Artifact GuideEU

EU Machinery Regulation Partly Completed Machinery

Partly completed machinery is not treated as finished machinery: it cannot itself perform a specific application and is intended to be incorporated into machinery, other partly completed machinery, or equipment.

This page helps separate partly completed machinery from finished machinery, prepare the EU declaration of incorporation and assembly instructions, and define what the final assembler must complete.

Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
Sections
5

Structured answer sets in this page tree.

Primary sources
2

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 25, 2026
Overview

Regulation (EU) 2023/1230 gives its own compliance path. The manufacturer must address the relevant essential health and safety requirements, keep technical documentation, and supply an EU declaration of incorporation and assembly instructions. The product should not be treated as complete machinery unless it can perform its intended specific application as placed on the market.

Section 1

Where the boundary sits

The boundary starts with function. is an assembly that is not yet machinery because it cannot itself perform a specific application. It is supplied for incorporation into machinery, other partly completed machinery, or equipment so that the resulting assembly becomes machinery.

Use that definition to avoid two common errors: selling an unfinished subsystem as if it were complete machinery, or forcing a finished machine into the route. If the product can already perform the specific application for which it is supplied, analyze it as machinery or a related product instead.

The Regulation's main product duties apply from 20 January 2027. A product placed on the EU market before that date must be assessed under Directive 2006/42/EC, while Article 52 allows products already placed on the market in conformity with the Directive to continue to be made available.

  • Record the intended specific application and explain why the supplied assembly can or cannot perform it on its own.
  • Identify what must be added by the incorporator: controls, guards, power transmission, software, integration, structural support, or other equipment. The Regulation names a drive system as an example of , but the example does not replace the specific-application and incorporation tests.
  • Keep the file separate from the final-machine conformity file, while making the handoff documents usable by the final assembler.
Section 2

Manufacturer package before placing on the market

For , the manufacturer does not use the finished-machinery package of EU declaration of conformity plus CE marking under the Regulation's machinery route. The partly completed machinery package is the EU declaration of incorporation and assembly instructions, supported by technical documentation for the relevant essential health and safety requirements that have been demonstrated.

The EU declaration of incorporation states that the relevant essential health and safety requirements have been demonstrated. It follows the model structure in Annex V, Part B, must be kept updated, and must be translated into the language or languages required where the is placed or made available on the market.

  • Do not affix Machinery Regulation CE marking merely because a file exists; CE marking belongs to machinery or related products after the applicable conformity route is completed.
  • Keep the technical documentation and EU declaration of incorporation available for market surveillance authorities for at least 10 years after the is placed on the market.
  • Include in the declaration the applied and fulfilled Annex III requirements, the standards or other technical specifications used, an undertaking and method for transmitting relevant information on reasoned authority request, and the statement that the must not be put into service until the final machinery has been declared in conformity.
  • If source code or programming logic is included in the technical documentation, prepare a controlled process for reasoned authority requests when that material is needed to check compliance.
  • An importer must verify the Annex IV Part B file exists and the required documents and identification are present before placing the item on the market. A distributor must verify the declaration of incorporation, assembly instructions, required language, and manufacturer or importer identification before making it available.
Section 3

Assembly instructions and digital handoff

Assembly instructions are not optional integration notes. They must describe the conditions needed for correct incorporation so that the resulting machinery, other , or equipment does not compromise health and safety, and where relevant domestic animals, property, or the environment.

The Regulation allows digital assembly instructions, but the manufacturer must tell the incorporator how to access them and provide them in a format that can be printed, downloaded, saved, and accessed during a breakdown. If the incorporator asks at purchase, paper assembly instructions must be provided free of charge within one month.

  • Include the incorporation limits: interfaces, loads, control assumptions, software version, residual risks, protective measures, and conditions the final assembler must satisfy.
  • State the language version supplied and make sure it is understandable to the person incorporating the , as determined by the relevant Member State.
  • Include the EU declaration of incorporation in the assembly instructions or provide the internet address or machine-readable code where it can be accessed.
  • When assembly instructions are digital, keep them accessible online for at least 10 years after placing the on the market; keep a digital declaration of incorporation accessible for the same minimum period.
Recommended next step

Review partly completed machinery handoffs

Check whether your subsystem is finished machinery or partly completed machinery, then align the declaration of incorporation, assembly instructions, technical documentation, and final-assembler handoff.

Section 4

Final assembler obligations

The final assembler cannot rely on the declaration of incorporation as a finished-machine declaration. The declaration of incorporation confirms the manufacturer's responsibility for the requirements it has demonstrated; the final assembler must still assess the resulting machinery and complete the conformity path for that final machinery where applicable.

The handoff should make that work practical. The final assembler needs enough information to integrate the without undermining safety and to decide what remains open: hazards created by the final configuration, safeguards not supplied with the subsystem, control-system integration, instructions for use, and the final technical documentation.

  • For supplier review, require the declaration of incorporation, assembly instructions, model identification, applicable standards or specifications, and a list of applied essential health and safety requirements.
  • For final-machine release, document which risks were closed by the supplier and which risks were assessed or tested by the final assembler.
  • Do not treat a supplier's declaration of incorporation as permission to place the final machinery on the market without the final conformity assessment, instructions, documentation, and marking decisions required for the completed product.
Section 5

Technical documentation checklist

Build the file around the requirements actually applied and fulfilled. The record should let a reviewer understand the assembly, the assessed risks, the protective measures already built in, the standards or specifications used, the test evidence, and the open conditions for safe incorporation.

Keep the checklist tied to the product model and configuration. A generic supplier certificate is weak evidence unless it identifies the , the version, the requirements covered, and the assumptions the final assembler must preserve.

  • Product identity: model, type, serial or batch logic, manufacturer details, intended incorporation, and configuration limits.
  • Engineering evidence: overall drawings, control-circuit drawings, relevant detailed drawings, calculations, test reports, certificates, and standards or technical specifications used.
  • Risk evidence: applied essential health and safety requirements, protective measures, residual risks, assumptions for final integration, and a copy or controlled reference to the assembly instructions.
  • Retention evidence: owner, location, access controls, authority-response process, and the 10-year availability rule for the technical documentation and declaration of incorporation.
  • Reassessment record: reopen the file when the intended incorporation, product function, interfaces, loads, controls, safety-related software, protective measures, production process, design, or applied standard changes. Article 11 requires series-production procedures to account for changes that can affect conformity.
Primary sources

References and citations

eur-lex.europa.eu
Referenced sections
  • Summarizes that partly completed machinery must be designed and constructed against the relevant essential health and safety requirements.
"relevant essential health and safety requirements"
eur-lex.europa.eu
Referenced sections
  • Annex IV, Part B lists technical-documentation content for partly completed machinery and Article 11 sets the retention obligation.
"technical documentation set out in Annex IV, Part B"
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