Developer Builds AI Agent to Detect Unsupported Claims in EU MDR Clinical Dossiers

A medical writer has created the MDR Evidence Gap Agent, a learning project that uses AI to identify unsupported claims within a synthetic EU Medical Device Regulation clinical evaluation dossier. The agent queries structured content stored in Sanity using GROQ, allowing it to detect missing evidence links rather than relying on keyword matching. Built around a fictional Class III vascular closure device called VascuSeal, the demo uses invented claims, studies, and paraphrased regulatory requirements to illustrate how evidence gaps map to specific MDR articles. When asked which claims lack supporting evidence, the agent independently identified two planted gaps and linked them to relevant MDR requirements including Article 61(1) and Annex XIV. The project is purely educational and not intended as regulatory advice, with the live demo hosted on free-tier infrastructure through approximately October 2025.