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Use an EU Declaration of Conformity for machinery or a related product when the manufacturer has drawn up the Annex IV Part A technical documentation, completed the relevant conformity assessment procedure, and demonstrated conformity with the applicable essential health and safety requirements in Annex III.

The DoC is the manufacturer's formal responsibility statement for that machinery or related product. It must follow the Annex V Part A model structure, identify the product, list the Union harmonisation legislation and standards or technical specifications relied on, and be kept with the technical documentation for market surveillance.

Match the declaration to the exact model or type and the configuration assessed. A supplier declaration for a component, or a DoI for partly completed machinery inside the assembly, is input evidence for the final manufacturer's file; neither replaces the final DoC for complete machinery.

The Regulation's declaration forms and related product duties apply from 20 January 2027. For products placed on the market before then, use the declaration and transition rules of the Machinery Directive and retain the first-placement date; do not reissue an earlier declaration under the Regulation solely because the product remains in use or is resold.

Use an EU Declaration of Incorporation for partly completed machinery. Regulation (EU) 2023/1230 defines partly completed machinery as an assembly that is not yet machinery because it cannot by itself perform a specific application and is only intended to be incorporated into or assembled with machinery, other partly completed machinery, or equipment.

The DoI does not say that a final machine is complete or ready for CE marking. It states that the relevant essential health and safety requirements for the partly completed machinery have been demonstrated, and it must follow the Annex V Part B model structure.

Both declarations depend on technical documentation, but they point to different annexes and different product states. Machinery and related products use Annex IV Part A; partly completed machinery uses Annex IV Part B.

For complete machinery, the technical documentation must show how conformity with the applicable essential health and safety requirements is achieved. For partly completed machinery, the technical documentation must show conformity with the relevant essential health and safety requirements and include evidence that the partly completed machinery can be assembled and incorporated safely.

The practical boundary is whether the item is already machinery or a related product, or whether it is only partly completed machinery intended for incorporation. If the item can perform the intended application as machinery and the manufacturer places it on the market or puts it into service, the DoC and CE marking path applies.

If the item cannot perform a specific application by itself and needs incorporation into final machinery or equipment, the DoI and assembly-instructions path applies. The final machinery manufacturer then needs to assess the assembled machine, close any remaining essential health and safety requirements, prepare the final technical documentation, issue the final DoC where applicable, and affix CE marking to the final machinery.

EHSRs are the essential health and safety requirements in Annex III of Regulation (EU) 2023/1230. The general principles require the manufacturer to carry out a risk assessment, determine which Annex III requirements apply, and then design and construct the machinery or related product to eliminate hazards or minimise the relevant risks.

The mapping should start with the intended use, reasonably foreseeable misuse, product limits, hazardous situations, severity, probability, and required risk reduction. Annex III says the first chapter is general and applies to all machinery or related products, while the other chapters apply where the risk assessment shows more specific hazards such as mobility, lifting, underground work, lifting persons, or certain product categories.

A harmonised standard does not replace this applicability decision. It can provide a presumption of conformity only for the Annex III requirements it covers, so the EHSR map should record full, partial, or no standards coverage and identify the other technical evidence used for every remaining requirement.

These Regulation-specific Annex III duties apply from 20 January 2027. Products placed on the market before that date remain subject to the Machinery Directive transition in Article 52, so keep the first-placement date and the applicable legal basis with the map instead of retroactively relabelling an earlier file.

The Annex III general principles describe an iterative process: determine product limits, identify hazards and hazardous situations, estimate severity and probability, evaluate whether risk reduction is required, then eliminate hazards or reduce risks using protective measures in the required priority order.

That means the EHSR map should be hazard-led. A mechanical movement hazard might point to guards or protective devices; a control-system hazard might point to safety and reliability of control systems; a software or data-integrity hazard might point to protection against corruption; and a mobility hazard might require the mobility chapter in addition to the general chapter.

Software belongs in the Annex III map when it affects safety. The Regulation covers safety components as physical or digital components, including software, and Annex III includes specific requirements for protection against accidental or intentional corruption of hardware, software, and data that are critical to compliance with EHSRs.

For control systems, Annex III requires design and construction that prevent hazardous situations, including attention to faults in hardware or logic, errors in control-system logic, reasonably foreseeable malicious attempts where relevant, and limits of safety functions established through the manufacturer's risk assessment. Where safety-related software versions or interventions are relevant, the Regulation also grounds tracing-log and source-code or programming-logic evidence in defined circumstances.

Test the supplementary EHSRs against the real product and use. Record why each chapter applies or does not apply, then connect its design duties to drawings, material specifications, calculations, tests, cleaning or maintenance instructions, and residual-risk information.

Food, cosmetics, and pharmaceutical machinery needs evidence for material compatibility, cleanability, drainage or discharge, prevention of contamination, and instructions for cleaning, disinfecting, and rinsing. Lubricants or auxiliary substances that could contact products need a controlled design and maintenance basis. Hand-held and hand-guided machinery needs handling, control, stability, and vibration evidence. Portable fixing and impact machinery and woodworking machinery require their specific protective measures rather than a generic guarding statement.

Plant-protection machinery needs evidence covering operator and environmental exposure, filling and emptying, leakage, drift or unintended dispersion, distribution and calibration, cleaning, servicing, inspection, and the tests and instructions needed for safe adjustment. Mobile machinery needs visibility, operator position, travel control, stability, rollover or falling-object risks, braking, and information on vibration where applicable. Underground machinery, lifting machinery, and machinery lifting persons each require the corresponding strength, stability, control, access, carrier, anchorage, emergency, and marking checks.

Annex IV requires technical documentation to specify the means used to ensure conformity with applicable Annex III EHSRs. For machinery and related products, that documentation includes a complete product description, risk-assessment documentation, the list of applicable EHSRs, protective measures, residual risks, drawings and schemes, standards or common specifications applied, tests and calculations, instructions for use, declarations, production controls, and selected software or sensor-system evidence where relevant.

A useful EHSR map therefore has one row per applicable requirement or hazard cluster, with cross-references to the risk assessment, design evidence, verification evidence, instruction text, standards basis, residual-risk treatment, and declaration support. If a harmonised standard or common specification is only partly applied, the record should say which parts were applied and what other technical specifications close the remaining EHSR gap.

Annex III answers the question: which essential safety requirements apply to this product and how were the risks eliminated or reduced? Annex I answers a different question: is the product in a category that must follow one of the specified conformity-assessment procedures under Article 25?

Keep both analyses in the same compliance pack, but do not merge them. Annex I classification may affect whether a notified body route is needed, while Annex III mapping remains the substantive evidence that the applicable health and safety requirements have been addressed.

Overlap matters most when a safety function depends on software, sensor data, machine learning, autonomous operation, or fully or partially self-evolving behaviour. The Machinery Regulation does not turn every AI feature into a machinery-specific AI issue; the machinery question is whether the system affects an essential health and safety requirement or the conformity assessment route.

For AI Act Article 6(1), an AI system is high-risk only when both conditions are met: it is intended as a safety component of a product, or is itself a product, covered by Union harmonisation legislation listed in AI Act Annex I; and that product must undergo third-party conformity assessment before market placement or putting into service under that legislation. From 27 July 2026, the Machinery Regulation is listed in Section B of that Annex. The listing alone does not make every AI system in machinery high-risk.

For a high-risk AI system related to a product under AI Act Annex I Section B, amended AI Act Article 2(2) makes only Article 6(1), Article 60a, and Articles 102 to 112 directly applicable. Articles 57 to 59 apply only once the high-risk requirements have been integrated into the sectoral law. New Machinery Regulation Article 8 requires Commission delegated acts to add Annex III health and safety requirements reflecting AI Act Chapter III Section 2 and Articles 17, 19, 72, and 73; those delegated acts must apply by 2 August 2028.

The Commission standardisation request describes the machinery-AI intersection as machinery products with systems ensuring safety functions, with fully or partially self-evolving behaviour using machine learning approaches. CEN-CENELEC Q&A material also frames the issue around predictability: for Machinery Regulation purposes, the concern is relevant when unpredictable or self-evolving behaviour concerns a safety function.

Do not confuse the two Annex I lists. Machinery Regulation Annex I classifies machinery and related products for Article 25 conformity assessment. AI Act Annex I lists product legislation for the Article 6(1) high-risk test. AI-enabled safety functions can affect the machinery conformity route when the machinery or related product falls within Machinery Regulation Annex I. Products in Part A are subject to the specific procedures in Article 25(2). Products in Part B use the Article 25(3) route, and self-assessment is possible only where the product is designed and constructed in accordance with relevant harmonised standards or common specifications that are specific to the category and cover all relevant essential requirements.

Article 6 also lets the Commission amend Annex I in light of technical progress, advances in knowledge, or new scientific evidence. One listed criterion for Part A inclusion is uncertainty in existing risk-assessment methods for new machinery categories or technologies, which is the relevant machinery-official source boundary for novel AI-enabled safety functions.

The Machinery Regulation technical documentation must show how the manufacturer ensures conformity with applicable essential health and safety requirements. For AI-enabled safety functions, the machinery file should be concrete enough to connect the hazard, the protective measure, the safety-related software or data input, and the verification evidence.

Annex IV requires risk-assessment documentation, applied harmonised standards or common specifications, design calculations, test and inspection results, and, where relevant, source code or programming logic of safety-related software after a reasoned authority request. It also calls out sensor-fed, remotely driven, or autonomous machinery where safety-related operations are controlled by sensor data: the record should describe the system's general characteristics, capabilities, limitations, data, development, testing, and validation processes.

The standards context is still a machinery context. The 2025 machinery standardisation request asks CEN and CENELEC to draft or revise standards for machinery products with fully or partially self-evolving behaviour or logic, safety functions governed by such systems using machine learning approaches, and safety functions based on external connections, software, or data that must be protected against corruption.

The request also says standards developed under the machinery mandate should take into account work under the AI Act and Cyber Resilience Act and be prepared as machinery-specific standards. That is useful context for standards monitoring, but it is not a shortcut for claiming compliance with the AI Act.

The evidence should start with the Machinery Regulation safety question: could a connected device, remote communication path, software change, data change, or control-system logic failure create a hazardous situation? If yes, the cybersecurity record belongs inside the machinery risk assessment and technical documentation, not only in a separate IT security file.

Annex III section 1.1.9 requires protection against corruption for safety-critical signal or data hardware, software, and data. It also requires the machinery or related product to identify software necessary for safe operation and to collect evidence of legitimate or illegitimate interventions in relevant hardware, software, installed software, or configuration.

Scope the controls to machinery safety. The Regulation calls for proportionate protection against malicious third parties where interference can affect product safety; it does not make the machinery technical file a substitute for a separate assessment under other cybersecurity legislation that may apply to the product.

These Machinery Regulation requirements apply from 20 January 2027. Before that date, document the legal basis used for the product placed on the market and keep this Annex III analysis as transition evidence; do not present it as replacing any separate Cyber Resilience Act, radio-equipment, network-security, or sector-specific assessment that applies.