EU: Dual Application of MDR/IVDR and AI Act for AI-Based Medical Devices

The Medical Device Coordination Group (MDCG), in collaboration with the Artificial Intelligence Board (AIB), has released MDCG 2025-6, a joint guidance document detailing how the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the new Artificial Intelligence Act (AIA) must be applied in tandem to Medical Device Artificial Intelligence (MDAI) systems.

The document establishes that a MDAI qualifies as a “high-risk AI system” under Article 6(1) AIA if both of the following conditions are met:

1. The AI system is either a safety component of the device or the AI system is the medical device itself, and

2. The device is subject to third-party conformity assessment by a Notified Body under MDR or IVDR.

Crucially, it is the MDR/IVDR classification that determines whether the AIA applies—not the other way around. Under Article 8(2) AIA, manufacturers may embed AIA-mandated testing, monitoring, and documentation into existing MDR/IVDR processes (e.g. quality management systems, technical documentation, post-market surveillance), as long as full compliance with both regulatory frameworks is ensured.

The guidance provides clarity on:

• the distinction between “deployer” (AIA) and “user” (MDR/IVDR),

• data governance with attention to bias mitigation and data quality,

• requirements for human oversight, and

• obligations for transparency and explainability of AI behavior.

Structured as an FAQ, MDCG 2025-6 is an evolving document intended to support consistent and efficient implementation. For MDAI manufacturers, it is a critical step in preparing for full compliance with the AIA from August 2, 2027 onward.

Source:

EC: Latest updates - MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025)