AI Assurance Directory

Tools for EU MDR + AI Act

Listed tools whose cited public page names this framework. Read the EU MDR + AI Act explainer first. Related reading is on the articles index.

No verified tool listings yet. We found no product whose public page names EU MDR + AI Act, so we list none. We do not infer framework support. Official documents are listed below.

Official documents and working-group pages

These are the primary public pages we cite for EU MDR + AI Act. They are not directory listings and are not endorsements.

Sources last checked on 15 October 2026.

  1. Regulation (EU) 2017/745 on medical devices - EUR-Lex
  2. AI Act Service Desk: Annex I - European Commission
  3. Regulation (EU) 2024/1689 (consolidated) - EUR-Lex
  4. IEC 62304:2006 - Medical device software — Software life cycle processes - IEC

Questions

Why are there no commercial tools tagged for EU MDR + AI Act?

We only tag a tool when the cited public page names this framework (or, for SAE G-34, EUROCAE WG-114, ED-324 or ARP6983). We do not infer support from a related aviation standard.

Where are the official EU MDR + AI Act documents?

The official documents and working-group pages are listed on this page and on the EU MDR + AI Act explainer.

← All tools · EU MDR + AI Act explainer · Updates

Free next step: take the AI assurance readiness self-check or create a free account. Quoted evidence stays on Pro.