--- title: "EU Machinery Regulation FAQ" canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/faq" source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/faq/items/page/2" author: "Sorena AI" description: "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." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU Machinery Regulation" - "Regulation (EU) 2023/1230" - "partly completed machinery" - "Annex I machinery" - "Article 25 conformity assessment" - "digital instructions" - "CE marking" - "Machinery scope" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # 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. *FAQ* *EU* ## EU Machinery Regulation FAQ Direct answers to recurring Machinery Regulation questions on machinery scope, related products, partly completed machinery, high-risk Annex I categories, Article 25 modules, digital instructions, software, cybersecurity, substantial modification, and CE documentation. The answers focus on what changes product classification, conformity assessment, documentation, and market placement under Regulation (EU) 2023/1230. This FAQ answers practical Machinery Regulation questions for manufacturers, importers, distributors, integrators, and product teams preparing machinery or related products for the EU market under Regulation (EU) 2023/1230. ## Browse sub-FAQ modules ### [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. - 4 items ### [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. - 5 items ### [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. - 4 items ### [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. - 4 items ### [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. - 5 items ### [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. - 4 items ### [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. - 5 items ### [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. - 4 items ### [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. - 4 items Browse all indexed questions: [/artifacts/eu/machinery-regulation/faq/items](/artifacts/eu/machinery-regulation/faq/items.md) ## All FAQ items *Page 2 of 2. Showing 19 of 39 items.* ### [Exclusions that often change the answer](/artifacts/eu/machinery-regulation/faq/machinery-definition.md#exclusions-that-often-change-the-answer) *Module: [What counts as machinery under Regulation (EU) 2023/1230?](/artifacts/eu/machinery-regulation/faq/machinery-definition.md)* Article 2 contains specific exclusions, so a product can match part of the machinery concept and still fall outside the Regulation for that reason. The exclusion analysis should be narrow and source-tied, because several exclusions contain exceptions for machinery mounted on excluded transport products. - For air, water, rail, motor-vehicle, two- or three-wheel vehicle, quadricycle, and tractor cases, check whether the machinery mounted on the transport product remains carved back into scope. - For electrical and electronic products, check whether the item falls within the listed Article 2 product categories and within the Low Voltage Directive or Radio Equipment Directive scope. - Do not use an exclusion as a shorthand for all obligations; document the exact Article 2 point and any other EU product law that remains relevant. Sources for this answer: - [Regulation (EU) 2023/1230 Article 2 exclusions](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Lists products outside the Regulation and preserves scope for certain machinery mounted on transport products. - [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission sector page used for machinery policy context and links to EU machinery legislation resources. ### [Evidence for a machinery-definition decision](/artifacts/eu/machinery-regulation/faq/machinery-definition.md#evidence-for-a-machinery-definition-decision) *Module: [What counts as machinery under Regulation (EU) 2023/1230?](/artifacts/eu/machinery-regulation/faq/machinery-definition.md)* A useful scope record is short but specific. It should identify the item assessed, the intended application, moving parts, drive system or manual lifting-load basis, missing components or software, installation dependency, and whether multiple units are arranged and controlled as an integral whole. - Attach product drawings, bill of materials, control-system descriptions, software-release notes, installation assumptions, and intended-use statements that support the classification. - For partly completed machinery, keep the incorporation rationale and the evidence showing why the item cannot itself perform the specific application. - For exclusions, cite the exact Article 2 exclusion and preserve the analysis of any carve-back, such as machinery mounted on a transport product. Sources for this answer: - [Regulation (EU) 2023/1230 Article 10 manufacturer obligations](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Requires technical documentation and conformity assessment before machinery or a related product is placed on the market or put into service. - [Regulation (EU) 2023/1230 Annex IV technical documentation](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Specifies technical documentation content for machinery, related products, and partly completed machinery, including applied standards and specifications. ### [When a software update needs Machinery Regulation review](/artifacts/eu/machinery-regulation/faq/software-updates.md#when-a-software-update-needs-machinery-regulation-review) *Module: [When can a software update affect Machinery Regulation compliance?](/artifacts/eu/machinery-regulation/faq/software-updates.md)* Review a software update before deployment when it touches software or data that is critical to meeting essential health and safety requirements. Regulation (EU) 2023/1230 expressly treats safety components as physical or digital components, including software, and recognises machinery that is missing only the upload of application-specific software. - Classify the release by product model, installed software version, configuration, affected safety function, and intended use. - Map the change to the relevant essential health and safety requirements, especially Annex III points 1.1.9 on corruption protection and 1.2.1 on safety and reliability of control systems. - Hold deployment when the update could create a new hazard, increase an existing risk, weaken a protective measure, or make existing instructions inaccurate. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the treatment of software in machinery, safety components, substantial modification, technical documentation, instructions, and Annex III protection against corruption. - [ISO 12100:2010 - Safety of machinery risk assessment and risk reduction](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Grounds the risk assessment and risk reduction method used to review safety-related software changes. ### [Safety software, corruption protection, and logs](/artifacts/eu/machinery-regulation/faq/software-updates.md#safety-software-corruption-protection-and-logs) *Module: [When can a software update affect Machinery Regulation compliance?](/artifacts/eu/machinery-regulation/faq/software-updates.md)* Annex III requires software and data critical for conformity with essential health and safety requirements to be identified and protected against accidental or intentional corruption. It also requires machinery to identify the software needed for safe operation and provide that information in an easily accessible form. - Record installed safety-software versions and configuration after each safety-related upload. - Verify that intervention evidence, modification evidence, and version tracing still work after the update. - For safety-related control systems, check that faults, logic errors, malicious third-party attempts, and unintended external influences do not lead to hazardous situations where relevant to the risk assessment. - For self-evolving or machine-learning safety functions, confirm that the update does not expand task or movement space beyond the defined limits and that safety decision data needed for conformity remains available. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the treatment of software in machinery, safety components, substantial modification, technical documentation, instructions, and Annex III protection against corruption. - [ISO/TR 22100-4:2018 - IT-security aspects that can influence machinery safety](https://www.iso.org/standard/73335.html?ref=sorena.io) - Grounds cybersecurity screening where IT-security threats can influence machinery safety. ### [Substantial modification and risk-assessment update](/artifacts/eu/machinery-regulation/faq/software-updates.md#substantial-modification-and-risk-assessment-update) *Module: [When can a software update affect Machinery Regulation compliance?](/artifacts/eu/machinery-regulation/faq/software-updates.md)* The Regulation defines substantial modification as a post-market or post-service modification by physical or digital means that was not foreseen or planned by the manufacturer, affects safety by creating a new hazard or increasing an existing risk, and requires specified protective changes. Software updates should be screened against that definition before release to customers or fielded equipment. - Reopen the risk assessment when the update changes hazards, severity, probability, exposure, protective measures, residual risks, or foreseeable misuse warnings. - Check whether added guards, protective devices, safety-control-system changes, or added protective measures for stability or mechanical strength are now required. - Document the yes/no substantial-modification decision with the exact software version, affected product models, safety rationale, tests, and approver. - If the conformity basis changes, update the technical documentation, standards mapping, declaration workflow, and market-release gate before deployment. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the treatment of software in machinery, safety components, substantial modification, technical documentation, instructions, and Annex III protection against corruption. - [ISO 12100:2010 - Safety of machinery risk assessment and risk reduction](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Grounds the risk assessment and risk reduction method used to review safety-related software changes. ### [Instructions, user notice, and CE file maintenance](/artifacts/eu/machinery-regulation/faq/software-updates.md#instructions-user-notice-and-ce-file-maintenance) *Module: [When can a software update affect Machinery Regulation compliance?](/artifacts/eu/machinery-regulation/faq/software-updates.md)* Software updates can make existing instructions wrong. Article 10 and Annex III require instructions to describe the corresponding product model, intended use, precautions, safe installation and use, residual risks, protective measures, maintenance, breakdown response, and other safety information. Digital instructions are allowed, but access, download, print, lifetime availability, and paper-on-request requirements still matter. - Update instructions when the release changes installation, connection, commissioning, safe use, maintenance, residual risks, spare parts, breakdown recovery, or user protective measures. - Tell users what changed when continued safe operation depends on installing the update, applying a configuration, avoiding an old mode, or following revised precautions. - Keep release notes, risk-assessment updates, test evidence, cybersecurity/corruption checks, software identifiers, intervention logs, instructions versions, declaration impacts, and approval records together in the technical file. - For partly completed machinery, align assembly instructions and the EU declaration of incorporation access point when the update changes incorporation, maintenance, repair, connection, or safe-use assumptions. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the treatment of software in machinery, safety components, substantial modification, technical documentation, instructions, and Annex III protection against corruption. ### [What is the short answer for used machinery?](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md#what-is-the-short-answer-for-used-machinery) *Module: [When does used or modified machinery need a new conformity assessment?](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md)* Start with the market boundary. Regulation (EU) 2023/1230 defines placing on the market as the first making available of an in-scope product on the Union market, and putting into service as the first use in the Union for its intended purpose. A second-hand machine that was already lawfully placed on the EU market is not automatically treated as newly placed on the market just because it is sold again. - For EU-origin used machinery, confirm whether the item was already placed on the EU market or put into service and whether the planned work is repair, maintenance, a manufacturer-planned update, or a substantial modification. - For machinery first moved into the EU after earlier use outside the EU, assess first EU putting into service before production use. - For modified machinery, test the modification against the Regulation's substantial-modification definition before deciding whether a new conformity assessment is required. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Defines placing on the market, putting into service, and substantial modification for machinery and related products. - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the used-machinery distinction between first EU use and existing EU machinery under the prior machinery regime. ### [How to test whether a modification is substantial](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md#how-to-test-whether-a-modification-is-substantial) *Module: [When does used or modified machinery need a new conformity assessment?](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md)* Apply the substantial-modification test in sequence. The modification must occur after placing on the market or putting into service; be physical or digital; be outside what the manufacturer foresaw or planned; affect safety by creating a new hazard or increasing an existing risk; and require either guards or protective devices that change the existing safety control system, or additional protective measures for stability or mechanical strength. - Record the before-and-after intended use, operating envelope, safety functions, guards, protective devices, control-system logic, software version, stability assumptions, and mechanical-strength assumptions. - Map each new or increased risk to the essential health and safety requirement it affects and to the protective measure selected. - If only one machine in an assembly is affected, keep the risk assessment tight enough to show why the new conformity work is limited to that affected machinery or related product. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Provides the substantial-modification definition and Article 18 obligations for the person carrying out the modification. - [ISO 12100:2010 safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Supports using documented hazard identification, risk estimation, risk evaluation, risk reduction, and verification when reassessing machinery changes. ### [What changes when the answer is yes?](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md#what-changes-when-the-answer-is-yes) *Module: [When does used or modified machinery need a new conformity assessment?](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md)* If the event is first EU placing on the market, first EU putting into service, or a substantial modification by a professional operator, the responsible person cannot simply annotate the old file. For machinery and related products, Article 10 requires design and construction in line with Annex III, technical documentation under Annex IV Part A, the relevant Article 25 conformity assessment procedure, an EU declaration of conformity, CE marking, instructions, and retention of the technical documentation and declaration for market surveillance authorities. - Update the technical documentation, risk assessment, drawings, calculations, test records, standards mapping, safety-control evidence, software or programming-logic evidence where relevant, instructions, and declaration affected by the change. - Use Article 25 to select the procedure: Annex I Part A categories require notified-body routes; Annex I Part B categories can use internal production control only when the applicable harmonised standards or common specifications cover all relevant essential health and safety requirements; non-Annex I machinery uses module A. - Keep the old evidence linked but clearly mark what remains valid, what was superseded, and what was newly assessed for the modified configuration. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Articles 10, 11, 18, and 25 ground the manufacturer obligations, partly completed machinery evidence, substantial-modification responsibility, and conformity assessment choices. - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Explains the role of harmonised standards in supporting presumption of conformity under EU product rules. ### [What evidence should market surveillance be able to follow?](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md#what-evidence-should-market-surveillance-be-able-to-follow) *Module: [When does used or modified machinery need a new conformity assessment?](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md)* The record should let a market surveillance authority or decision owner see why the machine was treated as resale, first EU use, ordinary repair, planned update, or substantial modification. The evidence should not be a generic compliance statement; it should tie the actual modification to the legal test and the updated risk assessment. - Keep the original declaration, instructions, serial or type identification, import or resale documents, and evidence of first EU placing on the market or first EU putting into service. - For modifications, keep a dated change description, substantial-modification analysis, risk assessment, affected EHSRs, standards or specifications used, tests, safety-control verification, software version evidence, updated instructions, declaration, and CE-marking decision. - For authority readiness, keep the accountable economic operator, customer or site location, corrective-action log, complaint or incident links, and the file index showing where technical documentation can be made available. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the technical documentation, declaration retention, authority cooperation, and product-withdrawal or recall hooks under the Machinery Regulation. - [Regulation (EU) 2019/1020 on market surveillance](https://eur-lex.europa.eu/eli/reg/2019/1020/oj?ref=sorena.io) - Grounds market surveillance checks, corrective-action powers, restrictions, withdrawal, and recall for products on the Union market. ### [Common mistakes in used and modified machinery decisions](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md#common-mistakes-in-used-and-modified-machinery-decisions) *Module: [When does used or modified machinery need a new conformity assessment?](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md)* Most errors come from skipping the boundary question. A team treats a used machine as automatically exempt, or treats every repair as a new machine, without documenting first EU use, the manufacturer's planned configuration, and whether the modification actually creates a new hazard or increases an existing risk. - Do not call a change non-substantial without checking both safety impact and the protective measures required by the Regulation's definition. - Do not use a declaration for partly completed machinery as if it were a declaration of conformity for complete machinery. - Do not ignore digital changes: software, safety components, control logic, and cybersecurity-related safety effects can be part of the modification analysis. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the distinction between machinery, related products, partly completed machinery, safety components, software, and substantial modifications. - [ISO/TR 22100-4:2018 safety of machinery and IT-security](https://www.iso.org/standard/73335.html?ref=sorena.io) - Supports considering IT-security threats where they can influence machinery safety during placing on the market or putting into service. ### [When does Annex I require a notified body?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md#when-does-annex-i-require-a-notified-body) *Module: [When is a notified body needed under the EU Machinery Regulation?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md)* Start with Annex I. Part A covers categories that must use one of the third-party routes in Article 25(2): EU type-examination followed by conformity to type, full quality assurance, or unit verification. Those routes involve a notified body. - Annex I Part A includes removable mechanical transmission devices and guards, vehicle servicing lifts, portable cartridge-operated fixing and impact machinery, certain machine-learning safety components, and machinery embedding such systems for safety functions. - Annex I Part B includes listed woodworking and meat-processing saws, certain presses, moulding machinery, underground machinery, refuse trucks with compression mechanisms, lifting devices over 3 m fall hazard, protective devices, safety logic units, ROPS, and FOPS. - Substantial modification can put the person making the modification into the manufacturer role, including the duty to apply the relevant Article 25 route. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Article 25 and Annex I define the conformity-assessment routes that determine whether a notified body is required. - [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission sector page identifying Machinery Regulation (EU) 2023/1230 and the official machinery-law context. ### [How should a manufacturer find a notified body?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md#how-should-a-manufacturer-find-a-notified-body) *Module: [When is a notified body needed under the EU Machinery Regulation?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md)* Use the EU Single Market Compliance Space notified-bodies search by legislation. Select Regulation (EU) 2023/1230 on machinery, then check bodies notified for the legislation and the relevant conformity-assessment activity before approaching one. - Search the Single Market Compliance Space by legislation and choose Regulation (EU) 2023/1230 on machinery. - Check the notified body's legal name, identification number, country, legislation, and assessment scope against the module being used. - Retain the lookup date, body profile, certificate or decision reference, and the product models or category covered. Sources for this answer: - [Single Market Compliance Space - notified bodies by legislation](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - EU listing used to find bodies notified to carry out conformity assessments for Regulation (EU) 2023/1230 on machinery. - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Articles 26 to 42 cover notification, notified-body requirements, identification numbers, and notified-body obligations. ### [What does the notified body assess?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md#what-does-the-notified-body-assess) *Module: [When is a notified body needed under the EU Machinery Regulation?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md)* Under Module B, the notified body examines the technical design, reviews technical documentation, checks representative specimens where required, and issues or refuses an EU type-examination certificate. The manufacturer then uses Module C to keep production in conformity with the approved type. - Module B output: EU type-examination certificate, evaluation report, and any additions or review actions tied to the approved type. - Module H output: quality-system approval decision, audit reports, visit reports, test reports where applicable, and decisions on quality-system changes. - Module G output: certificate for the unit and the notified body's identification number on the approved machinery or related product. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Annexes VII, IX, and X define what notified bodies examine under Modules B, H, and G. - [Single Market Compliance Space - notified bodies by legislation](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - Official lookup starting point for finding machinery notified bodies before using a third-party route. ### [What must the manufacturer still own?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md#what-must-the-manufacturer-still-own) *Module: [When is a notified body needed under the EU Machinery Regulation?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md)* A notified-body certificate is not the whole compliance file. The manufacturer must still demonstrate that the product meets the applicable essential health and safety requirements in Annex III, draw up technical documentation, issue the EU declaration of conformity, affix the CE marking, and keep required records available for market surveillance. - Keep the Annex I classification and Article 25 route rationale with the technical file. - Keep the standards or common-specifications coverage map, including any partial application or uncovered EHSRs. - Keep notified-body certificates, decisions, audit reports, test reports, and correspondence linked to the exact model, type, unit, or quality system. - Reassess the route after material design, software, safety-function, production, supplier, standard, or intended-use changes. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Articles 10, 20, 21, 24, 25 and Annex IV define manufacturer duties, presumption of conformity, declarations, CE marking, route selection, and technical documentation. - [European Commission harmonised standards for machinery](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/machinery-md_en?ref=sorena.io) - Commission machinery standards page used to check harmonised-standard references relevant to Machinery Directive/Machinery Regulation transition work. ### [Which conformity assessment module applies under Article 25?](/artifacts/eu/machinery-regulation/faq/article-25-modules.md#which-conformity-assessment-module-applies-under-article-25) *Module: [Which Article 25 conformity assessment module applies?](/artifacts/eu/machinery-regulation/faq/article-25-modules.md)* Article 25 does not ask teams to choose a module by preference. It first separates machinery and related products into Annex I Part A, Annex I Part B, or not listed in Annex I, then limits the available conformity assessment procedures for that route. - Use Module A for products not listed in Annex I, and for Annex I Part B only when the Article 25 standards or common-specification condition is met. - Use Module B plus C when a notified body examines the type and the manufacturer then controls production to keep manufactured products aligned with the approved type. - Use Module H when the conformity route is based on an approved full quality assurance system under notified-body surveillance. - Use Module G when conformity is assessed by unit verification for the individual machinery or related product. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Article 25 is the binding source for the Module A, Module B plus C, Module H, and Module G route selection rules. - [European Commission - machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission machinery page confirming the Regulation's machinery-policy context, harmonisation approach, and notified-body resources. ### [How do Annex I categories change the route?](/artifacts/eu/machinery-regulation/faq/article-25-modules.md#how-do-annex-i-categories-change-the-route) *Module: [Which Article 25 conformity assessment module applies?](/artifacts/eu/machinery-regulation/faq/article-25-modules.md)* Annex I Part A contains the categories that trigger Article 25(2), including removable mechanical transmission devices and their guards, vehicle servicing lifts, portable cartridge-operated fixing and other impact machinery, certain machine-learning safety components, and machinery with embedded self-evolving machine-learning systems ensuring safety functions in respect of those systems. - Record the exact Annex I Part A or Part B item relied on, not just a general label such as high-risk machinery. - For Part B, attach the standards or common specifications matrix showing which EHSRs are covered and where coverage is only partial. - For machine-learning safety functions, separate the Annex I classification from any wider AI governance analysis; Article 25 still requires the machinery conformity route to be documented. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Annex I and Article 25 identify the Part A and Part B category triggers for conformity assessment procedures. - [European Commission - machinery harmonised standards](https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/machinery-md_en?ref=sorena.io) - Commission machinery standards page used for the OJEU harmonised-standards and presumption-of-conformity context relevant to Part B route decisions. ### [What does the notified body do in each route?](/artifacts/eu/machinery-regulation/faq/article-25-modules.md#what-does-the-notified-body-do-in-each-route) *Module: [Which Article 25 conformity assessment module applies?](/artifacts/eu/machinery-regulation/faq/article-25-modules.md)* In Module B, the notified body examines the technical design, reviews the technical documentation, examines a representative specimen, checks use of harmonised standards or common specifications, and issues or refuses an EU type-examination certificate. Module C is then the manufacturer's production-control step against that approved type. - For Module B plus C, keep the EU type-examination certificate, certificate conditions, additions or renewals, and production controls showing conformity to the approved type. - For Module H, keep the quality-system documentation, approval decision, change approvals, periodic audit reports, unexpected-visit reports, and test reports where relevant. - For Module G, keep the unit technical documentation, notified-body examination and test evidence, the unit-verification certificate, and the notified-body identification-number record. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Annexes VII, VIII, IX, and X define the notified-body tasks and manufacturer obligations for Modules B, C, H, and G. - [Single Market Compliance Space - notified bodies by legislation](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - Official EU database source for checking notified bodies by legislation, including machinery conformity-assessment legislation. - [European Commission - machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission page noting that notified bodies under both the Machinery Directive and Regulation can be found through the NANDO information system. ### [What should the technical file show?](/artifacts/eu/machinery-regulation/faq/article-25-modules.md#what-should-the-technical-file-show) *Module: [Which Article 25 conformity assessment module applies?](/artifacts/eu/machinery-regulation/faq/article-25-modules.md)* The technical documentation should make the Article 25 route auditable. It should show the intended use, applicable EHSRs, risk assessment, protective measures, residual risks where relevant, drawings and schemes, standards or common specifications applied, other technical specifications used where standards are not fully applied, and reports or results from calculations, tests, inspections, and examinations. - Do not treat an Annex I classification memo as the technical file; it is only the route-selection record. - Do not use Module A for Annex I Part B unless the file shows full coverage by category-specific harmonised standards or common specifications for all relevant EHSRs. - Do not rely on a certificate without checking the notified body's legislation and scope, the certificate conditions, and whether product changes or state-of-the-art changes affect the approval. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Annex IV Part A defines technical documentation content for machinery and related products; Annexes VI to X add route-specific records. - [European Commission - machinery harmonised standards](https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/machinery-md_en?ref=sorena.io) - Commission source for checking machinery harmonised-standard references used in the standards matrix. ## FAQ Pagination - Canonical index (page 1): [/artifacts/eu/machinery-regulation/faq/items](/artifacts/eu/machinery-regulation/faq/items.md) - Page 1 rule: `/page/1` is intentionally not generated; use the canonical index markdown URL. - Current page: 2 of 2 Pages: [1](/artifacts/eu/machinery-regulation/faq/items.md) | [2](/artifacts/eu/machinery-regulation/faq/items/page/2.md) [Previous page](/artifacts/eu/machinery-regulation/faq/items.md) *Recommended next step* *Placement: after CE documentation section* ## Review Machinery Regulation scope and CE evidence Use Sorena to check whether a machinery product, related product, partly completed machinery item, software change, or substantial modification changes the applicable conformity assessment and documentation route. - [Open Research Copilot](/solutions/research-copilot.md): Answer Machinery Regulation scope, Article 25, and documentation questions with cited outputs. - [Talk through implementation](/contact.md): Review your product scope, Annex I category, conformity route, and CE evidence model. --- [Privacy Policy](https://www.sorena.io/privacy) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). 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