December 2025 – Digital Health Consult

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…Read More

December 9, 2025

Industry players request that FDA Center for Devices and Radiological Health (CDRH) withdraw certain guidances and prioritize other guidances in fiscal year 2026

The comment period for the CDRH fiscal year 2026 (FY 2026) proposed guidance development closed on December 1, 2026 and it was reported recently in RAPS that certain industry participants officially asked both for withdrawal of certain guidances…Read More

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Month: December 2025

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

Industry players request that FDA Center for Devices and Radiological Health (CDRH) withdraw certain guidances and prioritize other guidances in fiscal year 2026

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