For medical device companies looking to grow globally, expanding into both the US and EU often feels like the logical next step. But many teams quickly learn that what works in one region doesn’t always translate to the other. Despite some similarities, the US and EU operate within different regulatory and commercial frameworks. Each market demands its own strategy, timeline, and approach to evidence generation—meaning a one-size-fits-all plan won’t cut it.

US Launch: Fast Track to Market

‍The US is an attractive market for many device sponsors,  partly due to the predictability and relative speed of the FDA’s 510(k) pathway. Through this process, device manufacturers can demonstrate substantial equivalence to a predicate device, often enabling quicker market entry than other global regulatory frameworks.

Typical go-to-market strategies in the US include:

• Direct outreach to specialists (e.g., endocrinologists, cardiologists) through field sales and key opinion leader (KOL) engagement
• Strategic partnerships with patient advocacy groups and support networks
• Alignment with CPT codes to streamline reimbursement for physicians and clinics
• Digital marketing campaigns highlighting innovation, usability, and integration with electronic health records (EHRs)

In this environment, messaging around improved clinical outcomes and patient usability resonates strongly. Providers are often empowered to trial and adopt new technologies rapidly, with reimbursement following demonstrated clinical use. This leads to a relatively fast-paced commercialization pathway: one where devices can enter the market, build clinical traction, and generate revenue while reimbursement evolves in parallel.

EU Launch: Regulatory Complexity and Reimbursement Hurdles

While the EU offers access to a large and diverse patient population, its market presents more complex regulatory and market access challenges, particularly under the current Medical Device Regulation (MDR) framework. CE marking under the MDR can require extensive clinical evaluation reports, robust post-market surveillance (PMS) plans, detailed risk management documentation, and evidence generation that exceeds what is typically needed for FDA submissions. However, obtaining CE marking does not guarantee market access or reimbursement across EU countries, as each member state has its own processes, payer systems, and data requirements. Each member state has its processes, payer systems, and data requirements. For example:

• In Germany, Health Technology Assessment (HTA) bodies may require comparative cost-effectiveness analyses versus existing standard-of-care devices.
• In France, authorities may request local real-world evidence demonstrating device benefits for the French patient population.
• In Spain, regional healthcare authorities often prefer working with established distributor networks rather than engaging in direct sales relationships.

In this fragmented landscape, CE marking is not the end goal: it is the beginning of multiple, parallel market access efforts. Success in the EU requires tailoring launch strategies to national systems, languages, and clinical expectations.

Strategic Implications: Two Markets, Two Mindsets‍

At a high level, the US and EU operate on different go-to-market streategies:

In the US:

• Launch nationally, educate prescribers, build real-world clinical evidence, and secure reimbursement based on demonstrated utility.
• Competitive advantage is often achieved through early market presence and strong provider relationships.

In the EU:

• Secure reimbursement before widespread adoption by meeting rigorous HTA criteria and payer expectations.
• Country-by-country strategies are essential, and funding typically precedes clinical adoption.

These differences impact more than commercial strategy: they influence clinical trial design, evidence generation plans, budget allocation, and timelines.

What Medical Device Sponsors Should Know

To avoid missteps and delays, medical device companies targeting both the US and EU markets should consider the following:

1. Design Studies With Dual Objectives

Plan clinical trials to support both FDA clearance and EU market access from the outset. This means collecting not only clinical efficacy data but also health economic and quality-of-life endpoints that meet HTA requirements in Europe.

2. Map Regulatory Pathways in Parallel

The US 510(k) process is not directly comparable to the EU MDR framework. Sponsors should plan for parallel, not sequential, regulatory strategies to minimize delays and ensure that the evidence generated is applicable across both markets.

3. Integrate Market Access Into Development

Pricing and reimbursement considerations should be factored into product development early on. European payers often require cost-effectiveness data that goes beyond clinical safety and performance. Identify and plan for these data requirements at the protocol design stage.

4. Localize Commercial Approaches

A global product does not mean a one-size-fits-all strategy. European commercialization requires local distributor partnerships, country-specific value dossiers, and sometimes even localized clinical trials to support adoption.

Building an Integrated Global Strategy

The most successful medical device sponsors no longer think in terms of choosing between the US and EU, they plan for both, from the beginning. At Lindus Health, we help sponsors with trials that generate the evidence you need for both FDA clearance and EU market access—simultaneously, not sequentially. We help medical device companies design studies that satisfy both regulatory pathways while collecting the relevant data.

Ready to go global the right way? Talk to our team today.