Swiss Authorized Representative Deadline: Class IIa and IIb non-implantable devices

Class IIb non-implantable and Class IIa device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

This is noted in the Swiss Medical Device Ordinance, Article 104a:

“If the manufacturer is domiciled in an EU or EEA state or if the manufacturer has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must, for all devices placed on the market after 26 May 2021, designate an authorised representative in accordance with Article 51 paragraph 1 within the following time periods: a. for class III devices, class IIb implantable devices and active implantable devices: by 31 December 2021; b. for non-implantable class IIb devices and class IIa devices: by 31 March 2022; c. for class I devices: by 31 July 2022. For systems and procedure packs, an authorised representative in accordance with Article 51 paragraph 5 must be appointed by 31 July 2022.“

Labeling Requirements:

• MDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device
• MDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label or in the instructions for use
• AIMDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use or in a document accompanying the device
• AIMDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use
• MDR devices (all): on the label as of the Swiss AR (“CH-REP”) appointment and Swiss marketing date

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