‘swissdamed’ Actor Registration Module
11 May 2023UDI Carrier: Class IIb/IIa and IVD Class D
11 May 2023Class B and C IVD device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.
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 until 31 March 2025. Starting 1 April 2025, the CH-REP must be identified on the label.
IVDR devices already on the Swiss market before 26 May 2022 have until 31 March 2023 to appoint and add the CH-REP to the labeling. IVDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP on the label.
IVDR intended for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label. IVDR devices already on the Swiss market before 26 May 2022 have until 31 December 2022 to appoint and add the CH-REP to the labeling. IVDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP on the label.
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. The deadline to appoint and identify the CH-REP is by 31 March 2023.
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. The deadline is as soon as the manufacturer begins marking the device in Switzerland.