The integration of artificial intelligence (AI) in medical technologies is rapidly reshaping the healthcare landscape. As AI becomes more embedded in medical and in vitro diagnostic devices, the need for regulatory clarity grows. To support this evolving reality, EU regulators have released a significant new document:
MDCG 2025-6 / AIB 2025-1 – FAQ on the Interplay Between the Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR), and the Artificial Intelligence Act (AIA)
📄 Download the guidance document here
A Complementary Framework for High-Risk AI in Medical Devices
The Artificial Intelligence Act (AIA) complements the existing MDR (EU 2017/745) and IVDR (EU 2017/746) by introducing AI-specific legal requirements that focus on safeguarding health, safety, and fundamental rights. In line with the New Legislative Framework (NLF) approach, this means that for medical devices containing one or more high-risk AI systems, both the AIA and the MDR/IVDR apply simultaneously and in a complementary manner.
This joint application of legal frameworks introduces both challenges and responsibilities for key stakeholders across the medical technology ecosystem, including manufacturers, notified bodies, and competent authorities.
What the MDCG 2025-6 / AIB 2025-1 FAQ Covers
This new FAQ document provides the first official guidance on how the AIA interacts with the MDR and IVDR. Although intended primarily for regulatory professionals and industry stakeholders, the content is broadly relevant to anyone involved in the development, assessment, or regulation of medical devices incorporating AI.
Key areas addressed include:
- Data Governance: Requirements on data quality and data sets used to train and validate AI systems
- Transparency: Information obligations to ensure that AI systems are explainable and their behavior is predictable
- Accuracy, Robustness, and Cybersecurity: Technical requirements and safeguards for safe and reliable system performance
- Clinical and Performance Evaluation: Ensuring alignment between AI validation processes and the clinical expectations of MDR/IVDR
- Technical Documentation and Post-Market Surveillance: Integrating AIA-specific elements into existing regulatory documentation and lifecycle monitoring practices
A Living Document
It is important to note that the MDCG 2025-6 / AIB 2025-1 FAQ is a living document. It represents an evolving set of answers that will be continuously updated as the implementation of the AIA progresses and practical experience accumulates across the industry.
Why This Matters
For manufacturers, this guidance provides much-needed direction on how to navigate compliance in a dual-regulatory environment. For notified bodies and authorities, it helps align expectations and responsibilities when assessing AI-driven technologies under both sets of rules.
Given the increasing complexity of regulatory requirements for AI-enabled devices, early adaptation and strategic planning are essential.
If your organization needs support interpreting or implementing these new guidelines, our regulatory experts are available to assist with compliance assessments, documentation updates, and strategic regulatory planning.
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