Glossary · EU medical devices: MDR
AI in medical devices (MDR, IVDR and AI Act)
Also known as: AI-enabled medical device, Medical device AI (MDAI), AI medical device software
Under the EU AI Act (Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744), an AI system that is a medical device or IVD, or a safety component of one, and that requires notified-body conformity assessment under the MDR or IVDR is a high-risk AI system under Article 6(1), because both regulations are listed in Annex I Section A. The AI Act requirements apply to such systems from August 2, 2028 and are assessed within the MDR or IVDR conformity assessment by the notified body.
- EU
- MDR
- IVDR
- AI
In one sentence
AI in medical devices: AI that is or is part of a notified-body-assessed device is high-risk under the AI Act from August 2, 2028, assessed within MDR or IVDR.
Example
A manufacturer of class IIa AI software that flags suspected fractures on X-rays keeps one set of technical documentation covering MDR Annex II and the AI Act, and plans for its notified body to assess both in one procedure once the AI Act requirements apply.
How it applies
- Qualification first: Whether AI software is a device at all is decided under the MDR or IVDR: see medical device software and MDCG 2019-11. Classification then usually follows Rule 11, which places most diagnostic or therapeutic decision support in class IIa or higher.
- High-risk trigger: It is the need for notified-body involvement under the MDR or IVDR that makes the AI system high-risk under Article 6(1). A class I device assessed by the manufacturer alone does not meet this condition. See Annex I Section A and Section B.
- Timing: For devices, the AI Act high-risk requirements apply from August 2, 2028. The MDR and IVDR requirements apply now, regardless of the AI Act.
- One assessment: The notified body checks the AI Act requirements as part of the MDR or IVDR conformity assessment, and a single set of technical documentation is allowed. MDCG 2025-6 explains how the two frameworks fit together.
- Changes and learning: Model updates must be assessed against the MDR or IVDR change rules and, for the AI Act, against the substantial modification concept. Monitoring for AI drift belongs in the post-market surveillance plan.
- Technical documentation: Add the AI-specific content, such as data governance, training and test data, performance metrics, human oversight and logging, to the existing device documentation rather than keeping a parallel file; see technical documentation (AI Act).
Medical device AI vs. AI used by the manufacturer
AI that fulfills a medical purpose for patients is regulated as or within a device. AI that a manufacturer uses internally, for example to draft complaint summaries or plan production, is not a device; it falls under quality system software validation (see CSV and CSA) and, where relevant, other AI Act obligations. Label each AI function in your documentation with the regime that applies.
Compared with the USA
The FDA regulates AI-enabled device software functions within its existing premarket pathways. A predetermined change control plan under section 515C of the FD&C Act lets a manufacturer authorize planned model changes in advance; the FDA finalized its guidance on PCCPs for AI-enabled device software functions in December 2024. The EU has no identical instrument, so planned changes are discussed with the notified body.