What is a CHRN (Swiss Single Registration Number)?
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January 15, 2022
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- What is a Swiss Single Registration Number (CHRN)?
- Why is a CHRN Needed?
- Is a CHRN Mandatory or Voluntary?
- Who Needs a CHRN?
- How Do I Obtain a CHRN?
- What is the Deadline to Obtain a CHRN?
- How Long Does it Take to Get a CHRN?
- What is the Fee for a CHRN?
- How Long is the CHRN Valid?
- Recap: Differences Between a Swiss CHRN & EU SRN
What is a Swiss Single Registration Number (CHRN)?
The CHRN is Switzerland’s version of the EUDAMED Single Registration Number (SRN).
Why is a CHRN Needed?
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.
Further, Swissmedic is developing its own EUDAMED-like registration database, called Swissdamed.
It will consist of two registration modules:
- Economic Operators
- Medical Devices
It will launch in phases through 2023-2024.
For more information, please read: Swiss Registration Database (Swissdamed)
Is a CHRN Mandatory or Voluntary?
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 EUDAMED is fully functional. Full functionality is currently projected to be Q2 2024 and then followed by a six-month transition period for the Actor, Vigilance, Clinical Investigation & Performance Studies and Post-market Surveillance modules, after which its use will be mandatory. Another 18-month transition period is granted for the UDI/Device and Notified Body & Certificates modules.
A CHRN is required for economic operators of both MDR/IVDR CE marked devices and legacy devices CE marked to the old Directives.
Who Needs a CHRN?
The following need a CHRN:
- Only four types of organizations require a CHRN: Manufacturers, System/Procedure Pack Producers, Authorized Representatives and Importers.
- Only companies located in Switzerland require a CHRN. For example, a manufacturer located in Germany or Canada, does not need, and cannot get, a CHRN. This is different from Europe, which requires an SRN for all manufacturers, irrespective of where they are located. Instead, the foreign manufacturer’s Swiss Authorized Representative (AR) and Importer must obtain 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.
How Do I Obtain a CHRN?
Swiss Manufacturers, Authorized Representatives (AR) and Importers must submit an application to Swissmedic.
(1) Complete application: BW630_11_001 defi_FO_Antrag_Registrierung_CHRN
- The language can be changed by clicking on the flag at the top left
(2) Email [email protected] and attach the following:
- Completed application form – do not send a scanned or hard copy of the form or it will be rejected
- Commercial registry (proof of operation in Switzerland)
- Authorized Representatives only: Mandate form with the manufacturer and AR’s details
(3) Swissmedic will review the application, and barring any questions, send a letter confirming the CHRN by post
(4) Swissmedic will send the invoice after the CHRN has been processed
What is the Deadline to Obtain a CHRN?
Swiss Manufacturers, Authorized Representatives and Importers must obtain a CHRN within three months of placing their first product on the Swiss market.
How Long Does it Take to Get a CHRN?
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”.
What is the Fee for a CHRN?
Swissmedic charges an hourly fee of CHF 200 to process CHRN requests. Swissmedic advised that most applications are processed in one hour, unless there are questions or findings made.
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.
How Long is the CHRN Valid?
CHRNs do not expire. However, Swissmedic must be notified of changes within one week.
The types of changes that must be notified include:
- Details of the economic operator
- Change to the Swiss Economic Operator’s Person Responsible for Regulatory Compliance (PRRC)
- Contact details for the organization
- Update to invoice address
Change notifications should be made to [email protected] and the following form attached: BW630_12_002defi_FO Notification of information changes
Note about the Mutual Recognition Agreement
A CHRN is required for as long as there is no MRA for medical devices between Switzerland and the EU. If the lapsed MRA is eventually resolved, then presumably manufacturers will either have their information rolled into EUDAMED by Swissmedic, or more likely, be required to re-register in EUDAMED and obtain an EU SRN.
Recap: Differences Between a Swiss CHRN & EU SRN
| EUDAMED SRN | Swiss CHRN |
|---|---|
| Voluntary until Q2 2027 | Mandatory within three months of placing a new device onto the Swiss market |
| SRN can be obtained by both medical devices and IVDs with MDD/AIMDD/IVDD/MDR/IVDR CE Marking | CHRN currently only applicable to medical devices with MDD/AIMD/MDR CE Marking |
| 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 emailed to Swissmedic |
| 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 reivew & 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 Mandate to Swissmedic, 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 | No renewal verification needed for the CHRN |
| SRN information must be updated as changed | CHRN information must be updated as changed |
