Must the risk assessment be updated if the machine is modified after market placement?

Yes. Any substantial modification — changes to control software, increases in speed or power, modification of guards, addition of new tooling — requires a review of the risk assessment. If the modification is significant enough to change the risk level or introduce new hazards, the modified machine may be considered a new machine under the Regulation, requiring a new CE declaration of conformity.

Is it mandatory to use EN ISO 12100:2010 to comply with Article 12?

EN ISO 12100:2010 is a harmonised standard published in the Official Journal of the EU in relation to MR 2023/1230. Its use confers a presumption of conformity with Article 12 requirements. It is not formally mandatory — a manufacturer may demonstrate conformity by other means — but in practice, any notified body or market surveillance authority will expect the risk assessment to follow the ISO 12100 methodology. Departing from it without robust justification creates a significant risk of technical file rejection.

What happens if an accident reveals that the risk assessment was inadequate?

If an accident occurs and the investigation concludes that the manufacturer failed to identify a foreseeable hazard or did not apply sufficient reduction measures, the consequences include: market withdrawal and possible prohibition of commercialisation (market surveillance authority decision), civil liability of the manufacturer for damages caused (EU Product Liability Directive, currently under revision), and potential criminal liability of the company's technical managers if gross negligence is established. The technical file containing the risk assessment is the first documentation requested by authorities following a serious accident.

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Article 12 of the Machinery Regulation 2023/1230 — Risk Assessment: Methodology, EN ISO 12100 and AI Risks

Equip IgeraSolutions

July 1, 2026

13 min read

Ingeniero de seguridad realizando evaluación de riesgos en maquinaria industrial con EN ISO 12100

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Article 12 of Machinery Regulation (EU) 2023/1230 requires risk assessment and reduction as part of the design process. Complete guide: 4 stages per EN ISO 12100, intended use vs. reasonably foreseeable misuse, risk matrix, new AI risks and what to include in the technical file.

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