Switzerland Explores Importing U.S. FDA-Approved Medical Devices Amidst EU Market Access Challenges

Switzerland explores importing U.S. FDA-approved Medical Devices amidst EU Market access challenges and regulatory implementation concerns. The entry delivers a forecast for the impact on Medical Device manufacturers.

# Background

Ever since the inception of the Mutual Recognition Agreement between the European Union (EU) and Switzerland in July 2002, Switzerland has consistently aligned with the principles of the New Legislative Framework (NLF) approach. This methodology, devised by the EU, is designed to enhance the internal market for goods and fortify the prerequisites for introducing a diverse array of products into the EU market. This encompasses the evaluation of medical devices' adherence to stringent safety and health preservation criteria before their circulation and placement within the European Single Market. At present, Switzerland exclusively accepts medical devices for domestic distribution that not only adhere to but also have been officially certified under the European Medical Devices Regulation (EU) 2017/745 (MDR), which signifies the presence of the EU CE mark on these medical devices.

Nonetheless, the updated European Medical Devices Regulation (MDR), which came into force on May 26, 2021, mandates the (re)certification of all medical devices, encompassing both existing and new products, according to the new regulatory framework. The implementation of the revised MDR has encountered significant challenges, primarily due to the scarcity of authorized notified bodies—private institutions responsible for assessing medical device conformity with the MDR—and a notable escalation in technical and administrative prerequisites. As a result, medical device manufacturers have substantially curtailed their product portfolios, resulting in a detrimental impact on the availability of medical devices in Switzerland. This impact has been amplified by Swiss legislation stipulating that foreign medical device manufacturers must meet requirements surpassing those outlined in the revised MDR. This includes the obligation to appoint an (additional) Swiss-Authorized Representative (CH-REP), an individual or legal entity based in Switzerland authorized to act on behalf of a foreign manufacturer, as per Swiss regulations.

Historically, healthcare providers and patients within Switzerland exclusively had access to medical devices endorsed by an EU certification. Following the decision by both the Council of States and the National Council, a motion has been sanctioned, granting Switzerland the capability to recognize medical devices sanctioned by the FDA. Swiss Medtech expresses appreciation for the directives presented by the Parliament to the Federal Council, urging the alignment of domestic legislation in accordance with these developments.

Anticipations indicate that as the MDR's transitional period concludes, no later than 2024, the cumulative effect of these supplementary demands could significantly imperil the medical device supply within the Swiss market, thereby jeopardizing the provision of medical treatment to Swiss patients.

As a consequence of the fresh regulatory challenges arising from the implementation of the MDR, a growing number of Swiss startups and small to medium-sized enterprises are opting to seek initial approval for their medical devices from the FDA. This trend is poised to result in the expansion of innovative Swiss products into international markets, while regrettably withholding these advancements from Swiss patients.

The conclusive consideration and endorsement of the motion put forth by Councilor of States Damian Müller (20.3211), titled "Enhancing Flexibility in Acquiring Medical Devices for Meeting the Needs of the Swiss Population," by the National Council has directed the Federal Council to modify domestic regulations. Consequently, medical devices that have obtained approval from the U.S. Food & Drug Administration (FDA) will be acknowledged within Switzerland's regulatory framework. The conclusive consideration and endorsement of the motion put forth by Councilor of States Damian Müller (20.3211), titled "Enhancing Flexibility in Acquiring Medical Devices for Meeting the Needs of the Swiss Population," by the National Council has directed the Federal Council to modify domestic regulations. Consequently, medical devices that have obtained approval from the U.S. Food & Drug Administration (FDA) will be acknowledged within Switzerland's regulatory framework.

"We highly appreciate the significant and visionary choice made by the policymakers," states Peter Biedermann, Managing Director of Swiss Medtech. "This decision reflects a response to circumstances that have become impossible to disregard. More precisely, the challenges related to the execution of the recent European medical device regulation and the adverse outcomes impacting the accessibility, assortment, and caliber of medical devices across Europe. Given that novel advancements are progressively being unveiled initially in the U.S. market, the introduction of new products to Europe is inevitably delayed at best", Biedermann articulates.

# Understanding Switzerland's Shift: The Rationale Behind Embracing FDA Device Imports

Practically, Switzerland has joined a cohort of nations that have broadened their regulatory permissions for medical devices to ensure the uninterrupted provision of healthcare to their populations. As indicated by the Swiss Medical Technology Association (Swiss Medtech), the implementation of these novel regulations will furnish greater flexibility when it comes to sourcing medical devices and in vitro diagnostic (IVD) products for Swiss patients. Industry manufacturers, Notified Bodies, and healthcare providers have collectively observed escalating obstacles arising from the enactment of the European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Anticipated challenges encompass limitations in Notified Body capacity to accommodate new clients and more stringent regulatory prerequisites, both of which are projected to culminate in shortages of devices possessing valid CE certification.

Swiss Medtech emphasizes that in Switzerland, the circumstance is exacerbated by the enhanced provisions of the revised domestic medical device ordinance, which introduces more stringent barriers to imports. The organization highlights that among the 5,000 foreign medical device manufacturers, over 1,000 have opted to discontinue their operations within Switzerland due to complexities related to market access.

Advocates contend that by permitting entry of products into the Swiss market that have previously undergone scrutiny in the United States, manufacturers will encounter streamlined access to the Swiss market. Simultaneously, the public can place trust in the safety and effectiveness of these products, which have undergone evaluation by U.S. regulatory authorities.

The extent of the acknowledgment and whether it will encompass all FDA approvals, clearances, and authorizations for medical devices remains unspecified. Manufacturers whose medical devices fall under FDA regulation are recommended to vigilantly track the progress of Swiss legislative proceedings. This vigilance is essential to ensure their readiness to furnish the Swiss market with their products promptly and efficiently.

# Implications for Manufacturers Solely Holding CE Certification Amidst These Developments

Minding the perspective of medical device manufacturers, the situation should be closely monitored, and the insights should be translated into the management approach of the medical device and its lifecycle. The opening of other countries to similar exceptions will reduce the competitiveness of CE-only medical device producers. This should also serve as a lesson for legislators and notified bodies in terms of streamlining requirements and effective (resource) planning when faced with realistic execution. Manufacturers solely operating under CE certifications should conduct a qualifying study and a commercial risk analysis associated with not pursuing the path of additional FDA certification, aiming to enhance the competitiveness of their products in the face of a hypothetical influx of American-origin equipment into the European market.