The basics
The IVDR (Regulation (EU) 2017/746) has applied since 26 May 2022, with transition periods staggered by Regulation 2022/112 and extended by Regulation 2024/1860. AI-based IVDs must meet the IVDR and may also be high-risk AI under the AI Act. The joint MDCG 2025-6 / AIB 2025-1 FAQ (June 2025) covers both MDR and IVDR devices.
Which AI IVDs are high-risk?
| IVDR class | High-risk under the AI Act? |
|---|---|
| Class A sterile | Yes |
| Classes B, C, D | Yes |
| Class A non-sterile | No |
| In-house IVDs (Art. 5(5)) | No, but other AI Act duties such as prohibitions still apply |
The rule is the same as for devices: high-risk when a notified body is involved in conformity assessment.
IVD-specific points
- The IVDR uses performance evaluation rather than clinical evaluation, and performance studies can serve as real-world testing under the AI Act.
- The FAQ does not address companion diagnostics specifically.
- More guidance on in-house AI devices is planned.
- As for medical devices: one conformity assessment, one technical file, and AI Act quality elements integrated into the existing QMS.
Dates after the 2026 amendment
Annex I high-risk duties now apply from 2 August 2028 under Regulation (EU) 2026/1744 (previously 2 August 2027). The Commission’s December 2025 proposal to revise the MDR and IVDR (COM(2025) 1023) is still pending.
Reuse terms
Commission health pages are CC BY 4.0; the FAQ states it is not a Commission document. IVDR text on EUR-Lex is reusable with attribution, with the Official Journal authentic.
Using these sources in AI and RAG
- Tag each IVD by class to answer the high-risk question.
- Link performance evaluation documents to AI Act data governance and accuracy requirements.
- Note the 2028 date wherever the FAQ says 2027.
- Keep IVDR transition deadlines (by class) alongside AI Act dates.
- Label pending proposals.
Common mistakes
- Assuming Class A non-sterile AI IVDs are high-risk.
- Treating in-house AI as outside the AI Act entirely.
- Missing companion diagnostic questions not covered by the FAQ.
- Using the 2027 date.
Checklist
- IVD class mapped to AI Act status
- Performance studies planned as real-world testing
- Technical file covers AI Act items
- Dates updated
- In-house AI reviewed for prohibitions
How AskDona helps
AskDona checks your performance evaluation reports and technical documentation against IVDR and AI Act requirements together, with citations for each finding.
Run a sample IVDR and AI Act documentation 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
Are AI diagnostics high-risk under the AI Act? IVDR Class A sterile, B, C, and D devices are, when a notified body is involved.
Can performance studies count as real-world testing? Yes, according to the MDCG and AI Board FAQ.
When do the duties apply? From 2 August 2028, after the 2026 amendment.
Does the FAQ cover companion diagnostics? Not specifically.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| MDCG 2025-6 / AIB 2025-1 FAQ (PDF) | IVD high-risk criteria, performance studies |
| Commission: MDR/IVDR overview | IVDR dates, proposal |
| Council: AI Act final green light (Jun 2026) | Annex I date 2 Aug 2028 |
| European Commission: Legal notice | CC BY 4.0 |