Exporting Machinery to the EU Without an EU Entity: Who Does What

Published 30 August 2026Verified against the EU legal texts

A perfect CE file is not enough: since July 2021, machinery may only be placed on the EU market if an economic operator established in the Union is responsible for it. This guide explains who that can be, how the roles differ, what the Machinery Regulation changes in 2027, and what to have in place before your first shipment.

The rule that surprises exporters

The Machinery Directive 2006/42/EC never mentions importers or distributors; all its obligations rest on the manufacturer or its authorised representative. That gap is closed elsewhere: Article 4 of the Market Surveillance Regulation (EU) 2019/1020, which expressly covers machinery and has applied since 16 July 2021. It says a product may only be placed on the market if there is an economic operator established in the Union responsible for defined compliance tasks. Four setups qualify:

a manufacturer established in the EU (for exporters: a subsidiary),
an importer, where the manufacturer is outside the EU,
an authorised representative with a written mandate covering the Article 4 tasks, or
an EU fulfilment service provider handling the product, where none of the above exists.

That operator must verify that the declaration of conformity and technical documentation exist, keep the declaration available for authorities, hand over documentation on a reasoned request, report products presenting a risk, and cooperate on corrective action (Article 4(3)). Its name and postal address must appear on the product, its packaging, the parcel or an accompanying document (Article 4(4)). This is enforced at the border: the authorities controlling imports, customs in most member states, must suspend a product's release for free circulation when required documentation or markings are missing, the CE marking appears false or misleading, or no Article 4 operator is indicated or identifiable (Regulation 2019/1020, Article 26).

Today you need two EU touchpoints

Until 19 January 2027 the Machinery Directive adds a second, often-missed requirement: every EC Declaration of Conformity must name the person authorised to compile the technical file, and that person must be established in the Community (Annex II 1.A.2; the same applies to the Declaration of Incorporation for partly completed machinery). The Commission’s application guide reads this as the EU contact point for non-EU manufacturers: any EU-established natural or legal person you entrust with assembling the file on a reasoned request.

In practice the two roles are usually bundled: one authorised representative under a single written mandate acts as the Article 4 responsible operator and as the person authorised to compile the technical file. If you sell through an EU importer instead, the importer is automatically the Article 4 operator, and only the technical-file person remains to be named.

Selling directly to EU end users, including online, does not avoid any of this: an offer targeted at end users in the Union is deemed a making available on the EU market (Regulation 2019/1020, Article 6). Drop-shipping machinery from a third-country warehouse into the EU without an EU operator is not a lawful route.

Importer or authorised representative: choosing your setup

Selling through an EU importer

Simple: the importer is the responsible operator by law, carries growing verification duties, and from 2027 must put its own name and contact details on your machine. The trade-off is dependence: the importer sits between you and the market, and if it sells under its own brand or modifies the machine in a compliance-relevant way, it legally becomes the manufacturer.

Direct sales with an authorised representative

You keep the customer relationship and invoice EU buyers directly; the AR provides the EU establishment, holds the documentation tasks and is named on the declaration and the product papers. Mind the limits: an AR acts within its written mandate, and it cannot take over your design obligations or the drawing-up of the technical documentation. Those stay with you.

One development raises the stakes for both routes: the new EU Product Liability Directive (EU) 2024/2853 applies to products placed on the market after 9 December 2026 and expressly makes the importer or the authorised representative of a non-EU manufacturer liable for defective products, software included. Expect EU partners to demand complete, defensible technical documentation before they lend you their name.

What changes on 20 January 2027

The Machinery Regulation (EU) 2023/1230 writes the supply-chain duties directly into machinery law. The pieces that matter for exporters:

Importers get explicit, checkable duties (Article 13)

Before placing your machine on the market, the importer must verify that you carried out the conformity assessment, drew up the technical documentation, affixed the CE marking and supplied the required documents. It must add its name, postal address and a digital contact to the machine, keep your EU Declaration of Conformity for 10 years, and where appropriate run sample tests and keep a complaints register. Expect EU importers to demand complete documentation packages contractually, well before the deadline.

Distributors must check before they sell (Article 15)

CE marking present, declaration available, instructions in a language easily understood in the member state, and the manufacturer and importer markings in place. A missing language version can now stop your machine at the distributor, not just at an inspection.

The technical-file person disappears, the Article 4 operator stays

The new EU Declaration of Conformity (Annex V) names only the manufacturer and, where appointed, the authorised representative; the separate person authorised to compile the technical file no longer exists. The authorised representative remains optional (Article 12: a manufacturer may appoint one). The Regulation 2019/1020 Article 4 requirement for an EU-established responsible operator continues to apply, so the practical need for an EU partner does not go away. Manufacturers must also indicate a single digital contact point, and declarations may be provided digitally.

Add the enforcement backdrop: member states must have their penalty rules for the new Regulation in place by 20 October 2026, and those may include criminal penalties for serious infringements. The scale is already real today: in Germany, conformity offences on machinery carry administrative fines of up to 100,000 euros per case, and the EU's Safety Gate alert system reported a record 4,671 dangerous-product alerts in 2025 with almost 5,800 follow-up actions such as border stops, recalls and sales bans. Non-compliance is not a paperwork risk; it is detained shipments and a public, named alert.

Checklist before your first shipment

CE conformity done and documented: Risk assessment, technical file, EC Declaration of Conformity, CE marking, instructions in the right languages. Without this, no operator setup helps.

EU responsible operator appointed: Importer, authorised representative or fulfilment provider, agreed in writing, with the Article 4(3) tasks covered.

Person authorised to compile the technical file named: Established in the EU, named with address in every EC Declaration of Conformity (required until 19 January 2027).

Operator details on the product or its papers: Name and postal address of the Article 4 operator on the machine, packaging, parcel or accompanying document.

Documentation package for your EU partner: Copy of the declaration, access route to the technical file, instructions. From 2027 importers must verify all of this before placing your machine on the market, so expect contractual demands early.

Language versions planned: Instructions in the official language(s) of each target member state, marked as original or translation.

Brand and modification clauses in the contract: Who declares what, who may rebrand, who may modify. Rebranding or compliance-relevant modification shifts the manufacturer role to your EU partner.

EORI number, if you act as customs declarant: Any operator lodging customs declarations in the EU needs an EORI number; non-EU operators register in the member state of their first declaration. Shipping DDP without one stalls at the border.

Per-unit placing dates documented: Around the 20 January 2027 cut-over, the date each unit was first supplied into the EU decides which law applies. Keep evidence.

FAQ

Frequently asked questions

Do I need an EU subsidiary to sell machinery into the EU?

No. What Regulation (EU) 2019/1020 Article 4 requires is an economic operator established in the Union who is responsible for defined compliance tasks. Four setups qualify: an EU-established manufacturer, an importer, an authorised representative with a written mandate, or, where none of those exists, an EU fulfilment service provider handling the product. A subsidiary is one way to have an EU operator, not the only one.

Is an authorised representative mandatory for non-EU machinery manufacturers?

No, and it stays optional under the new Machinery Regulation (Article 12: a manufacturer 'may' appoint one). What is mandatory is an EU-established responsible economic operator under Regulation 2019/1020 Article 4, and an importer satisfies that automatically. Under the current Machinery Directive there is a second EU touchpoint: every EC Declaration of Conformity must name a person established in the Community who is authorised to compile the technical file. A single authorised representative can cover both roles under one written mandate.

Can I sell machinery online directly to EU customers from outside the EU?

Only with an EU-established responsible operator in place. An online offer that is targeted at end users in the Union counts as making the product available on the EU market (Regulation 2019/1020 Article 6), so drop-shipping from a third country does not avoid EU product law. Without an EU importer in the chain, you need an authorised representative or an EU fulfilment service provider before the offer goes live.

Whose name has to be on the machine?

Today: the manufacturer's marking required by the Machinery Directive, plus the name and postal address of the Article 4 economic operator on the product, its packaging, the parcel or an accompanying document (Regulation 2019/1020 Article 4(4)). From 20 January 2027 the Machinery Regulation adds that importers must indicate their name, registered trade name or mark, postal address and a website, email or other digital contact on the machinery or, where not possible, on its packaging or accompanying documentation (Article 13(3)).

What happens if my EU importer sells the machine under its own brand?

It legally becomes the manufacturer. Under the Machinery Regulation, an importer or distributor that places a product on the market under its own name or trademark, or modifies it in a way that might affect compliance, assumes the full manufacturer obligations (Article 17). The same principle applies today via the Commission's Blue Guide. Supply contracts should state explicitly who carries the manufacturer duties.

Does the Article 4 requirement also apply to partly completed machinery?

The position is not clearly settled. Article 4(5) of Regulation 2019/1020 lists the Machinery Directive as a whole, which covers partly completed machinery, but partly completed machinery carries no CE marking and no EU declaration of conformity, around which the Article 4 tasks are framed. In practice: agree the compliance setup with your EU integrator in the supply contract, and make sure the Declaration of Incorporation and its EU-established documentation contact are in place either way.

Who can act as the person authorised to compile the technical file?

Any natural or legal person established in the EU whom the manufacturer entrusts with assembling and providing the technical file on a reasoned request; the Commission's Machinery Directive guide names the authorised representative as a typical choice. The role must be named in every EC Declaration of Conformity today. From 20 January 2027 this construct disappears: the new EU Declaration of Conformity under the Machinery Regulation names only the manufacturer and, where appointed, the authorised representative.

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This guide is written by the team behind CE-Copilot, a software platform covering the whole EU CE process for machinery: risk assessment per EN ISO 12100, research across 3,100+ standards with harmonisation status, functional safety documentation, the technical file, and EU declarations of conformity with document exports in English, French, Italian and German. The platform interface is currently German — we are gauging demand for a full English version.

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More English guides

EU Machinery Regulation 2023/1230: What Changes on 20 January 2027 CE Marking for Machinery: Step-by-Step Guide for Exporters

This guide is general information for machinery manufacturers, verified against the official EU legal texts as of 30 August 2026. It is not legal advice. For decisions about your specific product, consult the legal texts (EUR-Lex) or a qualified advisor.