Article 11 of Machinery Regulation 2023/1230: the obligations of the manufacturer of partly completed machinery
Direct answer: Article 11 of Regulation (EU) 2023/1230 governs the obligations of the manufacturer of partly completed machinery — a related product intended to be incorporated into machinery or assembled with other partly completed machinery to form machinery, but which cannot in itself perform a specific application. The manufacturer must draw up the relevant technical documentation under Annex IV, issue a declaration of incorporation (not an EU declaration of conformity), and provide assembly instructions with the partly completed machinery, in addition to keeping that documentation for ten years and cooperating with market surveillance authorities.
Article 11 rounds out the catalogue of obligations we examined in the article on Article 9 for the manufacturer of complete machinery, adapting it to a product that, by definition, is not functionally autonomous: partly completed machinery. Understanding this category is essential for manufacturers of components, motors, hydraulic systems or robotic modules sold to be integrated into final machinery built by third parties — a very common scenario in complex industrial supply chains.
What is partly completed machinery under Regulation 2023/1230?
Partly completed machinery (related product to be incorporated): an assembly which is almost machinery but which cannot in itself perform a specific application, since it is intended only to be incorporated into other machinery or other partly completed machinery, or assembled therewith, to form machinery to which the Regulation applies.
The essential difference from complete machinery is functional: partly completed machinery lacks the operational autonomy to fulfil a specific application on its own. Motors, gearboxes, braking systems, robotic arms without their own controller, or hydraulic units intended for integration into a production line are typical examples of partly completed machinery regulated under Article 11.
What technical documentation does Article 11 require?
Article 11(1) requires the manufacturer of partly completed machinery to draw up the relevant technical documentation describing the essential health and safety requirements of Annex III that have been applied and satisfied, as well as those not yet satisfied because they depend on final assembly with the machinery into which it will be incorporated. This documentation must be kept for ten years from the placing on the market of the partly completed machinery or, where several units are produced, from the placing on the market of the last unit.
- Relevant technical documentation under Annex IV, identifying which EHSRs have been applied and which remain to be met by the manufacturer carrying out the integration.
- Declaration of incorporation, stating which essential requirements have been applied and satisfied, and specifying that the partly completed machinery must not be put into service until the final machinery into which it is incorporated has been declared to conform.
- Assembly instructions, explaining how the partly completed machinery must be integrated into the final machinery without compromising health or safety.
How does a declaration of incorporation differ from an EU declaration of conformity?
The EU declaration of conformity, required from the manufacturer of complete machinery under Article 9(2), certifies that the machinery satisfies all the essential health and safety requirements applicable to it and allows the CE marking to be affixed. The declaration of incorporation, by contrast, does not authorise CE marking of the partly completed machinery: it merely states which EHSRs have been met at that stage and expressly warns that the partly completed machinery must not be put into service until it has been incorporated into final machinery that is itself declared to conform as a whole.
| Aspect | Complete machinery (Art. 9) | Partly completed machinery (Art. 11) |
|---|---|---|
| Conformity document | EU declaration of conformity | Declaration of incorporation |
| CE marking | Yes, mandatory | Not applicable |
| Standalone putting into service | Allowed after full assessment | Prohibited until integrated into final machinery |
| Mandatory additional documentation | Full instructions manual | Assembly instructions |
| Document retention | 10 years (Art. 9(3)) | 10 years (Art. 11(1)) |
Affixing CE marking to partly completed machinery under the assumption that a declaration of incorporation is equivalent to an EU declaration of conformity. Article 11 never authorises CE marking of partly completed machinery: final conformity is only certified once the complete, integrated machinery passes its own conformity assessment procedure under Article 25.
What information must the assembly instructions include?
Article 11(1) requires the assembly instructions accompanying partly completed machinery to describe the conditions to be met for correct incorporation into the final machinery, without compromising health and safety. These instructions must be drafted in a language that can be easily understood by the manufacturer who will integrate the partly completed machinery, and must enable that manufacturer to identify which EHSRs remain to be verified after assembly.
What other obligations does Article 11 place on this manufacturer?
Article 11(2) refers, where relevant, to several of the general obligations set out for manufacturers of complete machinery in Article 9: identification on the product (name, registered trade name or registered trademark and postal contact address), traceability through a type, batch or serial number, immediate action if the manufacturer finds that partly completed machinery already placed on the market does not conform to the documentation and instructions provided, and cooperation with market surveillance authorities requesting information or documentation to verify conformity.
Draw up the relevant technical documentation
Identifying which EHSRs from Annex III are met and which depend on subsequent assembly.
Issue the declaration of incorporation
Warning that the partly completed machinery must not be put into service until integrated into the final machinery.
Provide clear assembly instructions
Enabling integration of the partly completed machinery without compromising health or safety.
Keep the documentation for ten years
From the placing on the market of the partly completed machinery or of the last unit produced.
Monitor and cooperate after placing on the market
Act immediately in the event of non-conformity and respond to requests from market surveillance authorities.
IgeraIndustria in action: distinguishing partly completed machinery from complete machinery
A manufacturer of hydraulic units for industrial presses, who sells its product to integrators who install it in complete production lines, asked whether it needed to draw up an EU declaration of conformity and affix CE marking to its unit before shipping it to the integrating customer.
How IgeraIndustria resolves it
Question:
"Do we need to affix CE marking to our hydraulic unit before shipping it to the integrator who will install it in their press?"
IgeraIndustria answers:
"No. If your hydraulic unit cannot perform a specific application on its own, it is partly completed machinery under Art. 11, and CE marking does not apply. You must draw up the relevant technical documentation, issue a declaration of incorporation stating which EHSRs are met, and provide assembly instructions for the integrator. CE marking is only affixed to the final machinery, once the integrator completes its own conformity assessment procedure."
Is your product partly completed machinery or complete machinery?
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In summary: Article 11 and the manufacturer of partly completed machinery
- Partly completed machinery cannot perform a specific application on its own and is intended to be incorporated into final machinery.
- The manufacturer must draw up relevant technical documentation, issue a declaration of incorporation, and provide assembly instructions.
- Partly completed machinery never carries CE marking or its own EU declaration of conformity.
- Documentation must be kept for ten years from the placing on the market of the last unit.
- The manufacturer must act immediately in the event of non-conformity and cooperate with market surveillance authorities.
Frequently asked questions about Article 11
Can an electric motor be partly completed machinery?
It depends on whether the motor, on its own, can perform a specific application. If it is intended to be integrated into other equipment and does not operate autonomously for a defined use, it is considered partly completed machinery under Article 11 and requires a declaration of incorporation and assembly instructions, not an EU declaration of conformity.
Who affixes the final CE marking when a product is made up of several items of partly completed machinery?
The manufacturer who assembles the various items of partly completed machinery to form the final machinery, to which the Regulation applies as a whole, is the one who must complete the conformity assessment procedure under Article 25, draw up the EU declaration of conformity, and affix the CE marking, under Article 9.
What happens if the manufacturer of partly completed machinery fails to provide assembly instructions?
This is a direct breach of Article 11(1), which makes it mandatory to accompany the partly completed machinery with assembly instructions. It also makes it harder for the integrating manufacturer to correctly complete its own risk assessment and EU declaration of conformity for the final machinery.
Can partly completed machinery be put into service independently?
No. The declaration of incorporation itself must expressly warn that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared to conform with the provisions of Regulation (EU) 2023/1230.
How long must the manufacturer of partly completed machinery keep the documentation?
Ten years from the placing on the market of the partly completed machinery or, where several units are manufactured, from the placing on the market of the last unit produced — matching the timeframe Article 9(3) sets for manufacturers of complete machinery.
How does IgeraIndustria help with compliance under Article 11?
IgeraIndustria lets you check in seconds whether your product qualifies as partly completed machinery or complete machinery under the Regulation, and which exact documents — declaration of incorporation, assembly instructions or EU declaration of conformity — apply to each case.
Turn Article 11 into an operational checklist
IgeraIndustria tells you what documentation is missing before you ship your partly completed machinery to the integrator.
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Last updated: July 2026 | Author: Jordi Bassols, Industrial Safety Engineer, COEIC registered | Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery (OJ L 165, 29.6.2023), Article 11 and Annexes III and IV. This article is for informational purposes only and does not constitute legal or engineering advice. | IgeraIndustria — try free for 14 days. EUR-Lex — Regulation (EU) 2023/1230 This content is for informational purposes only and does not constitute legal or engineering advice. For conformity assessment of your machinery, consult a notified body or a qualified industrial safety engineer.