The New Dual Regulatory Framework for Medical AI
The European Union’s regulatory environment for medical devices utilising Artificial Intelligence (MDAI) is now defined by a complex dual framework. This mandate requires manufacturers to comply simultaneously with the existing Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR) and the new Artificial Intelligence Act (AIA).
The MDR and IVDR, published in 2017, address risks related to general software, but they did not account for the specific, novel hazards inherent to modern AI systems. The AIA steps in to bridge this gap, focusing on issues specific to AI.
In June 2025, the Medical Device Coordination Group (MDCG) and the Joint Artificial Intelligence Board (AIB) published the essential guidance document: MDCG 2025-6 / AIB 2025-1. This document clarifies the specific interplay between these legislative acts, providing a singular framework for compliance.
Key Compliance Requirements: Transparency and Explainability
The MDCG guidance and the AIA place significant focus on mandatory requirements to ensure trust and accountability in AI systems. The core focus areas for high-risk medical AI include:
- Transparency: Manufacturers must address transparency and data processing requirements. The AIA emphasises new requirements concerning transparency and supports the use of comprehensive accompanying Instructions for Use (IFU). This is designed to enable critical, informed decision-making by users.
- Explainability: Manufacturers must ensure that AI systems are designed to enable the understanding and documentation of all decisions made. This explainability is paramount.
For MDAI, the IFU must go beyond simple descriptions. It must be clear and comprehensible, providing necessary information on the system’s capabilities and, crucially, its limitations. This allows deployers to choose and apply the AI systems responsibly and correctly, ensuring they understand any precluded uses.
High-Risk Classification and Adoption Challenges
An MDAI system is classified as High-Risk under the AIA if it is subject to mandatory third-party conformity assessment by a Notified Body in accordance with the MDR or IVDR.
This focus on transparency and explainability is critical, as a recent report from the European Commission identified these aspects as the biggest challenges to wider AI adoption. These challenges are particularly evident among healthcare providers and impact patient trust.
Given that manufacturers are still managing the transition to the MDR—a regulation released in 2017—the introduction of the AIA now forces immediate alignment. Manufacturers must integrate the AI Act’s quality management system (QMS) and risk requirements directly into their existing MDR/IVDR procedures to manage this dual framework efficiently. Navigating this dual mandate requires specialised expertise to integrate QMS and manage change control effectively, ensuring compliance and continued market access.
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For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.
