Background

In November 2022, Swiss Parliament voted to accept US FDA devices in Switzerland, on an equal basis as European CE Marking. As a result, the Swiss Federal Council was instructed to adapt the medical device/IVD legislation to reflect this decision.

This was in opposition to the Swiss Federal Council’s June 2022 press release, which stated that US FDA devices were not required to ensure the supply of medical devices on the Swiss market.  

Since then, Swiss MedTech has published two reports on how and why Parliament’s vote should be implemented and continued its lobbying efforts.

Overview

Swiss MedTech published an update on the status to Motion 20.3211: HERE

“25 September 2024 – Information for the industry

Once a motion has been accepted, the authorities generally have two years to develop a solution (in our case until November 2024). Swiss Medtech participated in the technical discussion meetings on behalf of the Swiss industry. The FOPH [Federal Office of Public Health] is now in the process of drafting a solution that it can submit to the Federal Council. Following the Federal Council’s decision, the FOPH will reformulate the decision into a legal text and initiate a revision of the MedDO/IvDO [Medical Device Ordinance/IVD Ordinance] and/or the TPA [Therapeutic Products Act]. This will take some time.”

High-level: the initiative is still “in play”, with a solution to be presented to the Federal Council for review.

Casus will continue to closely monitor progress.

NEW UPDATE: 30 April 2025

The above was originally published in September 2024. Since then, the Swiss Federal Council has published a long-awaited update on the proposal to allow FDA-authorized medical devices in Switzerland.

For the most current information, please read: Swiss Federal Council Taking Steps to Allow US FDA Devices in Switzerland