Name: MDCG 2025-4 Medical Device Software Apps on Online Platforms by Miloš Cigoj
Duration: 22 min 1 s
Description: The regulatory grey zone for digital health in the European Union has finally cleared. In a landmark move, the EU's Medical Device Coordination Group (MDCG) has issued the MDCG 2025-4 Guidance, a document that fundamentally reshapes the responsibilities for medical device software (MDSW) and Software as a Medical Device (SaMD) distributed through major online platforms.

Read insights at https://www.excellence-consulting.services/resources/mdsw_appstore_guidance.php

The regulatory grey zone for digital health in the European Union has finally cleared. In a landmark move, the EU's Medical Device Coordination Group (MDCG) has issued the MDCG 2025-4 Guidance, a document that fundamentally reshapes the responsibilities for medical device software (MDSW) and Software as a Medical Device (SaMD) distributed through major online platforms.

MDCG 2025-4 Medical Device Software Apps on Online Platforms

Miloš Cigoj

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Miloš Cigoj

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