Role of the Swiss Authorized Representative (CH-REP)
Manufacturers located outside of Switzerland* must appoint a Swiss Authorized Representative (AR) before they can begin placing their devices in Switzerland. The Swiss AR is also referred to as a ‘CH REP’.
The responsibilities of the Swiss AR are similar to the responsibilities of the European AR. This is because until 2021, a Mutual Recognition Agreement existed between Switzerland and the EU for medical devices and IVDs.
The Swiss medical device regulations (MedDO/IvDO) had been amended to meet the MDR/IVDR, in expectation of resolving the lapsed MRA and eventually returning to the European single market. It therefore references MDR/IVDR Article 11 (Authorised Representative) as the requirements for the Swiss AR to meet.
*NOTE: due to a customs treaty, Switzerland allows Liechtenstein-based companies to act as Swiss Authorized Representatives. Further, manufacturers and importers in Liechtenstein are exempt from having to appoint a Swiss Authorized Representative, 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
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 inquiries, including notifying manufacturers of any complaints or reported events and coordination of vigilance reporting to Swissmedic
When is the deadline to appoint a Swiss AR?
Swissmedic has provided the below transition period to appoint a Swiss AR:
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 applies to manufacturers with products already marketed in the European Economic Area ( EEA ) prior to the MDR/IVDR dates of application.
The requirement to appoint a Swiss AR applies to both IVDD and IVDR CE marked devices. If the device is IVDD CE marked, then the above AR appointment date is based on the device’s eventual new classification under the IVDR.
If a manufacturer does not meet the above criteria, then the Swiss AR must be appointed immediately. In other words, if you are not already established on a EEA market and are newly entering the market, then you must comply with the Swiss AR requirement immediately. The transition period does not apply.
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. At that time, medical devices should be registered.
For more information, please read: Swiss Registration Database (Swissdamed)
*The only exception is for custom-made devices, which should be registered irrespective of where the manufacturer is located.