Swiss-EU MRA Lapses for IVDs
11 May 2023Swiss AR Deadline: Class D IVDs
11 May 2023Class I 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 2021 have until 31 July 2022 to appoint and identify the CH-REP. MDR devices newly placed onto the market after 26 May 2021 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 July 2022.
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.