Does Your Robot Cell Need Its Own CE Marking? Machinery Regulation 2023/1230 Explained for U.S. Integrators

Yes, in most cases. Under the EU Machinery Regulation (EU) 2023/1230, an assembly of machines that are arranged and controlled so that they function as an integral whole to achieve the same end is itself ‘machinery’. The CE marking on the robot, the safety scanner or the conveyor covers those products only, not the cell you built from them. If your U.S. company sells that cell under its own name into the EU, the Regulation treats you as its manufacturer, with the full set of manufacturer duties.

Which rules apply, and from when (EU vs. U.S.)

This article is about EU law. It matters to American integrators and machine builders when a cell is placed on the EU market or put into service there. It does not change anything for a cell installed in a U.S. plant, where OSHA rules and U.S. consensus standards apply instead (more on that below).

• EU, today (October 2026): machinery placed on the EU market before 20 January 2027 must comply with the Machinery Directive 2006/42/EC, according to the European Commission's machinery sector page.
• EU, from 20 January 2027: Regulation (EU) 2023/1230 applies (Article 54) and Directive 2006/42/EC is repealed with effect from that date (Article 51).
• EU, AI safety functions: Regulation (EU) 2026/1744 (the ‘Digital Omnibus on AI’, published 24 July 2026) amended the Machinery Regulation on how AI-based safety components are handled.
• U.S.: OSHA states that there are currently no specific OSHA standards for the robotics industry; general industry standards such as 29 CFR 1910.147 (lockout/tagout) and 1910.212 (machine guarding) apply.

Because the Regulation is a regulation and not a directive, EU-OSHA notes that it is directly applicable in Member States, with no national transposition. The definitions below are quoted from the consolidated text of 29 May 2026.

Why a robot cell counts as new ‘machinery’

Article 3(1) of the Regulation lists what counts as machinery. Point (a) is the familiar definition: an assembly with a drive system other than directly applied human or animal effort, with linked parts at least one of which moves, joined together for a specific application. Point (d) is the one that catches integrators: ‘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’.

A typical palletizing or machine-tending cell fits that description: a robot, an end-effector, infeed and outfeed conveyors, guarding and presence-sensing devices, all sequenced by a common control system to do one job. Point (f) adds that an assembly missing only the upload of the application software is also machinery, so ‘we ship it without the program’ does not change the analysis.

Who is the manufacturer of the cell?

Article 3(18) defines the manufacturer as any person who (a) manufactures products in scope, or has them designed or manufactured, and markets them under its name or trademark, or (b) manufactures them and puts them into service for its own use. For a U.S. integrator delivering a turnkey cell to an EU customer under the integrator's name, point (a) applies. For an EU plant that builds its own cell from purchased equipment, point (b) applies: the plant becomes the manufacturer.

Two other EU roles matter when the manufacturer is based in the United States. An importer is a person established in the EU who places a product from a third country on the EU market (Article 3(20)); under Article 13 the importer must check that the conformity assessment was done, the technical documentation exists and the CE marking is affixed. An authorised representative is an EU-established person with a written mandate from the manufacturer; Article 12 says a manufacturer ‘may’ appoint one, and the mandate can never include the design obligations or drawing up the technical documentation.

What the cell manufacturer must do under Article 10

Once you are the manufacturer of the cell, Article 10 applies in full. Here is a working checklist built from the text:

1. Design to Annex III. The cell must be designed and constructed in accordance with the essential health and safety requirements (Article 10(1)), starting with a documented risk assessment covering the whole assembly.
2. Technical documentation (Annex IV, Part A). It must include the risk-assessment documentation, drawings and circuit schemes, test reports, the instructions for use and, where appropriate, copies of the EU declarations of conformity of incorporated machinery and the declarations of incorporation and assembly instructions of any partly completed machinery.
3. Conformity assessment (Article 25) under the right procedure for the cell's category (see the next section).
4. EU declaration of conformity (Article 21) and CE marking (Article 24), affixed before the cell is placed on the market or put into service. Where several EU acts apply, a single declaration covers all of them (Article 21(3)).
5. Identification and contact details on the machine: model or type, year of construction, serial number (Article 10(5)), plus name, postal address and a website, email or other digital contact (Article 10(6)).
6. Instructions for use (Article 10(7)). They may be digital if access is marked on the machine, they can be printed, downloaded and saved, and they stay online for the expected lifetime and at least 10 years; a paper copy must be supplied free within one month if the buyer asks at the time of purchase.
7. Retention: keep the technical documentation and the declaration available to market surveillance authorities for at least 10 years (Article 10(3)).

Which conformity assessment route applies to a robot cell?

Article 25 sets three cases. Industrial robots and robot cells are not listed as such in Annex I, which lists the higher-risk categories. For machinery not listed in Annex I, Article 25(4) requires internal production control (module A), i.e. self-assessment by the manufacturer. Things change if the cell is, or contains, something that Annex I does list.

When a notified body is involved in procedures B+C, H or G, Article 24(3) requires its identification number to follow the CE marking. Notified bodies under the Regulation can be found in the Commission's NANDO system, and the rules on notified bodies have applied since 20 January 2024.

How this fits with your U.S. practice

On the U.S. side, the OSHA Technical Manual chapter on industrial robots describes a parallel logic, though it is guidance for compliance officers, not EU law. It identifies ANSI/RIA R15.06-2012 Part 2 as the safety standard for integrating robot systems into robot applications, states that it is the integrator's responsibility to ensure a risk assessment is completed and documented prior to commissioning and to provide its results to the employer, and recommends that employers write R15.06 and RIA TR R15.606 compliance into the statement of work, then verify it at site acceptance.

So a U.S. integrator already producing a task-based risk assessment and site acceptance records has raw material for an EU technical file. But the EU file must map each applicable Annex III requirement to the protective measures taken (Annex IV, Part A, point (b)), and the content of ISO 10218 or ISO/TS 15066 is not something this article, or the Kopik base, reproduces: those standards are paid documents.

Common mistakes we see in the questions integrators ask

• Assuming the robot maker's CE marking covers the finished cell.
• Shipping the cell ‘without software’ to avoid being the manufacturer: Article 3(1)(f) still treats it as machinery.
• Treating an EU customer's later rework of the cell as their problem only: a substantial modification makes the modifier a manufacturer under Article 18.
• Waiting for an official Commission guide: the Commission's published guide covers Directive 2006/42/EC (edition 2.3, April 2024); no equivalent guide to Regulation 2023/1230 has been published.
• Buying a ‘voluntary certificate’: the Commission warns that voluntary certificates are not a recognised means of proving compliance.

To check a specific clause, you can query the EU robot and cobot machinery safety base with questions like ‘Our robot cell is built from a robot that already carries CE marking. Do we still have to CE-mark the whole cell again?’ and get answers quoting the article.