New Swissmedic Class 1 MDR Device Labeling Requirements

The Swissmedic guidance mandates the inclusion of CH-REP (Swiss Responsible Person) information on the labels of Class I MDR devices starting from 31st July 2023. (full legal text: New transitional provisions (swissmedic.ch)).

The inclusion of CH-REP information on the labels of Class I MDR devices is now mandatory as per the guidelines provided by Swissmedic. This regulation aims to ensure transparency and accountability in the Swiss market and strengthen the post-market surveillance of medical devices.