When Will FDA-Approved Medical Devices Be Available to Patients in Switzerland?

A Question That Could Change Lives - An analysis of the Swiss Federal Council's regulatory course and its practical implications for patient care and innovation.

Switzerland stands at a turning point in healthcare. The central question is: When will Swiss patients be able to benefit from medical devices that are already approved in the USA - but not (yet) available in Europe?

For years, experts have watched with concern as Switzerland has increasingly disconnected from innovative technologies due to the absence of an agreement with the EU (MRA). Heart implants, robot-assisted surgical systems, digital diagnostics - many of these devices are first used in the USA. This is due in part to FDA approval, which is often quicker and more innovation-friendly than the European CE procedure.

With the Federal Council's decision of April 30, 2025, a regulatory course correction has been initiated: Switzerland wants to approve FDA-authorized products in the future - through an independent process. But how quickly can such a system shift be implemented? And when will it be noticeable for patients?

A Historic Decision With Far-Reaching Implications

Motion 20.3211, the basis for the Federal Council's action, was submitted as early as 2020 - in response to the uncertainties following the expiration of the MRA in the field of medical technology. Its implementation amounts to nothing less than the establishment of an independent market access pathway for medical devices approved by the U.S. FDA.

This is new: until now, Switzerland strictly followed EU certification. The new approach would create an alternative approval route - initially for specific risk classes, and potentially broader later.

The decision is highly significant: it promises better access to innovative products and regulatory sovereignty. At the same time, it demands a systemic transformation - legally, technically, and organizationally.

The Planned System: Recognition With Conditions

At the heart of the new model is the concept of 'Regulatory Reliance'. FDA approval is not simply accepted automatically but reviewed through a structured short procedure. In the future, not only government bodies but also private conformity assessment bodies (CABs), accredited by Swissmedic, will be responsible.

These CABs are to check FDA dossiers for compliance with Swiss standards - for example in product safety, post-market surveillance, or technical documentation.

Swissmedic will remain the supervisory authority, responsible for monitoring CABs, market controls, and handling incidents. The system is thus a hybrid of state control and private implementation.

The Timeline: From Draft to Availability

The path to practical application is long. After publishing the guidelines, a draft regulation must now be prepared. This is expected to be submitted for public consultation (Vernehmlassung) by the end of 2025 - allowing associations, experts, and cantons to provide input.

Depending on the feedback received, the draft may need revision before the Federal Council can adopt it. The earliest the regulation could come into force is late summer or fall 2026.

Yet even with a valid regulation, access to FDA products will not be immediate. CABs must first be accredited by the Swiss Accreditation Service (SAS) - a process that may take another nine to twelve months. Only then can manufacturers submit their products for review.

Realistically compiling all stages leads to this picture: initial practical availability of FDA-approved medical devices for patients is not expected before the first half of 2028.

Why 2028 Is Realistic

This forecast is based not only on legislative experience in Switzerland but also on international projects. In the UK, implementing a comparable system (MHRA's 'International Recognition') took around 18 months.

Additionally, Switzerland's regulatory system is known for its thoroughness. Every step - from legal drafting to CAB accreditation and reimbursement integration - requires time and resources.

Swissmedic faces a major challenge: coordinating a new approval model while continuing its existing tasks, such as MDR market monitoring. Clinics, hospitals, and insurers must also align their processes with the new products.

Political Context: Opportunities and Risks

The opening to FDA products doesn't occur in a vacuum. Switzerland is simultaneously negotiating a new bilateral agreement with the EU. Critics fear that this solo effort in the medical field could strain relations with Brussels - especially if FDA alternatives displace CE-marked products.

The Federal Council has emphasized that the new procedure is not meant to replace EU approval, but to complement it - as a pragmatic response to supply gaps. Whether the EU will accept this rationale remains to be seen. Political resistance from Brussels cannot be ruled out, but currently seems unlikely.

Industry Must Step Up

While political negotiations continue, the responsibility now lies with industry. Those seeking to bring FDA products to Switzerland must prepare early: dossiers must comply with both FDA and Swissmedic standards, labeling must be adapted, and post-market data must be ready.

Early dialogue with future CABs should begin now. Only those involved from the start will be among the first manufacturers to have their products approved under the new system - and gain access to the Swiss market.

Payers and HTA committees must also prepare to evaluate new technologies more rapidly and integrate them into reimbursement schemes. Without financial viability, regulatory access alone won't suffice.

What's at Stake

The significance of this regulatory step can hardly be overstated. It's not just a technical issue - it's about innovation access, patient safety, and Switzerland's international competitiveness in healthcare.

Supply shortages experienced in recent years with heart implants or in-vitro diagnostics could be avoided with FDA access. At the same time, Switzerland would become more independent from the often overburdened EU approval structure.

However, all of this hinges on decisive yet careful implementation. The Federal Council has set the course - now it's up to regulators, industry, and the expert community to follow through.

Conclusion: 2028 Is Realistic - and Pivotal

Ralph Nowak, Partner at Winterberg Group AG, summarizes: "After thorough analysis of the regulatory roadmap, international comparison data, and involved processes, the conclusion is clear and well-founded: initial market access can be expected in the first half of 2028."

Fabian Kroeher, Partner at Winterberg Group AG, adds: "This timeline is realistic, though ambitious. It requires that political processes are not blocked, that Swissmedic accredits CABs quickly, and that manufacturers are ready to submit their dossiers promptly. A launch before the end of 2027 is conceivable - but only under optimal conditions. Delays until 2029 are possible if political or technical hurdles arise."

For Switzerland, 2028 is thus a target year of major significance. If the opening to FDA products succeeds, it could not only close supply gaps but also serve as a model for other small, innovation-friendly countries.

Ralph Nowak
Winterberg Group AG
Baarerstrasse 43
6300 Zug, Switzerland

Presscontact: Kaja Funke
kaja.funke@winterberg.group

A rapidly evolving world offers huge opportunities, but also poses significant challenges for today's wealth creators: economic uncertainty, increasing regulation, erosion of the right to privacy and public pressure to contribute more to society. In this environment, never has there been a greater need to protect wealth and manage family succession to ensure a lasting legacy. Winterberg Group is a multi-family office investment firm established and operated by a team of experienced investment and strategy consulting professionals.

This release was published on openPR.