Partly Completed Machinery: Declaration of Incorporation

What is partly completed machinery under Article 3?

Article 3(10) of Regulation (EU) 2023/1230 defines partly completed machinery as an assembly which is not yet machinery, because it cannot in itself perform a specific application. It is only intended to be incorporated into or assembled with machinery, other partly completed machinery or equipment, to form machinery.

Recital 21 explains the "specific application" as the well-defined operations for which the product is designed. Ask what the product can do on its own, and what is still missing before it can do its job.

Partly completed machinery is within the scope of the Regulation (Article 2(1)), with its own manufacturer obligations in Article 11.

Examples: what is partly completed, and what is not

The typical example is a 6-axis industrial robot arm supplied without its gripper (end effector), guards and cell safety system. It has a drive and it moves, but by itself it does not palletize, weld or pick.

Some products look incomplete but are machinery under Article 3(1):

Our Machinery Regulation course uses a fictional running case to show how this works. Kestrel Automation, an invented US company, builds the KP-400 robotic palletizing cell. It buys the robot arm from a robot maker, who supplies it as partly completed machinery with a declaration of incorporation. Kestrel adds conveyors, guarding, protective devices and a safety PLC. The finished cell is machinery, and Kestrel is its manufacturer.

What must the manufacturer of partly completed machinery provide?

Article 11 sets the obligations. The starting point is design: the product must meet the relevant essential health and safety requirements of Annex III (Article 8, second paragraph; Article 11(1)). Under Annex III, section 1.1.1, the requirements apply insofar as they are relevant. They do not cover requirements that can only be met when the product is incorporated. The principles of safety integration in section 1.1.2 always apply.

A robot maker can deal with the strength of the arm and the brakes. It cannot decide the guard layout of a cell that does not exist yet, so that part is left to the integrator.

Technical documentation (Annex IV, Part B)

Before placing the product on the market, the manufacturer draws up the technical documentation in Annex IV, Part B (Article 11(2)). It includes, among other items:

• a complete description of the product and its intended function once incorporated
• the risk assessment documentation, with the list of applicable essential requirements and the protective measures (Annex III, Part B, point 5 applies the general principles to this risk assessment)
• drawings, schemes and the explanations needed to understand them
• the harmonised standards or common specifications applied, and which parts if applied only partly
• calculation and test reports, production controls and a copy of the assembly instructions

The documentation and the declaration of incorporation are kept for at least 10 years after the product is placed on the market (Article 11(3)). Our guide to the technical file for CE marking explains how to organise such a file.

EU declaration of incorporation (Article 22 and Annex V, Part B)

The declaration of incorporation states that the relevant essential requirements have been fulfilled (Article 22(1)). By signing it, the manufacturer takes responsibility for the compliance of the product (Article 22(4)). Its model structure in Annex V, Part B includes:

• identification of the product and of the manufacturer, with a sole responsibility statement
• a sentence stating which Annex III requirements are applied and fulfilled, and that the documentation follows Annex IV, Part B (point 5)
• the standards or specifications applied, with their dates (point 6)
• an undertaking to send relevant information to national authorities on reasoned request (point 7)
• a statement that the product must not be put into service until the final machinery has been declared in conformity with the Regulation (point 8)

The declaration must be kept up to date and translated as required by the Member State (Article 22(2)). It can travel with the product, or the assembly instructions can give an internet address or machine-readable code where it can be found (Article 11(8)).

Assembly instructions (Annex XI)

Assembly instructions are written for the person who incorporates the product (Article 11(7)). Annex XI lists their content. It covers the conditions for correct incorporation, drawings and connection instructions, warnings about known misuse, the applicable essential requirements, stability and transport conditions, and maintenance information. The instructions may be digital, under conditions. If the integrator asks at the time of purchase, a paper copy must be provided free of charge within one month. The language is one the integrator can easily understand, as decided by the Member State concerned.

Does partly completed machinery carry the CE marking?

Partly completed machinery shall not bear the CE marking pursuant to Regulation (EU) 2023/1230. It shall be accompanied by the EU declaration of incorporation and the assembly instructions.

The CE marking rules in Article 24 apply to machinery and related products. The conformity assessment procedures of Article 25, including those with a notified body, also apply to machinery and related products. Article 11 does not refer to them for partly completed machinery.

The product may fall under another EU law that requires CE marking on its own. That CE marking does not attest conformity with the Machinery Regulation. Check every law that applies, as explained in CE Marking Fundamentals.

The product must still carry identification: designation, year of construction, model, and any serial or batch number (Article 11(5)). The manufacturer's name, postal address and a website, email or other digital contact are also required (Article 11(6)).

What the integrator must do with partly completed machinery

The company that builds the partly completed machinery into a final machine is the manufacturer of that machine (Article 3(18)). It takes on the obligations of Article 10 for the whole machine. In practice:

1. Read the declaration of incorporation: which requirements has the supplier fulfilled? The rest is your job.
2. Follow the assembly instructions and treat each condition as a design input.
3. Carry out the risk assessment for the complete machine, including interactions between its parts (Annex III, Part B, point 1).
4. Put the declaration of incorporation and the assembly instructions into your technical documentation (Annex IV, Part A, point (j)).
5. Run the conformity assessment for the complete machine, sign the EU declaration of conformity and affix the CE marking.

In the Kestrel example, the declaration of conformity covers the whole KP-400 cell, including the robot arm. Our guide to the EU declaration of conformity covers the content of that final declaration.

Check the transition too. Products placed on the market under Directive 2006/42/EC before 20 January 2027 may still be made available afterwards (Article 52(1), date as corrected by the corrigendum), so a robot arm from stock may come with a Directive declaration. A final machine placed on the market from 20 January 2027 must meet the Regulation. Check that the incorporated product allows the whole machine to meet Annex III, and ask suppliers early which declaration they will issue.

Common mistakes with declarations of incorporation

• Declaring a complete machine as partly completed. If the product can do its job once connected, fixed in place or loaded with its software, it is machinery. An authority can treat it as machinery without CE marking.
• Supplying a full cell with a declaration of incorporation because the customer connects it on site. On-site connection does not make a machine partly completed (Article 3(1)(b)).
• A vague point 5. If the declaration does not say which requirements are fulfilled, the integrator is left guessing.
• Thin assembly instructions. A catalogue manual without incorporation conditions does not meet Annex XI.
• Excluding the bought-in unit from the final declaration of conformity. The final declaration covers the complete machine.
• Losing the supplier documents. Keep the revision received with each batch in the file.

What changed from the Machinery Directive?

The basic approach is the same as under Directive 2006/42/EC. The correlation table in Annex XII of the Regulation shows where the provisions moved:

• the procedure for partly completed machinery: Article 13 of the Directive, now Article 11
• the declaration of incorporation: Annex II (section B) of the Directive, now Annex V, Part B
• the assembly instructions: Annex VI of the Directive, now Annex XI
• the technical documentation: Annex VII, Part B of the Directive, now Annex IV, Part B

The Regulation applies directly in all Member States. It also spells out several points in detail: conditions for digital assembly instructions, access to the declaration through an internet address or machine-readable code, a digital contact on the product, and the source code or programming logic of safety-related software on reasoned request. Importers and distributors of partly completed machinery have their own obligations in Articles 14 and 16. Check each point in the Regulation before you update your templates. The Commission's guide to application was still in draft as of October 2026 and is not legally binding.

For a wider comparison, see our guide on the Machinery Directive vs Regulation and the overview of Machinery Regulation 2023/1230 changes. The Machinery Regulation course works through the Kestrel case step by step.

Key points

• Partly completed machinery cannot perform a specific application by itself and is intended to be built into machinery (Article 3(10)).
• Its manufacturer meets the relevant Annex III requirements and prepares technical documentation per Annex IV, Part B.
• It is accompanied by the EU declaration of incorporation (Annex V, Part B) and assembly instructions (Annex XI).
• It shall not bear the CE marking pursuant to Regulation (EU) 2023/1230.
• The integrator becomes the manufacturer of the final machine, assesses the whole and issues the EU declaration of conformity.