Synthetic data only

MDR Evidence Gap Agent

An agent that finds claims in a device dossier with no supporting evidence, and the EU MDR requirements they affect. It reads structured content from Sanity through Sanity Context.

Ask the dossier

Answers take about 15 to 40 seconds. Ctrl + Enter also works.
The agent is reading the schema and querying Sanity…

What the agent did

Answer

Loading the dossier from Sanity…
Loading the coverage matrix from Sanity…

What this is

A demo for the Sanity Challenge on DEV (Path One). The content is a small, invented dossier for a fictional Class III vascular closure device called VascuSeal. An AI agent answers audit questions over that content by following references between documents.

A keyword search finds pages that mention things. It cannot find what is missing. Here the gap only exists as an empty reference list on a claim, and the agent finds it with GROQ.

How the content is structured

RequirementMDR article or annex Claimstatement in the CER Evidencestudy or test result requirements[] evidence[] empty evidence[] = a gap
  1. Schema and content. Three document types (requirement, claim, evidence) are defined in Sanity Studio, linked by references.
  2. Sanity Context. A read-only MCP endpoint exposes only those three types, with custom instructions for the agent.
  3. The agent. A Gemini model receives the endpoint's tools, reads the schema with initial_context and writes its own groq_query calls. You can see every query on the Ask tab.
  4. This site. The Dossier and Coverage tabs read the same content through the same endpoint. Keys stay on the server.

Limits, stated plainly

  • All data is synthetic. The device, claims and studies are invented.
  • The MDR requirement entries are short paraphrases of Regulation (EU) 2017/745, not the official wording. Some are simplified.
  • The agent reports what the linked documents show. It does not judge compliance and this is not regulatory advice.
  • The endpoint reads a dataset only. This demo does not use a Knowledge Base.
  • The dataset is small (15 documents). Questions are limited to 10 per visitor per hour to protect a free model quota.

Links

Sanity project ID: 0hmb0qqg (dataset production). Studio: mdr-evidence-gap.sanity.studio (requires a Sanity login). Challenge: Sanity Challenge on DEV.