Medical device artificial intelligence (MDAI)

The term appears in the joint guidance on how the EU MDR and IVDR interact with the AI Act. It helps manufacturers read both sets of requirements together, since an AI-based device can need to conform to both.

For the purposes of this document, AI systems used for medical purposes are referred to as Medical Device Artificial Intelligence (MDAI). All references to MDAI shall be understood to also cover MDR Annex XVI products, accessories to medical devices, in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices.

MDCG 2025-6 / AIB 2025-1, Introduction