Event Recap: US & EU Regulatory Update

Global Regulatory Alignment and Divergence

The fourth session of Navigating What’s Next: AI, Compliance, and Regulation in Life Sciences was a joint presentation from Nathan Downing, Managing Attorney at Gardner Law, and Dr. Cord Willhöft, Partner at Fieldfisher. The pair examined the accelerating pace of regulatory change in the United States and European Union. Both speakers highlighted how agencies are updating frameworks to accommodate artificial intelligence, digital health, and emerging technologies while maintaining patient safety and product quality as guiding principles.

Downing opened with an overview of U.S. developments, noting that the Food and Drug Administration (FDA) continues to advance its Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device (SaMD) Action Plan. The plan emphasizes algorithm transparency, real-world performance monitoring, and postmarket modification control. He explained that these initiatives reflect the FDA’s recognition that AI-enabled products must be managed through a lifecycle approach rather than a single premarket submission.

He also highlighted the FDA’s collaboration through the International Medical Device Regulators Forum (IMDRF), which enables alignment on best practices for adaptive algorithms, human factors validation, and data management. “The agency is increasingly interested in how companies maintain control and accountability over evolving systems,” Downing observed.

Dr. Willhöft then outlined the European Union’s regulatory trajectory, describing how the EU AI Act complements the existing Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Under the AI Act, any AI system incorporated into a regulated medical device is automatically deemed high risk and subject to conformity assessments, technical documentation, and postmarket monitoring obligations. He emphasized that the AI Act is not a replacement for MDR or IVDR but rather an additional compliance layer focused on transparency, bias mitigation, and lifecycle oversight.

Compliance Timelines and Implementation Challenges

Willhöft cautioned that implementation will require significant preparation. High-risk AI system obligations under the AI Act are expected to apply beginning in 2027, meaning manufacturers must update quality management systems, documentation processes, and supplier contracts well in advance. “Manufacturers should begin mapping where AI functionality exists within their devices today,” he advised, “and align technical documentation with the AI Act’s structure for risk classification, governance, and postmarket monitoring.”

Downing noted that the U.S. system, while less codified, is evolving in a similar direction through guidance and enforcement discretion. The FDA’s case-by-case oversight of software updates and algorithm changes mirrors the EU’s conformity assessment model but relies more heavily on voluntary disclosure and continuous engagement. This flexibility, he said, provides opportunities for innovation but introduces uncertainty for companies seeking predictable timelines and documentation requirements.

Trends Toward Convergence

Despite structural differences, both presenters agreed that regulatory systems are converging around shared values of transparency, traceability, and human oversight. Downing emphasized that “the ultimate goal is to ensure patient safety and public trust through demonstrable control.” Willhöft added that global coordination between the FDA, European Medicines Agency (EMA), and U.K. Medicines and Healthcare products Regulatory Agency (MHRA) continues to increase through joint task forces and the IMDRF. These collaborations are shaping consistent expectations for real-world evidence, labeling, and postmarket reporting.

Both speakers encouraged companies to move beyond minimal compliance toward building robust governance programs that integrate regulatory, quality, and cybersecurity considerations.

“Regulatory compliance should evolve from a checklist to a culture of transparency and continuous improvement.”
Nathan Downing, Managing Attorney

How Gardner Law Can Help

Gardner Law assists FDA regulated manufacturers in navigating United States and international regulatory frameworks. Our attorneys provide strategic counsel on device submissions, quality system updates, postmarket surveillance, and compliance with the FDA, EMA, and other global authorities. We also help clients prepare for upcoming EU AI Act and MDR obligations through tailored readiness assessments, documentation strategies, and governance planning.

If your team needs support evaluating regulatory impacts, updating documentation, or preparing for AI related obligations, contact us to start a conversation about how we can help.