DI) is only billed once, i.e., there is no annual registration maintenance fee.
The first set of invoices will be issued January 2027, for all devices with the status “on the market” as of 31 December 2026. Thereafter, any newly registered devices will be invoiced monthly.
All charges are billed through the Swiss AR for foreign manufacturers. Swiss manufacturers are invoiced directly.
