Swiss Authorized Representative for Medical Devices (CH-REP)
The EU Commission and the Swiss Federal Council were unable to come to terms and update the Mutual Recognition Agreement (MRA) to include the MDR / IVDR . As a result, compliance with medical device requirements in the EU, no longer constitutes compliance in Switzerland.
Swissmedic, the competent authority in Switzerland, implemented several additional requirements for medical device manufacturers, including the need to appoint a Swiss Authorized Representative (AR), also referred to as a CH-REP.
Swiss Authorized Representative’s responsibilities
The responsibilities of the Swiss Authorized Representative (AR) are similar to the responsibilities of the European AR. 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.
The obligations of the Swiss AR include:
Maintain a registered place of business in Switzerland
Submit mandates to formally notify Swissmedic of 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. Note that if your device is IVDD CE marked, then the above still applies. The AR appointment date will be 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.
NOTE: Due to a customs treaty between Switzerland and Liechtenstein, a manufacturer located in Liechtenstein is not required to appoint a Swiss AR.
Does the Swiss AR need to be on the device 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?
Swiss-based manufacturers must register certain devices with Swissmedic, such as Class I devices and IVDs. However, Swiss Authorized Representatives are not required to notify devices on behalf of non-Swiss manufacturers, other than custom-made devices.