---
title: "Machinery Regulation category and scope checks"
canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/category-and-scope-workflow"
source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/category-and-scope-workflow"
author: "Sorena AI"
description: "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."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU Machinery Regulation"
  - "Regulation (EU) 2023/1230"
  - "machinery scope"
  - "partly completed machinery"
  - "safety components"
  - "Annex I"
---
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---

# Machinery Regulation category and scope checks

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.

*Scope checks* *EU*

## EU Machinery Regulation category and scope checks

Use these checks to classify machinery, related products, partly completed machinery, safety components, substantial modifications, exclusions, and Annex I categories under Regulation (EU) 2023/1230.

The output should be a product-specific scope record that explains the category chosen, the exclusions checked, the Annex I result, the conformity path, and the evidence retained.

Category and scope under the EU Machinery Regulation starts with the product facts: what moves, what drives it, what safety function it performs, whether it is complete enough to perform a specific application, and whether an exclusion or Annex I listing changes the conformity route.

## Classify the product before choosing the conformity route

Record the product configuration, intended use, power source, moving parts, software needed for the specific application, supply-chain role, and Union market activity. Then classify it against Article 2 and Article 3 before discussing standards, declarations, labels, or release approval.

- Treat the product as machinery when it is an assembly with linked parts or components, at least one moving part, a drive system other than directly applied human or animal effort, and a specific application. Article 3 also captures assemblies missing only site connection components, assemblies installed on vehicles or structures, integral assemblies of machinery, lifting assemblies powered only by direct human effort, and assemblies missing only the manufacturer's foreseen software upload.
- Treat it as a related product when it is interchangeable equipment, a safety component, a lifting accessory, chains, ropes and webbing for lifting, or a removable mechanical transmission device.
- Treat it as partly completed machinery when it cannot itself perform a specific application and is intended only for incorporation into, or assembly with, machinery, other partly completed machinery, or equipment.
- For safety components, capture whether the component is physical or digital, including software, is designed or intended to fulfil a safety function, is independently placed on the market, and would endanger safety if it failed or malfunctioned.
- Keep a separate line for Article 2 exclusions. Check spare safety components supplied by the original manufacturer for identical replacement, fairground or amusement-park equipment, nuclear-use machinery, weapons, specified transport categories, seagoing vessels and offshore units, military or police designs, temporary laboratory research equipment, mine winding gear, performer-moving machinery, and listed electrical or high-voltage products.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Article 2 defines the scope and exclusions; Article 3 defines machinery, related product categories, safety components, partly completed machinery, placing on the market, putting into service, and substantial modification.
- [EUR-Lex summary - Machinery safety requirements](https://eur-lex.europa.eu/EN/legal-content/summary/machinery-safety-requirements.html?ref=sorena.io) - Summarises the regulation's scope as machinery, related products, and partly completed machinery, and lists the related product categories.

## Check substantial modification and Annex I category status

After the product category is clear, check whether a change or product listing shifts responsibility or conformity assessment. A substantial modification can make the person carrying it out responsible as a manufacturer, and Annex I can require a notified-body route.

- Flag a substantial modification only when a physical or digital modification after placing on the market or putting into service was not foreseen or planned by the manufacturer, affects safety by creating a new hazard or increasing an existing risk, and requires added guards or protective devices that change the existing safety control system or additional protective measures to ensure stability or mechanical strength.
- If a natural or legal person carries out a substantial modification, record whether Article 18 makes that person responsible as manufacturer for the affected machinery or related product and which Article 25 conformity assessment procedure is then needed.
- Check Annex I Part A first. Part A includes removable mechanical transmission devices including guards, guards for those devices, vehicle servicing lifts, portable cartridge-operated fixing and other impact machinery, safety components with fully or partially self-evolving machine-learning behaviour ensuring safety functions, and machinery with embedded systems of that kind in respect of those systems.
- For Annex I Part A categories, do not use internal production control alone. Article 25 requires EU type-examination plus conformity to type, full quality assurance, or unit verification.
- Check Annex I Part B next. Internal production control is available for Part B only when the machinery or related product is designed and constructed according to harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements; otherwise use one of the notified-body procedures in Article 25(3).
- If the product is not listed in Annex I, Article 25 points to internal production control, while the Article 10 technical documentation, Annex III essential health and safety requirements, declaration, instructions, and CE marking still need to be handled.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Article 6 links Annex I Parts A and B to conformity-assessment routes; Article 18 covers substantial modification; Article 25 sets the available procedures.
- [EUR-Lex summary - Machinery safety requirements](https://eur-lex.europa.eu/EN/legal-content/summary/machinery-safety-requirements.html?ref=sorena.io) - Explains when internal production control can be used and when Annex I categories require notified-body involvement.

*Recommended next step*

*Placement: after evidence section*

## Validate a Machinery Regulation scope classification

Turn your product facts into a cited Machinery Regulation scope record covering category, exclusions, substantial modification, Annex I status, conformity route, and retained evidence.

- [Open Research Copilot](/solutions/research-copilot.md): Answer Machinery Regulation scope, category, and evidence questions with cited outputs.
- [Talk through implementation](/contact.md): Review your product category, Annex I route, technical documentation, and release evidence.

## Evidence to retain for the scope decision

The scope record should let a reviewer reconstruct why the product was treated as machinery, a related product, partly completed machinery, excluded, substantially modified, or Annex I-listed. Keep the scope decision with the technical documentation rather than in a separate legal note.

- Product description: model, series or type, intended use, drive system, moving elements, software status, operating environment, user group, and whether the product is placed on the market, put into service, incorporated, or modified.
- Category analysis: Article 3 machinery definition points considered, related product category selected if any, safety-component function and failure effect if relevant, and partly completed machinery incorporation rationale if relevant.
- Exclusion analysis: Article 2 exclusions checked, the facts supporting any exclusion, and the regime or product approval path that remains in scope when another Union act covers the relevant essential health and safety requirements.
- Modification analysis: change description, whether the manufacturer foresaw or planned it, hazard or risk increase, guards or protective devices added, stability or mechanical-strength measures, and the Article 18 manufacturer-responsibility conclusion.
- Annex I and conformity route: Part A, Part B, or not listed; harmonised standards or common specifications relied on for any Part B internal-production-control route; notified body, certificate, quality-system, or unit-verification evidence where used.
- Technical documentation links: risk assessment, applicable Annex III essential health and safety requirements, protective measures and residual risks, drawings and circuits, applied standards or other technical specifications, test and inspection results, instructions, declaration of conformity or incorporation, CE-marking decision, and evidence kept for the required 10-year authority access period.

Sources for this answer:

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Article 10, Article 11, and Annex IV identify the technical documentation, declarations, risk assessment evidence, and 10-year authority access records for machinery, related products, and partly completed machinery.
- [EUR-Lex summary - Machinery safety requirements](https://eur-lex.europa.eu/EN/legal-content/summary/machinery-safety-requirements.html?ref=sorena.io) - Summarises required declarations, instructions, CE marking, and assembly instructions for machinery, related products, and partly completed machinery.

## Primary sources

- [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Primary legal source for scope, definitions, exclusions, substantial modification, Annex I categories, conformity assessment procedures, and technical documentation.
  - Quote: "This Regulation applies to machinery and the following related products"
- [EUR-Lex summary - Machinery safety requirements](https://eur-lex.europa.eu/EN/legal-content/summary/machinery-safety-requirements.html?ref=sorena.io) - Official EUR-Lex summary used for concise scope, related-product, Annex I, conformity-assessment, declaration, instruction, and CE-marking context.
  - Quote: "It also applies to partly completed machinery."

## Related Topic Guides

- [Declaration of Conformity vs Declaration of Incorporation | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/doc-and-doi.md): 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.
- [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 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.


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