--- title: "Machinery Regulation vs EMC Directive" canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/machinery-vs-emc" source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/machinery-vs-emc" author: "Sorena AI" description: "Compare EU machinery safety duties with EMC duties for equipment, CE documentation, harmonised standards, declarations, and combined technical files." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU Machinery Regulation" - "Regulation (EU) 2023/1230" - "Directive 2014/30/EU" - "Machinery vs EMC" - "CE marking" - "technical documentation" --- **[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) --- # Machinery Regulation vs EMC Directive Compare EU machinery safety duties with EMC duties for equipment, CE documentation, harmonised standards, declarations, and combined technical files. *Side-by-side* *EU* ## Machinery vs EMC what belongs in each file Machinery compliance is about machinery safety: scope, EHSRs, risk assessment, risk reduction, instructions, technical documentation, conformity assessment, and the machinery declaration. EMC compliance is a separate electromagnetic compatibility workstream. The Machinery grounding confirms EMC can apply in addition where machinery immunity or emissions affect electromagnetic compatibility. Use this comparison when a machine, related product, control system, or electrical assembly needs both machinery-safety evidence and electromagnetic-compatibility evidence. The practical question is not which label wins; it is which risks, standards, tests, declaration entries, and technical-file records support each CE claim. ## Machinery vs EMC: side-by-side comparison Use this table to decide what belongs in the machinery safety file, what belongs in the EMC file, and what can be reused without losing traceability. - **Machinery**: Machinery covers the machine or related product safety case: EHSRs, risk assessment, risk reduction, instructions, technical documentation, conformity assessment, CE marking, and the Machinery declaration. - **EMC**: EMC covers electromagnetic compatibility issues such as disturbance and immunity. The Machinery grounding confirms the EMC Directive can apply in addition for those issues. | Dimension | Machinery | EMC | Operational implication | Sources | | --- | --- | --- | --- | --- | | Scope boundary | Is the product machinery, a related product, or partly completed machinery under Regulation (EU) 2023/1230, and which Machinery obligations follow from that classification? | Does the equipment need a separate EMC assessment for electromagnetic disturbance or immunity under Directive 2014/30/EU? | A powered machine with electronics can need both files: Machinery for safety risks and EMC for electromagnetic compatibility. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery scope and product classifications.
[Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the EMC-in-addition overlap for machinery immunity and emissions. | | Covered actors | Machinery starts from hazards, EHSRs, risk assessment, risk reduction, residual risks, and instructions for safe use. | EMC starts from electromagnetic disturbance and immunity evidence; do not use EMC tests as a substitute for the machinery hazard analysis. | Keep separate matrices: one EHSR and risk-reduction matrix for Machinery, one EMC standards and test-evidence matrix for EMC. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery EHSR and technical-documentation risk-assessment requirements.
[ISO 12100:2010 - Safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Grounds the machinery risk-assessment and risk-reduction method. | | Trigger | Machinery standards support presumption or evidence of conformity only for the EHSRs they cover; the declaration should identify applied standards and any partial application. | EMC standards support the EMC claim; they should be listed as EMC evidence, not as proof that the machine safety risk assessment is complete. | Create one standards register with columns for regime, requirement, edition, OJEU or source status, test or design evidence, and limits of reliance. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds declaration references to harmonised standards and partial application.
[European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Grounds the Machinery model of mandatory EHSRs and voluntary harmonised standards. | | Core obligations | Machinery documentation should include the EHSR analysis, risk assessment, design and manufacturing information, instructions, conformity-assessment records, and declaration. | EMC documentation should include the EMC standards, test plan, test reports, design assumptions, and declaration evidence used for the EMC claim. | A combined technical file is acceptable only if reviewers can see which document supports Machinery, EMC, or both. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the Machinery technical-documentation content and retention concepts.
[Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the specific EMC overlap that should be reflected in the technical file. | | Evidence record | The Machinery declaration identifies the machinery or related product and the Union harmonisation legislation and standards used for the Machinery conformity claim. | Where EMC also applies, the CE declaration set should identify Directive 2014/30/EU separately rather than hiding EMC under the Machinery entry. | Before affixing CE marking, check that each applicable regime has supporting assessment records and a declaration entry. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the Machinery declaration fields and CE marking requirements.
[European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Grounds the implementation notice that CE marking follows testing and conformity assessment under applicable EU harmonisation legislation. | | Timing and deadlines | Machinery remains the safety framework, but Article 9 allocates risks to more-specific Union harmonisation legislation where that legislation wholly or partly covers the same EHSR risk. | EMC should be treated as the more-specific workstream for electromagnetic compatibility issues, while Machinery still covers the machine safety hazards not displaced by a specific law. | Do not delete Machinery requirements wholesale; allocate specific risks and keep a written rationale for each allocation. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the Article 9 specific Union harmonisation legislation allocation rule. | | Enforcement | Partly completed machinery follows the Machinery Regulation route for assembly instructions, relevant EHSRs, and an EU declaration of incorporation. | Any EMC work for the component or final assembly should be mapped separately so downstream integrators know which assumptions, installation conditions, and tests they can rely on. | Do not convert a partly completed machinery file into a finished-machine CE pack unless the final machinery conformity assessment has been completed. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds assembly instructions and declaration of incorporation for partly completed machinery. | | Overlap and reuse | When Machinery and EMC both apply, keep the machinery safety case and the EMC evidence in separate sections of the same file so each requirement stays traceable. | Treat EMC as a parallel compliance file, not as a substitute for the machinery risk assessment or EHSR matrix. | Reuse design data where it helps both regimes, but record the legal basis, the test basis, and the requirement each item supports. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery scope and product classifications.
[Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the EMC-in-addition overlap for machinery immunity and emissions. | | Practical decision rule | Start with Machinery when the product is a machine, related product, or partly completed machinery and you need the safety file, EHSR review, risk reduction record, instructions, and declaration of conformity. | Start with EMC when the item is electrical or electronic apparatus whose main remaining question is electromagnetic disturbance or immunity under Directive 2014/30/EU. | If both apply, finish the machinery safety file first, then add EMC evidence and a separate EMC declaration entry so the final CE pack shows both legal bases clearly. | [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery scope and product classifications.
[Directive 2014/30/EU on electromagnetic compatibility](https://data.europa.eu/eli/dir/2014/30/oj?ref=sorena.io) - Grounds the EMC side and its separate compliance basis.
[Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the overlap statement for EMC in addition to machinery obligations. | Sources for Scope boundary: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery scope and product classifications. - Quote: "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 EMC-in-addition overlap for machinery immunity and emissions. - Quote: "EMC Directive 2014/30/EU is applicable in addition" Sources for Covered actors: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery EHSR and technical-documentation risk-assessment requirements. - Quote: "analysis and assessment of the risk" - [ISO 12100:2010 - Safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Grounds the machinery risk-assessment and risk-reduction method. - Quote: "identifying hazards" Sources for Trigger: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds declaration references to harmonised standards and partial application. - Quote: "partial application of harmonised standards" - [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Grounds the Machinery model of mandatory EHSRs and voluntary harmonised standards. - Quote: "voluntary harmonised standards" Sources for Core obligations: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the Machinery technical-documentation content and retention concepts. - Quote: "technical documentation" - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the specific EMC overlap that should be reflected in the technical file. - Quote: "immunity of machinery to electromagnetic radiation" Sources for Evidence record: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the Machinery declaration fields and CE marking requirements. - Quote: "EU declaration of conformity" - [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Grounds the implementation notice that CE marking follows testing and conformity assessment under applicable EU harmonisation legislation. - Quote: "performing the conformity assessment procedure" Sources for Timing and deadlines: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds the Article 9 specific Union harmonisation legislation allocation rule. - Quote: "to the extent that that specific Union legislation covers such risks" Sources for Enforcement: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds assembly instructions and declaration of incorporation for partly completed machinery. - Quote: "EU declaration of incorporation" Sources for Overlap and reuse: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery scope and product classifications. - Quote: "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 EMC-in-addition overlap for machinery immunity and emissions. - Quote: "EMC Directive 2014/30/EU is applicable in addition" Sources for Practical decision rule: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery scope and product classifications. - Quote: "machinery and related products" - [Directive 2014/30/EU on electromagnetic compatibility](https://data.europa.eu/eli/dir/2014/30/oj?ref=sorena.io) - Grounds the EMC side and its separate compliance basis. - Quote: "electromagnetic compatibility" - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the overlap statement for EMC in addition to machinery obligations. - Quote: "EMC Directive 2014/30/EU is applicable in addition" ### Practical decision rule - Use Machinery first when you need the safety case: scope, EHSRs, risk assessment, risk reduction, instructions, conformity assessment, CE marking, and the Machinery declaration. - Use EMC first when the immediate question is electromagnetic compatibility and the item falls under Directive 2014/30/EU. - If both regimes apply, complete both files separately and combine them only at the declaration and evidence-index level so reviewers can see which record supports which legal basis. ## Separate the safety case from the EMC case The Machinery Regulation requires machinery and related products to satisfy the applicable essential health and safety requirements, supported by technical documentation that includes an analysis and assessment of risks. ISO 12100 is the machinery-safety reference in the grounding folder for the design process: identify hazards, estimate and evaluate risks, reduce risks, and document the result. The EMC workstream answers a different question: whether electromagnetic disturbance from the equipment, or immunity to electromagnetic radiation, is addressed under Directive 2014/30/EU. The Machinery Directive guide in the grounding folder states that the EMC Directive applies in addition for those machinery immunity and emissions issues. - Keep the Machinery record focused on hazards to people, domestic animals, property, and where applicable the environment, plus the EHSRs and risk-reduction measures used to address them. - Keep the EMC record focused on electromagnetic disturbance and immunity evidence, including the EMC standards and test reports used for the CE claim. - When one design measure supports both files, list it twice in the evidence index and state which legal requirement or standard it supports in each workstream. 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 Machinery side: EHSRs, risk assessment, technical documentation, CE marking, and EU declaration obligations for machinery and related products. - [ISO 12100:2010 - Safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Grounds the machinery risk-assessment and risk-reduction method used to build the safety case. - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the overlap point that EMC can apply in addition for machinery immunity and emissions. ## Build one CE pack with traceable parts A combined CE pack can be efficient, but it should not blur legal bases. The Machinery Regulation declaration template requires the object of the declaration, the Union harmonisation legislation, and references to harmonised standards or other technical specifications used. If both Machinery and EMC apply, the shared declaration and evidence index should make the split visible. For machinery, the technical documentation should allow assessment against the relevant EHSRs and include risk analysis and assessment. For EMC, the same CE pack can reference EMC-specific standards and test evidence, but those records should not be used as a substitute for the machinery risk assessment, EHSR matrix, instructions, or conformity-assessment route. - Use a declaration table that lists Regulation (EU) 2023/1230 and Directive 2014/30/EU as separate entries when both regimes apply. - Map each harmonised standard to the requirement it supports; Machinery standards support EHSR conformity, while EMC standards support electromagnetic compatibility evidence. - Keep a single document index if useful, but tag each test report, drawing, risk assessment, instruction, declaration, and notified-body record to the regime it supports. 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 declaration content, technical documentation, harmonised-standard references, and authority-access records for Machinery. - [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Grounds the Commission statement that machinery legislation combines mandatory EHSRs with voluntary harmonised standards. - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds practical treatment of EMC as an additional product-law workstream for electromagnetic immunity and emissions. *Recommended next step* *Placement: after comparison section* ## Review the combined CE evidence map Check whether your machinery safety file, EMC evidence, declaration entries, standards list, and technical documentation index show which requirement each record supports. - [Open Research Copilot](/solutions/research-copilot.md): Ask Machinery and EMC scoping questions with cited outputs. - [Talk through implementation](/contact.md): Review your combined CE evidence model and remaining gaps. ## When both regimes apply Treat both regimes as applying when the product is machinery or a related product and also presents EMC issues such as electromagnetic disturbance or immunity. The Machinery Regulation has a specific rule for more-specific Union harmonisation legislation: where another Union law covers an EHSR risk more specifically, Machinery does not apply to that risk to the extent the specific law covers it. That is a risk-by-risk allocation rule, not permission to drop the machinery safety case. The release gate should therefore ask two questions. First, has the machinery safety file covered scope, EHSRs, risk assessment, risk reduction, instructions, conformity assessment, CE marking, and declaration records? Second, has the EMC file covered electromagnetic compatibility evidence and the declaration entry for Directive 2014/30/EU? - Escalate if a team wants to rely on EMC tests alone to close a machinery hazard, because EMC evidence does not supersede the EHSR and risk-reduction file. - Escalate if a team wants the Machinery declaration to imply EMC conformity without separate EMC standards, test evidence, and declaration mapping. - Escalate if the product is partly completed machinery, because the Machinery Regulation uses assembly instructions and an EU declaration of incorporation rather than treating the item as complete CE-marked machinery. 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 Article 9 allocation rule for more-specific Union harmonisation legislation and the separate treatment of partly completed machinery. - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the practical overlap statement for EMC immunity and emissions in machinery. - [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Grounds the Commission implementation context for Machinery Regulation, harmonised standards, notified bodies, and CE marking. ## Primary sources - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Grounds Machinery scope and product classifications. - Quote: "machinery and related products" - [Directive 2014/30/EU on electromagnetic compatibility](https://data.europa.eu/eli/dir/2014/30/oj?ref=sorena.io) - Grounds the EMC side and its separate compliance basis. - Quote: "electromagnetic compatibility" - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Grounds the overlap statement for EMC in addition to machinery obligations. - Quote: "EMC Directive 2014/30/EU is applicable in addition" - [European Commission machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Grounds the implementation notice that CE marking follows testing and conformity assessment under applicable EU harmonisation legislation. - Quote: "performing the conformity assessment procedure" - [ISO 12100:2010 - Safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Grounds the machinery risk-assessment and risk-reduction method. - Quote: "identifying hazards" ## Related Topic Guides - [Declaration of Conformity vs Declaration of Incorporation | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/doc-and-doi.md): FAQ on when machinery needs an EU Declaration of Conformity and when partly completed machinery needs an EU Declaration of Incorporation under Regulation (EU) 2023/1230. - [Directive 2006/42/EC to Machinery Regulation transition](/artifacts/eu/machinery-regulation/transition-from-directive-2006-42-ec.md): Transition guide for moving EU machinery files from Directive 2006/42/EC to Regulation (EU) 2023/1230, focused on the 20 January 2027 changeover, pipeline products, declarations, standards, technical documentation, software, cybersecurity, and digital instructions. - [EU Machinery Regulation Applicability Test](/artifacts/eu/machinery-regulation/applicability-test.md): Test whether a product is machinery, a related product, partly completed machinery, a safety component, substantially modified, excluded, or covered by overlapping EU product laws. - [EU Machinery Regulation compliance](/artifacts/eu/machinery-regulation/compliance.md): Machinery Regulation compliance checklist covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, software, transition, and market surveillance. - [EU Machinery Regulation compliance checklist](/artifacts/eu/machinery-regulation/checklist.md): Checklist for Regulation (EU) 2023/1230 covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, digital duties, transition, and market surveillance. - [EU Machinery Regulation deadlines and compliance calendar](/artifacts/eu/machinery-regulation/deadlines-and-compliance-calendar.md): Calendar for Regulation (EU) 2023/1230 dates, Directive 2006/42/EC transition, release documentation gates, standards monitoring, and substantial-modification reviews. - [EU Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq.md): Answers to Machinery Regulation questions on scope, partly completed machinery, Annex I categories, Article 25 conformity assessment, digital instructions, software, cybersecurity, transition, CE files, and overlap with other EU product laws. - [EU Machinery Regulation Partly Completed Machinery](/artifacts/eu/machinery-regulation/partly-completed-machinery.md): What counts as partly completed machinery under Regulation (EU) 2023/1230, what documents travel with it, and where the final assembler takes over. - [EU Machinery Regulation requirements](/artifacts/eu/machinery-regulation/requirements.md): Requirements under Regulation (EU) 2023/1230: machinery scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declaration, CE marking, software evidence, transition, and surveillance. - [EU Machinery Regulation Safety Components](/artifacts/eu/machinery-regulation/safety-components.md): Definition, scope, conformity assessment, technical documentation, declaration, CE marking, and grounded examples for safety components under Regulation (EU) 2023/1230. - [EU Machinery Regulation scope and machine categories](/artifacts/eu/machinery-regulation/scope-and-machine-categories.md): Scope guide for Regulation (EU) 2023/1230 covering machinery, related products, partly completed machinery, Annex I categories, exclusions, substantial modification, and category evidence. - [EU Machinery Regulation substantial modification decision workflow](/artifacts/eu/machinery-regulation/substantial-modification-workflow.md): Workflow for assessing substantial modification under Regulation (EU) 2023/1230: change facts, hazard and risk impact, manufacturer obligations, conformity assessment, CE marking, and evidence. - [EU Machinery Regulation vs LVD](/artifacts/eu/machinery-regulation/machinery-vs-lvd.md): Compare the EU Machinery Regulation and Low Voltage Directive boundary for machinery EHSRs, electrical risks, excluded electrical products, CE documentation, and evidence reuse. - [EU Machinery Regulation vs Market Surveillance Regulation: compliance comparison](/artifacts/eu/machinery-regulation/machinery-vs-msr.md): Compare Machinery Regulation product compliance duties with EU MSR market surveillance duties, authority requests, online sales, corrective action and evidence records. - [EU Machinery Regulation: autonomous mobile and collaborative machinery](/artifacts/eu/machinery-regulation/autonomous-mobile-and-collaborative-machinery.md): Grounded guide to Regulation (EU) 2023/1230 requirements for autonomous mobile machinery, human-machine interaction, controls, software, cybersecurity, risk assessment, technical documentation, and conformity routes. - [EU Machinery Regulation: when does a modification constitute substantial modification?](/artifacts/eu/machinery-regulation/substantial-modification.md): Guide to substantial modification under Regulation (EU) 2023/1230: change triggers, risk assessment, EHSRs, technical documentation, conformity assessment, CE marking, and records. - [EU Machinery Risk Assessment Method](/artifacts/eu/machinery-regulation/risk-assessment-method.md): How to document an EU Machinery Regulation risk assessment: ISO 12100 hazard identification, EHSR mapping, risk reduction, residual risk, software, cybersecurity, and technical-file evidence. - [How to map Annex III EHSRs under the EU Machinery Regulation | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/annex-iii-ehsr.md): FAQ on mapping Annex III essential health and safety requirements to hazards, risk reduction, software controls, technical documentation, and Annex I classification under Regulation (EU) 2023/1230. - [Machinery CE documentation template for Regulation (EU) 2023/1230](/artifacts/eu/machinery-regulation/machinery-ce-documentation-template.md): Template fields for Machinery Regulation CE documentation: product identity, scope, EHSR risk assessment, standards, tests, instructions, EU declaration, CE marking, notified body route, software, cyber, and substantial modification checks. - [Machinery Regulation and EU AI Act overlap for AI-enabled safety functions](/artifacts/eu/machinery-regulation/faq/ai-act-overlap.md): FAQ on Machinery Regulation overlap with the EU AI Act for self-evolving or machine-learning safety functions, Annex I categories, standards work, and technical documentation boundaries. - [Machinery Regulation Annex I conformity route workflow](/artifacts/eu/machinery-regulation/annex-i-route-workflow.md): Classify machinery against Annex I Part A and Part B, choose the Article 25 conformity assessment route, and assemble the technical evidence file. - [Machinery Regulation Annex I high-risk categories](/artifacts/eu/machinery-regulation/annex-i-and-high-risk-machinery.md): Explain what Annex I does under Regulation (EU) 2023/1230, which listed machinery categories trigger special conformity routes, and what evidence to keep. - [Machinery Regulation category and scope checks](/artifacts/eu/machinery-regulation/category-and-scope-workflow.md): Check whether a product is machinery, a related product, partly completed machinery, a safety component, excluded from scope, or listed in Annex I under Regulation (EU) 2023/1230. - [Machinery Regulation conformity assessment and CE marking](/artifacts/eu/machinery-regulation/conformity-assessment-and-ce.md): EU Machinery Regulation guide to Article 25 conformity assessment routes, Annex I machinery categories, technical documentation, EU declarations, CE marking, and instructions. - [Machinery Regulation cybersecurity evidence FAQ](/artifacts/eu/machinery-regulation/faq/cybersecurity.md): What cybersecurity evidence connected or software-enabled machinery should keep for protection against corruption, safety-related control systems, and machinery risk assessment. - [Machinery Regulation digital instructions](/artifacts/eu/machinery-regulation/digital-instructions.md): EU Machinery Regulation guide to digital instructions for use: access marking, print and download access, paper copies, non-professional safety information, languages, and records. - [Machinery Regulation penalties and enforcement](/artifacts/eu/machinery-regulation/penalties-and-fines.md): EU Machinery Regulation enforcement guide covering Member State penalty rules, corrective action, market surveillance powers, and cross-border authority cooperation. - [Machinery Regulation related products scope guide](/artifacts/eu/machinery-regulation/related-products.md): Classify EU Machinery Regulation related products, including interchangeable equipment, safety components, lifting accessories, lifting chains, ropes, webbing, and removable transmission devices. - [Machinery Regulation software and cybersecurity considerations](/artifacts/eu/machinery-regulation/software-and-cybersecurity-considerations.md): How Regulation (EU) 2023/1230 treats safety-related software, control systems, corruption protection, technical documentation, and cyber-safety risk evidence. - [Machinery Regulation Technical Documentation and Technical File](/artifacts/eu/machinery-regulation/technical-documentation-and-technical-file.md): What to keep in the EU Machinery Regulation technical file: product identification, risk assessment, EHSR mapping, standards, tests, instructions, declarations, software evidence, retention, and notified-body records. - [Machinery Regulation technical file acceptance workflow](/artifacts/eu/machinery-regulation/technical-file-acceptance-workflow.md): Release-gate workflow for accepting an EU Machinery Regulation technical file: scope, EHSR risk evidence, standards, tests, declarations, notified-body records, software, cyber, and signoff. - [Machinery Regulation Timeline and Transition: practical guide](/artifacts/eu/machinery-regulation/timeline-and-transition.md): EU Machinery Regulation guide to Timeline and Transition with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps. - [Machinery Regulation vs EU AI Act: machinery safety overlap](/artifacts/eu/machinery-regulation/machinery-regulation-vs-eu-ai-act.md): A grounded comparison of the EU Machinery Regulation and EU AI Act for machinery with AI-enabled safety functions, software, cyber-safety and technical documentation overlap. - [Machinery Regulation vs Machinery Directive](/artifacts/eu/machinery-regulation/machinery-regulation-vs-machinery-directive.md): Grounded comparison of Regulation (EU) 2023/1230 and Directive 2006/42/EC across legal form, timing, scope, digital instructions, cybersecurity, conformity assessment, documentation, and CE marking. - [Machinery vs RED comparison](/artifacts/eu/machinery-regulation/machinery-vs-red.md): Compare EU Machinery Regulation and Radio Equipment Directive boundaries for machinery safety, radio equipment scope, CE documentation, and shared evidence. - [What counts as machinery under Regulation (EU) 2023/1230?](/artifacts/eu/machinery-regulation/faq/machinery-definition.md): FAQ on the Machinery Regulation definition of machinery, including assemblies, drive systems, missing components, software, related products, partly completed machinery, safety components, and exclusions. - [When can a software update affect Machinery Regulation compliance?](/artifacts/eu/machinery-regulation/faq/software-updates.md): FAQ on when machinery software updates can trigger Machinery Regulation review, including safety functions, substantial modification, corruption protection, instructions, and CE technical-file evidence. - [When does used or modified machinery need a new conformity assessment? | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md): FAQ on used and modified machinery under Regulation (EU) 2023/1230, including substantial modification, first EU use, technical documentation, and market surveillance evidence. - [When is a notified body needed under the EU Machinery Regulation?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md): FAQ on when Machinery Regulation Annex I products need a notified body, how to find designated bodies, and what manufacturers still own. - [Which Article 25 conformity assessment module applies? | EU Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/article-25-modules.md): FAQ on Article 25 of Regulation (EU) 2023/1230: Module A, Module B plus C, Module H, Module G, Annex I triggers, notified body involvement, and technical file evidence. --- [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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