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.

If and when the Swiss Federal Council implements a new framework agreement with Europe, then use of EUDAMED will become mandatory again in Switzerland.

In the meantime, Swissmedic is developing its own EUDAMED-like medical device registration database, called ‘swissdamed’.

It will launch in 2024 and consist of two registration modules:

  1. Economic Operators (manufacturers, system/procedure pack producers, authorized representatives, importers)
  2. Medical Devices and IVDs


Until the swissdamed registration database is launched, only a limited number of medical devices require registration in Switzerland. 

The current registration requirements are outlined below. For the detailed overview and application forms, please refer to Swissmedic’s website: medical devices, IVDs

Only applicable to Swiss manufacturers; Swiss Authorized Representatives (CH-REPs) are not obligated to notify Class I devices on behalf of third country (i.e., non-Swiss) manufacturers, although the CH-REP is obligated to verify that the device complies with the Swiss medical device ordinance (MedDO).

Only applicable to Swiss manufacturers; Swiss Authorized Representatives (CH-REPs) are not obligated to notify IVD medical devices on behalf of third country (i.e., non-Swiss) manufacturers, although the CH-REP is obligated to verify that the device complies with the Swiss medical device ordinance (IvDO).

Only applicable to assemblers based in Switzerland; Swiss ARs are not obligated to notify system/procedure packs on behalf of third country manufacturers.

Required for all custom-made devices. The registration is made by the manufacturer, authorized representative (CH-REP), importer or distributor in Switzerland before making the product available on the market.

Like Europe, Switzerland requires the registration of economic operators. Swissmedic references the definition of an economic operator from the EU MDR/IVDR: “the manufacturer, authorised representative, importer, distributor or natural or legal person as specified in Article 22 paragraphs 1 and 3 EU-MDR“.

However, even though they reference the MDR/IVDR, Swissmedic has deviated from the European requirements regarding economic operator registration. Unlike the MDR/IVDR, which requires that all manufacturers, authorised representatives and importers register in EUDAMED, Swissmedic only requires Swiss manufacturers, authorized representatives and importers to register.

So, while the MDR/IVDR requires all manufacturers, irrespective of where they are located, to register themselves in EUDAMED (once mandatory), Swissmedic only requires Swiss manufacturers to complete the economic operator registration.

Note that this may change once swissdamed is implemented.

When an economic operator registers in EUDAMED, they are issued a Single Registration Number (SRN). When an economic operator registers with Swissmedic, they are issued a Swiss Single Registration Number, abbreviated as CHRN (“CH” being the country abbreviation for Switzerland).

Obtaining the CHRN is mandatory for Swiss-based manufacturers, authorized representatives and importers. This is different from Europe, where obtaining an SRN is currently voluntary.

Not all manufacturers / devices have to be registered in Switzerland. Please refer to the above section to see which devices require registration.

If your device does require registration, Swissmedic charges a fee of CHF 300 per notification. An additional administrative fee of CHF 200/hour may be charged, in certain cases. For example, “due to incomplete or inappropriate documentation, withdrawal of a notification after work has already been carried out, requests for information or the correction of a notification as a result of a mistake made by the notifying company.”

It takes Swissmedic approximately one month to process notificatiosn. However, you may begin marketing the device in Switzerland as soon as the notification is submitted. You do not need to wait for Swissmedic to complete process.

Processing a notification takes approximately one month from receipt. This assumes that the notification contains all the necessary information and documentation. However, the statutory notification obligation is fulfilled with the submission of the notification.

As mentioned in the above section, at this time only Swiss-based manufacturers, authorized representatives, and importers require a CHRN.

If you require a CHRN, Swissmedic charges an hourly fee of CHF 200 to process requests. Most applications are processed within one hour, unless there are questions or findings during Swissmedic’s review.

Swissmedic’s official timeframe to process CHRN requests is 30 days. However, they also state that “if the volume of applications is low, the processing time may be shorter”.