Europe remains one of the biggest growth opportunities for American medical companies. With an advanced healthcare system, a population of over 450 million, and an aging demographic driving demand for innovative devices and treatments, the EU medical device market alone is valued at over €140 billion.
But Europe is no easy win. Strict regulations, diverse cultures, fragmented systems, and tough competition mean U.S. companies must plan carefully in order to succeed.
Here’s a quick look at the main challenges and how to tackle them.
1. Complex Regulations
The EU's regulatory environment is a major hurdle for American medical companies. The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), implemented in 2021 and 2022 respectively, have raised the bar for approvals, imposing new and rigorous requirements for clinical evaluations, post-market surveillance and CE marking. For example, getting a CE mark can take anywhere between 12 to 18 months and costs far more than U.S. FDA approvals. Strict data protection laws (GDPR) add extra compliance layers, especially for digital health solutions.
Tip: Work with local regulatory experts and notified bodies. It saves time and avoids costly mistakes, as non-compliance risks fines, market exclusion, or reputational damage.
Bonus read: 5 GDPR Non-Compliance Risks in Europe
2. Cultural and System Differences
Unlike the U.S., Europe’s healthcare systems vary widely by country - from Germany’s insurance-driven model to the UK’s NHS. What works in one market may not in another. Moreover, American firms accustomed to the U.S.’s profit-driven healthcare model may also struggle with Europe’s focus on cost-effectiveness, patient outcomes, and equitable access. For instance, European payers prioritize devices and drugs with proven long-term value, unlike the U.S.’s emphasis on rapid market entry. Plus, multilingual labelling and local patient education are essential. Missteps, like poorly translated instructions, can erode trust, as seen in cases where U.S. companies failed to adapt to local preferences.
Tip: Conduct thorough market research, hire local teams or partners who understand regional differences, and tailor your value proposition to each market.
3. Fierce Competition
European giants like Siemens Healthineers (based in Germany) and Philips (Headquartered in the Netherlands) already dominate key segments. Emerging players from Asia, particularly China, also compete in cost-sensitive segments. Additionally, Europe’s "single market" isn’t fully harmonized as local requirements differ, with countries like Germany enforcing stricter standards than Ireland or the Netherlands, requiring country-specific strategies. As a result, U.S. companies targeting Spain, for example, must navigate regional variations in public sector procurement, which can delay market entry.
Tip: Start with easier-entry markets like Ireland or the UK, which offer regulatory familiarity and English-speaking healthcare professionals. Build trust through local distributors or hospital partnerships.
4. Talent and Operational Hurdles
Hiring local experts is critical, but labor laws, high expectations for work-life balance, and cultural fit make it tricky for U.S. firms. Europe’s strict labor laws, such as those in France or Spain, complicate hiring and retention compared to the U.S.’s at-will employment mode. Additionally, integrating small European teams with U.S. headquarters often leads to cultural disconnects, with high turnover rates for general managers hired to lead European operations.
Tip: Use regional talent hubs like Dublin or Basel. Partner with local HR firms (such as Eurodev) to navigate labor laws and offer competitive benefits, such as flexible work arrangements, and to attract top talent.
Related content: The Employer of Record (EOR) Model: Transforming Global Employment
5. Geopolitical and Economic Risks
Geopolitical and economic factors, such as potential U.S. tariffs or supply chain disruptions, impact medical companies. Tariffs on medical devices or pharmaceuticals could raise costs, while disruptions like those in the Red Sea increase shipping expenses and delay deliveries. Local sourcing and production may help reduce this risk.
Tip: Set up European distribution or manufacturing bases and stay connected to trade bodies for early updates on policy shifts.
Related content: Key Impacts of EU Tariffs on U.S. MedTech & Life Sciences Companies
Key Takeaway
Europe’s sophisticated healthcare systems and huge patient base make it too important to ignore. While at first glance the challenges may seem significant, with careful planning, local partnerships, and smart regulatory navigation, American medical companies can thrive and use Europe as a launchpad for global growth.
For more information, visit our Sales Outsourcing page and find out how EuroDev can help you expand your business to Europe.
