---
title: "Declaration of Conformity vs Declaration of Incorporation"
canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/faq/doc-and-doi"
source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/faq/doc-and-doi"
author: "Sorena AI"
description: "FAQ on when machinery needs an EU Declaration of Conformity and when partly completed machinery needs an EU Declaration of Incorporation under Regulation (EU) 2023/1230."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU Machinery Regulation"
  - "Declaration of Conformity"
  - "Declaration of Incorporation"
  - "partly completed machinery"
  - "CE marking"
---
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# Declaration of Conformity vs Declaration of Incorporation

FAQ on when machinery needs an EU Declaration of Conformity and when partly completed machinery needs an EU Declaration of Incorporation under Regulation (EU) 2023/1230.

*FAQ* *EU Machinery Regulation*

## Machinery Regulation FAQ DoC vs DoI

A Declaration of Conformity belongs to machinery or related products whose conformity assessment has been completed before placing on the market or putting into service.

A Declaration of Incorporation belongs to partly completed machinery that cannot perform a specific application by itself and is intended to be incorporated into machinery or other equipment.

Under Regulation (EU) 2023/1230, the EU Declaration of Conformity and EU Declaration of Incorporation answer different questions. The DoC is for machinery and related products after the applicable essential health and safety requirements have been demonstrated through the relevant conformity assessment. The DoI is for partly completed machinery, where only the relevant essential health and safety requirements for that partly completed machinery have been demonstrated and the final safety case is completed by the party that incorporates it into the final machinery.

## When is a Declaration of Conformity used?

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.

- The DoC side is the CE-marked side: Article 10 links the completed conformity assessment to drawing up the DoC and affixing the CE marking.
- The DoC can cover more than one Union legal act when more than one act requires an EU declaration of conformity, but it must identify those acts and publication references.
- A declaration alone is not the technical file; it points to the underlying Annex IV Part A documentation, risk assessment, tests, standards mapping, instructions, and production-control evidence.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Articles 10 and 21 and Annexes IV and V support the DoC, technical documentation, CE marking, and declaration-content points.
- [European Commission - Machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission machinery page confirms the Machinery Regulation alignment with the New Legislative Framework and warns that CE marking follows the prescribed conformity assessment procedure.

## When is a Declaration of Incorporation used?

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.

- The manufacturer of partly completed machinery must draw up Annex IV Part B technical documentation before placing it on the market.
- The DoI must identify which Annex III essential health and safety requirements are applied and fulfilled and state that the relevant technical documentation was drawn up under Annex IV Part B.
- Partly completed machinery must be accompanied by assembly instructions under Annex XI, and those instructions must include the DoI or access details for it.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Articles 3, 11, and 22 plus Annexes IV, V, and XI support the partly completed machinery, DoI, technical documentation, and assembly-instruction boundary.

## How do the documents relate to the technical file?

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.

- For a DoC, keep the declaration with the Annex IV Part A technical documentation, conformity assessment evidence, instructions for use, and CE-marking record.
- For a DoI, keep the declaration with the Annex IV Part B technical documentation, assembly instructions, applied-and-fulfilled EHSR mapping, and incorporation assumptions.
- If partly completed machinery is incorporated into final machinery, the final machinery technical documentation can include the DoI and assembly instructions as inputs, but the final DoC remains the final machinery manufacturer's responsibility.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Annex IV Part A and Part B separate technical documentation for machinery and related products from technical documentation for partly completed machinery.

## What is the CE and assembly boundary?

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.

- Do not issue a DoI for a finished CE-marked machine just because another party installs it at a customer site.
- Do not treat a DoI as proof that the final assembled machinery complies; it only covers the partly completed machinery and the EHSRs stated in the declaration.
- Do not rely on voluntary certificates as a substitute for the prescribed conformity assessment, DoC, DoI, technical documentation, or CE-marking steps.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Articles 10, 11, 21, 22, 23, and 24 support the split between completed machinery with CE marking and partly completed machinery with a DoI and assembly instructions.
- [European Commission - Machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission machinery page warns that voluntary certificates are not a recognised compliance proof and that CE marking follows the required conformity assessment.

## Primary sources

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Primary source for machinery, related products, partly completed machinery, technical documentation, DoC, DoI, CE marking, and assembly instructions.
  - Quote: "EU declaration of incorporation"
- [European Commission - Machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission machinery page used for implementation context, CE-marking caution, notified-body context, and warnings on voluntary certificates.
  - Quote: "CE marking can only be affixed"

## Topic Guides

- [Directive 2006/42/EC to Machinery Regulation transition](/artifacts/eu/machinery-regulation/transition-from-directive-2006-42-ec.md): Transition guide for moving EU machinery files from Directive 2006/42/EC to Regulation (EU) 2023/1230, focused on the 20 January 2027 changeover, pipeline products, declarations, standards, technical documentation, software, cybersecurity, and digital instructions.
- [EU Machinery Regulation Applicability Test](/artifacts/eu/machinery-regulation/applicability-test.md): Test whether a product is machinery, a related product, partly completed machinery, a safety component, substantially modified, excluded, or covered by overlapping EU product laws.
- [EU Machinery Regulation compliance](/artifacts/eu/machinery-regulation/compliance.md): Machinery Regulation compliance checklist covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, software, transition, and market surveillance.
- [EU Machinery Regulation compliance checklist](/artifacts/eu/machinery-regulation/checklist.md): Checklist for Regulation (EU) 2023/1230 covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, digital duties, transition, and market surveillance.
- [EU Machinery Regulation deadlines and compliance calendar](/artifacts/eu/machinery-regulation/deadlines-and-compliance-calendar.md): Calendar for Regulation (EU) 2023/1230 dates, Directive 2006/42/EC transition, release documentation gates, standards monitoring, and substantial-modification reviews.
- [EU Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq.md): Answers to Machinery Regulation questions on scope, partly completed machinery, Annex I categories, Article 25 conformity assessment, digital instructions, software, cybersecurity, transition, CE files, and overlap with other EU product laws.
- [EU Machinery Regulation Partly Completed Machinery](/artifacts/eu/machinery-regulation/partly-completed-machinery.md): What counts as partly completed machinery under Regulation (EU) 2023/1230, what documents travel with it, and where the final assembler takes over.
- [EU Machinery Regulation requirements](/artifacts/eu/machinery-regulation/requirements.md): Requirements under Regulation (EU) 2023/1230: machinery scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declaration, CE marking, software evidence, transition, and surveillance.
- [EU Machinery Regulation Safety Components](/artifacts/eu/machinery-regulation/safety-components.md): Definition, scope, conformity assessment, technical documentation, declaration, CE marking, and grounded examples for safety components under Regulation (EU) 2023/1230.
- [EU Machinery Regulation scope and machine categories](/artifacts/eu/machinery-regulation/scope-and-machine-categories.md): Scope guide for Regulation (EU) 2023/1230 covering machinery, related products, partly completed machinery, Annex I categories, exclusions, substantial modification, and category evidence.
- [EU Machinery Regulation substantial modification decision workflow](/artifacts/eu/machinery-regulation/substantial-modification-workflow.md): Workflow for assessing substantial modification under Regulation (EU) 2023/1230: change facts, hazard and risk impact, manufacturer obligations, conformity assessment, CE marking, and evidence.
- [EU Machinery Regulation vs LVD](/artifacts/eu/machinery-regulation/machinery-vs-lvd.md): Compare the EU Machinery Regulation and Low Voltage Directive boundary for machinery EHSRs, electrical risks, excluded electrical products, CE documentation, and evidence reuse.
- [EU Machinery Regulation vs Market Surveillance Regulation: compliance comparison](/artifacts/eu/machinery-regulation/machinery-vs-msr.md): Compare Machinery Regulation product compliance duties with EU MSR market surveillance duties, authority requests, online sales, corrective action and evidence records.
- [EU Machinery Regulation: autonomous mobile and collaborative machinery](/artifacts/eu/machinery-regulation/autonomous-mobile-and-collaborative-machinery.md): Grounded guide to Regulation (EU) 2023/1230 requirements for autonomous mobile machinery, human-machine interaction, controls, software, cybersecurity, risk assessment, technical documentation, and conformity routes.
- [EU Machinery Regulation: when does a modification constitute substantial modification?](/artifacts/eu/machinery-regulation/substantial-modification.md): Guide to substantial modification under Regulation (EU) 2023/1230: change triggers, risk assessment, EHSRs, technical documentation, conformity assessment, CE marking, and records.
- [EU Machinery Risk Assessment Method](/artifacts/eu/machinery-regulation/risk-assessment-method.md): How to document an EU Machinery Regulation risk assessment: ISO 12100 hazard identification, EHSR mapping, risk reduction, residual risk, software, cybersecurity, and technical-file evidence.
- [How to map Annex III EHSRs under the EU Machinery Regulation | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/annex-iii-ehsr.md): FAQ on mapping Annex III essential health and safety requirements to hazards, risk reduction, software controls, technical documentation, and Annex I classification under Regulation (EU) 2023/1230.
- [Machinery CE documentation template for Regulation (EU) 2023/1230](/artifacts/eu/machinery-regulation/machinery-ce-documentation-template.md): Template fields for Machinery Regulation CE documentation: product identity, scope, EHSR risk assessment, standards, tests, instructions, EU declaration, CE marking, notified body route, software, cyber, and substantial modification checks.
- [Machinery Regulation and EU AI Act overlap for AI-enabled safety functions](/artifacts/eu/machinery-regulation/faq/ai-act-overlap.md): FAQ on Machinery Regulation overlap with the EU AI Act for self-evolving or machine-learning safety functions, Annex I categories, standards work, and technical documentation boundaries.
- [Machinery Regulation Annex I conformity route workflow](/artifacts/eu/machinery-regulation/annex-i-route-workflow.md): Classify machinery against Annex I Part A and Part B, choose the Article 25 conformity assessment route, and assemble the technical evidence file.
- [Machinery Regulation Annex I high-risk categories](/artifacts/eu/machinery-regulation/annex-i-and-high-risk-machinery.md): Explain what Annex I does under Regulation (EU) 2023/1230, which listed machinery categories trigger special conformity routes, and what evidence to keep.
- [Machinery Regulation category and scope checks](/artifacts/eu/machinery-regulation/category-and-scope-workflow.md): Check whether a product is machinery, a related product, partly completed machinery, a safety component, excluded from scope, or listed in Annex I under Regulation (EU) 2023/1230.
- [Machinery Regulation conformity assessment and CE marking](/artifacts/eu/machinery-regulation/conformity-assessment-and-ce.md): EU Machinery Regulation guide to Article 25 conformity assessment routes, Annex I machinery categories, technical documentation, EU declarations, CE marking, and instructions.
- [Machinery Regulation cybersecurity evidence FAQ](/artifacts/eu/machinery-regulation/faq/cybersecurity.md): What cybersecurity evidence connected or software-enabled machinery should keep for protection against corruption, safety-related control systems, and machinery risk assessment.
- [Machinery Regulation digital instructions](/artifacts/eu/machinery-regulation/digital-instructions.md): EU Machinery Regulation guide to digital instructions for use: access marking, print and download access, paper copies, non-professional safety information, languages, and records.
- [Machinery Regulation penalties and enforcement](/artifacts/eu/machinery-regulation/penalties-and-fines.md): EU Machinery Regulation enforcement guide covering Member State penalty rules, corrective action, market surveillance powers, and cross-border authority cooperation.
- [Machinery Regulation related products scope guide](/artifacts/eu/machinery-regulation/related-products.md): Classify EU Machinery Regulation related products, including interchangeable equipment, safety components, lifting accessories, lifting chains, ropes, webbing, and removable transmission devices.
- [Machinery Regulation software and cybersecurity considerations](/artifacts/eu/machinery-regulation/software-and-cybersecurity-considerations.md): How Regulation (EU) 2023/1230 treats safety-related software, control systems, corruption protection, technical documentation, and cyber-safety risk evidence.
- [Machinery Regulation Technical Documentation and Technical File](/artifacts/eu/machinery-regulation/technical-documentation-and-technical-file.md): What to keep in the EU Machinery Regulation technical file: product identification, risk assessment, EHSR mapping, standards, tests, instructions, declarations, software evidence, retention, and notified-body records.
- [Machinery Regulation technical file acceptance workflow](/artifacts/eu/machinery-regulation/technical-file-acceptance-workflow.md): Release-gate workflow for accepting an EU Machinery Regulation technical file: scope, EHSR risk evidence, standards, tests, declarations, notified-body records, software, cyber, and signoff.
- [Machinery Regulation Timeline and Transition: practical guide](/artifacts/eu/machinery-regulation/timeline-and-transition.md): EU Machinery Regulation guide to Timeline and Transition with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps.
- [Machinery Regulation vs EMC Directive](/artifacts/eu/machinery-regulation/machinery-vs-emc.md): Compare EU machinery safety duties with EMC duties for equipment, CE documentation, harmonised standards, declarations, and combined technical files.
- [Machinery Regulation vs EU AI Act: machinery safety overlap](/artifacts/eu/machinery-regulation/machinery-regulation-vs-eu-ai-act.md): A grounded comparison of the EU Machinery Regulation and EU AI Act for machinery with AI-enabled safety functions, software, cyber-safety and technical documentation overlap.
- [Machinery Regulation vs Machinery Directive](/artifacts/eu/machinery-regulation/machinery-regulation-vs-machinery-directive.md): Grounded comparison of Regulation (EU) 2023/1230 and Directive 2006/42/EC across legal form, timing, scope, digital instructions, cybersecurity, conformity assessment, documentation, and CE marking.
- [Machinery vs RED comparison](/artifacts/eu/machinery-regulation/machinery-vs-red.md): Compare EU Machinery Regulation and Radio Equipment Directive boundaries for machinery safety, radio equipment scope, CE documentation, and shared evidence.
- [What counts as machinery under Regulation (EU) 2023/1230?](/artifacts/eu/machinery-regulation/faq/machinery-definition.md): FAQ on the Machinery Regulation definition of machinery, including assemblies, drive systems, missing components, software, related products, partly completed machinery, safety components, and exclusions.
- [When can a software update affect Machinery Regulation compliance?](/artifacts/eu/machinery-regulation/faq/software-updates.md): FAQ on when machinery software updates can trigger Machinery Regulation review, including safety functions, substantial modification, corruption protection, instructions, and CE technical-file evidence.
- [When does used or modified machinery need a new conformity assessment? | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md): FAQ on used and modified machinery under Regulation (EU) 2023/1230, including substantial modification, first EU use, technical documentation, and market surveillance evidence.
- [When is a notified body needed under the EU Machinery Regulation?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md): FAQ on when Machinery Regulation Annex I products need a notified body, how to find designated bodies, and what manufacturers still own.
- [Which Article 25 conformity assessment module applies? | EU Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/article-25-modules.md): FAQ on Article 25 of Regulation (EU) 2023/1230: Module A, Module B plus C, Module H, Module G, Annex I triggers, notified body involvement, and technical file evidence.

*Recommended next step*

*Placement: after implementation section*

## Map the declaration boundary before release

Classify each item as machinery, a related product, or partly completed machinery before assigning the DoC, DoI, technical documentation, CE marking, and assembly-instruction work.

- [Open Research Copilot](/solutions/research-copilot.md): Check Machinery Regulation declaration, technical-file, and CE-marking questions with cited outputs.
- [Talk through implementation](/contact.md): Review whether your item needs a DoC, DoI, assembly instructions, or final CE-marking evidence.


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