In a significant move for the medical device industry, the European Commission's Medical Device Coordination Group (MDCG) and the newly established European Artificial Intelligence Board (AIB) have jointly issued guidance documents AIB 2025-1 and MDCG 2025-6. This collaboration marks the first time these two bodies have come together to provide unified guidance, aiming to clarify the interplay between the Medical Device Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR), and the Artificial Intelligence Act (AIA) for AI-enabled medical devices.
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EU Regulators Release Joint Guidance on AI-Enabled Medical Devices
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Why This MDCG Release Is Historic
This is the first-ever joint guidance issued by the Medical Device Coordination Group (MDCG) and the newly established European Artificial Intelligence Board (AIB).
The MDCG is a well-established entity within the EU regulatory framework and operates under MDR/IVDR.
The AIB, on the other hand, operating under the AI Act, is a parallel body to MDCG tasked with coordinating the uniform application of the EU’s horizontal AI legislation.
Given the growing relevance of AI-enabled medical devices, this guidance is a key step toward aligning the regulatory expectations under both frameworks.
What’s Inside the Document
AIB 2025-1 / MDCG 2025-06 provides a set of frequently asked questions (FAQs) that clarify how the MDR/IVDR and AIA intersect, particularly regarding:
- Obligations for manufacturers of AI-enabled medical and IVD devices
- Responsibilities of notified bodies
- Expectations for competent authorities
- Implementation scenarios and transitional aspects
These FAQs aim to harmonize the understanding and implementation of overlapping requirements under the MDR/IVDR and the AI Act, especially in high-risk AI applications.
Conclusion
The release of AIB 2025-1 and MDCG 2025-6 represents a pivotal moment in the regulation of AI-enabled medical devices within the EU. By providing clear guidance on the intersection of MDR, IVDR, and the AI Act, these documents aim to streamline compliance processes for manufacturers and ensure the safety and efficacy of AI-driven medical technologies. Stakeholders are encouraged to review the guidance thoroughly to align their practices with the evolving regulatory landscape.
For more information and to access the full guidance document, visit the European Commission's official publication: MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation, In Vitro Diagnostic Medical Devices Regulation, and the Artificial Intelligence Act
Author
Dr. Andrei Ninu
Dr. Andrei Ninu is a highly experienced regulatory expert specializing in active medical devices, with a strong focus on functional and software safety as well as artificial intelligence (AI) applications in healthcare. He has extensive expertise in EU regulatory compliance, particularly in certification and conformity assessment processes for medical device manufacturers.
Beyond his regulatory expertise, Dr. Ninu brings over a decade of hands-on experience in software development, having witnessed firsthand the evolution of AI systems in healthcare and their transformative impact on medical technology.
His academic background includes a Master’s degree in Control Systems and Robotics and a PhD in Computer Science/Biomedical Engineering from the Vienna University of Technology, where he focused on human-machine interaction in rehabilitation. He further advanced this field during his postdoctoral research at the University Medical Center Göttingen, specializing in robotic-assisted rehabilitation.
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