Machinery Regulation 2023/1230: what changes for robot users

The EU Machinery Regulation applies from 20 January 2027. What it means for a plant that runs robots, and what to ask your suppliers before then.

Motion1 Inc. · 2026-11-03

Not legal advice. This article summarises the published text of the Regulation. For a decision about your own site, talk to your safety advisor or a notified body.

Machinery Regulation 2023/1230 in one paragraph

Regulation (EU) 2023/1230 on machinery replaces the Machinery Directive 2006/42/EC. It applies from 20 January 2027, and the Directive is repealed on the same day. As a regulation it applies directly in every Member State, so there is no national version to wait for. It keeps the familiar model of essential health and safety requirements, harmonised standards and the CE mark, and adds rules for software, cyber threats to safety functions, safety functions that use machine learning and digital paperwork.

Most of its obligations fall on the manufacturer. A plant takes on those obligations in two cases: when it builds machinery and puts it into service for its own use, or when it makes a substantial modification. The second case decides most of what you need to do as a robot user.

What changes from the Machinery Directive on 20 January 2027

The date. The Regulation was first published with 14 January 2027. A corrigendum published on 4 July 2023 corrected it to 20 January 2027. Some older summaries still carry the wrong date.

What happens to machines you already have. Machinery placed on the market under the Directive before 20 January 2027 can still be sold and used after that date. The Commission says machinery placed on the market before the date must comply with the Directive, and its maker may also declare conformity with the Regulation. Robots already running on your floor do not need a new CE mark because the law changed. A substantial modification is a different matter (see below).

Software counts. A safety component can now be "physical or digital", software included. Machinery that is complete apart from the software for its task still counts as machinery. For a humanoid that receives a new skill on site, both points matter.

Control systems must resist tampering. The control system has to withstand "reasonably foreseeable malicious attempts from third parties" that could lead to a hazard. It must also keep a log of interventions and of each version of safety software uploaded after delivery, for five years after each upload, for authorities who ask.

Higher-risk categories get a third party. Annex I lists machinery that a notified body has to assess. Two new entries on that list concern machine learning (next section).

Robots that learn: safety functions with AI behaviour

The Regulation separates two kinds of software. Software that only executes programmed functions falls outside the new AI rules. Software that learns and changes its behaviour, which the text calls "self-evolving behaviour using machine learning approaches", falls inside them when it ensures a safety function.

Third-party assessment. Annex I, Part A, now lists:

safety components with fully or partially self-evolving behaviour using machine learning that ensure safety functions;
machinery with such systems embedded, for those systems only.

For anything in Part A, the manufacturer cannot self-certify. Article 25(2) requires EU type-examination, full quality assurance or unit verification, each involving a notified body.

Limits on what a learning robot may do. Annex III, section 1.2.1, says the control system of a machine with self-evolving behaviour must:

keep the machine within its defined task and movement space;
record data on safety-related decisions and keep it for one year, for authorities who ask;
let people correct the machine at all times to keep it safe.

The same section bars changes to the limits of the safety functions, including changes the machine generates itself during a learning phase, where they could lead to a hazard.

What this means on your floor. A robot that learns a task is not automatically an Annex I product. The test is whether the learning part ensures a safety function. A humanoid can learn how to pick a part while a separate, conventional safety system handles slowing and stopping near people. Ask your supplier which applies to the robot you are getting, and in writing.

The AI Act link. In July 2026 the EU adopted the Digital Omnibus on AI, Regulation (EU) 2026/1744. It moves machinery to a sectoral approach: the AI Act's requirements for high-risk AI in machinery will be written into the Machinery Regulation's Annex III through delegated acts, which must apply by 2 August 2028. It does not move the 20 January 2027 date. Our safety and EU compliance guide covers the AI Act itself.

Substantial modification: when your line becomes new machinery

This is the part of the Regulation that reaches the plant most directly.

The definition. A substantial modification is a change to machinery, made by physical or digital means after it was placed on the market or put into service, that:

the manufacturer did not foresee or plan, and
affects safety by creating a new hazard or increasing an existing risk, and
requires new guards or protective devices that change the existing safety control system, or extra measures for stability or mechanical strength.

The consequence. Whoever makes a substantial modification is treated as the manufacturer (Article 18). That person has to run the conformity assessment, draw up the declaration and take responsibility for the modified machine. If the change affects only one machine in an assembly, the obligations can be limited to that machine, as long as the risk assessment shows it.

What does not count. The recitals say repair and maintenance that do not affect compliance are not substantial modifications.

Why it matters when a robot joins a line. The Regulation counts an assembly of machines arranged and controlled to work as an integral whole as one machine. Put a robot into an existing line, link it to the line's controls and change the guarding, and you may have made a new assembly or substantially modified the old one. "Digital means" covers software: an update the maker did not plan that adds a hazard can qualify too.

Questions to settle before each change:

Did the robot or line manufacturer foresee this use, layout or update in their risk assessment?
Does the change add a hazard or raise a risk?
Does it need new guards, new protective devices or changes to the safety controls?
Who in the project will carry the manufacturer's obligations if the answer is yes?

Answer them before installation, not after. If nobody agrees who the manufacturer is, the obligations still land on someone, usually the party that made the change.

Digital instructions and the declaration of conformity

Instructions can be digital (Article 10(7)). When they are, the manufacturer must:

mark on the machine, its packaging or an accompanying document how to find them;
provide them in a form you can print, download and save, so they are available during a breakdown;
keep them online for the machine's expected lifetime and at least 10 years after it was placed on the market.

Paper on request. If you ask at the time of purchase, the manufacturer must send paper instructions free of charge within one month. Ask in the purchase order, not afterwards. Instructions must be in a language users can easily understand, as set by the Member State.

The declaration of conformity can be a link (Article 10(8)). The machine comes either with the EU declaration of conformity or with an internet address or machine-readable code pointing to it in the instructions. A digital declaration must stay online for the machine's lifetime and at least 10 years.

Still moving. In May 2025 the Commission proposed a further amendment on digitalisation, COM(2025) 504, which also touches the Machinery Regulation. On 2 November 2026, EUR-Lex still listed it as a proposal. It does not change the application date.

What to ask your robot supplier and integrator

For any robot, robot cell or line change you put into service from 20 January 2027:

Which law does the CE mark rest on? The Directive if the machine was placed on the market before 20 January 2027, the Regulation after.
Does any safety function use machine learning? If yes, ask for the notified body certificate under Annex I, Part A. If no, ask for that in writing.
What is the defined task and movement space? Get it in the documentation. It is the boundary your own risk assessment works from.
How are updates handled? Ask which updates the manufacturer foresees in its risk assessment, how you will be told about them, and where the five-year log of safety software versions lives.
Who is the manufacturer of the cell or line? Name the party that signs the declaration for the assembly, before installation.
Where are the instructions and the declaration? Get the link or code, check that it works, and ask for paper copies in the order if you want them.
Which harmonised standards were applied? These show how the supplier meets the essential requirements, and they feed your own risk assessment.

Every Motion deployment includes a risk assessment for your site. It is one of the steps in your first humanoid deployment, week by week. The questions above work for any supplier.

Checklist before January 2027

[ ] List every robot or line change you plan to put into service after 20 January 2027.
[ ] For each, record whether the CE mark will rest on the Directive or the Regulation.
[ ] Ask each robot supplier whether any safety function uses machine learning, and get the answer in writing.
[ ] For learning safety functions, get the notified body certificate before delivery.
[ ] Add the "substantial modification" questions to your change-management procedure.
[ ] Name who signs the declaration for every new cell or modified line.
[ ] Put "paper instructions" in purchase orders where your site needs them.
[ ] Store the links or codes for digital instructions and declarations where maintenance can reach them during a breakdown.
[ ] Brief maintenance and IT that safety software updates are logged and must not be changed without the manufacturer.
[ ] Book a review of your risk assessments for any line where a robot will join after the date.

If you are planning a humanoid deployment that will go live after the date, send us the task and we will cover the compliance route on the call.

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