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It is the EU’s first official guidance that systematically coordinates the sector-specific medical device regulations with the horizontal AI Act. -
It provides a unified practical basis for the regulation and compliance review of AI medical devices. -
It is the core compliance handbook for manufacturers of all AI medical devices and MDAI (medical device AI software) placed on the EU market, addressing the key industry pain points of dual regulation under the MDR/IVDR and the AIA: conflicting compliance requirements, ambiguous interpretations and overlapping procedures.
1. Criteria in the guidance for identifying high-risk AI systems:
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The horizontal, general risk-classification framework for AI systems and the sector-specific statutory classification system for medical devices under the EU MDR/IVDR are two regulatory systems whose legislative purposes, scope, classification rules and legal effect are completely independent. They only intersect in the case of medical AI (MDAI); neither replaces nor contains the other. -
AI systems are classified in four tiers: minimal risk, limited risk, high risk and prohibited. -
An MDAI is considered a high-risk AI system only if both of the following conditions are met: (1) the MDAI is a safety component, or the AI system is itself a medical device; and (2) a notified body must be involved in the conformity assessment. The table below gives a non-exhaustive overview of how Article 6(1) of the AIA applies under the MDR/IVDR:
2. Core compliance requirement modules
3. Compliance recommendations
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Parallel application, complementary not conflicting: MDAI must comply with both the MDR/IVDR and the AIA. -
Integrated compliance: documentation, processes and testing may be combined to reduce the burden. -
Risk-based: all requirements are proportionate to the risk level of the device / AI system. -
Dynamic adaptation: watch for upcoming EU technical guidance (e.g. on data governance and detailed rules on substantial modifications) and plan the compliance path for algorithm updates in advance.
Conclusion
This guidance makes EU regulation of medical AI more systematic, sets a reference benchmark for regulatory coordination in this field worldwide, and supports compliant innovation in the industry. EVERBIZ is happy to share medical device expertise with industry clients, and hopes our extensive practical experience in quality systems and product registration will be helpful. Let’s contribute together to the development of the medical device industry – if you have any questions or needs, please contact us.