In a landmark move, the Swiss Federal Council has decided to recognize approvals from the U.S. Food and Drug Administration (FDA), ensuring continued patient access in Switzerland.
This decision is a strategic response to growing shortages of essential medical technologies since the expiration of the Mutual Recognition Agreement (MRA) with the EU. By acknowledging FDA-approved / cleared devices — particularly in cases of unmet patients’ needs — Switzerland aims to diversify its regulatory pathways and reduce dependence on EU approvals.
With this decision, Switzerland will become the first European country to formally accept FDA approval / clearence as a basis for market access — a bold step that could reshape regulatory thinking across Europe.
Here is the press release of the Swiss government and Swiss Medtech official statement.
🔜 Next Steps
The Federal Council has tasked the Federal Department of Home Affairs (FDHA), in cooperation with the Federal Departments of Economic Affairs (EAER) and Foreign Affairs (FDFA), to further develop and operationalize this new regulatory pathway.
We will be closely monitoring these developments and keep you informed as concrete measures and timelines are introduced.
