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.
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.
For more information, please refer to the link below.
MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf
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