Streamlining Multi-Region Submissions: Orchestrating MDR, FDA, and EU AI Act Documentation for AI-Enabled Devices

Bringing AI-enabled medical devices to market means meeting overlapping FDA, EU MDR, and EU AI Act requirements. The AI Act classifies most medical AI as high-risk, requiring conformity assessment, data governance, transparency, and human oversight alongside MDR’s clinical evaluation and post-market surveillance. In the U.S., the FDA expects full traceability under design control, risk management per ISO 14971, and documented verification and validation of software, algorithms, and data changes across the lifecycle.