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AI Act × MDR Trilemma Check

The EU AI Act (EU 2024/1689) and MDR/IVDR interlock for AI software. This check shows whether dual conformity applies, based on Art. 6 of the AI Act.

Question 1 of 3

Is your product a medical device or IVD under MDR (EU 2017/745) or IVDR (EU 2017/746)?

Orientation only, not a substitute for a regulatory assessment.

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