On November 28, 2022, the Swiss Parliament reached a key decision by instructing the Swiss Federal Council to adapt national laws to enable Switzerland to accept medical devices with FDA approval.
The reasoning behind the vote is to ensure the availability and sustainable supply of medical devices for the Swiss population. This decision came after the country ended its Mutual Recognition Agreement for medical devices and IVDs with the European Union in May 2021.
CE marked and FDA approved medical devices on the Swiss market
At the moment, Switzerland is still recognizing EU CE Marked devices, although with the additional requirement to appoint a Swiss Authorized Representative. However, the Parliament expressed its concerns over potential shortages of high-quality medical devices and has now decided to open up the Swiss market also to US Food & Drug Administration (FDA) approved medical devices.
The decision has been positively received by Swiss Medtech, whose Managing Director Peter Biedermann has defined this action as “important” and “forward-thinking.” While Sandra Rickenbacher, member of Swiss Medtech’s Management Board, has further underlined the importance that “the motion is implemented quickly and pragmatically”.
It is now up to the Swiss Federal Council to adapt the Swiss legislation to implement the motion and elaborate the technicalities.
Obelis Swiss will carefully follow the next developments, stay tuned for further updates!
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Regulatory Affairs Department
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