Machinery Regulation safety components

Article 2 lists safety components as related products within the Machinery Regulation's scope. That matters because a safety component placed on the market as its own product follows the machinery-and-related-product obligations, not the partly completed machinery declaration route.

Use the Article 3 definition as a gating test. The component must be physical or digital, may include software, must be designed or intended for a safety function, must be independently placed on the market, and its failure or malfunction must endanger the safety of persons. The definition also excludes components that are necessary for the product to function unless a normal component may be substituted for that function.

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 in Annex III when properly installed, maintained, and used as intended or under reasonably foreseeable conditions.

The technical file should therefore start with a risk-assessment record, not with a label. Annex IV, Part A requires documentation of the risk-assessment procedure, the applicable EHSRs, protective measures for each applicable requirement, and residual risks where relevant.

Article 25 chooses the conformity assessment route by Annex I status. If the safety component is in Annex I, Part A, the manufacturer must use one of the Article 25(2) procedures: EU type-examination with conformity to type, full quality assurance, or unit verification.

Annex I, Part A expressly includes safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions. If a safety component is not listed in Annex I, Article 25(4) points to internal production control.

Before placing a safety component on the market, 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. Once compliance is demonstrated, 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, so a component can still need analysis even if it is not named there. Use the list as a practical check against the definition and the market-placement facts.

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.