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Risk assessment of a machine (Annex III)

The risk assessment is not one document among others: it is what determines which essential requirements apply to your machine. It is done before the final design.

The manufacturer carries out a risk assessment to determine the applicable essential health and safety requirements (Annex III), then designs and builds the machine taking its results into account. It precedes the final design and is part of the technical documentation.

Art. 8, Annex IIIAnnex IV Part A

The process, in short

  • determine the limits of the machine (intended use and reasonably foreseeable misuse);
  • identify hazards and hazardous situations;
  • estimate and evaluate the risks;
  • reduce risks by design, then by protective measures, then by information;
  • document the process and the residual risks.

Substantial modification: when you become the manufacturer

Not every later change is a substantial modification. Only where the conditions of Art. 3(16) are met — in particular a new or increased risk requiring additional protective measures — does whoever carries it out become the manufacturer, with the obligations under Art. 18. The risk assessment must then be redone.

Cybersecurity: the bridge to the CRA

For connected machinery, Annex III (points 1.1.9 and 1.2.1) touches on protection against corruption and the safety of control systems. The Cyber Resilience Act connects here: CRA conformity can make it easier to demonstrate these points, but the synergy must be demonstrated by the manufacturer (recital 53).

The technical file for your machine

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Read next

EU declaration of conformityAnnex V Part ADeclaration of incorporationAnnex V Part BOne file, two regulationsThe principle

Sources. Article and annex references are taken from the versions published in the Official Journal: Regulation (EU) 2023/1230, OJ L 165, 29.6.2023; Regulation (EU) 2024/2847, OJ L, 2024/2847, 20.11.2024.

Annex details are checked against the versions published in the Official Journal; they are paraphrased and shortened, the official text prevails.

normakte is a drafting and calculation aid; it replaces neither the conformity assessment, nor a notified body, nor legal advice.