We use privacy-by-default, cookieless analytics.

Optional analytics cookies are used only if you accept them.

Read our Terms of Use and Privacy Policy.

Scope checksEU

EU Machinery Regulation category and scope checks

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

For releases before 20 January 2027, first apply Directive 2006/42/EC and the transition rules. Use this Regulation workflow for products placed on the market or put into service from that date.

Back to main artifactReview sources
Author
Sorena AI
Published
May 9, 2026
Updated
Oct 15, 2026
3 sections2 primary sources
Overview

Regulation (EU) 2023/1230 generally applies from 20 January 2027. For a product placed on the market or put into service from that date, start with the product facts: what moves, what drives it, what safety function it performs, whether it is or complete enough to perform a specific application, and whether an exclusion or Annex I listing changes the conformity route. Products placed on the market under Directive 2006/42/EC before that date remain covered by the Article 52 transition rule.

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.

Record the legal cut-off as well as the product category. Directive 2006/42/EC remains the main placing-on-the-market framework until 20 January 2027. Regulation (EU) 2023/1230 applies generally from that date, subject to the earlier application dates for specific provisions in Article 54.

  • 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 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. The component must also be unnecessary for the product to function, or replaceable by normal components that allow it to function.
  • 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.
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. Article 18 excludes a non-professional user modifying their own machinery or related product for their own use; for assemblies, the duty is limited to the affected machinery or related product where the risk assessment demonstrates that only its safety is affected.
  • 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.
Recommended next step

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.

Research workflow
Open Research Copilot

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

Explore next step
Talk to Sorena
Talk through implementation

Review your product category, Annex I route, technical documentation, and release evidence.

Explore next step
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, , 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 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.
Primary sources

References and citations

EUR-Lex summary - Machinery safety requirements
eur-lex.europa.eu4 citations
Referenced sections
  • Official EUR-Lex summary used for concise scope, related-product, Annex I, conformity-assessment, declaration, instruction, and CE-marking context.
  • Summarises the regulation's scope as machinery, related products, and partly completed machinery, and lists the related product categories.
  • Official summary of conformity-assessment routes. Article 25 of the Regulation controls the Part B exception that permits Module A when the category-specific coverage condition is met.
Show 1 more
  • Summarises required declarations, instructions, CE marking, and assembly instructions for machinery, related products, and partly completed machinery.
"It also applies to partly completed machinery."
More quoted passages
"This regulation covers machinery and the following related products"
"manufacturers must draw up the EU declaration of incorporation"
Regulation (EU) 2023/1230 on machinery
eur-lex.europa.eu4 citations
Referenced sections
  • Primary legal source for scope, definitions, exclusions, substantial modification, Annex I categories, conformity assessment procedures, and technical documentation.
  • Articles 2 and 3 define scope, exclusions, product categories, market activities, and substantial modification. Articles 51, 52, and 54, as corrected, set the repeal, transition, and general application date of 20 January 2027.
  • Article 6 links Annex I Parts A and B to conformity-assessment routes; Article 18 covers substantial modification; Article 25 sets the available procedures.
Show 1 more
  • 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.
"This Regulation applies to machinery and the following related products"
More quoted passages
"Categories of machinery and related products listed in Annex I"
"The technical documentation shall specify the means used by the manufacturer"

Related guides

Directive 2006/42/EC to Machinery Regulation transition

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

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

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

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

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

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.

Show all related guides (40)

EU Machinery Regulation Partly Completed Machinery

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

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

Definition, scope, conformity assessment, technical documentation, declaration, CE marking, and cited examples for safety components under Regulation (EU) 2023/1230.

EU Machinery Regulation scope and machine categories

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

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

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

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

Source-based 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?

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

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.

Machinery CE documentation template for Regulation (EU) 2023/1230

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 Annex I conformity route workflow

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

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

EU Machinery Regulation guide to Article 25 conformity assessment routes, Annex I machinery categories, technical documentation, EU declarations, CE marking, and instructions.

Machinery Regulation digital instructions

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

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

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

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

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

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

EU Machinery Regulation timeline covering corrected application dates, the Directive 2006/42/EC changeover, certificate continuity, product placement decisions, and transition evidence.

Machinery Regulation vs EMC Directive

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

A cited-source 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

Official source 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

Compare EU Machinery Regulation and Radio Equipment Directive boundaries for machinery safety, radio equipment scope, CE documentation, and shared evidence.

Declaration of Conformity vs Declaration of Incorporation | Machinery Regulation FAQ

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.

How to map Annex III EHSRs under the EU Machinery Regulation | Machinery Regulation FAQ

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 Regulation and EU AI Act overlap for AI-enabled safety functions

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 cybersecurity evidence FAQ

What cybersecurity evidence connected or software-enabled machinery should keep for protection against corruption, safety-related control systems, and machinery risk assessment.

What counts as machinery under Regulation (EU) 2023/1230?

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?

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

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?

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

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.