Switzerland Outlines Timeline for Reliance on US FDA Medical Device Authorizations

Background

Although Switzerland is not a member of the European Union (EU), it recognizes medical devices and in vitro diagnostic medical devices (IVDs) that comply with EU legislation for access to the Swiss market. 

Over the past several years, Switzerland has been working on legislation to enable market access for medical devices authorized by other third-country regulators, such as the U.S. Food and Drug Administration (FDA). These efforts have centered on Motion 20.3211, which tasked the Swiss Federal Council with adapting regulations to allow such devices, particularly those authorized by the FDA, to enter the Swiss market.

When we last reported on this initiative, a working group had proposed conditions for the introduction of FDA-authorized devices on the Swiss market, and the Federal Council tasked several federal departments with further exploration of the proposal. More than a year later, the Federal Council has provided an update on its efforts to enable reliance on FDA authorizations.

Switzerland declares intent to facilitate reliance on FDA-authorized devices

Following a November 2025 joint statement between Switzerland and the U.S. aimed at stabilizing bilateral trade relations, the Federal Council published a declaration outlining how it intends to implement its commitments. 

Among other trade-related measures, the declaration states Switzerland’s intent to facilitate the acceptance on the Swiss market of medical devices cleared or approved by the FDA. The Federal Council intends to modify the relevant ordinances by the third quarter of 2027, providing a clearer indication of the anticipated time frame for these efforts.

The declaration also includes a statement of Switzerland’s intent to “ensure that US conformity assessment bodies are treated no less favorably than its own.”

What will this reliance pathway look like?

While publicly available information remains limited, the Federal Council’s press release from April 2025 provides some insight into the potential approach. At the time, the Federal Council intended to have Swiss conformity assessment bodies (CABs) carry out a simplified conformity assessment procedure on the documentation of FDA-authorized devices. Proposed conditions included compliance with Swiss legal requirements for data protection and quality management systems, the establishment of a post-marketing surveillance plan, and potential requirements for clinical evidence. Switzerland’s intent is to make the CAB review complementary to, rather than duplicative of, existing FDA reviews and assessments.

The Swiss Federal Office of Public Health is also conducting an impact analysis regarding provisions for placing FDA-authorized devices on the Swiss market, which is scheduled to conclude on Dec. 31, 2026. 

Concluding remarks

Switzerland’s latest declaration represents another step toward establishing a regulatory reliance mechanism for FDA-authorized medical devices. Although FDA authorizations are not currently acknowledged for Swiss market access and the specific requirements and conditions remain under development, the stated intent to amend the relevant ordinances by the third quarter of 2027 provides a clearer indication of Switzerland’s intended direction and time frame. 

The initiative also reflects a broader trend toward regulatory reliance, as seen in the United Kingdom, Brazil and elsewhere.

Emergo by UL will continue to monitor developments in Switzerland and globally, as jurisdictions continue to explore regulatory reliance pathways for medical devices.