Switzerland’s MedTech industry has long been a cornerstone of healthcare innovation, generating 24 billion Swiss francs in 2023 and employing over 70,000 people. Swiss distributors of medical devices are key players in this ecosystem, ensuring hospitals and clinics have access to cutting-edge medical products. However, the introduction of the EU Medical Device Regulation (MDR) in 2021, coupled with the discontinuation of Switzerland’s Mutual Recognition Agreement (MRA) with the European Union, has significantly complicated the landscape, placing new burdens on Swiss distributors who must now navigate a tougher regulatory environment.
Ensuring Compliance: The Evolving Role of Swiss Distributors Amid Regulatory Challenges
While Swiss distributors don’t certify products themselves, they are responsible for ensuring that the devices they distribute comply with Swiss regulations set by Swissmedic. Since Switzerland is no longer part of the Mutual Recognition Agreement (MRA) with the EU, manufacturers of MDR-certified products must appoint a Swiss Authorized Representative (CH-REP) to register their products with Swissmedic before selling them in Switzerland. This regulatory step adds complexity, as distributors must coordinate with both manufacturers and CH-REPs to confirm product registration and approval for the Swiss market. According to Fabian Kroeher, Managing Partner at Winterberg Group, this process often results in significant administrative burdens, particularly when manufacturers lack complete data on their portfolio’s registration status in Switzerland. This further complicates the distributor's role in maintaining compliance and ensuring product availability without unnecessary delays.
Ensuring Product Availability: Navigating Delays, Re-certifications and Limited Innovation Access
The introduction of the EU Medical Device Regulation (MDR) has had a significant impact on the portfolios of medical device distributors. Under the MDR, stricter requirements for product certification, post-market surveillance and clinical evaluation have significantly increased the complexity and cost of bringing new medical devices to market. In addition to these challenges, existing products that were previously certified under older regulations must also undergo re-certification to remain available. This dual burden of re-certifying existing products while meeting requirements for new innovations has caused significant delays in product availability. As a result, distributors may face shortages in certain devices or be forced to discontinue offering products that manufacturers opt not to re-certify due to the high costs and regulatory hurdles imposed by the MDR.
The time and cost of MDR compliance have led many manufacturers to prioritize high-margin devices, often at the expense of smaller or niche products. This reduction in product variety limits distributors' access to the full range of devices they previously offered. As a result, they must navigate a more limited and potentially more expensive selection, making it harder to maintain a competitive and comprehensive portfolio that meets healthcare providers' diverse needs.
Increased time and costs of MDR compliance have led many manufacturers to prioritize launching innovations in markets with faster regulatory approvals. As a result, new technologies often launch in the U.S. before reaching the EU and Switzerland, delaying distributors’ ability to provide cutting-edge products to healthcare clients.
A Call for Swiss Regulatory Reform: Implementing Motion 20.3211
In response to the growing regulatory challenges, many industry stakeholders are advocating for the Swiss Federal Council to adopt the framework established by Motion 20.3211, which was passed by the Swiss Parliament. The motion calls for Switzerland to recognize FDA-certified medical devices, allowing such products to be approved for the Swiss market. This measure could alleviate regulatory bottlenecks, reducing the time and cost for Swiss distributors to ensure compliance with new and re-certified products. According to Fabio Fagagnini, CEO of Healthcare Holding Schweiz AG, recognizing FDA-approved medical devices "would be a game changer for the industry". He emphasizes that this reform would drastically reduce delays and allow Swiss healthcare providers faster access to cutting-edge technologies. With the current MDR framework and the loss of the MRA with the EU, product availability has lagged behind as manufacturers understandably prioritize larger markets. Fagagnini argues that by adopting Motion 20.3211, "Switzerland could maintain its competitive edge in the MedTech space, ensuring we’re not left behind in terms of innovation and quality care". The reform would simplify supply chains, mitigate shortages and help distributors deliver better outcomes for Swiss patients.
Navigating Regulatory Challenges: Proactive Strategies for Swiss Distributors in the MedTech Industry
To navigate the increasingly complex regulatory landscape and maintain competitiveness, Swiss distributors must adopt proactive strategies to adapt and thrive:
- Build Regulatory Expertise and Offer CH-REP Services
Given the growing importance of regulatory compliance, Swiss distributors can invest in developing in-house regulatory expertise. By offering Swiss Authorized Representative (CH-REP) services to manufacturers, distributors can position themselves as key partners in helping foreign companies bring their products to the Swiss market. This not only adds value to the distributor’s portfolio but also strengthens relationships with manufacturers by streamlining the compliance process. - Scout for FDA-Approved Products Early
With the potential adoption of Motion 20.3211, which would recognize FDA approvals in Switzerland, Swiss distributors should begin scouting for innovative FDA-approved products in advance. Establishing early contact with manufacturers will allow distributors to be at the forefront when these products become available in Switzerland, ensuring a competitive edge and faster access to cutting-edge technologies. - Enhance Product Portfolio Management Tools
Investing in advanced portfolio management tools that track regulatory status and registration of devices across markets can help distributors stay ahead of compliance issues. These tools allow distributors to monitor which products are certified or registered for the Swiss market, ensuring more efficient portfolio management and avoiding potential gaps in product availability.
By adopting these strategies, Swiss distributors can stay agile, enhance their services and navigate the evolving regulatory landscape, ensuring Swiss healthcare providers have timely access to diverse, high-quality medical devices.