Regulatory Briefing

The Omnibus deferred Annex III.
It did not touch Article 50.

Five days before the deadline the whole sector had marked, the rules changed. Most summaries published since report a general reprieve. There was no general reprieve, and the difference is the part that binds you today.

Lunara Society  ·  Independent AI governance and certification
Counts on this page are computed live at the moment you load it.

What actually happened

On 24 July 2026 the Digital Omnibus on AI, Regulation (EU) 2026/1744, was published in the Official Journal. It entered into force on 27 July, six days before the EU AI Act's original 2 August high-risk deadline.

It moved two things and deliberately left a third where it was. Almost every summary written since collapses all three into a single sentence about the AI Act being postponed, which is how a compliance team ends up relaxed about an obligation that is already enforceable against them.

Moved

High-risk obligations

Risk management, data governance, logging, human oversight and conformity assessment. Annex III standalone systems deferred by sixteen months. AI embedded in products already regulated under Annex I legislation, including medical devices under the MDR, deferred by a further year beyond that.

Annex III  →  2 December 2027
Annex I  →  2 August 2028
Held

Article 50 transparency

A system that communicates with a person must disclose that it is AI. Synthetic content must be marked in a machine-readable format so it is detectable downstream as artificially generated. Unchanged, unpostponed, and enforceable now.

In force since 2 August 2026
Up to EUR 15,000,000 or 3% of worldwide turnover

The practical effect is an inversion. The obligation most organisations were preparing for has considerably more runway than they think. The one almost nobody was reviewing already applies.

Three distinctions that decide your date

Annex III or Annex I

If your system is a medical device under the MDR, or otherwise a safety component of a product already covered by EU product-safety legislation, it does not enter through Annex III at all. Its high-risk obligations fall under Article 6(1) and apply from 2 August 2028, not December 2027. Advisors quoting a single high-risk date for every client are wrong for a large share of them.

MDR conformity is not Article 50 evidence

These are separate regimes with separate assessments. A notified body does not assess Article 50, and a CE mark does not evidence it. Organisations that have invested heavily in MDR compliance are among the most likely to assume this is covered. It is not.

Provider or deployer

A hospital or company that builds an AI system internally and makes it available to patients or customers becomes a provider under the Regulation, not merely a deployer. The obligation set is materially different. This is the distinction most often missed by institutions that research and operate at the same time.

What is enforceable today

The instrument below computes from the application dates set by each legal instrument at the moment this page loads. Nothing in it is typed by hand.

Regulatory Clock

Article 50 of the EU AI Act is in force.

Transparency obligations have applied since 2 August 2026.

Why this reaches you outside the EU

The Act binds on output, not on establishment. A provider located anywhere is subject to Article 50 if the output of its system is used in the European Union, whether or not it holds an entity there.

There is a second-order consequence that matters more commercially than the penalty does. European procurement has been tightening against non-EU suppliers, and it rarely arrives as a written rule. It arrives as preference for local vendors and as tender questions that are cheap to ask and expensive to answer: who governs this system, who is accountable when it is wrong, and who can confirm that other than the vendor.

A supplier answering with its own documentation is asserting. A supplier answering with an independent certification and a public register entry the buyer can query directly is evidencing. On a panel that needs a defensible reason to choose between two capable suppliers, that is the reason they write down.

Sources

Every claim on this page is checkable. We would rather you checked it than took our word.

Where does your deployment actually sit?

Score your systems against the obligations that bind them today, with the articles cited. Five minutes, no account required.

Open the Risk Scorer