Machinery Regulation 2023/1230: the AI-specific checklist for manufacturers

In short: Items 5 and 6 of Annex I, Part A apply only when a machine learning approach, self-evolving behaviour, and a safety function exist together. In such cases, a notified body is mandatory for the conformity assessment. The Regulation becomes applicable from 20 January 2027.

Who this checklist is for

This article is intended for design engineers, CE coordinators, and those responsible for technical documentation. This checklist does not replace a case-by-case assessment.

Step 1 — Determining self-evolving behaviour

Recital 55 excludes software incapable of learning or evolving from the specific requirements of items 5 and 6. A frozen model points away from these items, as machine learning is not synonymous with self-evolving behaviour. A binding classification for such models must be clarified with a notified body. This preliminary question determines the necessity of a third-party assessment.

Step 2 — Classification of safety components

Item 5 refers to safety components with self-evolving behaviour using machine learning, while item 6 covers the corresponding embedded systems. A clear distinction exists between a safety function, which protects people, and a quality function. For instance, a system identifying defects for a counter is a quality function, whereas a system triggering an emergency stop is a safety function. Annex II distinguishes software ensuring safety functions from self-evolving machine learning components.

Step 3 — Selecting the conformity assessment route

For machinery under Annex I, Part A, the manufacturer may choose module B plus C, module H, or module G, as module A is not available even with harmonised standards. Machinery under Annex I, Part B, may use module A only if the standards cover all relevant requirements. For machinery not listed in Annex I, module A is permitted by the manufacturer. Each of the three options for Annex I, Part A involves a notified body.

Step 4 — Requirements for Design and Construction

Annex III contains the essential health and safety requirements for design and construction. The applicable requirements follow from the risk assessment, including the evolution of self-evolving behaviour. Particularly relevant for AI are section 1.1.9 regarding protection against corruption and section 1.2.1. This latter section covers the learning phase, a tracing log, and a one-year recording of data.

Step 5 — Technical Documentation Requirements

Technical documentation is governed by Annex IV, Part A. This documentation must show how the machinery meets the requirements of Annex III and include the risk assessment. It additionally requires the source code or programming logic of the safety software upon request by an authority. For sensor-controlled machinery, it includes a description of the system, data, and development processes.

Step 6 — Transition to the New Regulation

From 20 January 2027, the Regulation applies and the Directive is repealed on the same day. There is no choice between the two regimes. The date of placing on the market determines which regulation applies.

Step 7 — Interaction with the AI Act

The Machinery Regulation sits in Section B of Annex I to the AI Act. A delegated act will supplement Annex III of the Machinery Regulation by 2 August 2028. Items 5 and 6 of the Machinery Regulation remain unchanged.

Step 8 — Standardisation and Compliance

The Commission issued standardisation request C(2025) 129 on 20 January 2025. The status of harmonised standards must be checked before the declaration of conformity.

More on the deadlines: Digital Omnibus × Machinery Regulation: which deadlines actually apply to machinery now

The checklist to copy and paste

Self-evolving behaviour documented: The documentation must clarify whether the system exhibits fully or partially self-evolving behaviour.
Classification of items 5/6: A system falls under item 5 or 6 only if a machine learning approach, self-evolving behaviour, and a safety function exist together.
Assessment route: The manufacturer must determine the correct conformity assessment path, as module A is not available for items in Annex I, Part A.
Risk assessment requirements: The risk assessment must identify applicable Annex III requirements, specifically sections 1.1.9 and 1.2.1.
Technical documentation details: Documentation under Annex IV, Part A, must include data, development, testing, and validation processes.
Market placement date: The date of placing on the market must be checked against the 20 January 2027 deadline.
Future requirements: The status of the delegated act due by 2 August 2028 and the current state of standardisation must be monitored.
Classification date: The date of the latest classification for the system must be recorded.

Practical example: a camera application in injection moulding

From my work in customer support at an injection moulding machine OEM, I observed a camera used to detect part defects and report them to the control system. This application serves a quality function rather than a safety function. If the same camera were instead used to stop the machine via safety-related logic, it would fulfill a safety function. Such a configuration triggers Annex III, section 1.2.1 and Annex II, but does not automatically fall under item 5. Only the addition of self-evolving behaviour in operation would bring the system under item 5 according to Recital 55.

FAQ

Does every AI system in a machine have to be assessed by a notified body? No, a notified body is only required if the system combines a machine learning approach, self-evolving behaviour, and a safety function.

What is the status of a frozen model that does not keep learning? A frozen model points away from items 5 and 6 under Recital 55. Such cases must be clarified on a case-by-case basis with the notified body.

Is self-certification possible for item 5? No, the conformity assessment for items in Annex I, Part A, requires a notified body.

Where does the AI documentation belong? The relevant documentation is located in Annex IV, Part A, rather than Annex III.

What does the Digital Omnibus change? The Digital Omnibus moved the Machinery Regulation to Section B of the AI Act. It does not change the requirements for items 5 and 6 of the Machinery Regulation.

For your specific case

This information does not constitute legal advice or provide a binding classification. Please clarify your specific case with a notified body or your legal department.

Sources

More background: About me – 20 years in precision manufacturing, Meister, now software engineer.