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On June 17, 2025 (one day following the release of MDCG 2025-4), the EU commission published a revision to MDCG 2019-11, Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. While there are no substantive changes, several meaningful clarifications are worth mentioning.
Refined scope to include AI
The term medical device artificial intelligence (MDAI) appears for the first time, reflecting a growing regulatory focus on AI-enabled software as a distinct subset of medical device software (MDSW) and is subject to the AI Act.
European Revision of Primary Software Guidance (MDCG 2019-11 Revision 1) | Emergo by UL
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