Swiss Authorized Representative Appointment Deadline: Class D IVDs

Class D IVD device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

This is noted in the Swiss IVD Ordinance, Article 86:

“If the manufacturer is domiciled in an EU or EEA state or has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must designate an authorised representative in accordance with Article 44 paragraph 1 for all devices placed on the market as from 26 May 2022 within the following time periods: a. for class D devices: by 31 December 2022; b. for class B and C devices: by 31 March 2023; c. for class A devices: by 31 July 2023.“

Labeling Requirements:

• IVDD already marketed in Switzerland before 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device
• IVDD newly marketed in Switzerland after 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use
• IVDR not intended for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device
• IVDR devices for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label

For more information, please see Swissmedic’s Info Sheet Obligations for Economic Operators.