One missing role, and the product is the thing that waits at the border.
Since 13 December 2024 the EU General Product Safety Regulation, Regulation (EU) 2023/988, has applied in full across every member state. It carries a quiet but decisive rule: a consumer product cannot be placed on the EU market unless an economic operator established inside the Union is identifiable and responsible for it. For many industrial products, including machinery, Article 4 of the Market Surveillance Regulation (EU) 2019/1020 sets a comparable requirement. That responsibility does not transfer to a distributor simply because the distributor buys the goods and resells them under its own commercial relationships.
The hole in the chain goes unnoticed while volumes are small and nothing has gone wrong. It becomes visible at the worst possible moment, when the first market surveillance authority opens a query and asks who is responsible here, and finds no clean answer. The fix is cheap to put in place early and expensive to discover late.
A distributor moves your product. An Authorised Representative carries your standing.
A commercial relationship
Formed by purchase orders and margin. It owes its own distinct duties under the framework, but it is not, by default and by silence, your responsible person. It sells your product. It does not, by that act, hold your file.
A named legal role
Brought into existence by a written mandate. A specific operator established in the Union agrees to hold the declaration of conformity and technical file, stay reachable, and cooperate with market surveillance authorities. This is the instrument a regulator asks about first.
Manufacturers who would rather get the structure right at the start than rebuild it under pressure.
You manufacture outside the EU and are placing a product on the European market for the first time.
You are unsure whether your importer or distributor already qualifies as your responsible person, or whether a written mandate is missing.
You place machinery on the EU market and need the conformity and responsible-person setup ready before the 2027 Machinery Regulation bites.
You want the compliance anchor held under your control, not handed to the party who also profits from your volume.
Your supply chain mapped, the open points flagged, returned as one clear brief.
We map your supply chain and flag where the EU-established operator question is open, so your legal counsel can decide on the structure. We keep the frame in view that shapes the question: GPSR (EU) 2023/988, the Machinery Regulation (EU) 2023/1230 from 20 January 2027, and the revised Product Liability Directive (EU) 2024/2853 from 9 December 2026. You receive one clear brief of the open points and the practical options, with the conditions named openly, never buried.
No legal advice. Where legal assessment is required, we work alongside your counsel.
Where our role begins and ends.
This is built for industrial and machinery manufacturers, not for high-volume consumer sellers. A clear scope protects both sides.
We provide technical, regulatory-organisational and commercial consulting. We do not provide legal advice. Legal assessments are made by independent lawyers whom the manufacturer instructs directly.
Under the revised Product Liability Directive, an authorised representative of a non-EU manufacturer can itself be held liable. That is why the choice of operator is a structural decision for the manufacturer and its counsel, not a formality.
We advise on the structure. We do not take on the manufacturer's obligations or its product liability, which stays where the law puts it.
What manufacturers ask before the first shipment.
What is an EU responsible person and do I need one to sell in the EU?
Under the EU General Product Safety Regulation (GPSR, Regulation (EU) 2023/988, in force since 13 December 2024), no consumer product may be placed on the EU market unless an economic operator established in the Union acts as the responsible person. For a manufacturer outside the EU, that means an importer, an EU-based subsidiary, or an appointed Authorised Representative must be named, reachable, and willing to hold safety documentation before the first shipment, not after.
How is an Authorised Representative different from a distributor?
A distributor sells your product; an EU Authorised Representative holds your compliance standing, including the declaration of conformity and technical file, and answers to market surveillance authorities. The Authorised Representative role is created by a written mandate, a deliberate legal act. A distributor relationship is formed by purchase orders and margin. The two must never be collapsed into one party that also profits from your volume.
Can my EU distributor act as my responsible person?
A distributor is not, by default and by silence, your Authorised Representative or responsible person. It owes its own distinct duties, but unless a written mandate names it as Authorised Representative it does not carry the manufacturer's obligations. Handing the compliance anchor to the party who also profits from your volume aligns the wrong incentives. Whether this applies in your case is a legal question for qualified counsel.
When does the EU Machinery Regulation change the setup?
The EU Machinery Regulation (EU) 2023/1230 applies from 20 January 2027, replaces Directive 2006/42/EC, and removes self-declaration for six high-risk machinery categories, so non-EU manufacturers placing machinery on the EU market must rebuild their conformity, documentation and responsible-person setup before that date.
How does the new Product Liability Directive affect who carries my standing?
The revised Product Liability Directive (EU) 2024/2853 applies from 9 December 2026, extends strict liability to software and digital products, and shifts more of the burden onto economic operators. This raises the stakes for who carries a non-EU manufacturer's compliance standing in the Union and makes the choice of responsible person a liability decision, not a formality. Under the revised directive, an authorised representative of a non-EU manufacturer can itself be held liable.
How do you support the responsible-person question?
We map your supply chain and flag where the EU-established operator question is open, before the first shipment rather than after an authority's query, so your legal counsel can decide on the structure. A first brief typically follows within days of receiving complete information, with the open points and conditions named openly.
