Digital Omnibus sector guide

EU AI Act Product-Integrated AI Systems and the 2028 Timeline

If AI is embedded inside a regulated product, Regulation (EU) 2026/1744 sets 2 August 2028 as the application date for the Article 6(1) / Annex I product-integrated high-risk route. The practical issue is not only the date. It is how the product safety file, supplier evidence, technical documentation, and EU AI Act evidence plan fit together.

Use the product checklist Run the deadline router

Educational planning guide only. Not legal advice. Not a compliance guarantee. Regulation (EU) 2026/1744 is in force. The relevant Article 6(1)/Annex I high-risk provisions apply from 2 August 2028 under the consolidated AI Act.

Product-integrated AI systems map showing the 2028 application-date route, product safety file and EU AI Act evidence file — Product teams need a joined-up documentation route, not only a later date.

Quick answer

The 2028 track is a planning route for AI embedded in regulated products.

Regulation (EU) 2026/1744 is in force and sets 2 August 2028 as the application date for Article 6(1) / Annex I product-integrated high-risk systems. Product-sector rules still require route-specific review, including for medical devices, toys, lifts, machinery and watercraft.

So the real preparation task is to connect AI Act planning with the product safety route, the supplier evidence trail, and the technical file. Waiting for the final date without building the evidence map creates avoidable documentation debt.

Regulatory logic

What the official summaries say

Planning date

Regulation (EU) 2026/1744 sets 2 August 2028 as the application date for Article 6(1) / Annex I product-integrated high-risk systems.

Sector overlap

Council highlights medical devices, toys, lifts, machinery, and watercraft as sectors where overlap with sectoral legislation needed a compromise mechanism.

Guidance expectation

Regulation (EU) 2026/1744 adds a Commission guidance obligation to help economic operators minimise compliance burden for these product-linked high-risk systems.

Compliance team linking product safety documentation, supplier evidence, and EU AI Act records for an AI-enabled regulated product — The useful output is a joined-up evidence route across product, supplier, and AI governance files.

Decision table

What teams should separate clearly

Question	What to do	What not to assume
Is the AI function embedded in a regulated product?	Map the product type, product law route, AI function, and named owner.	Do not assume a general software-only route applies.
Which file will carry the evidence?	Connect the technical file, product safety documentation, supplier record, and AI Act note.	Do not leave AI evidence isolated from product documentation.
Is there sectoral overlap?	Record which sectoral requirements may cover similar AI-specific issues.	Do not assume overlap removes all AI Act work automatically.
What should be requested from suppliers?	Ask for intended purpose, instructions for use, testing summary, monitoring information, and change control.	Do not accept a generic marketing brochure as evidence.

Product-integrated checklist

Build the product AI evidence route in four steps

Step 1

Identify the product lane

Name the product and AI function.
Record the product law route and product owner.
Record whether the AI function appears safety relevant.
Separate currently applicable duties from future statutory application dates.

Step 2

Join the files

Create a bridge between the technical file and AI Act evidence note.
Link risk management, testing, logging, and change control.
Record supplier dependencies and open evidence gaps.
Assign owners for updates.

Step 3

Ask better supplier questions

Request intended purpose and system boundaries.
Request instructions for use and limitations.
Request testing and monitoring evidence.
Request change notices and version control process.

Step 4

Keep a source log

Log the source used for each planning assumption.
Record the consolidated current law and the route-specific application date.
Update when guidance or standards arrive.
Keep the decision owner and date visible.

Related EU AI Compass routes

Open the next tool or guide

Omnibus Deadline Router

Route one AI system to the relevant statutory application date.

Conformity Assessment Checklist

Review documentation and assessment steps for high-risk routes.

Technical Documentation Template

Structure the technical file and evidence owners.

IIoT Safety Validator

Stress test safety and risk assumptions in industrial AI contexts.

Digital Omnibus cluster

Use the cluster in the right order.

Start with the router, then open the guide that matches the application-date route: standards readiness, product-integrated AI, or SME and small-mid-cap relief.

TOOL · 3 MIN

Omnibus Deadline Router

Separate currently applicable duties from the 2026, 2027, and 2028 statutory application dates for one AI system.

GUIDE · 5 MIN

Standards Readiness After the Omnibus

Build evidence structures that can absorb harmonised standards and common specifications when they arrive.

GUIDE · 5 MIN · CURRENT PAGE

Product-Integrated AI Systems and 2028

Connect AI Act planning with the product safety file, supplier evidence, and sectoral-law overlap.

GUIDE · 5 MIN

Small Mid-Cap Relief After the Omnibus

Treat SME and small-mid-cap relief as a planning issue, not an exemption from records.

FAQ

Frequently asked questions

Is the 2 August 2028 date already final law?

Yes. Regulation (EU) 2026/1744 is in force and sets 2 August 2028 as the application date for Article 6(1) / Annex I product-integrated systems.

What does product integrated AI mean in this Omnibus context?

It refers to high-risk AI systems embedded in regulated products. The Commission summary gives examples such as lifts or toys. Council also discusses overlap with sectoral legislation in areas such as medical devices, toys, lifts, machinery, and watercraft.

Does the 2028 application date mean product teams can stop preparing now?

No. Product teams should use the extra time to connect the AI Act evidence file to the product safety file. The practical work includes intended purpose, technical documentation, change control, vendor evidence, testing rationale, logging, and the source review note.

Which sectors are most likely to care about this page?

Product manufacturers, medical device teams, machinery and industrial AI teams, toy and lift manufacturers, watercraft teams, product safety leaders, and any organisation whose AI function is embedded inside a regulated product.

How does sectoral law overlap with the AI Act here?

Regulation (EU) 2026/1744 provides an implementing-act mechanism to address specified overlaps where sectoral Union harmonisation law already contains equivalent AI-specific requirements. Apply it only through the relevant legal route; it is not a general exemption.

What should a deployer or buyer ask a product supplier now?

Ask for the system description, intended purpose, instructions for use, technical documentation route, testing summary, change control process, logging or monitoring information, and the supplier's current view of the AI Act and sectoral law overlap. Keep a dated vendor evidence trail.

Does this page determine whether my product is legally high risk?

No. This page is an operational planning guide. Final legal classification depends on the current consolidated legal text, the product, the AI function, applicable sectoral law, the conformity route, and qualified legal or regulatory review.

What should I do next after reading this page?

Run the Omnibus Deadline Router for one AI system, then create or update the product AI evidence file. If the AI function is embedded in a regulated product, connect the product safety file, supplier documentation, change log, and EU AI Act evidence plan before final standards or guidance arrive.