The deadline to appoint a Swiss Authorized Representative (AR) for Class I devices and System/Procedure Packs is almost here.
Manufacturers of must appoint their Swiss AR by 31 July 2022 in order to continue placing those devices onto the market.
The Swiss AR’s name and address must be identified with the device. Swissmedic has released a ‘CH-REP’ symbol, similar to the EC-REP symbol, for this purpose.
If you have devices in this category and are actively placing them onto the Swiss market, you must comply with the above requirement.
The deadline for higher risk devices has already passed:
- Class IIb implantable/III/AIMD – 31 December 2021
- Class IIa/IIb non-implantable – 31 March 2021
The deadline for IVDs are:
- Class D IVDs – 31 December 2022
- Class C, B IVDs – 31 March 2023
- Class A IVDs – 31 July 2023