EC Medical Devices · August 23, 2025

MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation, In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act

Original title: MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025)

FAQ clarifying how MDR, IVDR and the AI Act interact in the regulation of AI-enabled medical devices and diagnostics.

High obligation Framework Medical Devices & IVD Digital Health & AI EU-wide Medical devicesIn vitro diagnosticsEU AI ActAI governance

News announcement19 June 2025MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025)1 min read

Read the official source ↗

Published by EC Medical Devices. HealthSignal links to the original document; the summary above is extracted from the source text.