MDCG 2025-6: FAQ on Interplay between MDR/IVDR and the Artificial Intelligence Act

MDCG Guidance MDCG 2025-06
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MDCG 2025-6 — FAQ on Interplay between MDR/IVDR and the Artificial Intelligence Act

This is a guidance document endorsed by the Medical Device Coordination Group (MDCG) under the EU Medical Device Regulation (MDR 2017/745) and/or In Vitro Diagnostic Regulation (IVDR 2017/746).

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Document Details

Document IDMDCG 2025-6
TypeMDCG Guidance
AuthorityMDCG
Publication Date2025-06

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TypeMDCG Guidance
Published ByMDCG
Date2025-06

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