The Medical Device Coordination Group (MDCG) and the Artificial Intelligence Board (AIB) have collaborated to publish guidance on the application of the EU Artificial Intelligence Act to AI-powered medical devices under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). MDCG 2025-6 is an FAQ-style guidance document for manufacturers, notified bodies, and regulatory authorities, particularly for systems classified as high-risk under the AIA. In this context, it explains how they must comply with the common regulatory obligations for Artificial Intelligence in Medical Devices (MDAI).
First, what is MDAI? Let's clarify this.
What is MDAI?
MDAI, in the context of medical devices, stands for Medical Device Incorporating Artificial Intelligence. This term, which originated within the framework of European Union regulations, specifically encompasses the AI Act (AIA) and the MDR (Medical Device Regulation). Devices falling into this category are utilized in healthcare services for purposes such as diagnosis, supporting treatment decisions, image analysis, and risk assessment.
Under what conditions is an MDAI considered a high-risk AI system within the meaning of the AIA?
An MDAI is considered a high-risk AI system if it fulfills both of the following conditions, in accordance with Article 6(1) of the AIA:
- The MDAI is a safety component, or the AI system itself is a medical device, and
- the MDAI is subject to a conformity assessment by a body approved under the MDR/IVDR (see Table 1 below).
| Classification | Is the Notified Body involved? | Are the conditions for AIA High Risk (Article 6(1)) met? |
| MDR Class I (non-sterile, non-measuring, non-reusable surgical instruments) | No | No |
| MDR Class I (sterile, measuring, reusable surgical instruments) | Yes | Yes |
| MDR Class IIa, IIb, III | Yes | Yes |
| MDR Annex XVI10 | Yes | Yes |
| IVDR Class A (non-sterile) | No | No |
| IVDR Class A) | Yes | Yes |
| IVDR Class B, C, D | Yes | Yes |
| In-house facility according to Article 5(5) MDR/IVDR | No | No |
What risk management requirements are stipulated in the MDR/IVDR and AIA for high-risk MDAI?
The guideline recommends integrating MDAI into the Quality Management Systems (QMS), risk controls, and documentation of the MDR/IVDR.
- A continuously iterative risk management system is required, covering all product processes, including pre- and post-market activities, in accordance with the IVDR and AIA. It must aim to identify and mitigate risks to health, safety, and fundamental rights.
- The specific risk management requirements for MDAI must include continuous assessment, encompassing the analysis and mitigation of known and reasonably foreseeable risks to fundamental rights, data bias, and system integrity.
- High-risk MDAI must enable human oversight, provide explanations for their outcomes, and include clear instructions for the user.
- High-risk MDAI must be tested for their accuracy, robustness, and cybersecurity.
- In addition to supply chain transparency under the MDR/IVDR, the AIA mandates functional traceability, requiring automatic recording of system performance and behavior throughout its entire lifecycle.
For further information, please refer to „https://health.ec.europa.eu/latest-updates/mdcg-2025-6-faq-interplay-between-medical-devices-regulation-vitro-diagnostic-medical-devices-2025-06-19_en“.