Industry

Artículo 17 del Reglamento de Máquinas 2023/1230: cuándo un importador o distribuidor pasa a ser legalmente «fabricante»

Jordi Bassols
June 30, 2026
10 min read
Artículo 17 del Reglamento de Máquinas 2023/1230: cuándo un importador o distribuidor pasa a ser legalmente «fabricante»

Article 17 of the Machinery Regulation 2023/1230: when an importer or distributor legally becomes a «manufacturer»

Direct answer: under Article 17 of Regulation (EU) 2023/1230, an importer or distributor automatically becomes a «manufacturer» for legal purposes —with all the obligations of Article 10 or 11— in two scenarios: when it places a machine on the market under its own name or trademark, or when it modifies a product already placed on the market in a way that may affect compliance with the applicable requirements. There is no need to physically manufacture anything: putting your brand on the label or intervening on the equipment is enough. In this article we explain exactly where that line sits, why «private label» is the most common trap, and what taking on manufacturer liability actually means in practice.

Regulation 2023/1230, fully applicable from 20 January 2027, replacing Directive 2006/42/EC, retains a principle that already applied under the previous framework but formulates it with greater precision: legal responsibility as «manufacturer» does not depend on who physically manufactures the machine, but on who places it on the market under its own commercial identity, or who substantially alters its technical characteristics. This Article 17 is the gateway to obligations that many distribution companies are unaware of until they undergo an inspection.

✓ Definition: the two scenarios of Article 17
  • Placing on the market under own brand or name («private label»): the importer or distributor places a product within the scope of the Regulation on the market under its own trade name or registered trademark, instead of that of the original manufacturer.
  • Modification of a product already placed on the market: the importer or distributor alters a product that is already on the market in such a way that compliance with the applicable requirements «may be affected» — a deliberately broad threshold that does not require compliance to actually be broken, only that the risk exist.

Why does putting your brand on a machine make you a manufacturer?

Article 17 literally states that an importer or distributor «shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the manufacturer's obligations set out in Articles 10 and 11», when it places the product on the market «under its name or trademark». This scenario —known in the sector as private labelling or OEM rebranding— is extremely common: distribution chains, purchasing groups and industrial DIY companies commission manufacturing to a third party but sell the product under their own commercial brand.

The regulatory logic is simple: the end user who buys the machine trusts the brand they see on the rating plate and on the packaging, not the original manufacturer, who may remain completely invisible in the transaction. The Regulation shifts legal responsibility to whoever builds that commercial trust, regardless of who physically designed or assembled the equipment.

⚠ Common mistake:

Assuming that it is enough to keep the original EU Declaration of Conformity issued by the underlying manufacturer when the product is sold under a private label. In reality, once a company becomes a manufacturer for the purposes of Article 17, it must issue its own EU Declaration of Conformity under Article 21, taking on full responsibility for compliance with Annex III, even if it has not modified a single screw of the original product.

What type of modification turns a distributor into a manufacturer?

The second scenario of Article 17 is triggered when the importer or distributor «modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected». Unlike Article 18 —which governs «substantial modification» carried out by any natural or legal person on a machine already in service, and which we analyse in our dedicated article on that provision— Article 17 focuses on modifications carried out by an economic operator in the supply chain (importer or distributor) before or during the product's placing on the market.

The threshold does not require the modification to actually breach the essential requirements: it is enough that compliance «may be affected». This includes, among other common scenarios in commercial practice:

  • Replacing safety components (sensors, emergency stop devices, guards) with versions different from those originally evaluated.
  • Adapting the control software or operating parameters of the machine for a use or market different from that intended by the original manufacturer.
  • Assembling accessories, extensions or additional modules not covered by the original risk assessment.
  • Removing or altering protective devices to adapt the machine to a different workspace.

Own brand vs. modification: two paths to the same obligations

AspectPlacing on the market under own brandModification of the product
Triggering eventLabelling/selling under own name or brandAltering components, software or configuration
Requires technical intervention?No — can be purely commercialYes — physical or software intervention
New risk assessment requiredAdvisable to review the original manufacturer's existing oneMandatory for the modified elements
Must issue new EU Declaration of ConformityYes, under its own nameYes, for the modified product
Applicable Articles of the RegulationArt. 10 and 11 (manufacturer obligations)Art. 10 and 11 (manufacturer obligations)

What obligations exactly does a company assume once it becomes a «manufacturer»?

Once Article 17 triggers manufacturer status, the importer or distributor becomes fully subject to Article 10 (complete machinery) or Article 11 (partly completed machinery) of the Regulation, depending on the type of product. This entails, among other obligations:

  • Ensuring the machine complies with the essential health and safety requirements of Annex III, carrying out or reviewing the applicable risk assessment (Art. 12).
  • Preparing or adapting the technical documentation in accordance with Annex IV, which must be kept for 10 years.
  • Applying the corresponding conformity assessment procedure under Article 25, depending on whether the machine falls under Annex I, Part A or B.
  • Drafting and signing the EU Declaration of Conformity (Art. 21) on its own responsibility, including its name and address as manufacturer.
  • Affixing the CE marking in accordance with Articles 23 and 24, including, where applicable, the identification number of the notified body.
  • Drawing up the instructions for use in the language required by each Member State where it places the product on the market.
⚠ Common mistake:

Thinking that, since it did not design the machine, liability for an accident still rests with the original manufacturer. Legally, whoever has issued the EU Declaration of Conformity under its own name is the one who answers in the first instance to market surveillance authorities and to injured third parties, without prejudice to any recourse action it may bring against the original manufacturer under contract law.

IgeraIndustria in action: detecting the risk of «accidental manufacturer» status

How IgeraIndustria solves it

Question:

«We are going to buy 25 sheet metal folding machines from a Turkish manufacturer and sell them under our brand 'MetalPro'. What new obligations do we have?»

IgeraIndustria answers:

Under Article 17 of Regulation (EU) 2023/1230, by placing the product on the market under your brand «MetalPro» you acquire the legal status of manufacturer. You must: (1) review and take ownership of the Annex IV technical file for the 25 units, (2) draft and sign your own EU Declaration of Conformity under Art. 21, (3) verify the CE marking bears your information and not that of the Turkish manufacturer, (4) translate the instruction manual into Spanish. I have generated a 12-point checklist per unit. Would you like me to review the Turkish technical file first to detect gaps before you take on responsibility?

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Do you sell machinery under your own brand without knowing you are already a «manufacturer» in the eyes of the law?

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Case study: the purchasing group that discovered its liability too late

Suministros Aramendi, an agricultural machinery purchasing group based in Navarre, had for years been importing power tillers from an Italian manufacturer and selling them under the commercial brand «Aramendi Agro». Following an accident involving a model whose power take-off lacked an adequate guard, the market surveillance authority's investigation determined that Aramendi, having placed the equipment on the market under its own brand, held manufacturer status under the equivalent article of Directive 2006/42/EC, regardless of the fact that the design originated in Italy. The company had no technical file of its own nor a reviewed risk assessment, only the Italian manufacturer's documentation in its original language. The case resulted in administrative penalties and a full re-certification process for the entire catalogue under its own legal responsibility. Today, having implemented internal procedures aligned with the new Regulation 2023/1230, the company demands and reviews the complete technical file before agreeing to rebrand any machine.

Frequently asked questions about Article 17

Is it enough to add a sticker with my logo to trigger Article 17?

Yes. The provision does not distinguish between superficial rebranding (a simple sticker or label) and deep rebranding (manufacturing to your own specifications). It is enough for the product to be placed on the market under the distributor's or importer's name or trademark for that party to take on legal manufacturer status, regardless of the degree of actual technical intervention on the equipment.

What is the difference between Article 17 and Article 18 of the Regulation?

Article 17 applies specifically to importers and distributors within the commercial supply chain, in cases of private labelling or modification during placing on the market. Article 18, which we cover in a dedicated article in this series, has a broader scope: it applies to any natural or legal person —including maintenance workshops, integrators or the professional user itself— who carries out a «substantial modification» of a machine already in service, even years after it was placed on the market.

Can the original manufacturer still be held liable after rebranding?

Before market surveillance authorities and injured third parties, regulatory responsibility rests with whoever holds legal manufacturer status under Article 17, that is, whoever places the product on the market under its own brand. The internal relationships between the rebranding distributor and the original manufacturer —warranties, indemnities, supply agreements— are governed by the commercial contract between the two parties, but do not alter regulatory liability towards third parties.

Does Article 17 apply to partly completed machinery as well as complete machinery?

Yes. The provision refers both to Article 10 (manufacturer obligations for complete machinery) and Article 11 (manufacturer obligations for partly completed machinery), depending on the nature of the rebranded or modified product. If it is partly completed machinery, the resulting obligations include the technical file under Annex IV Part B and the Declaration of Incorporation, rather than the full EU Declaration of Conformity.

Do I need to repeat the entire risk assessment if I only sell under my brand without modifying anything?

The Regulation does not require the assessment to be literally repeated from scratch, but it does require the new «legal» manufacturer to be able to demonstrate and support with documentation that the machine complies with the essential requirements of Annex III. In practice, this means auditing the existing technical file, verifying that the harmonised standards cited are still in force, and formally taking ownership of the assessment before signing the new EU Declaration of Conformity.

What happens if the importer only modifies the machine's software?

A software modification that may affect the operation of safety systems, speed limits, force parameters or control behaviour also triggers Article 17, since the text does not distinguish between physical modifications and software or firmware modifications when these may affect compliance with the essential requirements.

IgeraIndustria — Detecting accidental manufacturer liability

IgeraIndustria analyses rebranding, private label and product modification operations to determine when Article 17 of Regulation (EU) 2023/1230 is triggered and what manufacturer documentation must be generated. Get a no-obligation consultation at igerasolutions.com/igeraindustria.

Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery (OJ L 165, 29.6.2023), Articles 10, 11, 17, 18, 21 and 25. This article is for informational purposes only and does not constitute legal or engineering advice.

Author: Jordi Bassols, Industrial Safety Engineer, Registered Member of COEIC | Official source: 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.

#Reglamento Máquinas 2023/1230#marcado CE maquinaria#seguridad industrial#normativa europea maquinaria

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