CECheck The reference for CE marking

Importer obligations

Last reviewed: October 2026 · Sources listed at the end of this page.

An importer, for the purposes of CE marking legislation, is a natural or legal person established in the Union who places a product from a third country on the EU market (Decision No 768/2008/EC, Article R1, point 5). The test is who first supplies a third-country product on the EU market from an EU establishment, which is not necessarily the party named on the customs declaration. The importer's obligations are set out in Article R4 of Decision 768/2008/EC and repeated in the aligned sectoral acts.

The importer is a verification party, not a primary conformity party. It does not perform the conformity assessment, does not draw up the technical documentation, does not affix the CE mark. It checks that the manufacturer has done so and that the product as offered for sale meets the procedural requirements. Where it goes beyond verification — by re-branding, by modifying, or by placing on the market under its own name — it becomes the manufacturer under Article R6 and assumes the full manufacturer obligations.

At a glance. Before placing a third-country product on the EU market, the importer checks that the manufacturer completed the conformity assessment and technical file, that the CE mark, documents and traceability details are in place, and adds its own name and address. These duties are in force. The importer does not need its own Notified Body, but where the route needs one it should check the body's number in NANDO. Key date: products placed on the market after 9 December 2026 fall under the new Product Liability Directive.

Legal basis

The main obligations under Article R4

Article R4 of Decision 768/2008/EC has nine paragraphs. The main obligations of importers are:

  1. Place only compliant products on the EU market. The importer must ensure that the product complies with the applicable harmonisation legislation before placing it on the market.
  2. Verify the manufacturer's conformity assessment. The importer must ensure that:
    • The manufacturer has carried out the appropriate conformity assessment procedure;
    • The manufacturer has drawn up the technical documentation;
    • The product bears the CE marking and is accompanied by the required documents;
    • The manufacturer has complied with the traceability requirements (name, address, type/batch/serial number on the product or packaging).
  3. Refuse to place non-compliant products on the market. Where the importer considers, or has reason to believe, that the product is not in conformity, it must not place it on the market until conformity is brought about. Where the product presents a risk, the importer must inform the manufacturer and the competent market surveillance authorities.
  4. Indicate identity and contact details on the product or, where this is not possible, on the packaging or accompanying documents. The importer's name, registered trade name or trade mark, and postal address must appear in addition to the manufacturer's.
  5. Ensure instructions and safety information accompany the product in a language easily understood by consumers and other end-users, as determined by the Member State concerned (Article R4(4)).
  6. Ensure storage and transport conditions do not jeopardise conformity. While the product is under the importer's responsibility, conditions must not affect compliance with the essential requirements — e.g., temperature control for sensitive electronics or medical devices.
  7. Carry out sample testing, investigate complaints, keep registers of non-conforming products and recalls, and keep distributors informed of any such monitoring, when deemed appropriate with regard to the risks presented by the product (Article R4(6)).
  8. Take corrective measures and inform authorities when there are reasons to believe a product on the market is not in conformity, in the same way as manufacturers under Article R2.

The importer must also keep a copy of the EU Declaration of Conformity available to market surveillance authorities for the period set by the sectoral act, commonly ten years after the product was placed on the market (Article R4(8)), ensure the technical documentation can be made available to those authorities on request, and be able to identify its suppliers and customers on request (Article R7).

What the importer's verification actually means

The Commission's Blue Guide 2022 (section 3.3) says the importer's obligations do not imply a need to resort systematically to additional control procedures or third-party testing, nor do they preclude them. It also says the importer is not a simple re-seller. In practice that means checking at least:

Where the importer's verification gives it reason to believe the product is not in conformity — for example, a Declaration listing acts that do not apply, a Notified Body number not matching a NANDO entry, or absent contact details — it must not place the product on the market until the issue is corrected (Article R4(2)).

Storage and transport conditions

Article R4(5) requires the importer to ensure that storage or transport conditions do not jeopardise conformity. This applies particularly to:

Where storage or transport conditions do affect conformity, the importer is responsible for the resulting non-conformity even if the manufacturer's original product was fully compliant.

The "economic operator established in the Union" duty

Since 16 July 2021, Article 4 of Regulation (EU) 2019/1020 has required that, for products covered by 18 listed acts (LVD, EMC, Machinery, PPE, Toys, RoHS, RED, and others), an economic operator established in the Union must perform compliance tasks: hold the Declaration and technical documentation, verify conformity of the procedure, provide information on reasoned request, cooperate with authorities. The operator is the manufacturer if EU-based. Otherwise it may be the importer or an authorised representative mandated for these tasks; where none of these is established in the Union, it is a fulfilment service provider for the products it handles (Article 4(2)).

The importer is therefore in practice the Article 4 operator where the non-EU manufacturer has not mandated an EU authorised representative. The duties largely overlap with Article R4: keep the Declaration of Conformity and ensure the technical documentation can be made available. The Blue Guide (section 3.6) confirms the operator need not hold the file itself, provided it has checked the file exists and has the manufacturer's assurance that it will be shared on request.

Sectoral additions

Medical Devices Regulation (EU) 2017/745

Article 13 of MDR adds: registration of the importer in EUDAMED (Article 31); forwarding complaints and reports of suspected incidents to the manufacturer and authorised representative; for non-EU manufacturers, the importer must verify that an authorised representative has been designated under Article 11.

Construction Products Regulation (EU) 2024/3110

Article 24 adds: verification that the product is accompanied by a declaration of performance and conformity (not a standard EU Declaration of Conformity), or that the declaration is available under Article 16, that the manufacturer has drawn up the technical documentation, and that the product is accompanied by the general product information, instructions for use and safety information set out in Annex IV.

General Product Safety Regulation (EU) 2023/988

For consumer products not covered by harmonised acts, Article 11 imposes parallel verification duties on importers, including traceability, safety information and informing authorities of dangerous products through the Safety Business Gateway. Article 11 does not apply to CE-marked products (Article 2(1)), but Article 20 does: importers who learn of an accident caused by a product must inform the manufacturer without undue delay.

Edge cases

Direct shipments from non-EU sellers to EU consumers

Where a non-EU seller ships directly to an EU consumer without an EU importer, the question of "who is the importer" is not always clear. Under the definition there is then no importer. For acts listed in Article 4(5) of Regulation 2019/1020, an EU-established fulfilment service provider takes on the economic-operator role for the products it handles where no manufacturer, importer or authorised representative is established in the Union. Online marketplaces have specific obligations under Article 22 of the GPSR and Article 31 of the Digital Services Act (Regulation (EU) 2022/2065). See CE marking for e-commerce sellers.

Importing for own use

Importing a product purely for one's own use is not placing it on the market, so the importer obligations are not engaged (customs formalities still apply). The threshold is the first making available on the EU market (Regulation 765/2008, Article 2). Check the act, however: some, such as the machinery rules, also apply on putting into service, so a business that imports a machine for use in its own plant may still have to ensure conformity.

Used and second-hand products

Harmonisation legislation applies to used and second-hand products imported from a third country when they enter the Union market for the first time. The Blue Guide (section 3.1) says the person who places such products on the Union market must assume the role of the manufacturer, as must anyone placing a product not designed or manufactured for the Union market.

Components and sub-assemblies

Whether a component is covered depends on the act. A component that falls outside the act's product definition is dealt with through the conformity of the finished product, which is the responsibility of its manufacturer. Where the item is itself a product covered by harmonisation legislation (for example, a power supply unit under the LVD), placing it on the EU market triggers importer obligations, even in B2B sales.

Spare parts imported separately

Spare parts placed on the market separately as finished products require their own compliance verification. A spare part shipped with a fully assembled product remains under the manufacturer's responsibility; placed on the market separately for repair use, it is treated as a finished product requiring its own marking where the underlying act applies.

Common errors

Consequences of failure

Under Article 16 of Regulation (EU) 2019/1020, market surveillance authorities may require the importer to bring the product into conformity, withdraw it, or recall it. National penalties vary by Member State and may include criminal sanctions for serious infringements. See penalties for incorrect CE marking.

Importers also carry civil liability. For products placed on the market or put into service after 9 December 2026, Directive (EU) 2024/2853 makes the importer of a defective product liable where the manufacturer is established outside the Union, without prejudice to the manufacturer's own liability (Article 8). Directive 85/374/EEC continues to apply to earlier products.

Frequently asked questions

Who is the importer: the buyer or the customs declarant?

The importer is the person established in the Union who places the third-country product on the Union market. That is usually, but not always, the party on the customs declaration. A logistics agent that only clears the goods is not an importer.

Does an importer have to test the product?

Not systematically. The obligations do not require additional testing as a rule, nor do they rule it out. Sample testing is required when appropriate given the risks, and doubts about conformity must be resolved before placing on the market.

Must the importer hold the technical file?

It must keep a copy of the Declaration of Conformity and ensure the technical documentation can be made available to authorities on request. It need not hold the file itself, but it must be able to obtain it.

When does an importer become the manufacturer?

When it places the product on the market under its own name or trademark, or modifies it in a way that may affect compliance (Article R6).

Sources

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