Market access in Europe: the role of an economic operator

What is an economic operator and why you need one

EU product law does not deal with a factory in Ohio or Shenzhen. It deals with an economic operator established in the EU. The economic operator serves as your official compliance contact in the EU: it verifies key documents, is named on the product and answers to market surveillance authorities, while the manufacturer remains responsible for the product itself.

Most CE-marked products, namely those covered by the acts listed in Art. 4(5) of Regulation (EU) 2019/1020 such as toys, electrical equipment, machinery and radio equipment, may only be placed on the market if such an operator is established in the EU (Art. 4(1)). Art. 16 GPSR extends this requirement to products covered by the General Product Safety Regulation. A non-EU manufacturer without an EU importer therefore appoints an economic operator to fulfill these obligations.

Representa GmbH provides full-service compliance solutions, acting as your economic operator and EU Authorized Representative for a smooth market entry.

Who can be the economic operator

• A manufacturer established in the EU.
• An importer, where the manufacturer is not established in the EU.
• An Authorized Representative with a written mandate from the manufacturer.
• A fulfilment service provider established in the EU, for the products it handles, where none of the above is established in the EU.

Key responsibilities of an economic operator

• Legal representation within the EU for the tasks set out in the law and in the mandate.
• Market surveillance and risk management: informing authorities when a product presents a risk and cooperating on corrective actions, including recalls (Art. 4(3)(c) and (d)).
• Product compliance support, including checking that the Declaration of Conformity and the technical documentation required for CE marking under the applicable EU directives have been drawn up (Art. 4(3)(a)).
• Traceability and management of compliance documentation: keeping the Declaration of Conformity available to authorities, making sure the technical documentation can be made available on request (Art. 4(3)(a)) and answering technical documentation requests from authorities (Art. 4(3)(b)).
• Liaison with consumers and regulatory authorities. The operator's name and contact details appear on the product, its packaging, the parcel or an accompanying document (Art. 4(4)).

Without an economic operator, non-EU manufacturers risk market bans, fines, legal penalties and loss of trust with European distributors and consumers.

Importer, fulfilment provider or Authorized Representative

Which role fits depends on how you sell. An importer established in the EU can take the role for the products it places on the market. A fulfilment service provider can take it only for the products it handles and only if no manufacturer, importer or Authorized Representative is established in the EU (Art. 4(2)(d)). Whoever takes the role has the same tasks under Art. 4(3), including the document checks.

Liability is no reason to prefer one role over another. Under the new Product Liability Directive (EU) 2024/2853, which member states must transpose by 9 December 2026 and which applies to products placed on the market after that date, both the importer and the authorized representative of a non-EU manufacturer can be held liable for defective products, and the fulfilment service provider where neither exists (Art. 8(1)(c)).

With an Authorized Representative, the manufacturer decides by written mandate which products and tasks are covered, independently of individual importers, distributors or sales channels.

How Representa GmbH supports non-EU manufacturers

Representa GmbH offers a full-service compliance package for seamless EU market access:

• EU Authorized Representative and Responsible Person services for obligations under GPSR, CE, EMC and RoHS.
• Regulatory documentation management and risk assessments.
• Market surveillance support, recalls and legal liaison with authorities.
• Traceability and post-market monitoring.
• End-to-end compliance consulting throughout the market entry process.
• Support for e-commerce platforms and distributors like Amazon and Shopify.

With Representa GmbH, non-EU businesses gain a trusted compliance partner, smooth market access and dedicated support for their regulatory challenges.