If guidance on medical device software (MDSW) were a series, we just got three episodes in one week. Kicking off the triple release was MDCG 2025-4, released on June 16, which tackled the safe deployment of medical device apps on digital platforms. On June 17, a revised MDCG 2019-11 version clarified the qualification and classification of software under MDR/IVDR and introduced the interplay with the European Health Data Space (EHDS). On June 19, AIB 2025-1 / MDCG 2025-6 was released, providing a much anticipated roadmap that explains how the Artificial Intelligence Act (AIA) is intended to interface with existing medical device regulations (Regulation 2017/745 (EU) MDR and Regulation 2017/746 (EU) IVDR). This update focuses on the latest guidance.
Decoding MDCG 2025-6: Interplay between the MDR/IVDR and AIA | Emergo by UL
Decoding MDCG 2025-6: Interplay between the MDR/IVDR and AIA
The European Commission has released three new pieces of guidance on medical device software.
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