EU Authorised Representative and Importer

Author Hugues Orgitello Last updated 27 May 2026 ~16 min read

Guide. EU economic operators

Regulation (EU) 2019/1020 on market surveillance and compliance of products has, since 16 July 2021, reshaped the architecture of liability along the EU supply chain. It consolidates the definitions of manufacturer, authorised representative and importer already present in Decision 768/2008, adds two further figures (distributor, fulfilment service provider) and requires, through its article 4, that an economic operator be established in the Union for most regulated products. This guide sets out the scope of the text, the duties attached to each category, the mandatory content of the written mandate, the interaction with online marketplaces and the sanctions regime.

Why a horizontal market surveillance regulation

Before 2019/1020, market surveillance rested on Regulation (EC) No 765/2008 and on the surveillance provisions specific to each directive (EMC, Low Voltage, RED, Toys, ATEX). Two recurring effects emerged from Commission evaluations: definitions of economic operator diverged from one act to another, and there was a structural difficulty in reaching non-EU manufacturers who distributed directly through e-commerce. A non-compliant product ordered on a foreign marketplace and delivered to a private address often had no European interlocutor.

Regulation 2019/1020 answers with three structuring choices. First, a unified definition of economic operators applicable to all harmonisation acts listed in its annex I. Second, article 4, which requires that at least one economic operator be established in the Union for those acts. Third, the explicit inclusion of fulfilment providers and online marketplaces in the surveillance perimeter.

The text entered into force on 16 July 2019 and became applicable on 16 July 2021 for most of its provisions, including article 4. Implementation has been continuous since that date, with a progressive reinforcement under Regulation (EU) 2022/2065 (Digital Services Act, DSA) for the platforms dimension.

The five categories of economic operator

Article 3 of the regulation defines the economic operators along the product chain. Five roles coexist. The table below summarises definitions and primary duties.

Role	Definition (article 3)	Primary duties
Manufacturer	Person who manufactures a product or has it designed or manufactured, and markets it under its own name or trademark	Compliant design, conformity assessment, EU declaration of conformity, CE marking, technical documentation, post-market surveillance
Authorised representative	Person established in the Union who has received a written mandate from the manufacturer to act on its behalf on specified tasks	Keep the DoC and technical documentation available to authorities (typically ten years), cooperate, transmit information
Importer	Person established in the Union who places on the EU market a product from a third country	Pre-market checks, name and address on the product, retain documents, cooperate with authorities
Distributor	Person, other than manufacturer or importer, who makes the product available on the EU market	Due care: CE marking present, DoC accessible or signposted, instructions provided, alert on non-compliance
Fulfilment service provider (FSP)	Person who, in commercial activity, offers at least two of warehousing, packaging, addressing or dispatching without owning the product	Maintain records, cooperate with authorities, act as article 4 operator in the absence of any other EU actor

The manufacturer remains the epicentre of the framework. All other figures derive their liability from the manufacturer and relay it into the European market. This hierarchy has a practical consequence: an authorised representative can never "replace" the manufacturer for what concerns design or the initial signature of the declaration of conformity. It can, however, be the sole direct interlocutor of surveillance authorities.

Article 4, the keystone

Article 4 is the most structuring provision of the regulation for imported products. It states:

A product shall be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3.

The paragraph 3 tasks are four in number:

1. Verify that the EU declaration of conformity and the technical documentation have been drawn up, that they are kept at the disposal of authorities for the period required by the applicable act, and that they can be made available on reasoned request.
2. Provide authorities, on request, with the information and documentation necessary to demonstrate the conformity of the product, in a language easily understood by those authorities.
3. Inform authorities if there is reason to believe a product presents a risk.
4. Cooperate with authorities on any action taken to eliminate a risk posed by the product.

The article 4 economic operator may be:

• a manufacturer established in the Union,
• an authorised representative designated by written mandate for these tasks,
• an importer established in the Union who actually places the product on the market,
• a fulfilment service provider (FSP) established in the Union, but only where none of the three above exists.

Paragraph 5 lists the harmonisation acts covered. The scope is broad.

Harmonisation acts covered by article 4

Act	Reference	Domain
Toy Safety Directive	2009/48/EC	Safety of toys
Low Voltage Directive (LVD)	2014/35/EU	Electrical equipment 50-1000 V AC / 75-1500 V DC
EMC Directive	2014/30/EU	Electromagnetic compatibility
Radio Equipment Directive (RED)	2014/53/EU	Radio transmitters and receivers
ATEX Directive	2014/34/EU	Explosive atmospheres
Pressure Equipment Directive (PED)	2014/68/EU	Pressure equipment above 0.5 bar
Machinery Regulation	2023/1230 (formerly Directive 2006/42/EC)	Machinery and partly completed machinery
RoHS Directive	2011/65/EU	Hazardous substances in EEE
Construction Products Regulation (CPR)	305/2011	CE marking for construction products
Medical Devices Regulation (MDR)	2017/745	Medical devices
In Vitro Diagnostics Regulation (IVDR)	2017/746	IVD reagents and instruments
Marine Equipment Directive	2014/90/EU	Equipment on board EU vessels
PPE Regulation	2016/425	Personal protective equipment
Gas Appliances Regulation	2016/426	Appliances burning gaseous fuels
Fertilising Products Regulation	2019/1009	EU fertilising products
Ecodesign Directive (and 2024/1781 framework)	2009/125/EC	Ecodesign requirements
Energy Labelling Regulation	2017/1369	Energy-related product labelling

The list is meant to be extended through delegated acts. The EU legislator has integrated article 4 into every subsequent CE-marking text covering products likely to be imported from third countries. For a non-EU manufacturer exporting equipment that combines several regimes (typically a radio device subject to RED, EMC and Low Voltage), a single designation of an economic operator is sufficient, but it must cover every applicable act.

Details on the general CE marking framework and its scope are consolidated in the CE marking page and in the scope definition.

The authorised representative: mandatory content of the written mandate

The authorised representative is, in the vast majority of non-EU import files, the preferred option. It offers contractual stability independent from the distribution channel: unlike the importer, whose status depends on the commercial transaction, the authorised representative is designated by the manufacturer and remains its representative whatever the European buyer.

Form of the mandate

The mandate must be written, dated and signed by the manufacturer and the authorised representative. A purely verbal arrangement has no legal value. Established practice adds three precautions: bilingual drafting (language of the manufacturer and language of the Member State where the representative resides), apostille for manufacturers based in jurisdictions without an administrative assistance treaty, and a fixed renewable term (typically three to five years) rather than an indefinite duration.

Mandatory items

Article 5 of the regulation and the sector acts (for example article 11 of MDR for medical devices) set the minimum content:

Item	Expected content
Identification of the manufacturer	Full legal name, address, regulatory contact, national registration number if applicable
Identification of the representative	Legal name, full EU address, regulatory contact, local registration
Products covered	Explicit list, by family or by reference, with applicable harmonisation acts
Delegated tasks	At minimum the four tasks of article 4 paragraph 3; optionally sector registrations (WEEE, batteries), document translation, archiving
Term	Effective date, duration, renewal and termination conditions
Applicable law and jurisdiction	Law of the representative's country, competent court for disputes
Limitations	Explicit exclusions (for example the inability to sign the DoC for regimes that forbid it)

What the authorised representative cannot do

The mandate never authorises the representative to:

• design or modify the product,
• manufacture the product,
• sign the initial EU declaration of conformity in place of the manufacturer (except where the sector act explicitly permits it; MDR partially permits this for some obligations),
• conduct the conformity assessment (audit of the quality management system, EU type examination).

Any mandate purporting to delegate these tasks is void for the part incompatible with the sector act. Authorities draw the consequences by going directly to the manufacturer.

Operational responsibilities

Once in place, the authorised representative carries at minimum:

• custody of the technical documentation and the DoC for the prescribed period (typically ten years for CE, fifteen years for implantable medical devices),
• cooperation with authorities: responding to requests, providing documents in the required language, attending in person where necessary for an inspection,
• immediate transmission to the manufacturer of any complaint, risk notification or information request,
• informing the manufacturer of withdrawal, recall or ban decisions taken by surveillance authorities.

The authorised representative is not a passive intermediary: where it falls short, it incurs its own civil and administrative liability vis-a-vis the authorities of the Member State in which it is established.

The importer: operational duties

The importer is the economic operator that purchases and places on the market a product from a third country. Its liability is by nature broader than the distributor's, because it is the point of entry of the product into the internal market.

Pre-market verifications

Before placing on the market, the importer ensures that:

• the manufacturer has carried out the appropriate conformity assessment,
• the EU declaration of conformity has been drawn up and is available,
• the CE marking is affixed on the product or its packaging,
• the technical documentation exists (the importer does not hold the full file but must have confirmation of its existence and access on reasoned request),
• the instructions and safety information are provided in the language of the destination Member State,
• the name, trade name or registered trademark of the manufacturer and its postal address appear on the product or, where not possible, on the packaging or accompanying document.

Identification duties

After placing on the market, the importer adds its own identification:

• its name, trade name or trademark and postal address on the product or, failing that, on the packaging,
• the retention, for the period prescribed by the sector act, of a copy of the DoC, and the ability to provide the technical documentation to authorities,
• the handling of complaints, non-conforming products and recalls,
• immediate cooperation with surveillance authorities.

Cumulative sectoral duties

The importer of consumer electronics often faces sector registrations in parallel:

Regime	Registration
WEEE (Directive 2012/19/EU)	National producer register (in France, ADEME / Syderep)
Batteries (Regulation 2023/1542)	National battery producer register
Packaging	National compliance scheme (in France, Citeo)
REACH Regulation	Where listed substances are involved, registration with ECHA
RoHS	No separate registration but documentation to maintain

These registrations are an obligation distinct from CE marking: a CE-compliant product not registered for WEEE in France cannot lawfully be sold. This is the most common error of first-time importers.

Importer reclassified as manufacturer

An importer can be reclassified as a manufacturer in three situations:

1. it places the product on the market under its own name or trademark,
2. it modifies a product already placed on the market in a way that may affect compliance with essential requirements,
3. it has a product manufactured to its specification (private label, OEM).

In each case it takes on the full obligations of the manufacturer: design, conformity assessment, DoC, CE marking, technical documentation, post-market surveillance. Reclassification is often ignored by retailer brands that have products manufactured in Asia under house brand.

The distributor: due care

The distributor is any actor in the supply chain, other than the manufacturer or the importer, who makes a product available on the market. The category covers wholesalers, physical retailers, online resellers (other than third-party marketplaces, see below) and integrators who resell without modifying.

Its duties fall under due care:

• visually verify the presence of the CE marking,
• verify that the DoC accompanies the product or that its availability is signposted (URL, reference),
• verify that the name and address of the manufacturer and importer appear on the product or its packaging,
• verify that instructions and safety information are provided in the required language,
• take corrective measures if there is reason to believe a product is non-compliant: stop making it available, inform the manufacturer or importer, alert authorities if necessary,
• maintain storage and transport conditions in line with the manufacturer's requirements.

The distributor does not hold technical documentation. Its liability remains confined to the logistics chain and the act of making available. It can however be reclassified as a manufacturer on the same grounds as the importer (placing on the market under its own name, product modification).

Importer / distributor distinction worked example

A French distributor buys IP cameras from a German importer that brought them in from China. The Chinese manufacturer has designated an authorised representative in Germany. The chain:

1. Chinese manufacturer: design, manufacture, DoC, CE marking.
2. German authorised representative: custody of DoC and technical documentation, cooperation with authorities.
3. German importer: import-side verification, identification (name and address on product), German WEEE registration, retention of DoC.
4. French distributor: due care, marking and DoC checks, translation of instructions into French.

The importer remains the actor that brought the product into the EU market. The same French distributor buying the same product directly from the Chinese manufacturer would itself become the importer, with all attendant duties.

The fulfilment service provider (FSP)

The FSP category is the most visible contribution of Regulation 2019/1020. Before 2021, a non-EU manufacturer could ship directly to a European logistics warehouse that handled storage and delivery without any clearly designated EU operator. The regulation closes that gap.

Definition

Article 3 defines the FSP as any natural or legal person that, in the course of a commercial activity, offers at least two of the following services without owning the product:

• warehousing,
• packaging,
• addressing,
• dispatching.

Postal and pure transport services (transport without storage) are excluded. Owner-operated warehouses (where the operator also owns the product) are not in scope either. In scope are:

• Amazon FBA (Fulfillment by Amazon),
• Cdiscount Fulfilment and equivalents,
• generalist 3PLs (third party logistics) holding third-party brand stocks,
• dropshipping centers and other cross-border logistics operators.

FSP duties

The FSP must:

• maintain records identifying the products stored, the manufacturer or seller, and volumes,
• cooperate with surveillance authorities: block a flagged product, provide manufacturer or seller contact details, facilitate stock inspections,
• act as the article 4 economic operator where no EU manufacturer, authorised representative or importer exists for the product. In that case, the FSP becomes the sole interlocutor of authorities for the four tasks of paragraph 3.

This last duty is heavy. A 3PL that accepts stocks shipped directly from China without an authorised representative being designated takes on the CE obligations for those products.

Online marketplaces and the DSA

Article 7 of Regulation 2019/1020 sets specific duties on online marketplaces (Amazon Marketplace, Cdiscount Marketplace, eBay, Rakuten France and equivalents). These duties have been strengthened by Regulation (EU) 2022/2065 (Digital Services Act, DSA), applicable since February 2024.

Article 7 of 2019/1020

Marketplaces must cooperate with surveillance authorities, in particular by:

• removing or disabling access to listings concerning flagged non-compliant products,
• transmitting information identifying the seller,
• limiting the availability of non-compliant products on the basis of information received from authorities.

What the DSA adds

The DSA adds, for marketplaces, the duty to:

• collect and verify seller traceability information (name, address, contact, commercial register number, self-certification of product compliance) before any listing goes live (article 30 DSA),
• suspend sellers who repeatedly supply illicit products or content,
• cooperate with authorities through a single point of contact,
• for designated very large online platforms (VLOPs), assess and mitigate systemic risks linked to the diffusion of illicit products.

The combined 2019/1020 + DSA chain creates a strengthened liability path: the marketplace can no longer invoke a passive hosting status to escape its duties. This shift has already triggered massive listing removals on Amazon EU during 2024 and 2025.

Penalties: national regime, common frame

Article 41 of the regulation sets the principle without harmonising the quantum:

• Member States lay down the rules on penalties applicable to infringements of the regulation and of the sector acts covered,
• those penalties must be effective, proportionate and dissuasive,
• they may include administrative fines, criminal sanctions, withdrawal, recall or market-ban measures.

Member State	Main reference	Notable sanctions
France	Consumer Code L.452-1 et seq.; Public Health Code for medical devices	Fines up to EUR 75,000 (natural person), EUR 375,000 (legal entity); customs withdrawal
Germany	Marktueberwachungsgesetz (MUEG, 2021)	Fines up to EUR 100,000 per breach; withdrawal by Land authorities
Spain	Law 21/1992 and sector orders	Fines up to 5 percent of turnover for serious breaches
Italy	Codice del Consumo, articles 112 et seq.	Administrative fines and confiscation

For regimes that require registration (WEEE, batteries, PPE), specific sanctions add up: per-product fines for products placed on the market without registration, retroactive calculation over three years, even bans on activity.

The direct economic impact of article 4 is not measured in fines but in customs non-admission. A container shipped to a European buyer without a designated economic operator can be held at customs, returned or destroyed at the consignor's expense. This is the most tangible consequence for non-EU manufacturers.

Interaction with MDR, GDPR and CRA

Several distinct regulations use vocabulary close to "economic operator" or "representative". Confusion is frequent.

MDR / IVDR: a dedicated authorised representative

Article 11 of the MDR 2017/745 requires a dedicated authorised representative for medical devices, with partly specific duties (incident notification, post-market surveillance). The MDR authorised representative can be the same legal entity as the 2019/1020 authorised representative, but its mandate must explicitly cover the additional MDR requirements. Article 15 of the MDR adds the figure of the Person Responsible for Regulatory Compliance (PRRC): a natural person inside the manufacturer or the representative, distinct from the legal representative. The PRRC has no direct equivalent in 2019/1020.

GDPR: the article 27 representative

Regulation (EU) 2016/679 (GDPR) requires, at its article 27, a representative in the Union for controllers and processors established outside the EU who process personal data of individuals located in the Union. This representative has no functional link with the 2019/1020 authorised representative: it acts on data protection, not on product compliance. The same entity may combine both roles, but the contracts are distinct.

CRA: future single point of contact

Regulation (EU) 2024/2847 (Cyber Resilience Act) reuses part of the 2019/1020 vocabulary and also requires an economic operator established in the Union for products with digital elements. Obligations add to those of 2019/1020 and include a specific reporting framework to ENISA. See the CRA guide on this site for detail.

Common pitfalls

Drawing on what surveillance authorities and European customs services have reported, six pitfalls recur with remarkable regularity.

Pitfall	Consequence	Corrective action
Non-EU manufacturer omitting an authorised representative	Customs refusal; product cannot be placed on the market	Designate an authorised representative before any shipment
Mandate too narrow (incomplete tasks)	The representative does not cover the four article 4 tasks; non-compliance	Draft a mandate explicitly covering all four tasks
Importer without WEEE / battery registration	National sanction; cannot sell	Register with the national compliance scheme before first placement
Distributor assumed exempt from any duty	Non-compliant products made available; liability incurred	Put in place an inbound check procedure (CE, DoC, labelling)
FSP unaware of its post-2021 status	Article 4 liability assumed de facto without operational capacity	Audit the non-EU client portfolio; refuse or require an authorised representative
Confusion among 2019/1020 representative, MDR representative and PRRC	Legally insufficient mandate for medical devices	Draft a separate mandate or a consolidated one explicitly covering both 2019/1020 AND 2017/745

The most structural pitfall is the first. A significant share of consumer electronics distributed via Amazon EU and other marketplaces is still shipped directly from Asia without any designated authorised representative. The filtering effect of the DSA and of article 4 has been intensifying from 2025; affected manufacturers can no longer defer designation.

For the reference definitions (economic operator, authorised representative, importer, distributor, FSP), see the spilma glossary.

See also

• Multi-marking layouts: CE, FCC, UKCA, ANATEL and other marks
• E-label vs physical label: rules by jurisdiction
• Component substitution: when does a swap trigger retest?
• Change management: FCC Class II permissive and RED delta

Working on 2019/1020 scoping and the designation of an authorised representative for an electronic product for a real product? AESTECHNO can audit your design and certification plan. Get in touch →

Summary: choosing your economic operator

Case	Recommended choice	Rationale
Non-EU manufacturer distributing through several channels	Authorised representative	Contractual stability independent of the buyer; single interlocutor for authorities
Non-EU manufacturer with a single exclusive EU importer	The importer may suffice	The importer assumes article 4 by default; check that its sectoral remit is explicit
Non-EU manufacturer shipping via Amazon FBA without a European interlocutor	Authorised representative is mandatory	The FSP will increasingly refuse to assume article 4
EU manufacturer	No specific action	The manufacturer is itself the article 4 operator
Importer producing under house brand	Reclassification as manufacturer	Full assumption of manufacturer duties; DoC drafting

The main decision criterion is the stability of the distribution channel. The more diversified the channel (multi-buyer, multi-marketplace), the more the authorised representative is preferable to the importer as article 4 operator. The more exclusive and stable the channel, the more the importer can suffice, provided it is fully aware of its duties.

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Sources & references

1. Regulation (EU) 2019/1020 on market surveillance and compliance of products , EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
2. Blue Guide 2022 on the implementation of EU product rules , Publications Office of the European Union op.europa.eu/en/publication-detail/-/publication/1ef9c0ec-d4fa-11ec-a95f-01aa75ed71a1
3. Regulation (EU) 2022/2065 on a Single Market for Digital Services (DSA) , EUR-Lex eur-lex.europa.eu/eli/reg/2022/2065/oj
4. European Commission, market surveillance in the Union , European Commission single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
5. Regulation (EU) 2017/745 (MDR), article 11 on the authorised representative , EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj