Scope checksEU

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.

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Author

Sorena AI

Published

May 9, 2026

Updated

May 9, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published May 9, 2026

Updated May 9, 2026

Overview

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.

Section 1

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

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

Summarises the regulation's scope as machinery, related products, and partly completed machinery, and lists the related product categories.

Section 2

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

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

Explains when internal production control can be used and when Annex I categories require notified-body involvement.

Recommended next step

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

Research workflow

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Answer Machinery Regulation scope, category, and evidence questions with cited outputs.

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Section 3

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

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

Summarises required declarations, instructions, CE marking, and assembly instructions for machinery, related products, and partly completed machinery.

Primary sources

References and citations

EUR-Lex summary - Machinery safety requirements

eur-lex.europa.eu

Referenced sections

Summarises required declarations, instructions, CE marking, and assembly instructions for machinery, related products, and partly completed machinery.

"manufacturers must draw up the EU declaration of incorporation"

Regulation (EU) 2023/1230 on machinery

eur-lex.europa.eu

Referenced sections

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.