Regulatory
The AI compliance cliff
Medical device companies have spent years asking what AI can do. The harder question now is what they can prove. Ellie Philpotts investigates with insight from experts at BD, Zimmer Biomet, UofL Health and academia.
T
he EU AI Act now adds a further compliance layer for those whose systems fall within its scope, including some AI used in or as medical devices. For high-risk systems, the rules cover areas including risk management, data governance,
transparency, human oversight, quality management and post-market monitoring. Not every AI-enabled medical device is automatically high-risk under the Act. For the product route, the AI must be a safety component, or itself a product, covered by legislation listed in Annex I and the product must require third-party conformity assessment. The main high-risk deadlines are now 2 December 2027 for systems classified under Annex III and 2 August 2028 for systems classified through the regulated-product route.
A commission proposal published in December 2025 would move the EU MDR and IVDR from Section A to Section B of the AI Act’s Annex I, changing how the Act interacts with AI-enabled medical devices. As of September 2026, that proposal has not become binding law, and the current consolidated AI Act still lists the MDR and IVDR in Section A. Manufacturers therefore need to distinguish current obligations from reforms still under negotiation.
How the sector is preparing.
“AI has enormous potential to improve quality and cost of healthcare, but its success will ultimately be defined by trust. BD has decades of experience operating in highly regulated environments where breakthrough innovation and effective governance go hand in hand,” a spokesperson for BD contributed. “Realising AI’s full potential requires transparency and collaboration across industry, regulators and healthcare providers. As the EU AI Act and similar policies take shape, reasonable, risk-based and globally aligned standards will be critical to ensuring trust keeps pace with innovation, enabling safer care and better patient outcomes.” At Zimmer Biomet, Dr Jonathan Vigdorchik, chief science, technology and medical affairs officer, sees proof as the defining issue. “The conversation in medtech has fundamentally shifted. The question is no longer only about what AI can do, or even how to integrate it into our products. Our industry’s defining question is now ‘can we prove our AI is designed responsibly, validated
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www.medicaldevice-developments.com
Generative AI/Adobe Firefl y
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