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AI safety functions in machinery: conformity after the Digital Omnibus on AI

Machines whose safety functions rely on machine learning face stricter conformity assessment under the Machinery Regulation. The Digital Omnibus on AI, signed on 8 July 2026, also changed how the AI Act applies to such machinery.

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Answers are written by a language model solely from this base's documents, with numbered sources. They can be wrong and aren't legal, medical or financial advice: check the sources before any important decision.

Self-evolving safety functions are in Annex I, Part A

Annex I, Part A lists safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions. It also lists machinery with embedded systems of that kind that have not been placed on the market independently, in respect of those systems only.

For Part A categories, the manufacturer must use EU type-examination (module B) followed by conformity to type (module C), full quality assurance (module H) or unit verification (module G). Internal production control (module A) is not one of the options.

What the Digital Omnibus on AI changed

Regulation (EU) 2026/1744 moves the Machinery Regulation from Section A to Section B of Annex I to the AI Act, a sectoral approach intended to avoid overlaps. For that machinery, the AI Act applies only through the provisions referred to in its Article 2(2).

Article 8 of the Machinery Regulation now requires the Commission to adopt delegated acts adding requirements for high-risk AI systems to Annex III. These must reflect Chapter III, Section 2, and Articles 17, 19, 72 and 73 of the AI Act, and apply by 2 August 2028.

Risk assessment for autonomous behaviour

Annex III requires the risk assessment to cover foreseeable hazards arising from the intended evolution of self-evolving behaviour or logic over the machine's lifecycle. It also covers risks from interactions between machines arranged to function as an integral whole.

The human-machine interface must be adapted to the foreseeable characteristics of operators, including for machinery with self-evolving behaviour designed to operate with varying levels of autonomy.

Frequently asked questions

Which standards can be used for AI safety functions before machinery-specific ones exist?

A new Article 20(10) provides that, until such standards or common specifications exist under the Machinery Regulation, high-risk AI systems that comply with those under Articles 40 and 41 of the AI Act are presumed to conform with the related Annex III requirements.

When did the Digital Omnibus on AI enter into force?

Regulation (EU) 2026/1744 was signed in Strasbourg on 8 July 2026. It entered into force on the third day after its publication in the Official Journal of the European Union.

How long does the Commission's power to adopt these AI delegated acts last?

For the delegated acts under the third paragraph of Article 8, the power is conferred for five years from 27 July 2026 and is tacitly extended unless the Parliament or the Council objects. Either institution can revoke it at any time.

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MCP URL
https://kopik.io/api/mcp?base=eu-robot-cobot-machinery-safety
Claude Code, Cursor and other clients
Claude Code
claude mcp add --transport http kopik-eu-robot-cobot-machinery-safety "https://kopik.io/api/mcp?base=eu-robot-cobot-machinery-safety" --header "Authorization: Bearer kpk_…"
JSON config (mcpServers)
{
  "mcpServers": {
    "kopik-eu-robot-cobot-machinery-safety": {
      "url": "https://kopik.io/api/mcp?base=eu-robot-cobot-machinery-safety",
      "headers": {
        "Authorization": "Bearer kpk_…"
      }
    }
  }
}

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curl
curl -X POST https://kopik.io/api/v1/bases/eu-robot-cobot-machinery-safety/query \
  -H "Authorization: Bearer kpk_…" \
  -H "Content-Type: application/json" \
  -d '{"question": "Your question here", "mode": "answer"}'

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