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Machinery Directive Annex II: Declaration of Conformity and Declaration of Incorporation

Annex II distinguishes completed machinery's declaration of conformity from partly completed machinery's declaration of incorporation.

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Direct answer

Annex II distinguishes completed machinery's declaration of conformity from partly completed machinery's declaration of incorporation. Determine actual function and delivery conditions before choosing the document. Partly completed machinery intended for integration must not be presented as independently ready for use solely by changing the heading.

Decision and evidence

Match manufacturer, machine identity, applied requirements and authorised signature to the file. Supply assembly information and clarify the integrator's remaining assessment duties where relevant.

Technical basis

For machinery, risk assessment, essential health and safety requirements, the technical file, declarations and CE marking must form one traceable chain under the applicable machinery legislation.

Related practical guide

Machinery CE: Integrated Lines, Partly Completed Machinery and Changes

Primary sources and currency

This page was technically reviewed on 22 August 2026 against the primary sources below. The current legislation, standard edition and official fee schedule at the application date take precedence.

EUR-Lex — Machinery Directive 2006/42/EC (current consolidated text) ↗EUR-Lex — Machinery Regulation (EU) 2023/1230 ↗EUR-Lex — Blue Guide on implementing EU product rules ↗

Practical questions

Do partly completed and ready-to-use machinery have the same declaration?

No. Partly completed machinery may be intended for incorporation and unable to perform its specific application independently. Its declaration and assembly information differ from completed machinery's declaration of conformity. The integrator must assess remaining risks and interfaces. Actual function and delivery conditions matter more than product names.

Does connecting CE-marked machines into a line require further work?

Assess whether shared control and function create an assembly. Feeding, transfer, trapping and coordinated stopping hazards may be absent from individual files. Identify the assembly's responsible manufacturer and conformity route. Component CE marks do not establish assessment of every integrated-system risk.

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22 August 2026 · Technical reviewKayra Patent · EXPERT GUIDE