The Machinery Regulation modernises EU machinery safety rules, including related products, partly completed machinery, high-risk categories, substantial modification, digital instructions, software, and cybersecurity considerations.
This page helps check whether a product is in scope, build the Annex III risk assessment and technical file, choose the right conformity route, and prepare instructions, declarations, CE marking, software evidence, and surveillance records.
For Regulation (EU) 2023/1230, the release file must classify the product, apply the relevant Annex III , document risk assessment and risk reduction, prepare instructions and technical documentation, complete the conformity route, and keep declaration, CE marking, software, and surveillance evidence available for authorities.
1
Section 1
Confirm the product and role before applying requirements
Start with Article 2 and Article 3 classification. The Regulation applies to machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, and partly completed machinery. The machinery definition also covers assemblies missing only the software upload intended for the manufacturer's specific application, and safety components can be physical or digital, including software.
Record whether the release is placing on the market, putting into service, an import/distribution activity, partly completed machinery, or a substantial modification. A person that carries out a substantial modification is treated as the manufacturer for the affected machinery or related product, so the release file should not treat software, control-system, guard, stability, or mechanical-strength changes as ordinary maintenance without a documented safety assessment.
Then assign the for the actual product and event. The manufacturer owns design, construction, risk assessment, technical documentation, conformity assessment, declaration, marking, instructions, production control, and corrective action. An authorised representative performs only its written mandate. An importer verifies the manufacturer's conformity work and required product information before first EU placement, adds its identity, preserves conditions, retains the declaration, and supports authority access. A distributor checks required marking, documents, instructions, identities, storage, transport, and any reason to believe the product is non-compliant before supply.
A person assembling a final system becomes responsible for the completed machinery where that person creates the functional assembly and places it on the market or puts it into service. A professional building machinery for its own use can trigger manufacturer duties at first putting into service. A private-label supplier or substantial modifier can also become the manufacturer. For partly completed machinery, the manufacturer draws up and retains Annex IV Part B technical documentation and supplies assembly instructions and an EU declaration of incorporation; the person completing the machinery must assess the final assembly and cannot use the incorporation declaration as a conformity declaration for the finished machine.
Screen exclusions in Article 2, including certain transport, vessel, military, research, fairground, nuclear, and electrical/electronic product categories, before assigning Machinery Regulation requirements.
Identify the : manufacturer, authorised representative, importer, distributor, or the person responsible for a substantial modification.
Separate machinery and related products from partly completed machinery because partly completed machinery uses technical documentation Part B, assembly instructions, and an EU declaration of incorporation rather than CE marking as a complete machine.
If a substantial modification affects only one machine or related product in an assembly, document the risk-assessment basis for limiting Article 18 manufacturer duties to that affected product. Also record when the express non-professional own-use exception applies.
For each release, keep a role row with the product type, unit or model, transaction, responsible legal person, EU establishment, duty trigger, required inputs, release or stop decision, and evidence handoff.
For a complete machine or related product, do not release without the applicable conformity route, EU declaration of conformity, CE marking, instructions, identification, and technical-file access. For partly completed machinery, do not present the product as complete or CE-mark it under the Machinery Regulation; pass the incorporation documents and integration limits to the final-system owner.
Where Regulation (EU) 2019/1020 Article 4 applies, identify the EU-based operator and keep its name and address with the product or accompanying material. Treat this as an additional market-surveillance contact requirement, not a replacement for the Machinery Regulation manufacturer, importer, or distributor role.
Current consolidated source for the scope, definitions, economic-operator duties, substantial-modification trigger, affected-product boundary, own-use exception, and separate treatment of partly completed machinery.
This Regulation applies to machinery and the following related products
Supports the separate Article 4 EU-based economic-operator requirement and market-surveillance cooperation duties where applicable.
Tasks of economic operators regarding products subject to certain Union harmonisation legislation
2
Section 2
Build the Annex III risk assessment and technical file
Annex III requires an iterative risk assessment and risk reduction process: determine the limits of the machinery, identify hazards and hazardous situations, estimate and evaluate risk, then eliminate hazards or reduce risk through protective measures. The technical documentation in Annex IV must show which apply, what protective measures were implemented, and which residual risks remain.
For machinery and related products, Annex IV Part A requires a complete description and intended use, drawings and explanations, applied harmonised standards or common specifications, other technical specifications where standards are partial or not used, design calculations, tests, inspections, production-control measures, instructions for use, incorporated-product declarations where relevant, and series-production controls. For partly completed machinery, Annex IV Part B requires the same evidence pattern but tailored to incorporation and relevant (EHSRs).
Use an EHSR matrix that links each applicable Annex III requirement to a design feature, guard or protective device, control-system function, test or calculation, residual-risk warning, and owner.
Keep the standards list precise: cite the harmonised standard or common specification used, its applied parts, and the alternative technical specification for any EHSR not fully covered.
Include software evidence where relevant: source code or programming logic for safety-related software must be available to competent authorities on reasoned request when necessary to check Annex III compliance.
Official source machinery-safety standard source for general design, risk assessment, and risk reduction principles used as technical support.
general principles for design, risk assessment and risk reduction
3
Section 3
Choose the conformity route, declarations, CE marking, and instructions
The conformity route depends on Annex I status. Annex I Part A categories must use EU type-examination plus conformity to type, full quality assurance, or unit verification. Annex I Part B categories may use internal production control only when designed and constructed according to harmonised standards or common specifications specific to the category and covering all relevant EHSRs; otherwise a notified-body route is needed. Products outside Annex I use internal production control.
After conformity is demonstrated, the manufacturer draws up the EU declaration of conformity and affixes CE marking before placing machinery or a related product on the market or putting it into service. Instructions may be digital if access is marked, printable and downloadable, available online for the expected lifetime and at least 10 years, and paper instructions are supplied free within one month when requested at purchase. Non-professional-use products still need essential safety information in paper format.
For machinery and related products, prepare Annex V Part A declaration contents: product identification, manufacturer details, sole-responsibility statement, applicable Union harmonisation legislation, standards/common specifications or other technical specifications, and notified-body details where applicable.
Affix CE marking visibly, legibly, and indelibly; add the notified-body identification number when the applicable conformity module requires it.
For partly completed machinery, provide assembly instructions and an EU declaration of incorporation under Annex V Part B; do not treat it as a complete CE-marked machine.
Supports conformity assessment routes, EU declarations, CE marking, digital and paper instruction requirements, and partly completed machinery documentation.
The manufacturer or the natural or legal person referred to in Article 18 shall apply
Official source for locating notified bodies under Regulation (EU) 2023/1230 where a third-party conformity route is required.
Regulation (EU) 2023/1230 on machinery
4
Section 4
Software, transition, and market surveillance controls
Software and cyber-related evidence belongs in the machinery requirements file when it affects safety. Annex III requires protection against accidental or intentional corruption of safety-critical hardware, software, and data; identification of software needed for safe operation; evidence of interventions or software/configuration changes; and control systems that withstand intended and unintended external influences, including reasonably foreseeable malicious attempts leading to hazardous situations.
Transition planning should be date-specific but narrow. Regulation (EU) 2023/1230 generally applies from 20 January 2027 and repeals Directive 2006/42/EC from that date; products placed on the market in conformity with Directive 2006/42/EC before 20 January 2027 may continue to be made available. Market surveillance can still require corrective action, withdrawal, recall, prohibition, or restriction where a product presents a risk or non-compliance persists.
For connected, remote, sensor-fed, autonomous, or self-evolving machinery, retain software version identification, change/intervention logs, safety-function limits, validation records, and data/process descriptions required by Annex III and Annex IV.
Regulation (EU) 2026/1744 was published on 24 July 2026 and entered into force on 27 July 2026. It moves the Machinery Regulation into Section B of AI Act Annex I and requires the Commission to adopt delegated acts adding Annex III requirements for AI systems classified as high-risk under Article 6(1) because they are a safety component of machinery or are themselves machinery. Those delegated acts must apply by 2 August 2028; until machinery-specific harmonised standards or common specifications are available, amended Article 20 provides a limited presumption route through relevant AI Act standards or common specifications.
Keep technical documentation, EU declarations, and relevant declarations of incorporation available for market surveillance authorities for at least 10 years after placing on the market or putting into service, as applicable.
Update the file after design, production, software, supplier, standard, common-specification, complaint, incident, recall, or authority-contact changes.
Published on 24 July 2026 and in force from 27 July 2026. Article 3 requires delegated Machinery Regulation Annex III requirements for qualifying high-risk AI systems to apply by 2 August 2028 and adds an interim standards-based presumption rule.
Recommended next step
Prepare a Machinery Regulation release file
Turn the scope decision, Annex III risk assessment, technical documentation, instructions, conformity route, declaration, CE marking, and software evidence into a reviewable release file.
Supports Annex III risk assessment, EHSR applicability, Annex IV technical documentation contents, and software evidence requirements.
Supports conformity assessment routes, EU declarations, CE marking, digital and paper instruction requirements, and partly completed machinery documentation.
Supports software/cyber EHSR, Article 10 retention and corrective-action duties, market-surveillance procedures, and 20 January 2027 transition.
"The technical documentation shall specify the means used by the manufacturer"
More quoted passages
"The manufacturer or the natural or legal person referred to in Article 18 shall apply"
"The machinery or related product shall collect evidence"
Current consolidated binding source for machinery scope, EHSR, risk assessment, technical documentation, instructions, conformity assessment, declarations, CE marking, software evidence, transition, and safeguard procedures.
Current consolidated source for the scope, definitions, economic-operator duties, substantial-modification trigger, affected-product boundary, own-use exception, and separate treatment of partly completed machinery.
"health and safety requirements for the design and construction of machinery"
More quoted passages
"This Regulation applies to machinery and the following related products"
Published on 24 July 2026 and in force from 27 July 2026. It adds the Machinery Regulation mechanism for qualifying high-risk AI requirements and an interim standards-based presumption of conformity.
Published on 24 July 2026 and in force from 27 July 2026. Article 3 requires delegated Machinery Regulation Annex III requirements for qualifying high-risk AI systems to apply by 2 August 2028 and adds an interim standards-based presumption rule.