Imagine a machine manufactured in China, imported into Europe by a German company, resold by an Italian distributor, and then modified by the end customer. Who is liable if that machine causes an accident?
Under the old Machinery Directive 2006/42/EC, the answer was almost always the same: the manufacturer. The entire compliance burden fell on whoever built the machine. Everyone else in the supply chain was practically invisible under the law.
Regulation (EU) 2023/1230 changes this picture radically. It introduces the concept of economic operator and assigns precise obligations to every actor who "touches" the machine along its journey from producer to end user. From 20 January 2027, there will no longer be a single responsible party: there will be four, each with distinct roles and obligations.
The four economic operators
Article 3(22) of the Regulation lists them: manufacturer, authorised representative, importer and distributor. Let's look at what each means in practice.
1. The Manufacturer — who built the machine (Art. 10)
The manufacturer is whoever designs and produces the machine, or whoever has it produced by a third party and markets it under their own name or brand. They are the primary party responsible for compliance.
They must carry out a risk assessment and build the technical file — the complete dossier documenting how the machine is built, what hazards it poses and how those hazards have been managed. They must ensure the machine meets the essential requirements of Annex III, follow the conformity assessment procedure under Art. 25, draw up the EU declaration of conformity (Art. 21) and affix the CE marking.
They must also indicate their name and contact details on the machine, and keep the technical file and declaration of conformity for 10 years from the date of placing on the market.
Something that surprises many people: you don't need to have physically built the machine to become the manufacturer. If a company has a machine built by a subcontractor and sells it under its own brand, it is the manufacturer in the eyes of the law. The same applies to anyone who carries out a substantial modification of a machine already on the market (Art. 18): they immediately become the new manufacturer of the modified machine, with all the resulting obligations.
2. The Authorised Representative — the EU contact for non-EU producers (Art. 12)
The authorised representative only exists when the manufacturer is based outside the European Union. If a Japanese or American company wants to sell machinery in Europe, it must appoint a representative within the EU.
The authorised representative does not build anything or assess risks: that responsibility always stays with the manufacturer. Their role is to be the European point of contact for supervisory authorities: they keep documentation available (declaration of conformity, technical file) for 10 years, cooperate with market surveillance authorities, and immediately notify the manufacturer if compliance issues arise.
3. The Importer — who brings the machine into the EU (Art. 13)
The importer is whoever purchases machines from non-European producers and places them on the EU market. This was a role that had no specific obligations under the old directive. Regulation 2023/1230 assigns them precise and independent responsibilities.
Before placing a non-EU machine on the market, they must verify that the manufacturer has done everything required: risk assessment, technical file, CE marking, declaration of conformity. They must check that the machine comes with instructions in the language of the destination country, indicate their own contact details on the machine, and keep a copy of the declaration of conformity for 10 years.
The key rule: if the importer has reason to believe a machine is not compliant, it cannot be placed on the market. Full stop. They must notify the manufacturer and the authorities. If the machine is already in circulation and proves dangerous, the importer is responsible for managing its withdrawal.
4. The Distributor — who resells in the supply chain (Art. 15)
The distributor is whoever markets the machine within the EU after it has already been imported or placed on the market by the manufacturer. Retailers, dealers, wholesalers: all fall into this category.
Their obligations are lighter, but they do exist. Before reselling a machine they must verify that it bears the CE marking, is accompanied by the declaration of conformity and instructions in the language of the destination country, and that the manufacturer and importer have indicated their details on the machine. The distributor also cannot sell a machine it knows to be non-compliant.
When roles change: the importer or distributor who becomes a manufacturer
Article 17 of the Regulation provides for a role shift that many do not expect. An importer or distributor automatically becomes a manufacturer — with all the associated obligations — in three situations:
They place the machine on the market under their own name or brand (private label); they modify the machine in a way that affects its original compliance; they carry out a substantial modification of the machine (Art. 18).
Concrete example: an Italian distributor who buys machines from a non-EU producer, adds their own labels and resells them as "Rossi brand machines" becomes the manufacturer in every respect. They will have to carry out the risk assessment, build the technical file, sign the declaration of conformity and affix the CE marking.
Traceability: 10 years of mandatory record-keeping (Art. 19)
Article 19 introduces an obligation that applies to all economic operators: each must be able to identify, for 10 years from the date of placing on the market, all parties from whom they received the machine and all those to whom they supplied it. Every step the machine takes through the supply chain must be documented and traceable: if a machine is recalled, authorities must be able to reconstruct the entire chain within days.
What this means for your company
If you manufacture machines under your own brand, you are the manufacturer and carry the heaviest obligations. If you import machines from Asia or the US, you are the importer — you can no longer simply rely on the producer saying "it's compliant". If you resell machines that others have already placed on the European market, you are the distributor.
And if you do several things — import, modify and resell under your own brand — you are the manufacturer, even if you've never operated a lathe in your life. From 20 January 2027, knowing exactly which box you fit into is the first step to being compliant.
This article is intended for informational purposes. For a specific assessment of your company's compliance with Regulation 2023/1230, contact us for a personalised consultation.