In November 2022, the Swiss Federal Assembly voted to approve Motion 20.3211 (link in French), which mandated the Swiss Federal Council to adopt regulations to allow medical devices authorized by non-European regulators — namely, the United States (U.S.) Food and Drug Administration (FDA) — to enter the Swiss market. At its meeting on April 30, 2025, the Federal Council defined guidelines for implementing this motion and assigning responsibility for review to private conformity assessment bodies (CABs) under a simplified conformity assessment procedure.
Swiss MedTech details (website) developments dating back to the initial submission of the motion (May 4, 2020).
Switzerland Continues Efforts to Recognize Non-European Regulatory Authorizations Emergo by UL
Switzerland Continues Efforts to Recognize Non-European Regulatory Authorizations
The Swiss Federal Assembly voted to approve Motion 20.3211, which mandated the Swiss Federal Council to adopt regulations to allow medical devices authorized by non-European regulators to enter the Swiss market.
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