Team NB MDR Clinical Evaluation Review Training: 27 Aug 2025 EU Afternoon, US Early Morning
17 April 2025
April “In All Other News”: Master UDI-DI Effective Date Postponed, IVD Q&A Progress, and More
2 May 2025Background
In November 2022, Swiss Parliament voted to support the recognition of US FDA medical devices, in addition to CE Marked devices: HERE
This initiative, introduced as Motion 20.3211 by Damian Müller (a member of the Council of States), was driven by two main factors:
- The lapse of the Mutual Recognition Agreement between Switzerland and the EU, resulting in added trade and regulatory barriers.
- Increased challenges manufacturers face in obtaining CE Marking under the EU MDR/IVDR.
Since the vote 2.5 years ago, public updates have been limited. However, Swiss MedTech continued its lobbying efforts in support of recognizing FDA-cleared or -approved devices.
Today’s Announcement
The Swiss Federal Council has now provided an update, available: HERE
Key Highlights:
- A working group was formed to explore how the motion could be implemented.
- The group examined regulatory differences between the Swiss and US systems.
- A proposal was submitted regarding how to enable access for FDA-authorized devices.
- Considerations include data protection, quality management systems, post-market surveillance, and potentially clinical evidence requirements.
- The proposal does not support automatic recognition of FDA-authorized devices. Instead, it recommends an independent assessment by a third party prior to market access.
- This mirrors the approach by the UK MHRA under its upcoming International Reliance procedure. The MHRA will similarly require an abridged review by a UK Approved Body.
In summary
Switzerland is taking steps to allow certain FDA-cleared or -approved devices onto its market — not through automatic recognition, but via a controlled, third-party assessment pathway. This potentially expands market access beyond CE marking, albeit with some additional regulatory oversight.
Additional Context
Swissmedic was recently accepted as a member of the IMDRF Management Committee. The IMDRF has recently stressed the importance of international reliance. For example, the March 2025 IMDRF meeting in Tokyo highlighted this as a key theme. Further, the UK MHRA (also active in the IMDRF), is advancing its own International Reliance program, which similarly seeks to streamline access for trusted foreign-authorized devices.
Next Steps
The Federal Council has tasked the Federal Department of Home Affairs (FDHA), in cooperation with the Federal Department of Economic Affairs, Education and Research (EAER), and the Federal Department of Foreign Affairs (FDFA), to further examine the feasibility and implementation of the proposal.
Casus will continue to report as updates occur, as it has been doing since this topic was first introduced in 2022.
