KAYRA PATENT · EXPERT GUIDE

Machinery Directive Annex I: Essential Health and Safety Requirements

Begin Annex I work with the machine's limits, intended use, foreseeable misuse and lifecycle hazards.

RELATED DECISION GUIDES

Continue with the relevant decision step

Direct answer

Begin Annex I work with the machine's limits, intended use, foreseeable misuse and lifecycle hazards. Select applicable requirements and show how design, protection and instructions address them. A fully ticked generic checklist cannot demonstrate that cleaning, maintenance or access hazards were evaluated.

Decision and evidence

Link each relevant requirement to drawings, calculations, tests or validated measures. Consider inherently safer design and safeguards before relying on warnings about residual risk.

Technical basis

For machinery, risk assessment, essential health and safety requirements, the technical file, declarations and CE marking must form one traceable chain under the applicable machinery legislation.

Related practical guide

Machinery CE: Integrated Lines, Partly Completed Machinery and Changes

Primary sources and currency

This page was technically reviewed on 22 August 2026 against the primary sources below. The current legislation, standard edition and official fee schedule at the application date take precedence.

EUR-Lex — Machinery Directive 2006/42/EC (current consolidated text) ↗European Commission — Machinery legislation and transition information ↗EUR-Lex — Machinery Regulation (EU) 2023/1230 ↗

Practical questions

Can a warning in the manual replace protective design?

Evaluate safe design and protective measures first. Information about residual risks matters, but is not a general substitute for applicable technical safeguards. Examine actual operation and maintenance. Language, installation, adjustment and maintenance instructions should satisfy the market's requirements.

Is software testing sufficient after adding automation to an old machine?

Control changes may affect sequences, speeds, access and safety functions. Compare risks before and after modification, and verify safety-related functions appropriately. Determine whether new conformity assessment is needed under applicable legislation and technical circumstances. Different modernisations do not necessarily produce the same decision.

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22 August 2026 · Technical reviewKayra Patent · EXPERT GUIDE