Swissmedic published additional updates regarding the Swiss Single Registration Number (CHRN) and device registration requirements.
The Swiss Single Registration Number (CHRN) is comparable to the European Single Registration Number (SRN). After the Mutual Recognition Agreement (MRA) for medical devices lapsed on 26 May 2021, Switzerland’s access to EUDAMED was removed. Therefore, Switzerland had to quickly find an alternate, equivalent system to identify Swiss Authorized Representatives, manufacturers and importers.
CHRNs are only required for Swiss entities, i.e., non-Swiss manufacturers do not need to obtain a CHRN, but their Swiss Authorized Representatives and Importers must obtain one.
Switzerland is also in the process of addressing the device registration gap, now that they no longer have Competent Authority level access to EUDAMED.
The Update – Swiss Single Registration Number
Swissmedic updated its Information Sheet ‘Unique Identification Number – CHRN’, publishing a revised version on 1 March 2022. While it doesn’t appear much has changed, the document outlines the information in a clearer way.
- CHRNs are required for Swiss-based Manufacturers, Authorized Representatives and Importers only; Distributors do not require a CHRN
- Steps to submit a CHRN application
- How to submit change notifications; Specifies that changes must be notified to Swissmedic within one week
- CHRN application fee: “Experience has shown that issuing the CHRN requires one hour of work, which therefore generally corresponds to a fee of CHF 200.”
CHRN requests must be made within three months of first placing a device onto the market and Swissmedic will issue the CHRN within 30 days.
The Update – Swiss Device Registration Database (“Swiss EUDAMED”)
Swissmedic advised the EUDAMED-like requirements for medical device registration are forthcoming, and that they are in the process of designing the database.
Swissmedic updated their medical device database’s webpage to state that they “will communicate a schedule for the introduction of the medical devices database by the middle of this year.”
Further, that the new database will be similar to EUDAMED, “due to continuing aim of equivalence between regulation in Switzerland and the EU.”
Fortunately, economic operators (i.e., Swiss-bsaed manufacturers, authorized representatives and importers) do not need to re-register once the new system goes live. Swissmedic will migrate the data.
In the meantime, industry should follow the current Swiss registration requirements.
The Information Sheet and Swissmedic website continue to indicate their longer-term intent to resolve the discontinuation of the MRA. The Information Sheet states the following, indicating they view the above as temporary measures:
“Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland.”
Pending the Swiss Federal Council and the EU Commission coming to terms and recreating the Single Market for medical devices, manufacturers must continue to comply with Switzerland’s new requirements. This includes appointing a Swiss Authorized Representative if not located in Switzerland, as well as other requirements put into place to address the lapsed MRA.