Machinery Regulation safety components

Article 2 lists safety components as related products. A qualifying component marketed as its own product follows the machinery-and-related-product obligations, rather than the declaration-of-incorporation route for partly completed machinery.

Apply every element of Article 3(3). The component may be physical, digital, or software. It must be designed or intended to fulfil a safety function, independently placed on the market, and capable of endangering persons if it fails or malfunctions. It must also be unnecessary for the product to function, or a normal component must be capable of replacing it while allowing the product to function. A component that satisfies only some of these conditions is not a safety component under this definition.

Article 2(2)(a) creates a narrow spare-part exclusion. It applies when a safety component is intended to replace an identical component and is supplied by the manufacturer of the original machinery, related product, or partly completed machinery. A compatible replacement from another supplier, or a replacement that is not identical, does not qualify for that exclusion on those facts alone.

From the Regulation's application date, a safety component that is a related product may be made available or put into service only if it meets the applicable essential health and safety requirements (EHSRs) in Annex III when properly installed, maintained, and used as intended or under reasonably foreseeable conditions.

Build the technical file from the risk assessment. Annex IV, Part A requires the risk-assessment procedure, the applicable EHSRs, the protective measures used for each applicable requirement, and residual risks where relevant.

Article 25 selects the conformity route by the product's Annex I status. A safety component in Annex I, Part A must use one of three Article 25(2) procedures: EU type-examination followed by conformity to type based on internal production control, conformity based on full quality assurance, or conformity based on unit verification.

The current Annex I, Part A expressly includes safety components with fully or partially self-evolving behaviour using machine-learning approaches that ensure safety functions. A safety component not listed in Annex I uses internal production control under Article 25(4). Because Annex I can be amended by delegated acts, check the current text again when selecting the release route.

Safety components can also fall in Annex I Part B, including protective devices designed to detect persons, logic units ensuring safety functions, and roll-over or falling-object protective structures. Article 25(3) permits Module A (internal production control) only when the product is designed and constructed according to category-specific harmonised standards or common specifications covering all relevant EHSRs; otherwise use Module B plus C (EU type-examination followed by conformity to type), Module H (full quality assurance), or Module G (unit verification).

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 add corresponding health and safety requirements to Annex III by delegated acts that apply by 2 August 2028 for AI systems classified as high-risk under Article 6(1) because they are safety components of machinery or are themselves machinery.

Before placing a safety component on the market under the Regulation from 20 January 2027, the manufacturer must draw up Annex IV, Part A technical documentation and carry out, or have carried out, the relevant Article 25 conformity assessment procedure. After that procedure demonstrates compliance, the manufacturer draws up the EU declaration of conformity and affixes the CE marking.

The EU declaration of conformity must state that the applicable EHSRs have been demonstrated, follow the Annex V, Part A model structure, stay updated, and be translated into the required Member State language or languages. The CE marking must be visible, legible, indelible, and affixed before the related product is placed on the market or put into service.

Annex II is an indicative list, not a closed classification list. A component can meet the Article 3 definition even if Annex II does not name it, and a similar product name does not remove the need to check every definition element. The Commission may amend Annex II by delegated acts, so use the current list.

Examples named in Annex II include protective devices designed to detect the presence of persons, logic units to ensure safety functions, emergency stop devices, two-hand control devices, valves with additional means for failure detection for dangerous movements, extraction systems for machinery emissions, and roll-over or falling-object protective structures.