Article 19 of Machinery Regulation 2023/1230: what the EU Declaration of Conformity must contain

Direct answer: Article 19 of Regulation (EU) 2023/1230 requires the manufacturer to draw up an EU Declaration of Conformity for each machine, certifying that the essential health and safety requirements are met, with mandatory minimum content, structured according to the model in Annex V, and to keep it available to the authorities for ten years from the placing on the market of the last unit manufactured. This is not a secondary administrative formality: it is the document that transfers legal responsibility directly to the manufacturer, and the first thing a market surveillance inspector will ask for. In this article we explain exactly what it must contain, who must sign it, how long it must be kept, and how it differs from the Declaration of Incorporation for partly completed machinery.

Regulation (EU) 2023/1230, fully applicable from 20 January 2027, replaces Directive 2006/42/EC and retains the requirement for an EU Declaration of Conformity, but tightens documentary traceability requirements and expressly allows the electronic format.

What must the EU Declaration of Conformity mandatorily include?

Article 19(1) refers directly to the model in Annex V, which sets a closed minimum content. The declaration must unequivocally identify the machine — model, batch or serial number —, the name and full address of the manufacturer and, where applicable, its authorised representative, and must state that it is issued under the sole responsibility of the manufacturer. It must then describe the machine in a way that allows traceability (function, type, brand), list all applicable Union harmonisation legislation — not only the Machinery Regulation, but also, where relevant, the Electromagnetic Compatibility Directive or the Radio Equipment Regulation —, reference the harmonised standards or common specifications used, and, where a notified body has been involved, include its name, identification number and, if applicable, the number of the certificate issued.

The declaration must bear the place and date of issue, as well as the identity and signature of the person empowered to bind the manufacturer or its authorised representative. Article 19(2) specifies that, where a machine is subject to more than one Union harmonisation legislative act requiring an EU declaration of conformity, a single declaration shall be drawn up covering all applicable acts, indicating the corresponding publication references, thereby avoiding duplication of documents for the same product.

Who must sign the declaration and under what responsibility?

The signature must be that of a person with the capacity to legally bind the manufacturer or, where the manufacturer is not established in the Union, its authorised representative established within Union territory. Article 19(1) is explicit: in drawing up the declaration, the manufacturer assumes sole responsibility for the conformity of the machine with the essential requirements of Annex III. This means the signature is not a protocol formality, but the legal act that transfers to the signatory — and the company it represents — full responsibility towards market surveillance authorities, customers and third parties harmed in the event of an accident.

Can the EU Declaration of Conformity be provided in electronic format?

Yes. Article 19(3) of Regulation (EU) 2023/1230 expressly permits the EU Declaration of Conformity to be provided in electronic format, provided that it is easily accessible and available on the manufacturer's website throughout the period during which the machine remains on the market or, if the retention period for the technical documentation is longer, for that extended period. This is a notable difference from Directive 2006/42/EC, which in practice was interpreted more restrictively regarding digital media, and it reflects the broader digitalisation introduced by the new Regulation, also seen in electronic CE marking and digital instructions for use.

How does it differ from the Declaration of Incorporation for partly completed machinery?

Partly completed machinery — an assembly that cannot function on its own for a defined application and is intended to be incorporated into other machinery — does not carry an EU Declaration of Conformity, but a Declaration of Incorporation, regulated in Article 25 and structured according to Annex VI. The difference is not purely terminological: the Declaration of Incorporation does not certify that the partly completed machinery already meets all the essential requirements of Annex III, but rather identifies which requirements are already met and which remain pending resolution once the partly completed machinery is incorporated into the final machine. It must also state the commitment to transmit, on reasoned request from the national authorities, relevant information about the partly completed machinery, and must be accompanied by the assembly instructions under Article 10.

A practical case: the incomplete declaration that delayed an export

Mecanizados Ferrall, a fictitious manufacturer of an Annex I Part A laser-cutting line, exported a machine to a German integrator accompanied by an EU Declaration of Conformity that listed the Machinery Regulation but omitted the reference to the Electromagnetic Compatibility Directive, also applicable because the machine incorporated a control cabinet with significant radio-frequency emissions. The German customer's quality department detected the omission during technical receipt and blocked commissioning until a corrected declaration was received covering both legislative acts in accordance with Article 19(2). The shipment was delayed by eleven days. The case shows why the declaration must be checked against the machine's complete technical file, not only against machinery legislation.

IgeraIndustria in action: generating the EU Declaration of Conformity

Frequently asked questions about Article 19

Is it mandatory to translate the EU Declaration of Conformity?

The Regulation does not set a single language for the declaration itself, but requires it to be translated into the language or languages required by the Member State where the machine is placed on the market or made available, following the same linguistic criterion applied to the instructions for use under Article 10.

Must it be delivered physically with each machine?

The declaration must accompany the machine when it is placed on the market, unless the electronic format provided for in Article 19(3) is chosen, in which case it is sufficient for it to be easily accessible from the manufacturer's website, with a clear indication of where to consult it in the documentation that does physically accompany the product.

What happens if the original EU Declaration of Conformity is lost?

The manufacturer must be able to reconstruct or reissue it based on the technical documentation kept for the mandatory ten-year period under Article 19(4). Loss of the document does not exempt the manufacturer from the obligation to have it available on request from market surveillance authorities.

Who can demand to see the EU Declaration of Conformity?

The market surveillance authorities of any Member State may request it at any time within the retention period. It is also commonly required contractually by industrial customers, integrators and buyers as part of the machine's technical acceptance.

Does the EU Declaration of Conformity replace CE marking?

No. They are complementary and both mandatory. The declaration is the document that certifies conformity; CE marking, regulated in Article 20, is the physical symbol placed on the machine itself as the visible consequence of that already-certified conformity.

Does IgeraIndustria draft the EU Declaration of Conformity for me?

IgeraIndustria generates a structured draft in accordance with Annex V from the technical data you enter, and verifies that no applicable legislative act is missing. Final signature and legal responsibility always remain with the manufacturer or its authorised representative.

Last updated: July 2026 | Author: Jordi Bassols, Industrial Safety Engineer, Registered with COEIC | Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery, Articles 19 and 25, Annexes V and VI (OJ L 165, 29.6.2023); Directive 2014/30/EU on electromagnetic compatibility. This article is for informational purposes only and does not constitute legal or engineering advice. IgeraIndustria — free trial. EUR-Lex — Regulation (EU) 2023/1230 This content is for informational purposes only and does not constitute legal or engineering advice. For the conformity assessment of your machinery, consult a notified body or a qualified industrial safety engineer.