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CE marking when importing into the EU: importer obligations

CE marking shows that a product meets the requirements of the EU harmonisation legislation that covers it, so it can be sold freely across the EU. It applies only to certain product groups, including toys, electrical and electronic equipment, machinery, personal protective equipment, medical devices and pressure equipment. An importer bringing such a product from outside the EU cannot rely on the mark printed on the housing: it must check that the manufacturer carried out the conformity assessment and prepared the documentation, and it must put its own name and address on the product or, where that is not possible, on the packaging or in an accompanying document.

By Hiram Trade Editorial Desk

Published

6 min read

Which products need CE marking

According to the Your Europe portal, CE marking is required for products covered by EU harmonisation rules, including:

  • toys,
  • electrical and electronic equipment,
  • drones,
  • pyrotechnic articles,
  • recreational craft and personal watercraft,
  • pressure equipment and gas appliances,
  • batteries,
  • machinery,
  • measuring instruments and weighing equipment,
  • personal protective equipment,
  • medical devices.

If no act requiring CE applies to a product, it must not carry the marking. That does not mean there are no requirements: consumer products without harmonisation rules fall under the General Product Safety Regulation (GPSR, Regulation (EU) 2023/988), and food, cosmetics and chemicals have their own regimes.

One product can fall under several acts at once. An electric toy, for instance, may need to meet both the toy rules and the electrical equipment rules. Start by identifying which acts apply; the tariff code can help orient you (see HS/CN classification), but the scope of each act, not the code, decides whether CE applies.

Who is responsible: manufacturer, importer, distributor

  • The manufacturer carries out the conformity assessment, prepares the technical documentation, signs the EU declaration of conformity and affixes the CE marking. A company that has a product made and sells it under its own name or brand is also a manufacturer. An importer that places a product on the market under its own brand takes on manufacturer obligations.
  • The importer is an EU business that places a product from a non-EU country on the EU market. It has its own obligations, described below.
  • The distributor checks that the product carries the marking, required documents and instructions before selling it.

Importer obligations

According to Your Europe, before placing a product on the market the importer must:

  1. make sure the manufacturer has carried out the right conformity assessment procedure and drawn up the technical documentation,
  2. check that the product bears the CE marking and required labels, and that it comes with instructions and safety information in a language easily understood by consumers and other end users in the country of sale,
  3. indicate on the product, its packaging or an accompanying document its name, registered trade name or trade mark and contact address,
  4. cooperate with market surveillance authorities and report products that present a risk, including through the EU Safety Business Gateway.

If the product does not conform, the importer must not place it on the market. For products in certain groups, Regulation (EU) 2019/1020 requires an economic operator in the EU (manufacturer, importer, authorised representative or fulfilment service provider) that keeps the declaration of conformity available for authorities and cooperates with them.

The EU declaration of conformity

The EU declaration of conformity is the document in which the manufacturer declares, under its sole responsibility, that the product meets the requirements of the listed acts. It includes product identification, manufacturer details, the legislation and harmonised standards or other specifications applied, and, where a notified body was involved, its details and certificate number.

What to check in a declaration from your supplier:

  • it covers exactly the model and version you are buying,
  • it identifies the legislation applicable to the product and to its placing-on-the-market date, including any transitional regime (a repealed act can still apply during a transition, so naming it is not automatically wrong),
  • it is signed by the manufacturer with date and place,
  • the notified body number (if any) matches the number next to the CE mark where the applicable procedure requires it there; notified bodies can be checked in the EU NANDO database.

A certificate from a company that is not a notified body for the relevant act, or a "CE certificate" from a test lab, is not the same as the manufacturer's declaration of conformity. This is a frequent problem with imports from Asia.

Technical documentation

The technical documentation shows how the product meets the requirements: description and drawings, risk assessment, standards applied, test reports, instructions. According to Your Europe, it must be kept for at least 10 years after the product is placed on the market. A non-EU manufacturer will not always hand the full file to the importer, but the importer must be confident that it exists and will be provided to authorities on request. Put this in the contract.

Self-assessment or notified body

In some cases the manufacturer carries out the conformity assessment alone. For higher-risk products, such as many medical devices, some machinery and higher-category personal protective equipment, a notified body must be involved. Its four-digit identification number is placed next to the CE marking only when the applicable conformity-assessment procedure requires it (for example, when the body is involved in the production-control phase); a body involved only in the design phase may not appear next to the mark. The applicable procedure depends on the specific act.

Checks at the border

Products entering the EU market can be checked by customs in cooperation with market surveillance authorities (Regulation 2019/1020). Missing marking or documents can lead to release for free circulation being suspended. Have the declaration of conformity and importer details ready before the goods arrive, not after they are stopped.

How to check a supplier before ordering

  • ask for the EU declaration of conformity and the list of standards before signing,
  • ask for test reports and the name of the lab that produced them,
  • verify the notified body number in NANDO,
  • agree the marking, labels, instructions and importer details in the contract,
  • book a pre-shipment inspection that includes a marking check,
  • verify the company itself; see verify a foreign supplier.

Importer checklist

  • Harmonisation acts covering the product identified.
  • EU declaration of conformity for the right model, signed by the manufacturer.
  • Access to technical documentation secured in the contract.
  • CE marking and notified body number where required.
  • Importer details on the product, packaging or accompanying document.
  • Instructions and safety information in the language of the country of sale.

Hiram does not verify documents, including declarations of conformity and certificates; responsibility for product compliance lies with the manufacturer and importer. You can compare suppliers and their offers on the Hiram market.

This article is informational. For higher-risk products, consult a notified body or a compliance specialist.

Sources

This article is for information only and is not legal, tax or customs advice. Rules and rates change: check the current official sources or consult an adviser before you decide.

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