Dialog: MDR/AI – Structured regulatory assessment for EU MDR and AI Act compliance

Summary: Dialog: MDR/AI provides a structured assessment of AI-enabled health products, detailing MDR classification, AI Act risk tiers, and their interaction. It identifies borderline cases and outlines necessary conditions and next steps, with expert review and fast delivery.

What it does

The tool generates a detailed regulatory report covering MDR classification with reasoning, EU AI Act risk tier, borderline assessments, and practical next steps based on the product’s stage. Each report is reviewed by an expert and delivered within one business day.

Who it's for

It is designed for teams and stakeholders involved in classifying AI-enabled health products under EU MDR and AI Act frameworks.

Why it matters

It addresses the lack of structured analysis in borderline regulatory cases, reducing unnecessary costs, delays, and misinformed engineering decisions.