The Medical Device Coordination Group ("MDCG") has recently published guidance on the interplay between the AI Act and the MDR/IVDR.
Background and objective
The MDCG has recently published the guidance document MDCG 2025-6 on the Interplay between the Medical Devices Regulations and the Artificial Intelligence Act ("Guidance").
The Guidance is presented in the form of a living FAQ and offers a first set of answers to the most frequently asked questions from manufacturers regarding the combined application of the MDR (EU 2017/745), the IVDR (EU 2017/746) and the new Artificial Intelligence Act (EU 2024/1689).
The Guidance aims to support implementation of the AI Act in the medical device sector and clarifies which obligations apply, how overlap should be managed, and how duplicative efforts can be avoided.
Scope and classification of AI-enabled medical devices
The AI Act applies to medical devices that are or contain an AI system, provided that the system qualifies as "high-risk" in accordance with Article 6(1) of the AI Act.
An AI system qualifies as high-risk under the AI Act if it constitutes a medical device or serves as a safety component of one, and is subject to third-party conformity assessment by a notified body under the MDR or IVDR.
Importantly, classification under the AI Act as "high-risk" does not affect the risk class assigned under the MDR or IVDR. Rather, it is the MDR/IVDR classification that determines whether the AI system qualifies as high-risk under the AI Act.
Integration of AI Act requirements into existing processes
To reduce regulatory burden, manufacturers are encouraged to integrate certain AI Act obligations - such as those related to risk management, quality systems, and post-market monitoring - into existing MDR or IVDR documentation and quality systems. This is expressly permitted under Article 8(2) of the AI Act.
However, requirements specific to AI, such as data governance, transparency, bias mitigation, and logging capabilities, must still be addressed in full. Even if integrated structurally into MDR/IVDR procedures, compliance with both frameworks must be ensured.
Conformity assessment and dual compliance
Where an AI system qualifies as high-risk under both the MDR/IVDR and the AI Act, the conformity assessment is primarily conducted under the MDR or IVDR. In such cases, AI Act obligations - particularly those relating to quality and risk management - must be taken into account as part of that assessment.
While this may reduce duplication, manufacturers remain responsible for meeting all applicable requirements under both frameworks. The Guidance does not currently specify how notified bodies should coordinate across the two frameworks, and further clarification on this point is expected.
There are ongoing calls from industry for clearer alignment between the AI Act and the medical device regulations, along with requests to extend certain deadlines. These measures are intended to avoid unintended regulatory burdens and to safeguard both innovation and patient access. For example, MedTech Europe has called for coherent implementation to unlock the full potential of AI in healthcare, as highlighted in their statement of 1 August 2025: "One year of AI Act: MedTech Europe calls for coherent implementation to unlock the full potential of AI in healthcare."
Performance validation of AI-enabled medical devices
The AI Act does not introduce new requirements for clinical investigations or performance evaluation, which remain governed exclusively by the MDR and IVDR. However, it does require validation of AI system performance, including accuracy and robustness, as part of overall conformity. This distinction is particularly relevant for medical device manufacturers, who should treat the AI Act's validation requirements as complementary to, rather than duplicative of, MDR/IVDR obligations.
The Guidance also clarifies that real-world testing of high-risk AI systems - i.e. use in clinical settings before CE marking - is permitted under the AI Act only if carried out in accordance with MDR/IVDR rules.
The AI Act thereby functions as a horizontal framework that complements, but does not override, sector-specific requirements for medical devices.
Next steps for manufacturers
Manufacturers of AI-enabled medical devices should assess whether their product qualifies as a high-risk AI system and identify gaps between existing MDR/IVDR compliance and AI Act requirements.
Where dual compliance is required, early regulatory engagement will be essential. To support this, the DMA will, for example, offer free 1:1 regulatory guidance from 22 September 2025 on the joint application of the AI Act and the MDR/IVDR for start-ups, SMEs, and Danish-based research and educational institutions.
You can find more information on the DMA's website (in Danish): Regulatorisk vejledning til medico-virksomheder. You are also welcome to contact Plesner's Regulatory Life Science team for any related questions.
In addition, manufacturers should be aware of the upcoming deadlines: while the AI Act will be implemented in stages, the specific provisions relevant to AI-based medical devices - classified as high-risk AI systems - will take effect from 2 August 2027 and will require full compliance, including conformity assessment, from that date.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
