Brief · Use case · Regulatory
AI Device Guidance Scan.
LiveScanTake stock of guidance, standards and drafts on AI-enabled device software from US and EU authorities in the last year, with the boundary and borderline items named.
AI Device Guidance Scan is a ready-made use case for Regulatory. It ships under the Scan template.
For regulatory affairs leads tracking a moving field. You get the scope rule, each document with its issuer, category and maturity, how the field divides and what was not covered. Items are cited to the issuing authority or marked as gaps.
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The decision
What regulatory guidance documents, standards and draft proposals on AI-enabled medical device software have US and EU authorities published in the last twelve months?
What is scanned
The window decides what is in. A scan run in October 2026 with a twelve-month window starts in October 2025, so older documents that are still in force are listed as borderline and not as findings.
| Source | What it holds | What the scan does with it |
|---|---|---|
| FDA guidance and lists | FDA’s January 2025 draft guidance on AI-enabled device software functions (docket FDA-2024-D-4488) and its list of authorized AI-enabled devices, which FDA says is not exhaustive and reports at more than 1,600 devices as of September 2026.1,2 | The draft is before the window and is still a draft, so it is listed as borderline. The list is used as context. |
| EU legislation | Regulation (EU) 2026/1744, the Digital Omnibus on AI, published 24 July 2026 and amending the AI Act, which sets 2 August 2028 for high-risk systems that are safety components of products such as medical devices.3 | Inside the window, and listed with its date and the recital that sets the date. |
| EU guidance | The joint guidance of the Medical Device Coordination Group and the AI Board on the interplay between the device regulations and the AI Act, published 19 June 2025.4 | Before the window, listed as borderline because it is described as continuously developing. |
| Change control | FDA’s final guidance of December 2024 on predetermined change control plans for AI-enabled device software functions.5 | Before the window; listed as borderline because it interacts with the draft. |
What the scan does
A window with a start date. The scan states the date it was run and the date its window opens, and applies the window the same way to every item. A document that falls just outside the window but is still being revised is listed as borderline.
What is final and what is draft. Each item carries its status, because the difference decides what a team can rely on. The FDA lifecycle guidance of January 2025 is labeled a draft that is not for implementation, and the final guidance on predetermined change control plans is labeled final.1,5
Dates that have moved. The 2026 amendment moved the application date for high-risk systems embedded in regulated products to 2 August 2028. The scan lists the date with its source and notes that the guidance published before the amendment may still describe the earlier date.3
Maturity, as analyst judgment. Each item is labeled Established, Emerging or Weak signal, and the labels are judgment.
Recommended length
Standard
A twelve-month window in two jurisdictions gives a short list. Standard carries the boundary, the items, how they divide and what was not covered in about 1,300 words.
You can pick another length on the form. The other two stay available.
Assumptions the scan checks
The scan states the assumptions its boundary and its sources rest on, and the closing section says what they leave out. Examples for this subject:
- The window is applied to the publication date and not to the date a document takes effect.
- A document that FDA or the Commission describes as a draft or a first set of answers is listed with that status.
- No newer version of a listed document has been published since the scan date.
Standards, guidance and sources
United States
- FDA draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, January 2025.1
- FDA, List of Artificial Intelligence-Enabled Medical Devices.2
- FDA final guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, December 2024.5
European Union
The decision practice behind the memo itself is on the template page.
What gets flagged
Any document at the edge of the window, any draft that a team might mistake for a final text, and any date that the scan could not tie to the legal text.
What arrives
- Scope and boundary
- How the scan was run
- What is out there
- How the field divides
- What stands out
- What this does not cover
What it will not do
It does not rank or score the items it finds, and it does not recommend one. A scan lists what exists; when you need a view on it, run a Comparison or a Decision Memo on the items you choose.
It is not legal advice and it does not tell you which documents apply to your device.
It does not rank or score the items. A scan says what exists; it does not say which item is preferable.
It is a snapshot of one date. It does not monitor the field after that date.
It lists what it could find in the sources it names. Items in sources it could not open are listed as not covered.
References
- [1] U.S. Food and Drug Administration. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. Draft guidance, January 2025. Docket FDA-2024-D-4488. Read on 9 October 2026: draft, not for implementation.
- [2] U.S. Food and Drug Administration. Artificial Intelligence-Enabled Medical Devices, including the List of Artificial Intelligence-Enabled Medical Devices. FDA reports over 1,600 authorized devices as of September 2026. Read on 9 October 2026. FDA says the list is updated periodically and is not exhaustive.
- [3] European Parliament and Council. Regulation (EU) 2026/1744 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 (Digital Omnibus on AI). Dated 8 July 2026; Official Journal, 24 July 2026. The 2 August 2028 date was read in recital 40; the amended Article 113 was not reached.
- [4] Medical Device Coordination Group and AI Board. MDCG 2025-6: FAQ on the interplay between the MDR and IVDR and the Artificial Intelligence Act. 19 June 2025. Title and date read on the page; the content is as summarized in search excerpts.
- [5] U.S. Food and Drug Administration. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Final guidance, December 2024. Status and date from FDA’s announcement and webinar pages; the guidance text was not read.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
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