Machinery Regulation FAQ DoC vs DoI

Use an EU Declaration of Conformity for machinery or a related product when the manufacturer has drawn up the Annex IV Part A technical documentation, completed the relevant conformity assessment procedure, and demonstrated conformity with the applicable essential health and safety requirements in Annex III.

The DoC is the manufacturer's formal responsibility statement for that machinery or related product. It must follow the Annex V Part A model structure, identify the product, list the Union harmonisation legislation and standards or technical specifications relied on, and be kept with the technical documentation for market surveillance.

Match the declaration to the exact model or type and the configuration assessed. A supplier declaration for a component, or a DoI for partly completed machinery inside the assembly, is input evidence for the final manufacturer's file; neither replaces the final DoC for complete machinery.

The Regulation's declaration forms and related product duties apply from 20 January 2027. For products placed on the market before then, use the declaration and transition rules of the Machinery Directive and retain the first-placement date; do not reissue an earlier declaration under the Regulation solely because the product remains in use or is resold.

Use an EU Declaration of Incorporation for partly completed machinery. Regulation (EU) 2023/1230 defines partly completed machinery as an assembly that is not yet machinery because it cannot by itself perform a specific application and is only intended to be incorporated into or assembled with machinery, other partly completed machinery, or equipment.

The DoI does not say that a final machine is complete or ready for CE marking. It states that the relevant essential health and safety requirements for the partly completed machinery have been demonstrated, and it must follow the Annex V Part B model structure.

Both declarations depend on technical documentation, but they point to different annexes and different product states. Machinery and related products use Annex IV Part A; partly completed machinery uses Annex IV Part B.

For complete machinery, the technical documentation must show how conformity with the applicable essential health and safety requirements is achieved. For partly completed machinery, the technical documentation must show conformity with the relevant essential health and safety requirements and include evidence that the partly completed machinery can be assembled and incorporated safely.

The practical boundary is whether the item is already machinery or a related product, or whether it is only partly completed machinery intended for incorporation. If the item can perform the intended application as machinery and the manufacturer places it on the market or puts it into service, the DoC and CE marking path applies.

If the item cannot perform a specific application by itself and needs incorporation into final machinery or equipment, the DoI and assembly-instructions path applies. The final machinery manufacturer then needs to assess the assembled machine, close any remaining essential health and safety requirements, prepare the final technical documentation, issue the final DoC where applicable, and affix CE marking to the final machinery.