Does Your Robot Cell Need Its Own CE Marking? The EU Machinery Regulation 2023/1230 for Integrators Supplying Europe
Usually, yes. The EU Machinery Regulation (EU) 2023/1230 defines an assembly of machines that are ‘arranged and controlled so that they function as an integral whole’ to achieve the same end as machinery in its own right. The CE marks on the robot arm, the light curtains and the conveyors cover those products, not the cell. If your organisation supplies the finished cell to a customer in the EU, you are very likely its manufacturer and must carry out the cell-level conformity assessment.
Scope of this guide: EU law only
Everything below concerns the EU framework, which applies to machinery placed on the EU market or put into service in the EU. The United Kingdom has its own machinery regime, which the Kopik base does not cover, so this article makes no claim about cells placed on the UK market or installed in UK plants: check the official UK guidance for those. The European Commission's machinery page itself points stakeholders to separate ‘Brexit’ sectoral guidance notices.
- Until 19 January 2027: machinery placed on the EU market must comply with the Machinery Directive 2006/42/EC (European Commission machinery sector page).
- From 20 January 2027: Regulation (EU) 2023/1230 applies (Article 54) and the Directive is repealed (Article 51(2)).
- Since July 2026: Regulation (EU) 2026/1744, the ‘Digital Omnibus on AI’, has amended the Machinery Regulation on AI-based safety components.
The definition that turns a cell into ‘machinery’
Article 3(1) of the Regulation (consolidated text of 29 May 2026) lists six kinds of machinery. Point (d) reads: ‘assemblies of machinery referred to in points (a), (b) and (c), or of partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole’.
Take a worked example. A UK integrator builds a machine-tending cell for a plant in the Netherlands: a six-axis robot, a gripper, two CNC machines, a part buffer, perimeter fencing with interlocked doors and a safety laser scanner, all sequenced by a single cell controller. The parts serve one purpose (loading and unloading the CNCs) and are controlled together. That is the textbook Article 3(1)(d) assembly. Point (f) closes a common loophole: an assembly missing only the upload of its application software is still machinery.
The risk nobody else has assessed
Annex III, Part B of the Regulation requires the manufacturer's risk assessment to include ‘risks resulting from interactions between machinery’ that are arranged and controlled to function as an integral whole. The robot supplier assessed the robot; the scanner supplier assessed the scanner. Only the cell manufacturer can assess what happens when the robot reaches into the CNC while an operator opens the buffer door.
Manufacturer, importer, authorised representative: who is who
The Regulation's definitions decide who signs the declaration of conformity:
Roles under Regulation (EU) 2023/1230, Article 3
| Role | Definition (summary) | Typical case for a robot cell |
|---|---|---|
| Manufacturer, point 18(a) | Manufactures, or has designed or manufactured, and markets under its own name or trade mark | Integrator delivering a turnkey cell under its brand |
| Manufacturer, point 18(b) | Manufactures and puts into service for its own use | Factory that assembles its own cell from bought-in equipment |
| Importer, point 20 | Established in the EU; places a product from a third country on the EU market | EU company bringing in a cell built outside the EU |
| Authorised representative, point 19 | Established in the EU, with a written mandate from the manufacturer | Optional: Article 12 says a manufacturer ‘may’ appoint one |
Two limits are worth knowing. The authorised representative's mandate can never include designing to Annex III or drawing up the technical documentation (Article 12(1)); those stay with the manufacturer. And an importer or distributor who puts the cell on the market under its own name, or modifies it in a way that might affect compliance, becomes a manufacturer itself (Article 17).
The manufacturer's to-do list for the cell
- Carry out the iterative risk assessment set out in Annex III, Part B: determine the limits of the cell, identify hazards, estimate and evaluate risks, then eliminate or reduce them in the order of priority the Annex lays down.
- Compile the technical documentation of Annex IV, Part A, including copies of the EU declarations of conformity of incorporated machinery and, for partly completed machinery, its declaration of incorporation and assembly instructions (points (j) and (k)).
- Apply the conformity assessment procedure required by Article 25 for the cell's category.
- Draw up the EU declaration of conformity (Article 21; a single declaration where several EU acts apply) and affix the CE marking before placing on the market or putting into service (Article 24).
- Mark the model or type, year of construction and serial number (Article 10(5)), and a single contact point with a postal address and a digital contact (Article 10(6)).
- Supply the instructions for use (Article 10(7)): digital is allowed if access is marked on the machine, the format can be printed and saved, and it stays online for the expected lifetime and at least 10 years; a free paper copy within one month if requested at purchase.
- Keep the file and declaration for at least 10 years (Article 10(3)).
Self-assessment or notified body?
Annex I lists the categories that need a stricter procedure, and robot cells as such do not appear in it. Machinery outside Annex I uses internal production control (module A) under Article 25(4). The picture changes when the cell is, or incorporates, a listed category:
- Annex I, Part B includes presses (including press brakes) for the cold working of metals with manual loading or unloading whose moving parts may travel more than 6 mm at more than 30 mm/s, injection or compression moulding machinery with manual loading or unloading, protective devices designed to detect the presence of persons, and logic units to ensure safety functions. Module A is only open if harmonised standards or common specifications covering all relevant requirements were applied (Article 25(3)).
- Annex I, Part A includes safety components, and embedded systems, ‘with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions’. These require EU type-examination plus conformity to type, full quality assurance or unit verification (Article 25(2)), with no self-assessment.
For AI-driven safety functions, note the July 2026 change: Regulation (EU) 2026/1744 tasks the Commission with adding AI requirements to Annex III through delegated acts that ‘shall apply by 2 August 2028’, and in the meantime presumes conformity for high-risk AI systems that follow harmonised standards or common specifications under Articles 40 and 41 of the AI Act.
What the base cannot tell you
Be wary of anyone quoting detailed figures from ISO 10218 or ISO/TS 15066 as if they were law: they are paid standards and their content is not in the base. Equally, there is no official Commission guide to Regulation 2023/1230 yet; the Commission's published guide (edition 2.3, April 2024) covers Directive 2006/42/EC. And the Commission warns that so-called voluntary certificates have no value as proof of compliance. You can test specific scenarios against the sources in the robot and cobot machinery safety base, for example: ‘Our robot cell is built from a robot that already carries CE marking. Do we still have to CE-mark the whole cell again?’
Check your cell against the actual text
The base indexes the consolidated Machinery Regulation, the Digital Omnibus amendment, the European Commission and EU-OSHA pages, plus US OSHA and NIOSH robotics guidance. Answers come with citations.
Frequently asked questions
Is a robot cell made from CE-marked parts automatically CE compliant?
No. Article 3(1)(d) of Regulation (EU) 2023/1230 makes an assembly that functions as an integral whole a machine in its own right, which needs its own conformity assessment, EU declaration of conformity and CE marking.
Who is the manufacturer of a cell I build in my own EU factory?
You are. Article 3(18)(b) covers anyone who manufactures machinery and puts it into service for their own use.
Does a UK-built robot cell sold into the EU need an EU importer?
Under Article 3(20), the importer is the EU-established person who places a product from outside the EU on the EU market, and Article 13 sets its checks. An authorised representative is optional under Article 12. The base does not cover UK domestic rules.
Can the instructions for a robot cell be supplied only as a PDF or QR code?
Yes, under Article 10(7), if access is marked on the machine, the format allows printing and saving, and the instructions stay online for the expected lifetime and at least 10 years. A buyer may request a free paper copy at purchase, delivered within one month.
When does the Machinery Regulation replace the Machinery Directive?
On 20 January 2027. Directive 2006/42/EC is repealed from that date, and products lawfully placed on the market under it before then can continue to be made available (Articles 51 and 52).
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