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REFERENCE / Risk assessment

Machinery risk assessment: from hazard to evidence

Use risk assessment to inform design, then connect protective measures to verification and instructions.

The Directive remains the current framework before 20 January 2027. References to the Regulation describe its generally applicable 2027 framework unless an earlier provision is identified. This is independent educational information.

Assess throughout the design process

Risk assessment is an iterative engineering process, not a form completed after the machine is built. The manufacturer identifies the applicable essential health and safety requirements and designs the machinery taking the assessment results into account. The current Directive uses Annex I; the Regulation uses Annex III.

Define machine limits, intended use and reasonably foreseeable misuse. Consider people, tasks, operating modes and lifecycle phases, including installation, adjustment, cleaning and maintenance. Looking only at normal automatic operation can miss the situations in which people approach moving parts or stored energy.

Describe hazardous situations precisely

A hazard record should explain the source of harm, the person exposed and the circumstances of exposure. “Mechanical hazard” alone is too broad to guide a design decision. Describe, for example, access to rotating tooling during a foreseeable intervention, without assuming that this fictional example identifies all hazards of a real machine.

Estimate and evaluate risk using a suitable method. Document the assumptions and the information available. A numerical matrix can help organise a review, but its score is not a statutory compliance result and cannot compensate for missing hazards.

Follow the risk-reduction order

First consider inherently safe design and construction. Then apply safeguards and protective measures for risks that cannot be eliminated. Explain residual risks and provide the necessary information for use. The order matters: instructions should not be used to bypass a feasible protective design.

Verification evidence should demonstrate the implemented measure, not merely restate the requirement. Keep the test configuration, acceptance criteria, results and the link to the relevant hazard record. Review the assessment after design changes or new information.

Connect the records

The technical documentation should make the reasoning traceable from an applicable requirement to the hazard, design measure and supporting evidence. Instructions should reflect the final configuration and residual risks.

The hierarchy below is an educational summary. Specific machine types and hazards can require additional measures, standards and expertise. It is not a complete design specification.

  1. Remove the hazard through design

    Start with inherently safe design and construction. Consider intended use and reasonably foreseeable misuse.

  2. Apply safeguards and protective measures

    Address risks that design alone cannot eliminate. Evaluate the complete protective system.

  3. Explain residual risk

    Provide information, instructions and, where relevant, training or protective-equipment needs. Warnings do not replace feasible design measures.

Sources & related reading

Continue with eu machinery law: the working framework, machinery regulation: the 2027 transition, machinery scope and product definitions.

Machine-specific interpretation and verification need competent assessment. This publication does not give legal advice or guarantee compliance.