Proposed amendment to EU MDR could relax rules on AI medical device software

There was recent news for the possible relaxation of rules for MDR with respect to medical device software (MDSW), including for MDSW utilizing artificial intelligence (AI). The December 16, 2025 proposed amendment to classification rules for MDSW for Rule 11 of the classification rules in Annex VIII of the MDR for MDSW could potentially allow a broader range of MDSW to fall under a Class I classification and therefore not require a Notified Body assessment.  This change could also impact the relevance of the EU AI Act to AI MDSW and potentially reduce the number of AI MDSW deemed “high risk” under the AI Act. This language is not yet final with an expectation to be finalized in 2026. Regardless, this proposal is a positive indication, as it signals that the EU MDR is considering a wider flexibility for developers of AI related MDSW looking to operate in EU territories.