Who may sign the EU Declaration of Conformity?

Article 16.1 specifies that the Declaration must be drawn up and signed by the manufacturer or by their authorised representative in the EU. The practical implications of this requirement are frequently underestimated.

Can a single Declaration cover a range of machines?

Regulation 2023/1230 permits a single Declaration to cover a range of machines where the products are sufficiently homogeneous — same product family, same risks, same conformity assessment process — and where the Declaration clearly identifies all models or types covered. Where there is any doubt, issuing individual Declarations for each model is the more prudent approach, since a defective Declaration affects every model it covers.

Is a new Declaration required after a substantial modification?

Yes. Article 2(k) of Regulation 2023/1230 defines a substantial modification as one that affects the safety of the machine in a way that alters the original risk assessment. A new EU Declaration of Conformity must be issued for the modified machine, and the technical file must be updated accordingly. Modifications that are not substantial must still be documented, and the rationale for that classification should be recorded.

What are the consequences of a non-compliant Declaration found during market surveillance?

Market surveillance authorities can require the manufacturer to bring the Declaration into conformity, restrict or prohibit placing the machine on the market, order a recall, and impose administrative fines under national law implementing the EU Market Surveillance Regulation (EU) 2019/1020. Repeated or serious non-compliance may result in the matter being referred to criminal prosecution authorities.

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Article 16 of the Machinery Regulation 2023/1230 — EU Declaration of Conformity: Mandatory Content and Invalidating Errors

Equip IgeraSolutions

July 1, 2026

11 min read

Responsable técnico firmando la Declaración UE de Conformidad para maquinaria industrial

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Article 16 of Machinery Regulation (EU) 2023/1230 requires the manufacturer to draw up the EU Declaration of Conformity before affixing the CE marking. Learn the 8 mandatory elements of art. 16.2, who may sign it and the 5 most common errors that invalidate the Declaration.

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#artículo 16 reglamento máquinas 2023/1230#declaración UE conformidad maquinaria#marcado CE maquinaria declaración#declaración incorporación cuasi-máquina art 17#IgeraIndustria declaración conformidad

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