30 April 2025 – To ensure adequate supplies of medical devices and guarantee patient safety, the Federal Council defined guidelines and intends to assign responsibility for reviewing the conditions for devices already authorised by the US Food and Drug Administration (FDA) in the US to private bodies. These bodies will review the relevant conditions under a simplified conformity assessment procedure, considering elements already performed by the FDA.

This is a result of the ongoing efforts to implement Motion 20.3211 brought by Damian Müller, a member of the Council of States, which is aimed at opening the possibility for medical devices from non-European regulatory systems to be placed on the Swiss market. Currently, only devices with a declaration of conformity issued in accordance with Swiss or EU legislation are recognised in Switzerland. A working group comprising representatives of the Federal Office of Public Health (FOPH), Swissmedic, the State Secretariat for Economic Affairs, and the Europe Division of the State Secretariat of the Federal Department of Foreign Affairs has proposed conditions for the introduction of devices authorised by the FDA. These involve compliance with Swiss legal requirements concerning data protection or a quality management system.

The Federal Council has requested the Federal Department of Home Affairs (FDHA), in collaboration with the Federal Department of Economic Affairs, Education and Research (EAER) as well as the Federal Department of Foreign Affairs (FDFA), to explore this approach in detail.

For more information, see here.