--- 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/3" 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: "2026-07-26" 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. ## Definitions ### EU Machinery Regulation **Term:** Machinery Regulation The Machinery Regulation is Regulation (EU) 2023/1230, the directly applicable EU law for machinery, five named related-product categories, and partly completed machinery. Its main product duties apply from 20 January 2027 and replace Directive 2006/42/EC from that date. It governs product scope, economic-operator duties, Annex III design requirements, technical documentation, conformity assessment, declarations, CE marking, instructions, and post-market action. **Why it matters here:** The Regulation is binding law. European Commission pages and standards can explain or support its application. Harmonised standards create a presumption of conformity only when their references are published in the Official Journal, and only for the Annex III requirements they cover. Product facts, intended use, market date, and actor role still control the result. Sources: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230?ref=sorena.io) ## 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. - 6 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. - 6 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 3 of 3. Showing 11 of 41 items.* ### [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 person who is not excluded from manufacturer status under Article 18, 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 where they have not been placed independently on the market, in respect only of those systems. - 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 determine when a notified body is required; Articles 52 and 54 establish the pre-20 January 2027 transition and application date. - [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 and any additions or review actions tied to the approved type. The notified body draws up the evaluation report but releases its content, in full or in part, only with the manufacturer's agreement. - 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 the Machinery Directive](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/machinery-md_en?ref=sorena.io) - Lists standards references published for Directive 2006/42/EC. It does not establish that those standards are cited under Regulation (EU) 2023/1230. ### [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 sets the Module A, Module B plus C, Module H, and Module G routes; Articles 52 and 54 establish the pre-20 January 2027 transition and application date. - [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 that have not been placed independently on the market, in respect only 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 Directive harmonised standards](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/machinery-md_en?ref=sorena.io) - Lists standards references published for Directive 2006/42/EC. It does not establish that those standards are cited under Regulation (EU) 2023/1230 for an Article 25(3) Part B route decision. ### [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 Directive harmonised standards](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/machinery-md_en?ref=sorena.io) - Commission source for checking standards references published for Directive 2006/42/EC. It does not establish citation under Regulation (EU) 2023/1230. ## 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: 3 of 3 Pages: [1](/artifacts/eu/machinery-regulation/faq/items.md) | [2](/artifacts/eu/machinery-regulation/faq/items/page/2.md) | [3](/artifacts/eu/machinery-regulation/faq/items/page/3.md) [Previous page](/artifacts/eu/machinery-regulation/faq/items/page/2.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.md) | [Terms of Use](https://www.sorena.io/terms-of-use.md) | [DMCA](https://www.sorena.io/dmca.md) | [About Us](https://www.sorena.io/about-us.md) (c) 2026 Sorena AB (559573-7338). 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