- Summarizes that partly completed machinery must be designed and constructed against the relevant essential health and safety requirements.
"relevant essential health and safety requirements"
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.
Use this page to separate partly completed machinery from finished machinery, prepare the EU declaration of incorporation and assembly instructions, and define what the final assembler must complete.
Structured answer sets in this page tree.
Cited legal and guidance references.
Regulation (EU) 2023/1230 gives partly completed machinery 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.
The boundary starts with function. Partly completed machinery 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 partly completed machinery route. If the product can already perform the specific application for which it is supplied, analyze it as machinery or a related product instead.
For partly completed machinery, 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 partly completed machinery is placed or made available on the market.
Assembly instructions are not optional integration notes. They must describe the conditions needed for correct incorporation so that the resulting machinery, other partly completed machinery, 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.
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.
The final assembler cannot rely on the declaration of incorporation as a finished-machine declaration. The declaration of incorporation confirms the partly completed machinery 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 partly completed machinery 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.
Build the partly completed machinery file around the requirements actually applied and fulfilled. The file 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 partly completed machinery, the version, the requirements covered, and the assumptions the final assembler must preserve.
"relevant essential health and safety requirements"
"technical documentation set out in Annex IV, Part B"