
Reflecting on President Trump’s first 100 days in office
Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the globe, frameworks such as the EU AI Act, ISO 13485 combined with the EU Medical Device Regulation (MDR), FDA’s regulatory pathways, and the U.S. Quality System Regulation (QSR) under 21 CFR Part 820 establish different expectations for AI-enabled devices. Understanding the nuances of these frameworks is essential for navigating this evolving landscape, and on April 29-30, Hogan Lovells is hosting its fourth annual AI Health Law & Policy Summit, where panelists will discuss global trends in this space.
The EU AI Act takes a forward-looking stance, addressing not just the technical and safety aspects of AI in medical devices but also its societal and ethical implications. AI-based medical devices (AIMD) are classified as "high-risk," requiring a CE mark and triggering strict oversight that builds upon ISO 13485 and MDR requirements. This includes:
Where ISO 13485 and MDR focus primarily on device safety and quality, the EU AI Act delves deeper into data integrity fairness, non-discrimination, and the fundamental rights impacted by AI.
In the United States, FDA’s regulatory framework reflects the dynamic and fast-paced nature of the AI field. The agency takes a pragmatic, patient-centered approach that builds on a longstanding focus on data integrity:
FDA's combined focus on adaptability, patient outcomes, and its well-established leadership in data integrity positions it as a strong regulatory force in this space.
ISO 13485 and the EU MDR remain the cornerstone standards for medical device compliance in Europe. Their focus is on ensuring safety, quality, and post-market surveillance. However, these frameworks leave certain gaps when it comes to AI, such as:
These limitations underscore the gap that the EU AI Act seeks to fill.
The U.S. QSR under 21 CFR Part 820 provides a structured, prescriptive framework for quality systems, with key provisions tailored to medical devices:
While sharing principles with ISO 13485, the QSR stands out with its stringent, U.S.-specific focus on compliance.
The regulatory landscape for AI in medical devices is complex, but it offers immense opportunities for those who navigate it successfully. This is where our global team excels. With expertise across the EU, U.S., and other regulatory environments, we provide comprehensive support to manufacturers facing these challenges.
Whether you are integrating AI into an existing product or launching a cutting-edge solution, we are here to guide you through every step of the process. Let us help you unlock the full potential of AI-enabled medical devices while meeting the highest standards of safety, quality, and ethical integrity.
While the EU AI Act prioritizes ethics and societal impact, FDA emphasizes adaptability and patient outcomes, and the QSR ensures prescriptive compliance. These frameworks, though distinct, converge on principles like safety, transparency, and bias mitigation. Together, they offer a roadmap for manufacturers to harness the transformative power of AI responsibly.
Navigating these frameworks is not just about meeting regulatory requirements — it is about setting the stage for innovation that truly changes lives. That is a journey we are passionate about supporting.
On April 29-30, Hogan Lovells and the AI Health care Coalition are hosting our fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers will address a variety of topics including U.S. and EU regulations, emerging health care AI legislation and policy considerations, AI ethics and consumer safety, global regulatory developments, and more. The article above is part of our thought leadership series designed to set the stage for the Summit and equip you with essential background information on this rapidly evolving landscape. Feel free to reach out to either author of this alert or the Hogan Lovells attorney with whom you regularly work with any questions.
Authored by Jodi Scott and Arne Thiermann.