Launching a European Medical Device Product in the U.S. Market

Expanding your medical device product from the European market to the U.S. can unlock vast opportunities but comes with unique challenges. The regulatory environment in the United States, primarily governed by the U.S. Food and Drug Administration (FDA), has distinct rules, processes, and expectations compared to Europe’s Medical Device Regulation (MDR).

This guide, brought to you by the European Biomedical Institute (EBI), provides a comprehensive roadmap for manufacturers looking to introduce their medical devices to the U.S. market.

  1. Understand the Regulatory Landscape

Unlike Europe, where devices are certified by Notified Bodies, the U.S. uses an FDA-centric system with strict oversight. Key components include:

  • Device Classification: Devices are classified into Class I, II, or III based on risk. Each classification has varying regulatory controls.
  • Premarket Pathways: Depending on the classification, you may need to follow:
    • 510(k) Premarket Notification: For devices that demonstrate substantial equivalence to an already marketed device.
    • De Novo Classification Request: For low-to-moderate risk devices without a predicate.
    • Premarket Approval (PMA): For high-risk Class III devices, requiring clinical data and comprehensive review.
  • Unique Device Identification (UDI): Mandatory labeling requirement for device tracking.
  1. Align with FDA’s Quality System Regulations (QSR)

The FDA mandates adherence to its 21 CFR Part 820 Quality System Regulations, which share similarities with ISO 13485 but have distinct differences:

  • Implement robust design controls and document processes.
  • Focus on corrective and preventive actions (CAPA) for continuous improvement.
  • Establish FDA-compliant supplier management and purchasing controls.

Regular inspections are conducted by the FDA to ensure compliance.

  1. Conduct a Gap Analysis

European manufacturers operating under MDR or ISO 13485 standards must perform a gap analysis to identify differences between these frameworks and FDA requirements. Areas to consider include:

  • Terminology differences (e.g., “technical documentation” vs. “design dossier”).
  • Clinical evidence requirements (FDA’s approach may demand more data).
  • Reporting timelines for adverse events and device malfunctions.
  1. Prepare for Biocompatibility and Safety Testing

Biocompatibility requirements under ISO 10993 apply globally, but the FDA often requires additional considerations:

  • Conduct a thorough biological risk assessment (BRA).
  • Address extractable and leachable testing for chemical compatibility.
  • Prepare a toxicological risk assessment (TRA) tailored to U.S. requirements.
  1. Design a U.S.-Specific Clinical Strategy

Clinical evidence requirements can differ significantly between the U.S. and Europe:

  • FDA’s emphasis on clinical trials: Especially for Class III devices, where U.S.-based studies may be necessary.
  • Institutional Review Board (IRB) approval: Required for all U.S. clinical investigations.
  • Ensure your study meets the requirements of the FDA’s Investigational Device Exemption (IDE).
  1. Secure a U.S. Agent and Establish Local Representation

For non-U.S. manufacturers, the FDA mandates the appointment of a U.S. Agent to act as a liaison between your company and the agency. This agent will:

  • Facilitate communication during registration and listing.
  • Respond to queries about your device.
  • Assist during inspections or audits.
  1. Register and List Your Device with the FDA

All medical device manufacturers must register their establishment and list their devices in the FDA database:

  • Establishment Registration: A prerequisite for marketing devices in the U.S.
  • Device Listing: Information about the marketed device, including proprietary names and intended use.

This process incurs an annual fee, which must be renewed.

  1. Comply with Labeling and Advertising Rules

FDA labeling requirements differ from Europe and must include:

  • Intended use and clear indications for use.
  • Appropriate warnings, precautions, and contraindications.
  • Compliance with UDI standards for product traceability.

Additionally, marketing materials must avoid misleading claims or unsubstantiated performance statements.

  1. Prepare for FDA Inspections

FDA inspections are a critical part of the approval process, focusing on:

  • Quality system compliance.
  • Manufacturing processes and documentation.
  • Complaint handling and post-market surveillance systems.

Being audit-ready is vital for a smooth launch.

  1. Develop a Robust Post-Market Surveillance Plan

Post-market surveillance in the U.S. involves stringent reporting obligations:

  • Submit Medical Device Reports (MDRs) for adverse events and device malfunctions.
  • Comply with FDA’s recall and correction procedures if safety issues arise.
  • Conduct regular post-market clinical follow-up (PMCF) as needed.
  1. Anticipate Cultural and Market Differences

The U.S. healthcare market has unique characteristics that impact commercialization:

  • Understand reimbursement pathways via Medicare, Medicaid, or private insurers.
  • Build relationships with Group Purchasing Organizations (GPOs), which influence purchasing decisions.
  • Tailor your marketing strategies to U.S. regulatory and consumer expectations.
  1. Leverage Expert Guidance

Navigating the transition from the European to the U.S. market requires expertise in both regulatory compliance and strategic planning. Partnering with experienced advisors, like the European Biomedical Institute (EBI), ensures a streamlined process, reducing risks and accelerating your market entry.

Conclusion

Launching a medical device in the U.S. market is a complex but rewarding endeavor. By understanding the regulatory environment, aligning with FDA requirements, and preparing comprehensively, European manufacturers can achieve successful market entry.

At EBI, we are committed to supporting manufacturers every step of the way, from regulatory compliance to biocompatibility testing and beyond.

About the Author: Prof. Łukasz Szymański

Prof. Łukasz Szymański is an expert in medical device biocompatibility testing, serving as the Chief Scientific Officer (CSO) of the ISO 17025-accredited and GLP-certified European Biomedical Institute (EBI) and North American Biomedical Institute (NABI). As a dedicated researcher and a key contributor to advancing safety standards in the biomedical field, Prof. Szymański plays an integral role in shaping scientific innovations and regulatory compliance within the industry.