Importer obligations
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 role is defined by the act of importing a product into the Union and offering it for sale; "import" in customs law and "importer" in EU product law are not identical, but the latter is broader — anyone in the EU who is the first economic operator to make a third-country product available within the Union is an importer for these purposes. The importer's obligations are set out in Article R4 of Decision 768/2008/EC and reflected in every sectoral act.
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.
Legal basis
- Decision No 768/2008/EC, Article R4 (importer obligations) and Article R6 (cases in which importers are treated as manufacturers).
- Regulation (EU) 2019/1020, Article 4 — for the 18 listed acts, the importer is one of the operators that may serve as the "economic operator established in the Union" responsible for compliance tasks where no manufacturer or authorised representative is EU-based.
- Sectoral acts — e.g., Article 12 of Regulation (EU) 2023/1230 (Machinery); Article 13 of Regulation (EU) 2017/745 (MDR); Article 9 of Directive 2014/35/EU (LVD); Article 9 of Regulation (EU) 2025/2509 (Toys).
The seven obligations under Article R4
Article R4 of Decision 768/2008/EC sets out the following obligations of importers:
- 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.
- 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).
- 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.
- 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. The single point of contact requirement applies to each operator separately.
- 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.
- Carry out sample testing, investigate complaints, keep registers of non-conforming products and recalls, and keep distributors informed of any such monitoring. The level of activity must be proportionate to the risks presented by the product.
- 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 ten years after the product was placed on the market (Article R4(7)), and ensure the technical documentation can be made available to those authorities on request.
What the importer's verification actually means
The Commission's Blue Guide 2022 (§3.3) clarifies that the importer's verification is procedural, not technical. The importer is not required to re-test the product or re-do the conformity assessment. It is required to verify documentary completeness and visible features:
- CE marking is present, correctly proportioned, of correct minimum size, and accompanied by the Notified Body identification number where required;
- The EU Declaration of Conformity exists and is signed, with the listed acts plausibly applicable to the product;
- The technical documentation exists and is held by an EU-based operator (the manufacturer if EU-based, or the authorised representative);
- The manufacturer's name, address, and product identifier are on the product or its packaging;
- User instructions and safety information are provided in the language(s) required by each Member State of destination.
Where the importer's verification reveals a discrepancy — for example, a Declaration listing acts that do not apply, a Notified Body number not matching a NANDO entry, or absent contact details — placing the product on the market is prohibited until the manufacturer corrects the issue.
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:
- Temperature-sensitive products — medical devices, in vitro diagnostics, certain batteries, pyrotechnics.
- Humidity-sensitive products — electronics, certain construction products, some toys with cellulose components.
- Mechanically vulnerable products — pressure equipment, lifts components, large machinery that may be damaged in handling.
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, Battery Regulation, 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 the authorised representative; otherwise the importer; or — under the General Product Safety Regulation, for consumer products — a fulfilment service provider.
The importer is therefore the "default" Article 4 operator where the non-EU manufacturer has not appointed an EU authorised representative. This raises the importer's documentation duties: it must hold the Declaration of Conformity and ensure the technical documentation can be made available, even though the documentation was prepared by the manufacturer.
Sectoral additions
Medical Devices Regulation (EU) 2017/745
Article 13 of MDR adds: registration of the importer in EUDAMED (Article 31); reporting of incidents identified at the importer's level (Articles 87–89); for non-EU manufacturers, the importer must verify that an authorised representative has been designated under Article 11.
Construction Products Regulation (EU) 2024/3110
Adds: verification that the manufacturer has issued a Declaration of Performance (not a Declaration of Conformity), and that the product is accompanied by the relevant documentation under Article 23 of the Regulation.
General Product Safety Regulation (EU) 2023/988
For consumer products in scope of GPSR but not covered by harmonised acts, Article 11 imposes parallel verification duties on importers: traceability, safety information, internal complaints register, and notification of dangerous products via Safety Gate.
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 Regulation 2019/1020 Article 4, a fulfilment service provider (operating EU-based warehousing for non-EU sellers) may be required to take on the economic-operator role for consumer products. Online marketplaces have specific obligations under Article 22 of the GPSR and Article 31 of the Digital Services Act (Regulation (EU) 2022/2065). The Commission has taken enforcement action against marketplaces for failing to ensure an EU-based responsible person exists for products sold via their platforms.
Importing for own use
Importing a product for one's own use, not for placing on the market, does not engage the importer obligations in product law (although customs duties may still apply). The threshold is placing on the EU market, defined as the first making available for distribution or use against payment or free of charge (Regulation 765/2008, Article 2(2)).
Components and sub-assemblies
Importing components for incorporation into a finished product manufactured in the EU does not place the component on the EU market for end-use. The component's compliance is the responsibility of the EU manufacturer of the finished product. Where the component is itself a finished product separately covered by harmonisation legislation (e.g., a power supply unit complying with the LVD), the act of placing it on the EU market — even for B2B sale — triggers importer obligations.
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
- Treating "manufacturer-supplied paperwork" as sufficient. Receiving a Declaration of Conformity from a non-EU manufacturer is not enough if the Declaration is incomplete, lists inapplicable acts, or is unsigned. The importer's verification is substantive in form: a faulty Declaration must be corrected before placing on the market.
- No importer contact details on the product or packaging. Both the manufacturer's and the importer's contact details must be present (Article R4(4)). Importer-only labelling is sometimes done in error in private-label scenarios where the importer has not realised it has become the manufacturer.
- No EU-based holder of technical documentation. Where the importer is the only EU operator and the non-EU manufacturer has no authorised representative, the importer must be able to produce the technical documentation. Holding only "what the manufacturer sends on request" does not satisfy Article 4 of Regulation 2019/1020.
- Absence of complaints registers and post-market monitoring. Article R4(6) requires the importer to keep a register of complaints, non-conforming products, and recalls. Many small importers maintain no such record.
- Failure to translate user instructions. The importer is responsible for verifying that instructions are in the language(s) of each Member State of destination. Importing English-only documentation into Italy without translation is non-compliance regardless of the manufacturer's choices.
- Acting as importer but invoicing through a non-EU entity. The legal importer is the EU operator that first places the product on the EU market, not necessarily the entity on the customs invoice. Customs and product-law characterisations can diverge.
- Branding the product and continuing to act as importer. Under Article R6, an importer that places a product on the market under its own name or trade mark becomes the manufacturer. Continuing to act as "importer" after re-branding leaves the file in the wrong name.
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 for failure to meet importer obligations vary substantially but typically include administrative fines of several thousand to several hundred thousand euros, with criminal liability for serious or repeated infringements under the laws of individual Member States. See penalties for incorrect CE marking.