EU Authorised Representative, Importer and Article 4

Hugues Orgitello updated 7 Oct 2026 16 min read

Regulation (EU) 2019/1020 on market surveillance and compliance of products has applied since 16 July 2021. It takes over the market surveillance chapter of Regulation (EC) No 765/2008, keeps the manufacturer, authorised representative, importer and distributor already defined in Decision 768/2008, adds the fulfilment service provider and, through its Article 4, requires an economic operator established in the Union for products under eighteen listed harmonisation acts. This guide reads each role against the texts that create it: Article 4 and 5 of Regulation 2019/1020, Articles R3 to R7 of Decision 768/2008, Articles 10 to 15 of the Radio Equipment Directive, the GPSR, the Cyber Resilience Act and the MDR.

Why a horizontal market surveillance regulation

Before 2019/1020, market surveillance of harmonised products rested on Chapter III (Articles 15 to 29) of Regulation (EC) No 765/2008 and on the provisions of each directive (EMC, Low Voltage, RED, Toys, ATEX). Regulation 2019/1020 deletes that chapter of 765/2008 (its Article 39) and replaces it. Three of its choices matter for a non-EU manufacturer:

• Article 4: for the acts listed in Article 4(5), at least one economic operator established in the Union must be responsible for defined tasks.
• Fulfilment service providers become economic operators (Article 3(11) and (13)).
• Information society service providers, which include online marketplaces, must cooperate with market surveillance authorities at their request (Article 7(2)).

The regulation entered into force on the twentieth day after publication in OJ L 169 of 25 June 2019 and applies from 16 July 2021; Articles 29, 30, 31, 32, 33 and 36 (Union Product Compliance Network, information system) applied from 1 January 2021 (Article 44).

The five economic operators

Role	Definition (Regulation 2019/1020, Article 3)	Main duties under the sector act (RED article given as example)
Manufacturer	Manufactures a product, or has it designed or manufactured, and markets it under its name or trademark (point 8)	Design to the essential requirements, conformity assessment, technical documentation, EU declaration of conformity, CE marking, keep documents 10 years (RED Art. 10)
Authorised representative	Established in the Union, holds a written mandate from a manufacturer to act on its behalf for specified tasks (point 12)	Tasks in the mandate; at least keep the DoC and technical documentation 10 years, answer reasoned requests, cooperate (RED Art. 11)
Importer	Established in the Union, places a product from a third country on the Union market (point 9)	Pre-market checks, own name and postal address on the product, keep a DoC copy 10 years, ensure technical documentation can be supplied (RED Art. 12)
Distributor	In the supply chain, other than manufacturer or importer, makes a product available on the market (point 10)	Due care: verify CE marking, accompanying documents, instructions, manufacturer and importer identification (RED Art. 13)
Fulfilment service provider (FSP)	Offers at least two of warehousing, packaging, addressing and dispatching, without owning the products; postal, parcel delivery and freight transport services excluded (point 11)	Cooperate with authorities; Article 4 operator for the products it handles only where no other EU operator exists (Art. 4(2)(d))

Every economic operator must, on request, identify who supplied it and to whom it supplied the product. Under RED Article 15 this information must be available for 10 years after being supplied and 10 years after supplying.

Article 4, the keystone

Article 4(1) reads:

Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may 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 in respect of that product.

Who can be the Article 4 operator (Article 4(2))

1. a manufacturer established in the Union;
2. an importer, where the manufacturer is not established in the Union;
3. an authorised representative with a written mandate designating it to perform the Article 4(3) tasks on the manufacturer's behalf;
4. a fulfilment service provider established in the Union, for the products it handles, where none of the three above is established in the Union.

The tasks (Article 4(3))

Point	Task	Blue Guide 3.6 reading
(a)	Where the act provides for an EU declaration of conformity (or declaration of performance) and technical documentation: verify they have been drawn up, keep the declaration available for the period the act requires, ensure the technical documentation can be made available on request	The operator need not hold the technical documentation itself; it checks it exists and obtains assurance that the manufacturer will share it on request
(b)	On a reasoned request, provide all information and documentation needed to demonstrate conformity, in a language the authority can easily understand	The language can be negotiated with the authority
(c)	Inform market surveillance authorities when it has reason to believe the product presents a risk	Inform each Member State where the product was made available
(d)	Cooperate, including making sure immediate corrective action is taken, or the risk mitigated	It must ensure action is taken (for example by the manufacturer) but does not have to take it itself if the sector act does not oblige it to

Identification on the product (Article 4(4))

The name, registered trade name or registered trade mark, and contact details including the postal address of the Article 4 operator must appear on the product or on its packaging, the parcel or an accompanying document. The Blue Guide (section 3.6) notes that when the operator is an EU manufacturer or an importer this information is normally already required by the sector act, and that labels such as "imported by" or "represented by" are not mandatory, provided the information does not mislead authorities.

Acts covered (Article 4(5))

Act	Reference	Domain
Construction Products Regulation	(EU) No 305/2011	Construction products
PPE Regulation	(EU) 2016/425	Personal protective equipment
Gas Appliances Regulation	(EU) 2016/426	Appliances burning gaseous fuels
Outdoor Noise Directive	2000/14/EC	Noise emission of outdoor equipment
Machinery Directive	2006/42/EC (repealed from 20 January 2027 by Regulation (EU) 2023/1230)	Machinery
Toy Safety Directive	2009/48/EC	Toys
Ecodesign Directive	2009/125/EC	Energy-related products
RoHS Directive	2011/65/EU	Hazardous substances in EEE
Pyrotechnic Articles Directive	2013/29/EU	Pyrotechnic articles
Recreational Craft Directive	2013/53/EU	Recreational craft and personal watercraft
Simple Pressure Vessels Directive	2014/29/EU	Simple pressure vessels
EMC Directive	2014/30/EU	Electromagnetic compatibility
NAWI Directive	2014/31/EU	Non-automatic weighing instruments
Measuring Instruments Directive	2014/32/EU	Measuring instruments
ATEX Directive	2014/34/EU	Equipment for explosive atmospheres
Low Voltage Directive (LVD)	2014/35/EU	Electrical equipment
Radio Equipment Directive	2014/53/EU	Radio equipment
Pressure Equipment Directive	2014/68/EU	Pressure equipment

The Blue Guide (footnote 164) also counts unmanned aircraft systems (drones), whose legislation refers to Article 4. Medical devices (MDR, IVDR) are not in the list; they have their own mandatory authorised representative. A connected product under RED, EMC, LVD and RoHS needs only one Article 4 operator, provided its mandate or role covers every act concerned.

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

The authorised representative

Optional under the CE acts, mandatory under the MDR

RED Article 11(1), Decision 768/2008 Article R3(1), GPSR Article 10(1) and CRA Article 18(1) use the same words: a manufacturer may, by a written mandate, appoint an authorised representative. The Blue Guide (section 3.2) is explicit: a manufacturer established outside the Union is not obliged to have one. Its footnote 133 lists the exceptions: the medical device and in vitro diagnostic regulations, the Marine Equipment Directive 2014/90/EU, and supply chains where an authorised representative is needed to act as the Article 4 operator (typically when no EU importer exists).

What the mandate must allow, act by act

Act	Minimum content of the mandate	Excluded from the mandate
Regulation 2019/1020, Art. 5	The Article 4(3) tasks (for the Article 4 role); copy of the mandate to authorities on request, in a Union language they determine; appropriate means to fulfil the tasks	Not specified
Decision 768/2008, Art. R3	Keep the declaration and technical documentation available for the period set by the act; answer reasoned requests; cooperate on risk elimination	Design and manufacture to the requirements (R2(1)); drawing up the technical documentation
RED 2014/53/EU, Art. 11	Keep DoC and technical documentation 10 years after placing on the market; answer reasoned requests; cooperate	Art. 10(1) obligations; drawing up the technical documentation (Art. 10(3))
GPSR 2023/988, Art. 10	Answer reasoned requests; inform the manufacturer of a dangerous product; notify corrective actions through the Safety Business Gateway where the manufacturer has not; cooperate	Not specified
CRA 2024/2847, Art. 18	Keep DoC and technical documentation at least 10 years or the support period, whichever is longer; answer reasoned requests; cooperate; copy of the mandate on request	Art. 13(1) to (11), first subparagraph of 13(12), and 13(14)
MDR 2017/745, Art. 11	Eight tasks (a) to (h): verify DoC, technical documentation and conformity assessment; keep documents for the Art. 10(8) period; registration (Art. 31); provide documents; forward requests for samples; cooperate; forward incident complaints; terminate the mandate if the manufacturer breaches its obligations	Manufacturer obligations of Art. 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)

Under the MDR the designation is valid only when accepted in writing by the authorised representative and covers at least all devices of the same generic device group (Article 11(2)). Document retention under MDR Article 10(8) is at least 10 years after the last device is placed on the market, 15 years for implantable devices. A change of authorised representative must follow an agreement covering the points of Article 12.

Tasks that can be delegated

The Blue Guide (section 3.2) describes the delegable tasks as administrative. Depending on the conformity assessment procedure and the act, the mandate can include affixing the CE marking and the notified body number, drawing up and signing the EU declaration of conformity, and acting as the Article 4 operator. The manufacturer can delegate neither the measures ensuring that manufacturing produces compliant products nor the drawing up of the technical documentation, and the authorised representative cannot modify the product on its own initiative. Commercial agents and authorised distributors are not authorised representatives in this sense.

The importer

Under RED Article 12 (and Decision 768/2008 Article R4), the importer:

• places only compliant radio equipment on the market;
• before placing it, ensures the conformity assessment was carried out, the technical documentation drawn up, the CE marking affixed, the instructions, DoC copy (or simplified DoC) and restriction information provided, and the manufacturer identification and type or serial number present;
• indicates its own name, registered trade name or trade mark and postal address on the equipment or, where that is not possible (including when the packaging would have to be opened), on the packaging or an accompanying document;
• ensures instructions and safety information are in a language easily understood by end users, as determined by the Member State concerned;
• protects compliance during storage and transport;
• keeps a copy of the EU declaration of conformity for 10 years and ensures the technical documentation can be made available on request;
• takes corrective action and informs authorities when the equipment presents a risk.

The Blue Guide (section 3.3) adds that these checks do not require importers to systematically carry out extra testing, and that on a reasoned request it is sufficient to provide the part of the technical documentation related to the claimed non-conformity. The importer needs no mandate, but must be able to reach the manufacturer.

When the importer becomes the manufacturer

RED Article 14 (Decision 768/2008 Article R6, CRA Article 21) treats an importer or distributor as the manufacturer when it places the product on the market under its own name or trade mark, or modifies a product already on the market in a way that may affect compliance (CRA: a substantial modification). Private-label goods made to order fall under the definition of manufacturer itself: whoever has a product designed or manufactured and markets it under its own name.

Registrations outside CE marking

The importer is often also the "producer" under waste and battery rules. Directive 2012/19/EU (WEEE) Article 16 requires each Member State to keep a register of producers, including those selling by distance communication, and Regulation (EU) 2023/1542 Article 55 requires producers to register in each Member State where they first make a battery available. These obligations are separate from the declaration of conformity.

The distributor

RED Article 13 requires the distributor to act with due care and, before making equipment available, to verify the CE marking, the documents required by the directive, instructions and safety information in the right language, and that the manufacturer and importer complied with the identification and labelling requirements. It must not make available equipment it has reason to believe is non-compliant, and informs the manufacturer or importer and the authorities where there is a risk.

The Blue Guide (section 3.4) is precise on two points: the distributor is not expected to hold the technical documentation, and it judges the product against the legislation applicable when the product was placed on the market, not against later changes.

Worked chain

A French distributor buys IP cameras from a German importer who brought them in from China. The Chinese manufacturer has also mandated an authorised representative in Germany.

1. Chinese manufacturer: design, conformity assessment, technical documentation, DoC, CE marking.
2. German authorised representative: the tasks in the mandate, at least those of RED Article 11(2); possibly the Article 4 role.
3. German importer: RED Article 12 checks, own name and address on the product, DoC copy for 10 years. As an importer it can itself be the Article 4 operator.
4. French distributor: RED Article 13 due care, including the French-language instructions check.

If the French company bought directly from the Chinese manufacturer, it would be the importer.

The fulfilment service provider

The Blue Guide (section 3.5) describes fulfilment service providers as entities that store products offered by online operators, then package and dispatch them after orders are received, sometimes handling returns. They cooperate with authorities for the products they handle and become the Article 4 operator only when no manufacturer, importer or authorised representative established in the Union is responsible. Depending on its business model, a fulfilment service provider may also qualify as a distributor, importer or authorised representative.

Online marketplaces: 2019/1020, DSA and GPSR

Text	Article	Obligation
Regulation 2019/1020	7(2)	Information society service providers cooperate with market surveillance authorities, at their request and in specific cases
Regulation 2019/1020	14(4)(k)	Authorities can require removal of content or a warning when no other means can eliminate a serious risk
DSA 2022/2065 (applies from 17 February 2024)	30	Platforms allowing distance contracts with traders obtain trader traceability information, including a self-certification of compliance, before the trader can offer products
DSA 2022/2065	23	Suspension, after a prior warning, of users who frequently provide manifestly illegal content
GPSR 2023/988 (applies from 13 December 2024)	22(1) to (3)	Single point of contact for authorities, registered on the Safety Gate Portal; single point of contact for consumers; internal product safety processes
GPSR 2023/988	22(4)	Act on removal orders within two working days
GPSR 2023/988	22(8)	Process product safety notices within three working days
GPSR 2023/988	22(9)	Listings show the manufacturer and, if it is outside the Union, the responsible person (GPSR Art. 16(1) or 2019/1020 Art. 4(1)), product identification with picture, warnings
GPSR 2023/988	19	Every economic operator selling at a distance shows the same information in its offer

GPSR recital 33 explains that the marketplace provisions apply to harmonised products where no specific provision with the same objective exists in their own legislation. For consumer products outside harmonisation legislation, GPSR Article 16 extends the Article 4 "responsible person" requirement, with additional periodic checks and an electronic address on the label. GPSR Article 2(1) excludes Chapter III Section 1 (Articles 9 to 18, which include Article 16) for products under Union harmonisation legislation: for a CE-marked radio device, the responsible person remains the one of 2019/1020 Article 4.

Customs and penalties

Under Article 26(1)(d) of Regulation 2019/1020, customs authorities suspend release for free circulation when the name and contact details of the Article 4 operator are not indicated or identifiable. Under Article 27, the product is released if, within four working days of the suspension, the market surveillance authorities have not asked to maintain it. The Blue Guide (section 3.6) therefore advises non-EU sellers to add the Article 4 operator details before shipping.

Penalties are national. Article 41 requires Member States to lay down effective, proportionate and dissuasive penalties for infringements of the regulation and of the acts listed in its Annex II, and to notify them to the Commission (by 16 October 2021 for the initial provisions). Fine levels differ between Member States and are set in national law.

Interaction with MDR, GDPR and CRA

MDR and IVDR

MDR Article 11 makes a sole authorised representative a condition for placing on the market when the manufacturer is not established in a Member State. That representative is jointly and severally liable with the manufacturer for defective devices where the manufacturer has not complied with Article 10 (Article 11(5)). The MDR guide covers registration and vigilance. The person responsible for regulatory compliance (Article 15) is a separate figure: manufacturers have one within their organisation (micro and small enterprises may have one permanently at their disposal instead), and authorised representatives must have one permanently and continuously at their disposal (Article 15(6)).

GDPR Article 27

Regulation (EU) 2016/679 Article 27 requires certain controllers and processors not established in the Union to designate a representative in the Union. It concerns data protection, not product compliance; the same company may hold both roles under separate contracts.

Cyber Resilience Act

The Cyber Resilience Act (Regulation (EU) 2024/2847) defines its own authorised representative, importer and distributor (Articles 18 to 20). Appointing an authorised representative is optional (Article 18(1)). Article 66 adds the CRA to Annex I of Regulation 2019/1020, not to the Article 4(5) list, so a product with digital elements falls under Article 4 through RED, EMC, LVD or RoHS, not through the CRA. The CRA reporting obligations for actively exploited vulnerabilities and severe incidents apply from 11 September 2026; the regulation applies in full from 11 December 2027.

Claims the texts contradict

Claim	What the texts say
"A non-EU manufacturer must appoint an authorised representative for CE marking"	RED Art. 11(1), Decision 768/2008 Art. R3(1) and CRA Art. 18(1) say "may". The Blue Guide (3.2): a manufacturer outside the Union is not obliged to have one. The MDR and IVDR are the exceptions.
"The authorised representative can never sign the EU declaration of conformity"	Blue Guide 3.2 lists drawing up and signing the DoC, and affixing the CE marking, among tasks that can be mandated. What is excluded is design and manufacture to the requirements and drawing up the technical documentation.
"Regulation 2019/1020 added the distributor and the fulfilment service provider"	The distributor was already defined in Decision 768/2008 (Article R1). Only the fulfilment service provider is new.
"The mandate must be bilingual, carry an apostille, be governed by the law of the representative and be renewed every few years"	None of the texts requires this. Regulation 2019/1020 Art. 5 requires a written mandate covering the Article 4(3) tasks, provided to authorities on request. The MDR requires written acceptance by the representative.
"The fulfilment service provider must keep records of stock and volumes"	No such duty in Regulation 2019/1020. It must cooperate with authorities and act as Article 4 operator only when no other EU operator exists.
"Selling through a fulfilment warehouse makes an authorised representative mandatory"	Article 4(2) accepts an EU importer as the operator. The authorised representative is the practical answer only where no importer or EU manufacturer exists.
"The distributor checks that the DoC is available or signposted, and holds no documents"	RED Art. 13(2) requires verifying the documents required by the directive, which for radio equipment include a copy of the DoC or a simplified DoC with each item (Art. 10(9)). The distributor is not expected to hold technical documentation (Blue Guide 3.4).
"The CRA extends Article 4 to products with digital elements"	CRA Art. 66 adds the CRA only to Annex I of 2019/1020; Article 4(5) is unchanged.
"GPSR Article 16 adds a second responsible person for CE-marked products"	GPSR Art. 2(1)(b) excludes Chapter III Section 1, which contains Article 16, for products under Union harmonisation legislation.

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: who can carry Article 4

Supply chain	Who can be the Article 4 operator	Text
EU manufacturer	The manufacturer itself	Art. 4(2)(a)
Non-EU manufacturer selling to an EU importer	The importer, or an authorised representative if mandated	Art. 4(2)(b) and (c)
Non-EU manufacturer selling directly to EU consumers online	An authorised representative; failing any EU operator, the fulfilment service provider for the products it handles	Art. 4(2)(c) and (d), Blue Guide footnote 133
Retailer selling under its own brand	The retailer, as manufacturer	Art. 3(8); RED Art. 14
Non-EU medical device manufacturer	A sole MDR authorised representative is mandatory	MDR Art. 11(1)

For the reference definitions, see the spilma glossary.

See also

• EU declaration of conformity
• GPSR, General Product Safety Regulation
• 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

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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, chapter 3, Publications Office of the European Union eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
3. Commission Notice C(2021) 1461, guidelines on the practical implementation of Article 4 of Regulation (EU) 2019/1020, European Commission ec.europa.eu/docsroom/documents/44908/attachments/2/translations/en/renditions/native
4. Decision No 768/2008/EC on a common framework for the marketing of products (Annex I, Articles R3 to R7), EUR-Lex eur-lex.europa.eu/eli/dec/2008/768/oj
5. Directive 2014/53/EU (RED), Articles 10 to 15, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
6. Regulation (EU) 2023/988 on general product safety (GPSR), Articles 2, 10 to 12, 16, 19 and 22, EUR-Lex eur-lex.europa.eu/eli/reg/2023/988/oj
7. Regulation (EU) 2024/2847 (Cyber Resilience Act), Articles 18 to 21 and 66, EUR-Lex eur-lex.europa.eu/eli/reg/2024/2847/oj
8. Regulation (EU) 2017/745 (MDR), Articles 10 to 15, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
9. Regulation (EU) 2022/2065 on a Single Market for Digital Services (DSA), EUR-Lex eur-lex.europa.eu/eli/reg/2022/2065/oj
10. Directive 2012/19/EU on waste electrical and electronic equipment (WEEE), Article 16, EUR-Lex eur-lex.europa.eu/eli/dir/2012/19/oj
11. Regulation (EU) 2023/1542 on batteries, Article 55, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1542/oj
12. European Commission, market surveillance in the Union, European Commission single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en