EU Authorised Representative and the Article 4 Responsible Person

What does Article 4 of Regulation (EU) 2019/1020 require?

Regulation (EU) 2019/1020 on market surveillance and compliance of products has applied since July 2021. Its Article 4 covers products under a list of EU laws. The list includes machinery, low voltage, electromagnetic compatibility (EMC), radio equipment, RoHS and several others.

For these products, there must be an economic operator established in the EU who is responsible for certain compliance tasks. If you are a manufacturer established outside the EU, you cannot fill this role yourself. Someone inside the EU must do it.

The name and contact details of that operator must be visible. They can be on the product, its packaging, the parcel or an accompanying document. If they are missing, customs must suspend release for free circulation and notify the market surveillance authority. A small labelling gap can therefore stop a whole shipment at the border.

For consumer products, the General Product Safety Regulation (GPSR), Regulation (EU) 2023/988, also requires an economic operator in the EU, and online listings must show this information. The GPSR course covers those rules.

Who can act as the EU responsible person?

EU law gives each link in the supply chain a name and a set of duties. The rules come from Decision No 768/2008/EC and Regulation (EU) 2019/1020. For a non-EU manufacturer, the Article 4 role can be filled in four main ways.

Each option fits a different business model. An importer is often the natural choice when you sell through a European distributor. An authorised representative does not buy or sell your product, so it can act for you whoever your EU customers are. Many fulfilment companies do not want the Article 4 role, so do not assume they will accept it. A subsidiary gives you control, but it needs people who understand compliance.

What are the Article 4 tasks?

Whatever option you choose, Article 4 gives the responsible operator four tasks:

1. Verify that the EU declaration of conformity and the technical documentation exist. Keep the declaration available to authorities, and make sure the technical documentation can be provided on request.
2. After a reasoned request, provide the information and documents needed to show conformity, in a language the authority understands.
3. Inform the authorities when it has reason to believe that a product presents a risk.
4. Cooperate with the authorities, including on corrective action.

Market surveillance authorities usually start with a request for documents. This is why your EU partner must be able to reach your file quickly. If your documents are spread over different systems and suppliers, test how long it really takes to put them together.

What an authorised representative can and cannot do

An authorised representative is a person or company established in the EU, appointed by a written mandate. Decision No 768/2008/EC sets the minimum tasks the mandate must allow:

• keeping the EU declaration of conformity and the technical documentation at the disposal of national authorities for the required period, usually 10 years
• providing authorities with the information and documents that show conformity, after a reasoned request
• cooperating with authorities, at their request, on any action to remove the risks posed by products covered by the mandate

The authorised representative may also affix the CE marking on your behalf. Importers and distributors may not.

There are limits. Under the rules of Decision No 768/2008/EC, which most product laws follow, the authorised representative cannot take over your duty to design and build the product in conformity with the essential requirements. It cannot draw up the technical documentation for you either. These duties stay with the manufacturer. A mandate gives you a reliable contact point in the EU. It does not move your responsibility to someone else.

Read the mandate carefully. It should state clearly which product lines and which laws it covers. For machinery under Directive 2006/42/EC, the declaration of conformity also names the person authorised to compile the technical file, who must be established in the EU. Agree with your partner whether it takes on that role.

Importer or authorised representative: the main differences

An importer is the EU company that places a product from a non-EU country on the EU market. Before doing so, it must check that you carried out the conformity assessment, that the technical documentation exists, that the product bears the CE marking with the required documents, and that your name and address are on it. It adds its own name, registered trade name and postal address, and keeps a copy of the declaration for 10 years. It must not place a product on the market if it believes the product does not conform. A good importer will ask you questions before the first order.

Watch for one trap. An importer or distributor becomes the manufacturer, with all the manufacturer's duties, if it sells the product under its own name or trademark, or modifies it in a way that may affect compliance. If your EU buyer plans to rebrand your product, both sides need to understand who is the manufacturer.

When the importer is also the Article 4 operator, one entry on the label may cover both roles. Plan the space on your data plate or label early, so the product does not need relabelling after arrival.

How to choose and brief an EU partner

Before you sign, check that your partner exists and can do the job:

• Look up the company in the national business register and check its VAT number.
• Make sure the address is a real office where letters and authority requests are received.
• Ask who will handle your file and whether they understand your type of product.
• Ask which other manufacturers they represent, and whether they hold product liability insurance where relevant.

Your partner can only do its tasks with the right material. The CE Marking Fundamentals course includes a checklist for choosing and briefing an EU partner. Send the signed EU declaration of conformity for each product and each version. Agree how they will get the technical documentation when an authority asks: some partners want a full copy, others accept fast access on request. Send the label and the instructions in every language you will use. Then agree the practical details: your technical contact, your response time, and how you will handle a complaint or a safety problem together. Keep your partner updated whenever the declaration changes.

Being close to the EU does not remove the requirement. Turkey, for example, forms a customs union with the EU and applies aligned product legislation, but a Turkish manufacturer still needs an EU-established responsible operator for the listed laws. The wider route, from applicable laws to labels, is set out in our guide to CE marking requirements, and the documents your partner must hold are covered in our guides to the technical file and the EU declaration of conformity.

Key points

• For products under the laws listed in Article 4, an economic operator established in the EU must be responsible for compliance tasks.
• That operator can be an importer, an authorised representative, a fulfilment service provider in limited cases, or your own subsidiary acting as importer.
• An authorised representative needs a written mandate covering at least three minimum tasks.
• Under the rules of Decision No 768/2008/EC, design duties and drawing up the technical documentation stay with the manufacturer.
• The operator's name and contact details must appear on the product, packaging, parcel or an accompanying document.