The Medical Devices Coordination Group (MDCG) and the Committee on Artificial Intelligence (AIB) have joined forces and a guide to the application of the EU Artificial Intelligence Act on Artificial Intelligent Medical Devices published as part of the Medical Products Ordinance (MDR) and the In-Vitro Diagnostic Ordinance (IVDR). The MDCG 2025-6 Guide is a FAQ-style guide for manufacturers, notified bodies and regulators, especially systems classified as risk in the framework of the AIA. In this context, it is explained how to meet the common regulatory obligations for artificial intelligence in medical devices (MDai).
First of all: What is MDAI? We want to clarify that.
What is MDAI?
MDAI is related to medical devices for Medical Device Incorporating Artificial Intelligence (medical devices with artificial intelligence). This term, which was created within the framework of the European Union's regulations, consists in particular of the AI Act (AIA) and the MDR (Medical Device Regulation). Devices that fall into this category are used in health services, such as diagnosis, support treatment decisions, image analysis and risk assessment.
Under what conditions does an MDAI be considered a highly risky AI system in the sense of the AIA?
An MDAI is considered a highly risky AI system if it complies with both of the following AIA Article 6(1) conditions:
- The MdAi is a security component or the AI system itself is a medical device and
- the MDAI is subject to a conformity assessment by a body approved according to MDR/IVDR (see Table 1 below).
| Classification | Is the notified body involved? | Are the conditions of the AIA High Risk (Article 6(1)) met? |
| MDR class I (unsterile, non-measuring, non-reusable surgery) | No | No |
| MDR class I (sterile, measurable, reusable surgery) | Aye | Aye |
| MDR class IIa, IIb, III | Aye | Aye |
| MDR Appendix XVI10 | Aye | Aye |
| IVDR class A (unsterile) | No | No |
| IVDR class A) | Aye | Aye |
| IVDR Class B, C, D | Aye | Aye |
| Internal facility according to Article 5 Paragraph 5 MDR/IVDR | No | No |
What risk management requirements are defined in MDR/IVDR and AIA for high-risk MDAI?
The guide recommends integrating MDAI into the quality management systems (QMS), risk controls and documentation of the MDR/IVDR.
- A continuously repeated risk management system is required that covers all processes of the product, including pre-marketing and post-marketing in accordance with IVDR and AIA. It must be aimed at identifying and mitigating risks to health, safety and fundamental rights.
- The specific risk management requirements for MDAI must include continuous assessment, including the analysis and mitigation of known and reasonably predictable risks to fundamental rights, data distortions and system integrity.
- Highly risky MDai must enable human intervention, provide explanations of the results and contain clear instructions for the user.
- Highly risky MDAI must be tested for accuracy, robustness and cyber security.
- In addition to supply chain transparency within the MDR/IVDR, AIA must have functional traceability that requires automatic recording of system performance and system behavior throughout the lifecycle.
For more information, see “https://health.ec.europa.eu/latest-updates/mdcg-2025-6-FAQ-Interplay-Betwee . n-medical-devices-regulation-vitro-diagnostic-medical-devices-2025-06-19_en".