Role of the Swiss Authorized Representative (CH-REP)
Switzerland and the EU no longer have a valid Mutual Recognition Agreement for medical devices. As a result, an EU Authorized Representative is no longer recognized in Switzerland. Instead, Swissmedic requires its own version of an EU Authorized Representative – a Swiss Authorized Representative (AR). The Swiss AR is also referred to as a ‘CH REP’.
The Swiss Authorized Representative is responsible for 1) verifying you have CE marked your device, 2) reporting vigilance on the manufacturer’s behalf (serious incidents and FSCAs), and 3) acting as the point of contact between you and Swissmedic when needed.
NOTE: Due to a customs treaty, Liechtenstein-based companies may act as Swiss Authorised Representatives. Further, manufacturers and importers in Liechtenstein are exempt from having to appoint a Swiss AR, though they must meet other obligations, such as obtaining a Swiss Single Registration Number (CHRN).
What are the obligations of the Swiss AR?
- Maintain a registered place of business in Switzerland or Liechtenstein
- Puts the Swiss Mandate in place for each manufacturer they represent
- Appoint a Person Responsible for Regulatory Compliance (PRRC)
- Ensure manufacturer has carried out the appropriate conformity assessment process and drawn up the relevant technical documentation
- Have access to the technical documentation in case of a request from Swissmedic
- Be the point of contact between the manufacturer and Swissmedic, where required to do so
- Support with vigilance, including notifying manufacturers of any complaints or reported events and coordination of vigilance reporting to Swissmedic*
*This requirement to report vigilance (serious incidents, FSCAs) is imposed onto the Swiss Authorized Representative. This is different from Europe; it is not the EU Authorized Representative’s responsibility to report vigilance on the manufacturer’s behalf.
When is the deadline to appoint a Swiss AR?
Swissmedic provided the below transition period to appoint a Swiss AR, which has now ended:
- Class IIb implantable, Class III, and AIMD – 31 December 2021
- Class IIb non-implantable, Class IIa – 31 March 2022
- Class I, systems and procedure packs – 31 July 2022
- Class D IVDs – 31 December 2022
- Class C, B IVDs – 31 March 2023
- Class A IVDs – 31 July 2023
The transition period only applied to manufacturers with products already marketed in the European Economic Area ( EEA ) prior to the MDR/IVDR dates of application. Manufacturers new to the EU/Swiss markets were required to appoint a CH-REP immediately.
The requirement to appoint a Swiss Authorized Representative applies to both MDD/AIMDD/IVDD legacy devices and MDR/IVDR CE Marked devices.
Why Should You Choose Casus?
As experts in navigating the European, Swiss and UK markets, we get your products to market quickly with our streamlined process
Our client onboarding is one of the fastest on the market – days compared to the weeks and months quoted by other providers. And our high-quality project management means you can be confident about the results.
We are transparent and fair – no hidden costs that you learn about too late, and no increased Swiss AR service fee if you add products later. Instead, you can expect straightforward, professional service from our knowledgeable team.
Does the Swiss AR need to be on the labeling?
Yes. The Swiss Authorised Representative is required on the device labeling (or document accompanying the device, for certain products).
Swissmedic has released a CH-REP symbol for use, similar in design as the EC-REP symbol. No minimum size has been defined, other than that it must be clearly legible to the naked eye. The CH-REP logo is available in various formats.
To download the CH-REP symbol, click here and then scroll to the bottom of the Swissmedic webpage.
The requirement on where to place the AR information on the label depends on EU Directive/Regulation leveraged.
For more information, please read: Labeling Requirements for the EU, UK and Switzerland In-Country Representative
Will the Swiss AR register my device(s) with Swissmedic?
Swissmedic only requires device registration for certain devices manufactured by Swiss manufacturers, such as Class I medical devices and IVDs. Non-Swiss manufacturers do not, and should not, register their devices* with Swissmedic.
NOTE: Swissmedic is in the process of developing a new registration database, which will be similar to the European Database on Medical Devices (EUDAMED). It is called Swissdamed and is expected to launch in 2023. Once the Swiss Medical Device and IVD Ordinances are updated accordingly, devices should be registered in Swissdamed.
For more information on Swissdamed, please read: Swiss Registration Database (Swissdamed)
For more information on the current registration process, please read: Swiss Medical Device & IVD Registration
*The exception is for custom-made devices, which should be registered irrespective of where the manufacturer is located.