The basics
The MDR (Regulation (EU) 2017/745) has applied since 26 May 2021. An AI medical device must meet the MDR, and it may also be a high-risk AI system under the AI Act. The key guidance is MDCG 2025-6 / AIB 2025-1, a June 2025 FAQ written jointly by the Medical Device Coordination Group and the AI Board. It is not legally binding.
When is an AI medical device high-risk?
Under AI Act Article 6(1), when two conditions are met: the AI is a safety component or is itself a device, and a notified body performs the conformity assessment.
| MDR class | High-risk under the AI Act? |
|---|---|
| Class I sterile, measuring, reusable surgical | Yes |
| Class IIa, IIb, III | Yes |
| Most Annex XVI products | Yes |
| Class I non-sterile, non-measuring | No |
| In-house devices (Art. 5(5)) | No |
The AI Act does not change MDR risk classes.
How compliance is combined
- One conformity assessment under the MDR; the notified body also checks AI Act requirements.
- One technical file.
- AI Act quality management elements can sit inside the MDR quality system.
- Data governance (Art. 10): representative, bias-checked datasets.
- Human oversight and transparency (Arts. 13-14), AI-specific cybersecurity, and real-world testing through clinical investigations.
- Changes planned and assessed in advance are not substantial modifications.
Dates after the 2026 amendment
The FAQ gave 2 August 2027 for Annex I (product-embedded) high-risk duties. The Digital Omnibus on AI (Regulation (EU) 2026/1744) moved this to 2 August 2028, and lets implementing acts limit duplication with sector law such as medical devices. Separately, the Commission’s proposal for a targeted MDR/IVDR revision (COM(2025) 1023, 16 December 2025) is still a proposal.
Reuse terms
Commission health pages are CC BY 4.0 under the Commission legal notice; the FAQ states it is not a Commission document. MDR text on EUR-Lex is reusable with attribution; only the Official Journal is authentic.
Using these sources in AI and RAG
- Index the MDR, AI Act, and FAQ as separate layers.
- Update the FAQ’s dates with a note on the 2026 amendment.
- Tag devices by class to answer the high-risk question.
- Map AI Act requirements into your MDR technical file structure.
- Keep proposals labeled until adopted.
Common mistakes
- Assuming all AI medical devices are high-risk.
- Planning two separate conformity assessments.
- Using the FAQ’s 2027 date.
- Treating the MDCG FAQ as binding.
Checklist
- Device class and notified body involvement checked
- AI Act requirements in the technical file
- QMS updated for AI Act elements
- Dates updated for 2028
- Layers separated in index
How AskDona helps
AskDona checks your technical file against MDR and AI Act requirements together, citing each article and showing where the evidence sits.
Run a sample MDR and AI Act technical file check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. The “conditions to check” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
Is my AI medical device high-risk under the AI Act? If it needs notified body assessment under the MDR, it generally is.
Do I need two conformity assessments? No. One MDR assessment covers AI Act requirements too.
When do AI Act duties apply to AI medical devices? From 2 August 2028, after the 2026 amendment.
Is MDCG 2025-6 binding? No, it is guidance.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| MDCG 2025-6 / AIB 2025-1 FAQ (PDF) | High-risk criteria, combined assessment |
| Commission: MDR/IVDR overview | MDR dates, COM(2025) 1023 |
| Commission: MDR/IVDR simplification proposal | Proposal |
| Council: AI Act final green light (Jun 2026) | Annex I date 2 Aug 2028 |
| European Commission: Legal notice | CC BY 4.0 |