The distinction the regulation draws.
Under EU market surveillance rules, the question is not what your commercial agreements call you — it is where the product you sell entered the EU market, and who placed it there.
You are an importer if…
you place a product from a non-EU manufacturer on the EU market for the first time. If you buy directly from a manufacturer outside the EU and bring their product in — even through an agent or supplier in the manufacturer's own country — you are the importer for the units you sell.
You are a distributor if…
you acquired the product from a manufacturer, an importer, or another supplier within the EU, and you make it available on the EU market. The product was already placed on the market before it reached you.
Common misreading
“First to place on the market” does not mean first company ever.
Many sellers read “first to place on the market” to mean that only the first company ever to import a product carries the importer's obligations — and that everyone after them is off the hook. That is incorrect. There can be multiple importers for the same product. Whenever you import a product directly from a non-EU manufacturer, you are the responsible economic operator for the units you sell — irrespective of who else has imported the same product before you.
What a distributor must do.
A distributor's duty is due diligence. You must be able to demonstrate that you took due care in checking that your supplier followed the regulation, and — if a market surveillance authority asks — you must be able to provide the name and details of the manufacturer or its authorized representative for the product. It is a matter of completing due diligence on the products you sell.
One further point in the distributor's favor: if the rules that apply to a product change after you have placed it on sale, bringing it into line with the new requirements is not your burden as the distributor.
What an importer must do.
If you are deemed an importer rather than a distributor, your obligations rise to a much higher threshold. Before the product goes on sale, you must:
- 01
Verify the manufacturer's compliance.
You must satisfy yourself that the manufacturer has met every regulation that applies to the product — including that the technical documentation is complete. This matters most for products covered by a directive that requires CE marking.
- 02
Check the labeling.
The manufacturer's name and contact details must appear on the labeling and packaging, and you must hold their contact information.
- 03
Add your own name.
The product or its packaging must also carry your name and contact details as the importer.
- 04
Be ready to produce documents.
If a market surveillance authority requests the technical documentation, you need to be able to access and provide it.
The duty to verify that the product complies with EU regulation is the obligation importers most often overlook.
The two roles, side by side.
| Obligation | Importer | Distributor |
|---|---|---|
| Where the product came from | Directly from a manufacturer established outside the EU. | From a manufacturer, an importer, or another supplier within the EU. |
| Placing on the market | You place the product on the EU market for the first time. | It was already placed on the market before it reached you. |
| What you must verify | That the manufacturer has met every regulation that applies to the product, and that the technical documentation is complete. | That you took due care in checking your supplier followed the regulation — a duty of care rather than an importer's threshold. |
| Your name on the product | The product or its packaging must carry your name and contact details as the importer, alongside the manufacturer's. | Not part of the distributor's duty of care — but you must be able to name the manufacturer or its authorized representative. |
| If an authority asks | You need to be able to access and provide the technical documentation. | You must be able to provide the name and details of the manufacturer or its authorized representative for the product. |
But I bought it through a middleman.
If you import a product made by a non-EU manufacturer that you bought from a secondary source in the manufacturer's country, you should still satisfy yourself that you know who the manufacturer is and that they have complied with the relevant EU requirements. The regulation does not require a defined relationship between manufacturer and importer — often there is none when buying through a distributor or supplier at source. But the absence of a relationship does not excuse you from ensuring the manufacturer complied.
Our guidance
We would suggest that no product should be imported unless you are confident of its compliance and confident you can access the relevant technical documentation if a market surveillance authority ever requests it.
One more inflection point to know: sell the product under your own name or trademark, or modify it substantially, and you become the manufacturer — with a manufacturer's obligations.
Outside the EU? This is about your dealers.
If you are a non-EU manufacturer whose products reach Europe through importers or dealers, everything above lands on them. That has a commercial consequence: most experienced EU importers prefer to deal with manufacturers that already have an authorized representative in place for the product. A single, clear point of contact that holds the technical documentation and answers to the market surveillance authorities benefits both sides — and it means your dealers are not left carrying obligations they may not know they have. Appointing an authorized representative also opens the option of selling direct to EU consumers alongside your dealer network.
Official references