Page Last Updated: 30 August 2024
The CHRN is Switzerland’s version of the EUDAMED Single Registration Number (SRN).
A CHRN is required in place of the EUDAMED Single Registration Number (SRN) because the Mutual Recognition Agreement (MRA) between Europe and Switzerland lapsed for medical devices and IVDs. After 26 May 2021 (medical devices) and 26 May 2022 (IVDs), the free movement of devices between the two areas was no longer allowed. Further, the EU Commission removed Switzerland’s Competent Authority level access to EUDAMED.
Since Switzerland’s regulations reference EUDAMED throughout, it had to quickly address the gap. This included creating its own version of European SRNs – Swiss Single Registration Numbers.
As a result, Swissmedic is developing its own EUDAMED-like registration database, called ‘swissdamed’. It consists of two registration modules:
The Economic Operator module has been live since 6 August 2024. The Medical Devices module is not expected to be functional until 2025
For more information, please read: Swiss Registration Database (Swissdamed)
A CHRN is mandatory for Swiss-based Manufacturers, Authorized Representatives and Importers. This is different from Europe, where the Single Registration Number (SRN) is voluntary until its use is published in the Official Journal of the EU, expected sometime in 2025.
The following need a CHRN:
NOTE: Even though a distributor is also an economic operator, they do not require a CHRN. This is the same as Europe’s Economic Operator registration requirements.
Swiss Manufacturers, Authorized Representatives, and Importers must submit an application via the swissdamed portal. But first, a user-specific CH-LOGIN (federal administration account) must be obtained. This is similar in concept to the ‘EU login account’ required for EUDAMED.
Swissmedic has published a User Guide, which details the exact steps to obtain a CH-LOGIN and complete the CHRN registration process.
The swissdamed public database is available: HERE
Swiss Manufacturers, Authorized Representatives and Importers must obtain a CHRN within three months of placing their first product on the Swiss market.
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”.
Swissmedic charges “a flat fee of CHF 200” to process CHRN requests.
This amount will be invoiced after the CRHN application has been processed. Invoices will only be issued to an address in Switzerland. Companies can wait to receive the invoice by post, or can submit a request to receive invoices by e-mail.
CHRNs do not expire. However, Swissmedic must be notified of changes within one week.
The types of changes that must be notified include:
Further, the CHRN data must be reviewed for correctness after 12-months, and then every two years thereafter.
EUDAMED SRN | Swiss CHRN |
---|---|
Voluntary until ~2025/2026 | Mandatory within three months of placing a new device onto the Swiss market |
SRN is issued by one of the many national Competent Authorities | CHRN is issued by Swissmedic |
SRN issuance timeframe varies, depending on which national competent authority is selected | CHRN issued within 30 days |
Registration request is made through the EUDAMED portal | Registration request is made through the swissdamed portal |
No fee to register in EUDAMED | Hourly fee of CHF 200 fee charged |
All manufacturers need an SRN, irrespective of where they are located | Only Swiss manufacturers need a CHRN |
Manufacturers identify their EU Authorized Representative (AR), and upload the AR Mandate, when they submit their SRN request to the Competent Authority | n/a – Foreign manufacturers have no interaction with Swissmedic during this process |
EU AR must obtain an SRN | Swiss AR must obtain an CHRN |
EU AR must review & verify the Mandate that was uploaded by the manufacturer, before an SRN can be issued by the national Competent Authority | Swiss AR can submit the manufacturer’s Mandate in swissdamed, but is not required to do so |
Importers need an SRN | Importers need a CHRN |
Distributors do not need an SRN | Distributors do not need a CHRN |
SRN data must be confirmed as still valid after one year, then every two years thereafter | CHRN data must be confirmed as still valid after one year, then every two years thereafter |
SRN information must be updated as changed | CHRN information must be updated as changed |