Optimizing Strategic Sourcing with Agentic AI: A Compliant and Dual EU/FDA Approach for Cutting Costs without Cutting Corners

Medical device manufacturers face relentless pressure to reduce and contain material spend while operating under the EU MDR/IVDR, the EU AI Act (set to be fully enforceable August 2026), and the FDA QMSR Part 820. Agentic AI – AI designed to proactively take actions to achieve goals – offers medical device manufacturers a new and refreshing opportunity to automate the repetitive and administrative burdens of procurement, freeing up valuable purchasing teams to focus on strategic initiatives such as cost reduction. However, the adoption of Agentic AI often generates concerns regarding regulatory compliance and potential classification as "high-risk" AI under the EU AI Act. This presentation will directly address these concerns, and provide tips for compliant Agentic AI deployment, especially for manufacturers faced with operating under dual EU and FDA regulatory frameworks.