Information from Swiss Medtech on placing on the market

During the shift from MDD to MDR, MDD-compliant devices can only be introduced into the Swiss market until a specified date. Consequently, there’s a potential scenario where certain products currently stocked in Swiss warehouses may become unsellable on May 27, 2024. To mitigate this risk, Swiss Medtech has developed a guidance document.

Any medical devices not transitioned to comply with MDR regulations may no longer be permitted for sale in Switzerland after May 26, 2024.

The purpose of this guidance is to offer clarity regarding the regulatory standards governing the introduction of medical devices into the Swiss market. It offers general insights into the terms and criteria for “placing on the market” in Switzerland. During the transition from MDD to MDR, the placement of MDD-compliant devices in the Swiss market is restricted up to a specified date, which varies depending on factors such as the device class, current certification status, and actions taken by the manufacturer.

This guidance presents various options for introducing medical devices into the Swiss market, ensuring that no fully compliant devices in stock need to be discarded and thereby preventing shortages of medical devices without compromising existing quality or safety standards. For information on the responsibilities of importers/distributors and compliance requirements, please refer to Swissmedic’s guideline MU600_00_016e_MB.

This resource outlines available avenues for placing medical devices on the Swiss market, ensuring that compliant devices in your inventory need not be discarded.