In recent years, many manufacturers have pivoted from a “Europe-first” approach to a “US-only” strategy for first-in-human, pilot, and pivotal studies. This shift has been driven largely by the perceived challenges of MDR implementation, efficiency of the
FDA’s restructured review processes, and the accessibility of FDA pre-submission consultations.
However, it’s worth taking a fresh look at Europe as a strategically valuable — and often underleveraged — clinical development location.
1. Access to Diverse Patient Populations and Real-World Settings
- Demographic diversity in European patient populations can be critical for demonstrating device safety and performance across varied use cases.
- Access to public healthcare systems in many European countries allows for more representative real-world clinical data, which strengthens submissions globally.
2. Multiple Regulatory Pathways for Global Leverage
- While MDR compliance was complex and demanding at first, implementation has now become standardized and offers greater alignment with global evidence expectations, meaning studies conducted in Europe can often be used to support both EU and FDA submissions with minimal adaptation.
- Not all devices require a full MDR clinical investigation route — risk-based pathways and equivalence claims remain viable for certain devices such as low-risk class devices, making Europe competitive for specific categories.
- Obtaining the CE mark under MDR grants access to all 30 countries of the European Economic Area (EEA), including European Free Trade Association (EFTA) countries, creating a single, harmonized market for your device. Furthermore, MDR provides a structured pathway for maintaining CE marking throughout the product lifecycle.
3. Robust Academic and Clinical Expertise
- Europe is home to world-class key opinion leaders (KOLs) and clinical networks with deep device-specific expertise, often concentrated in specialized centers of excellence.
- Many European investigators have experience working under both MDR and FDA requirements, providing globally credible datasets.
4. Operational and Cost Advantages
- The cost of operational execution of clinical studies (e.g. data and safety monitoring and management, medical writing, statistical analysis) is consistently lower than in the US .
- In many cases, site and investigator costs in Europe are significantly lower than in the US.
- Depending on the country, ethics and competent authority review timelines can be competitive or even faster than certain US Institutional Review Board (IRB) processes, especially with well-prepared submissions.
5. Strategic Risk Diversification
- A dual-region approach (or starting in Europe) reduces dependence on a single regulatory body — critical given current FDA restructuring and review backlog risks.
- Conducting early feasibility in Europe can de-risk technology and provide more flexibility if US review timelines shift or guidance changes mid-development.
6. Post-Market and HTA Synergy
- Clinical data generated in Europe can be directly leveraged for reimbursement discussions with EU health technology assessment (HTA) bodies, which increasingly require robust clinical evidence.
- Starting in Europe allows earlier engagement with payers in parallel with regulatory processes, helping accelerate market access.
Conclusion:
While US-only strategies have been attractive for speed and perceived regulatory clarity, the current uncertainty in US processes – combined with the maturation of MDR implementation and Europe’s operational advantages – makes it the right time to reconsider. Europe can still be safely considered as a primary or parallel region for clinical studies.
Manufacturers who diversify their study locations can gain faster, more robust datasets, mitigate regulatory risks, and position themselves for simultaneous or accelerated global market entry.
Abbreviations:
EEA: European Economic Area
EFTA: European Free Trade Association (Iceland, Liechtenstein, Norway, Switzerland)
FDA: Food and Drug Administration
HTA: Health technology assessment
IRB: Institutional Review Board
KOL: Key opinion leader
MDR: Medical Device Regulation
At XPER, we specialize in guidingmedical device manufacturers through the full process of designing and executing clinical studies in Europe. Our team combines deep knowledge of MDR requirements with operational excellence to help you:
- Identify optimal countries and sites
- Navigate ethics and regulatory submissions efficiently
- Design studies that meet both EU and FDA evidence expectations
- Accelerate patient recruitment and data collection
- Compile and present study results in an MDR-compliant Clinical Investigation Report (CIR)
If you’re exploring your next study location, now is the time to leverage our expertise to de-risk your program, ensure compliance, and position your device for faster, broader market entry.
Contact us for more information
