Class III/AIMD and Class IIb implantable device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

MDR: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 July 2023. Starting 1 August 2023, the CH-REP must be identified on the label.

MDR devices already on the Swiss market before 26 May 2022 have until 31 December 2021 to appoint and identify the CH-REP. MDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP. 

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. The deadline to appoint and identify the CH-REP is by 31 December 2021.

MDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

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. The deadline to appoint and identify the CH-REP is by 31 December 2021.

AIMDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland.