On 19 June 2025, the European Commission (EC), in collaboration with the Joint Artificial Intelligence Board (AIB) and the Medical Device Coordination Group (MDCG), released MDCG 2025-6, a Frequently Asked Questions (FAQ) document to clarify how the Artificial Intelligence Act (AIA) applies alongside the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
This marks the first official effort to guide manufacturers, notified bodies, and authorities in navigating the simultaneous and complementary application of MDR/IVDR and AIA requirements, particularly where Medical Device Artificial Intelligence (MDAI) is involved.
Why This Guidance Matters
AI-driven technologies in healthcare are evolving rapidly, and many medical devices now include high-risk AI systems. While MDR and IVDR focus on safety and performance of devices, the AIA introduces additional requirements to address risks specific to AI, such as accuracy, robustness, and cybersecurity.
This FAQ helps align expectations across regulatory frameworks, offering manufacturers clarity on where obligations overlap and where flexibility exists.
What the Guidance Covers
The FAQ covers a broad set of questions under the following key topics:
- Scope of application and classification
- Requirements on management systems, data governance, technical documentation, transparency/human oversight, and accuracy/robustness/cybersecurity
- Clinical/performance evaluation and testing
- Conformity assessment
- Substantial modification or significant change
- Post-market monitoring
- Other related questions
It also clarifies terminology differences, such as the distinction between a “deployer” under the AIA and a “user” under MDR/IVDR, and stresses that MDAI manufacturers are encouraged to integrate AIA documentation into their existing regulatory systems under MDR/IVDR, where appropriate, without duplicating efforts:
Published by European Commission on 19 June 2025
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