Under the MDR and AI Act, medical device AI counts as high-risk when the system is a device or safety component and requires third-party conformity assessment. An AI medical device whose documentation lists MDR Class IIa therefore defaults to high-risk status. This does not mean that every medical AI system is high-risk.
Key Takeaways
- Article 6(1) requires both a covered product relationship and third-party conformity assessment; a medical label alone is insufficient.
- MDR Rule 11 connects software purpose and potential harm to device class, which determines notified-body involvement.
- AI Act high-risk status does not raise the MDR or IVDR class. Classification and application dates need separate attention.
When medical device AI qualifies as high-risk
Article 6(1) of Regulation (EU) 2024/1689 defines a product-based route to high-risk AI classification. The system must be a product, or a safety component of one, covered by Annex I legislation. That product must also require third-party conformity assessment before entering the market or being put into service.
Both conditions matter. A reference to medical use does not, by itself, establish this classification. Equally, the article covers systems placed on the market independently of the relevant product. Separate packaging does not remove the need to examine the product relationship and assessment requirement.
For your team, a useful review question is: which part of the documentation establishes each condition? Request the intended role of the AI alongside the assessment route. For broader context, read our guide to the EU AI Act and healthcare for clinicians.
How Annex I links the AI Act to MDR and IVDR
Annex I, Section A of the AI Act explicitly lists the Medical Devices Regulation, Regulation (EU) 2017/745. It also lists the In Vitro Diagnostic Medical Devices Regulation, Regulation (EU) 2017/746. These entries connect the device legislation to Article 6(1), without making every covered AI system automatically high-risk.
The second condition still asks whether third-party assessment is required. This is the distinction to preserve when a presentation reduces the rule to medical AI equals high-risk. The Annex I listing establishes the relevant legislation; the conformity-assessment requirement completes the test.
Product-based high-risk AI means a covered product relationship plus required third-party assessment. Keep that definition next to the device classification in your review notes. If you are also reading our FDA-authorized AI/ML device tracker explainer, return to the EU product test when considering this classification.
How Rule 11 connects software purpose to notified-body review
MDR Rule 11 classifies software according to its intended purpose and the consequences described in the rule. Software informing diagnostic or therapeutic decisions starts at Class IIa, with higher classes for specified potential harm. Physiological monitoring has its own criteria, while other software falls into Class I.
For decision-support software, decisions that may cause death or irreversible deterioration place the software in Class III. Decisions that may cause serious deterioration or surgical intervention place it in Class IIb. These distinctions concern the impact of the decisions described in Rule 11.
Monitoring software is Class IIa unless it monitors vital physiological parameters whose variations could create immediate patient danger. That exception places it in Class IIb. The following table summarizes Rule 11 and the MDR class-to-assessment connection.
| Intended purpose or impact | MDR class | Notified-body review |
|---|---|---|
| Information for diagnostic or therapeutic decisions, without the specified higher-harm impacts | IIa | Required |
| Decisions potentially causing serious deterioration or surgical intervention | IIb | Required |
| Decisions potentially causing death or irreversible deterioration | III | Required |
| Physiological monitoring, without the vital-parameter exception | IIa | Required |
| Vital-parameter monitoring where variations could cause immediate danger | IIb | Required |
| All other software under Rule 11 | I | Generally not required |
Read the Class I row carefully: generally is doing real work here. The classification outcome matters because Article 6(1) asks about required third-party assessment. Bring the intended-purpose wording and proposed class to counsel or the relevant regulator when checking a particular product.
Why high-risk AI status does not raise the device class
MDCG 2025-6 / AIB 2025-1, dated June 2025, confirms the two-condition test for medical device AI. It also makes the direction of classification explicit: MDR or IVDR classification determines whether the AI meets Article 6(1). AI Act high-risk status does not increase the device’s MDR or IVDR class.
The guidance’s non-exhaustive table links MDR Classes IIa, IIb and III to notified-body involvement and Article 6(1) high-risk status. Its Class I entry for non-sterile, non-measuring, non-reusable surgical devices shows neither notified-body involvement nor high-risk status under that article.
A device risk class and AI Act high-risk status are distinct classifications. Keep both visible in a procurement summary, with the reasoning connecting them. Avoid treating an AI Act label as evidence that a Class IIa device has become Class IIb or III.
Checking the sources for application dates
The original AI Act’s Article 113 set 2 August 2027 for Article 6(1) and its corresponding obligations. Recital 40 of Regulation (EU) 2026/1744, the Digital Omnibus on AI, states 2 August 2028 for Article 6(1) systems. It separately states 2 December 2027 for systems classified under Article 6(2).
Those dates refer to different classification routes. The medical-device discussion here concerns the product route under Article 6(1); the separate Annex III route should not be folded into it. Cite the recital accurately, and have counsel check the operative amendment before treating a date as your organization’s compliance deadline.
A later AI Act application date is not an answer to the MDR classification question. Classes IIa, IIb and III require notified-body assessment under the MDR. Frame your review around the product’s intended purpose, its device class, the assessment route and the relevant AI Act provision.
Before accepting a planning slide that says you have until 2028, request the legal provision behind it. Take the classification reasoning and date reference together to counsel or a regulator for a case-specific assessment.
Frequently Asked Questions
Does the AI Act change my device’s MDR or IVDR class?
No. MDCG 2025-6 states that AI Act high-risk classification does not change MDR or IVDR risk classification. The device classification helps determine AI Act status, rather than the reverse.
What makes medical device AI high-risk under Article 6(1)?
The AI must be a covered product or its safety component, and the product must require third-party conformity assessment. Annex I explicitly includes MDR and IVDR legislation. Both conditions must be met.
What does the Digital Omnibus recital say about timing?
Recital 40 of Regulation (EU) 2026/1744 states 2 August 2028 for Article 6(1) systems and 2 December 2027 for Article 6(2) systems. Confirm the operative amendment with counsel before applying a deadline to your case.
Does all MDR software require a notified body?
No. Rule 11 assigns other software to Class I, which generally avoids notified-body assessment. Classes IIa, IIb and III require it. The software’s intended purpose and the harm criteria in Rule 11 determine its classification.
Sources
- EU AI Act, Regulation (EU) 2024/1689, Articles 6 and 113 and Annex I, EUR-Lex, 2024.
- Medical Devices Regulation, Rule 11 and conformity assessment, EUR-Lex, 5 April 2017.
- MDCG 2025-6 / AIB 2025-1: MDR, IVDR and AI Act interplay, Medical Device Coordination Group and Artificial Intelligence Board, June 2025.
- Regulation (EU) 2026/1744, Digital Omnibus on AI, Recital 40, Official Journal of the European Union, 24 July 2026.
This article is for general information and is not legal, regulatory or medical advice.