Brief · Use case · Regulatory
Regulatory Change Overview.
LiveOverviewUnderstand what a new regulation means for a product class, with the terms defined, how it interacts with the rules already in force, and what would change the picture.
Regulatory Change Overview is a ready-made use case for Regulatory. It ships under the Overview template.
For regulatory affairs leads facing a rule they have not read. The overview states the main thing to understand and how sure we are, defines each term once, shows how the regimes depend on each other and names the signposts to watch. Dates and obligations are cited to the legal text or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
How does the EU AI Act, as amended in 2026, apply to AI-based diagnostic software that is already regulated as a medical device under the MDR, and from what dates do the obligations apply?
What the overview covers
Two regimes apply to the same product. The overview defines the terms once, shows how the regimes depend on each other, and dates each obligation.
| Part of the picture | What the overview explains | Where it looks |
|---|---|---|
| Terms | What a provider, a deployer and a high-risk AI system are, and how the manufacturer of the MDR corresponds to the provider of the AI Act.2 | The Commission’s joint guidance on the interplay between the two regimes. |
| How the regimes fit together | That a device which is or contains a high-risk AI system meets both regimes at once, across its life cycle, and that the AI Act’s data quality and bias requirements are folded into risk management and evaluation.2,3 | The same guidance, and the guidance on how software is qualified and classified as a medical device. |
| Dates | From when the obligations apply to AI systems embedded in regulated products such as medical devices, after the 2026 amendment.1 | The 2026 regulation that amends the AI Act. |
| What is most likely to change | The guidance that is still developing and the dates that have already moved once.1,2 | The Commission’s guidance pages and the Official Journal. |
What the overview does
The dates, with their source. Regulation (EU) 2026/1744, the Digital Omnibus on AI, was published in the Official Journal on 24 July 2026. It amends the AI Act, and its recital 40 sets 2 August 2028 for high-risk systems that are safety components of products covered by Annex I legislation, which includes medical devices. The overview gives the date, says where in the text it comes from, and marks any other date it could not confirm as a gap.1
Two regimes, one product. The Commission’s guidance of 19 June 2025 maps the MDR and IVDR vocabulary onto the AI Act and sets out the questions that arise when a device is also a high-risk AI system. The overview uses it to define the terms a newcomer needs and to show where the two sets of requirements overlap.2
Is the software a device at all? Whether software is a medical device, and in which class, follows its intended purpose under the MDR. The overview states that test and cites the guidance on the qualification and classification of software.3
Most likely wrong. Dates in this area have already moved once, and the guidance is described by its publisher as a first set of answers that will be updated. The overview says which statements are most exposed to change.1,2
Recommended length
Comprehensive
A newcomer needs the terms defined and the way two regimes depend on each other shown. Comprehensive adds the how-it-works section and the terms table.
You can pick another length on the form. The other two stay available.
Assumptions the overview checks
The overview says which assumptions its conclusions rest on and names the most fragile one in its first paragraph. Examples for this subject:
- The software is both a medical device under the MDR and a high-risk AI system under the AI Act.
- The date that applies to the product is the Annex I date as amended.
- The Commission’s guidance has not been revised since the version the overview cites.
Standards, guidance and sources
The amended AI Act
- Regulation (EU) 2026/1744 (Digital Omnibus on AI), dated 8 July 2026 and published on 24 July 2026, amending Regulations (EU) 2024/1689, 2018/1139 and 2023/1230.1
Interplay with the medical device rules
The decision practice behind the memo itself is on the template page.
What gets flagged
Any date that is not in the text of the amended Act, any obligation attributed to guidance that is not binding, and any statement that depends on a revision of the guidance the overview did not see.
What arrives
- Bottom line
- Why it matters now
- What we know
- How it works
- What it means
- Terms and actors
- What would change this
What it will not do
It explains and does not recommend. If you need a recommendation on what to do next, the Decision Memo is the template for it.
It is not legal advice and it does not decide how an obligation applies to your product. Your regulatory counsel and notified body do.
It does not recommend an action. An overview explains; it does not decide. When you have a choice to make, a Decision Memo is the template for it.
It is one specialist’s reading of public sources. Check any figure you will act on against its primary source.
It does not replace reading the regulation, the filing or the guideline it cites.
References
- [1] European Parliament and Council. Regulation (EU) 2026/1744 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 to simplify the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI). Dated 8 July 2026; Official Journal, 24 July 2026. The 2 August 2028 date was read in recital 40; the text of the amended Article 113 was not reached.
- [2] Medical Device Coordination Group and AI Board. MDCG 2025-6: FAQ on the interplay between the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act. 19 June 2025. Title and date were read on the page; the content is as summarized in search excerpts.
- [3] Medical Device Coordination Group. MDCG 2019-11: Guidance on qualification and classification of software in Regulation (EU) 2017/745 and Regulation (EU) 2017/746. October 2019. The group has issued a revision; check the current version.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
To edit a saved template, open New → Brief → From template, or the library rail on the service form.