MDCG publishes guide on the joint application of the MDR, IVDR and AI Act: what manufacturers should know
The recent publication of document MDCG 2025-6 — Interplay between the Medical Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), and the Artificial Intelligence Act (AI Act) — marks an important step in aligning regulatory requirements for medical devices that incorporate Artificial Intelligence (AI) systems.
With the entry into force of the AI Act and its impact on medical devices and IVDs with AI functionalities, many manufacturers and notified bodies have raised questions about how to manage the overlapping requirements of these regulations. This new guidance, developed jointly by the MDCG and the Artificial Intelligence Board (AIB), provides practical recommendations to ensure coherent and effective implementation.
Why Is This Guidance Important?
Until now, specific risks associated with AI systems — such as dynamic performance, ethical concerns, data bias, or cybersecurity — were not thoroughly addressed in MDR/IVDR. The AI Act introduces an additional layer of requirements that manufacturers must now integrate into the regulatory lifecycle of their products.
This document helps clarify:
How to ensure simultaneous compliance with MDR/IVDR and the AI Act
What responsibilities manufacturers have at each stage of the device lifecycle
When an AI-based software update may be considered a substantial modification
Key Points from MDCG 2025-6
Scope and Classification: AI systems integrated into medical devices may be classified as high-risk systems under the AI Act.
Lifecycle and Risk Management: Manufacturers must continuously manage AI performance and safety, complementing MDR/IVDR obligations.
Quality Management System (QMS): AI Act requirements must be incorporated into the existing QMS for the medical device.
Enhanced Technical Documentation: Technical files must include all elements necessary to demonstrate dual compliance.
Bias Prevention: The AI Act requires strict controls to ensure AI systems are trained with robust, representative, and ethical data.
Transparency, Cybersecurity, and Human Oversight: Requirements are reinforced to ensure explainability, traceability, and human control over AI systems.
Post-Market Surveillance: Monitoring must cover AI system performance over time, with mechanisms for early detection of failures or deviations.
How Smart MDR Can Help
Smart MDR is already supporting several medical device manufacturers with AI components in preparing for the new AI Act requirements and updating their technical documentation and QMS.
We offer:
Integrated MDR/IVDR/AI Act analysis
Technical documentation updates
QMS adaptation
Strategy for substantial modifications
Audit preparation
If your company develops medical devices with AI — or plans to introduce them to the European market — contact us to ensure a compliant, safe, and strategic approach.
Be Smart. Be Compliant.
Access the full document below.
