Partly Completed Machinery: Definition, Obligations, Declaration of Incorporation and Assembly Instructions

Its manufacturer follows Article 11, not the Article 25 conformity assessment procedure.

Partly completed machinery is one of seven product categories that Article 2(1) of Regulation (EU) 2023/1230 brings into scope.

The Regulation applies from 20 January 2027 and replaces Directive 2006/42/EC, which applies until 19 January 2027 through national law, so the rules move from Article 13 of the Directive to Article 11 of the EU Machinery Regulation.

The sections below cover the definition and borderline examples, the four deliverables of the manufacturer, the Annex XI assembly instructions, the missing CE marking, the integrator and the 2027 change. The table gives eight core rules with their legal basis.

What Is Partly Completed Machinery?

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

Three elements must all be present: an assembly, no specific application of its own, and incorporation as its only intended use.

Article 2(1), second subparagraph, of the Regulation (EU) 2023/1230 text on EUR-Lex brings partly completed machinery into scope next to machinery and the five related products, such as safety components and lifting accessories; together they are the "products within the scope of this Regulation". It is the seventh of the product categories of the Machinery Regulation.

Not Yet Machinery: How the Definition Changed

Article 2(g) of Directive 2006/42/EC called partly completed machinery "almost machinery", and Article 3(10) of Regulation (EU) 2023/1230 calls it "not yet machinery". The Directive 2006/42/EC text on EUR-Lex also contained the sentence "A drive system is partly completed machinery", and Article 3(10) of the Regulation no longer contains that sentence.

Annex XII of the Regulation, the correlation table, maps every provision on partly completed machinery to its new place. The six pairs are compared below.

Full correspondence: Machinery Regulation vs Machinery Directive.

Partly Completed Machinery Examples and Borderline Cases

The test is whether the assembly can perform its specific application by itself: if it can, it is machinery, even when parts for the installation site are missing.

The Commission's Guide to application of the Machinery Directive 2006/42/EC, Edition 2.3 (April 2024), names a robot without its end-effector or application as a typical example of partly completed machinery.

The same Guide treats an assembly that can perform its application but lacks only guards or safety components as machinery, which may not be placed on the market in that state.

Examples from the Guide to Application of the Machinery Directive (Edition 2.3) refer to the Directive.

Machines or partly completed machines arranged and controlled to function as an integral whole form one machine under Article 3(1)(d) of Regulation (EU) 2023/1230, and follow the rules for assemblies of machinery.

What Must the Manufacturer of Partly Completed Machinery Do?

Instead of an Article 25 conformity assessment procedure, the manufacturer of partly completed machinery identifies which Annex III requirements apply, draws up the relevant technical documentation under Annex IV, Part B, writes assembly instructions under Annex XI and issues an EU declaration of incorporation under Article 22 and Annex V, Part B of Regulation (EU) 2023/1230.

Article 11, "Obligations of manufacturers of partly completed machinery", applies from 20 January 2027. Under Article 12(1), second subparagraph, the Article 11(1) design duty and drawing up the technical documentation are not part of an authorised representative's mandate.

Identifying the Relevant Requirements (Annex III, Part B, Point 5)

Article 8 requires partly completed machinery to meet the relevant essential health and safety requirements of Annex III, and Annex III, Part B, point 5 states that "these general principles shall apply to the risk assessment carried out by the manufacturer of partly completed machinery".

Section 1.1.1 of Annex III applies the requirements insofar as relevant; section 1.1.2 always applies.

The result goes into Annex IV, Part B, point (b): the requirements that apply and the protective measures, with residual risks where appropriate. Annex VII, Part B of Directive 2006/42/EC already asked for this documentation. The five steps are set out under machinery risk assessment.

Relevant Technical Documentation (Annex IV, Part B)

Article 11(2) of Regulation (EU) 2023/1230 requires the relevant technical documentation set out in Annex IV, Part B, which has 13 points, (a) to (m). Point (b) holds the risk assessment documentation and point (i) a copy of the Annex XI assembly instructions.

The manufacturer keeps it for at least 10 years after the partly completed machinery has been placed on the market (Article 11(3)). Source code or programming logic of safety-related software is made available to competent national authorities on a reasoned request where they need it.

The Signed Declaration That Travels with the Assembly

The EU declaration of incorporation under Article 22 of Regulation (EU) 2023/1230 states which relevant Annex III requirements have been fulfilled, and Annex V, Part B lists its 9 points, one more than the 8 of Directive 2006/42/EC.

Point 8 bars putting into service until the final machinery has been declared in conformity, and the declaration accompanies the product or its internet address or machine-readable code is given in the assembly instructions (Article 11(8)). Content and model layout are explained under declaration of incorporation for partly completed machinery.

Assembly Instructions for Partly Completed Machinery (Annex XI)

Annex XI of Regulation (EU) 2023/1230 sets the content of the assembly instructions, which tell the person who incorporates the partly completed machinery the conditions for correct incorporation and the information needed for the instructions of the final machinery.

Annex XI replaces Annex VI of Directive 2006/42/EC (Annex XII), and a copy of the instructions sits in the technical documentation (Annex IV, Part B, point (i)).

What the Assembly Instructions Must Contain

Annex XI is built in three points: what the instructions are for, the minimum content, and access to the declaration. The three points are listed below.

1. Point 1, purpose: the conditions for correct incorporation, so that the finished equipment does not compromise the health and safety of persons.
2. Point 2, minimum content: at least 14 items, (a) to (n), where applicable; item (n) is new: "a clear description of the version of the assembly instructions which corresponds to the partly completed machinery model". Products for machinery under Annex III, chapters 2 to 6, need extra information.
3. Point 3, declaration: the EU declaration of incorporation itself, or the internet address or machine-readable code where it can be accessed.

Language, Digital Format and Paper Copies

Article 11(7) of Regulation (EU) 2023/1230 requires assembly instructions in a language easily understood by the person who incorporates the partly completed machinery, as determined by the Member State concerned.

Annex VI of Directive 2006/42/EC instead asked for an official language acceptable to the manufacturer of the final machinery or its authorised representative. In Germany, § 2 of the MaschinenDG requires German for the assembly instructions and the declaration of incorporation from 20 January 2027, as set out under machinery rules in Germany.

Digital assembly instructions are allowed and stay online for at least 10 years after placing on the market. They must be printable, downloadable and savable, also when embedded in the software of the partly completed machinery.

A paper copy remains available: when the person who incorporates asks at the time of purchase, the manufacturer supplies it free of charge within one month.

Why Partly Completed Machinery Carries No CE Marking

Partly completed machinery never bears the CE marking under Regulation (EU) 2023/1230, because no Article 25 conformity assessment procedure applies to it; the EU declaration of incorporation and the assembly instructions accompany it instead.

CE marking is affixed by the manufacturer or its authorised representative (Article 30(1) of Regulation (EC) No 765/2008) before the product is placed on the market or put into service (Article 24(2) of Regulation (EU) 2023/1230). For the final machine, that manufacturer is the integrator.

The final machinery carries the CE marking once the integrator, as its manufacturer, has applied the Article 25 procedure and drawn up the EU declaration of conformity (Article 10(2) and Article 24(2)). The CE marking therefore appears once, on the final machine, never on the incorporated assembly; see CE marking of machinery.

Who Completes the Machine: What the Integrator Must Do

The integrator who incorporates partly completed machinery into a machine is the manufacturer of that final machinery under Article 3(18) of Regulation (EU) 2023/1230 and carries the Article 10 duties in full: a risk assessment of the whole machine, the Article 25 procedure, the EU declaration of conformity and the CE marking. Article 10 also requires Annex IV, Part A documentation for the complete machine.

The risk assessment covers the interactions between components, including partly completed machinery (recital 33 and Annex III, Part B, point 1). The declaration of incorporation shows which Annex III requirements the supplier has already covered, and its point 8 ties putting into service to the final declaration of conformity.

Under Article 13(2) of Directive 2006/42/EC, the assembly instructions and the declaration accompany the partly completed machinery until it is incorporated and then form part of the technical file of the final machinery.

No article of Regulation (EU) 2023/1230 reproduces that paragraph; Annex IV, Part A, point (j) puts both documents into the final machine's technical documentation "where appropriate". The final machine's route is explained under conformity assessment under the Machinery Regulation.

How to Supply Partly Completed Machinery in Compliance

Supplying partly completed machinery under Regulation (EU) 2023/1230 takes six steps in this order, from classifying the product to keeping the signed declaration on file. The steps are listed below.

1. Classify the product against Article 3(10) and the borderline cases above.
2. Identify the relevant Annex III requirements through the Annex III, Part B, point 5 risk assessment.
3. Compile the Annex IV, Part B documentation, points (a) to (m).
4. Write the Annex XI assembly instructions in the language required under Article 11(7).
5. Sign the 9-point declaration of incorporation and make it reachable with the product or through an address or code.
6. Keep everything for at least 10 years and pass the assembly instructions and the declaration to the integrator, whose own route the machinery conformity route finder shows.

What Changes for Partly Completed Machinery on 20 January 2027

From 20 January 2027, partly completed machinery placed on the market must meet Regulation (EU) 2023/1230, and until 19 January 2027 the rules of Directive 2006/42/EC (Article 13, Annex VI and Annex II, point 1, section B) apply through national law; there is no parallel period in which the manufacturer may choose.

Products placed on the market under the Directive before 20 January 2027 may continue to be made available (Article 52(1)). Chapter VI, on market surveillance, has applied to them since 19 July 2023 (Article 52(1), second sentence, and Article 54). All dates appear in the Machinery Regulation timeline.

Three items need updating before the date: item (n) in the assembly instructions, the 9-point declaration, and the Member State language rule of Article 11(7).

Importers and Distributors of Partly Completed Machinery

Importers and distributors of partly completed machinery have their own duties under Articles 14 and 16 of Regulation (EU) 2023/1230, and whoever completes the machine takes on the Article 10 duties of its manufacturer. The three roles are listed below.

• Manufacturer of the final machine: Article 10, see manufacturer obligations under the Machinery Regulation.
• Importer: Article 14, records kept at least 10 years (Article 14(7)), see importer obligations for machinery.
• Distributor: Article 16, see distributor obligations for machinery.

The Commission proposed in COM(2025) 504 of 21 May 2025 (procedure 2025/0134(COD)) that declarations of incorporation be drawn up in digital format and reached through an internet address or machine-readable code (proposed Article 11(2) and 11(8)). It is pending as of 12 November 2026; see amendments to the Machinery Regulation.

Partly Completed Machinery Questions

Four questions recur about partly completed machinery: putting it into service on its own, how long its documents are kept, robots without an end-effector and digital-only assembly instructions.

Can partly completed machinery be put into service on its own?

No: the declaration of incorporation states that it shall not be put into service until the final machinery into which it is incorporated has been declared in conformity with the Regulation (Annex V, Part B, point 8).

How long must the documents for partly completed machinery be kept?

At least 10 years after the partly completed machinery is placed on the market, for the technical documentation and the declaration of incorporation (Article 11(3)). Digital assembly instructions and a digital declaration stay online for at least 10 years (Article 11(7), 11(8)), and importers keep their records for at least 10 years (Article 14(7)).

Is a robot without an end-effector partly completed machinery?

The Commission's guide to Directive 2006/42/EC names a robot without its end-effector or application as a typical example. Whether a given robot is machinery depends on whether it can perform its specific application by itself (Article 3(10)).

Can assembly instructions be supplied only in digital form?

Yes, Article 11(7) allows digital assembly instructions, but the person who incorporates the product can ask at the time of purchase for a paper copy, supplied free of charge within one month. Article 10(7) sets the same idea for the instructions of complete machines, as explained under machinery instructions and digital format rules.