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A manufacturer based outside the EU needs an EU authorised representative when no manufacturer or importer established in the Union is responsible for its product; for medical devices, appointing one is always mandatory. If you manufacture in the UK, the US or Asia and want to sell through the Netherlands, this page explains the obligations, the liability risk and what to put in the mandate.
What is an EU authorised representative?
An EU authorised representative is a person or company established in the European Union that a manufacturer has appointed in writing to carry out specific legal tasks on its behalf. The manufacturer stays responsible; the representative is the contact point for the authorities.
That is the definition in Article 3(12) of Regulation (EU) 2019/1020 on market surveillance. Article R1(4) of Decision No 768/2008/EC, the basis of the New Legislative Framework, uses the same definition. The Decision contains model provisions for product legislation (Article 2), so the exact tasks depend on the rules for your product.
When must an economic operator in the EU be responsible?
For many CE-marked products and for consumer products under the GPSR, the rule is the same: the product may only be placed on the market if an economic operator established in the Union is responsible for the statutory tasks for that product.
For CE-marked products the rule is in Article 4(1) of Regulation 2019/1020, which has applied since 16 July 2021 (Article 44). Article 4(5) lists the legislation covered, for example the Machinery Directive 2006/42/EC, the Toy Safety Directive 2009/48/EC, the Low Voltage Directive 2014/35/EU, the EMC Directive 2014/30/EU and the Radio Equipment Directive 2014/53/EU.
For consumer products, Article 16(1) of the General Product Safety Regulation (EU) 2023/988 applies the same system. The GPSR has applied since 13 December 2024. Read more in our guide to the General Product Safety Regulation.
Who can be the responsible economic operator?
The law lists four options: a manufacturer established in the EU, an importer, an authorised representative with a written mandate and, only if none of these is established in the Union, the fulfilment service provider for the products it handles.
The list is in Article 4(2)(a) to (d) of Regulation 2019/1020.
| Situation | Responsible economic operator | Legal basis |
|---|---|---|
| Manufacturer established in the EU | The manufacturer itself | Art. 4(2)(a) |
| Manufacturer outside the EU, importer in the EU | The importer, or an authorised representative appointed by the manufacturer | Art. 4(2)(b) and (c) |
| Manufacturer outside the EU sells directly to EU customers | The authorised representative | Art. 4(2)(c) |
| No manufacturer, importer or authorised representative in the EU | The fulfilment service provider, for the products it handles | Art. 4(2)(d) |
| Medical device, manufacturer outside the EU | Always a single authorised representative; an importer has separate obligations | Art. 11(1) MDR |
If a Dutch distributor buys your goods and places them on the EU market itself, that distributor is the importer (Article 3(9)) and carries the tasks.
What does an EU authorised representative have to do?
The representative checks that the EU declaration of conformity and the technical documentation exist and keeps them available. It answers requests from the authorities, reports risks and cooperates on corrective action.
These four tasks are set out in Article 4(3)(a) to (d) of Regulation 2019/1020. The name, registered trade name or trade mark and contact details, including the postal address, of the responsible operator must appear on the product, its packaging, the parcel or an accompanying document (Article 4(4)). The GPSR also requires an electronic address (Article 16(3)). In addition:
- The representative gives the authority a copy of the mandate on request, in an EU language the authority chooses (Article 5(2)).
- It must have the appropriate means to perform its tasks (Article 5(3)).
- Under the GPSR, it regularly checks the product against the technical documentation and the identification and contact requirements, and shows documented evidence of those checks on request (Article 16(2)).
- A GPSR representative tells the manufacturer about a dangerous product and reports measures through the Safety Business Gateway if the manufacturer has not already done so (Article 10(2)).
Are you about to appoint a representative in the EU, or has an EU distributor offered to take on the role? MAAK Advocaten advises on the role and drafts or reviews the mandate before you sign. Have your EU authorised representative mandate reviewed.
What can a manufacturer not hand over to its representative?
Designing and manufacturing the product in line with the legal requirements stays with the manufacturer, and so does drawing up the technical documentation. Those obligations cannot form part of the mandate.
Model Article R3(1) of Decision 768/2008/EC excludes the obligations in Article R2(1) and the drawing up of technical documentation from the mandate. Article 12(1) of the Machinery Regulation (EU) 2023/1230 does the same. For medical devices, Article 11(4) of Regulation (EU) 2017/745 (MDR) lists the manufacturer’s obligations that the mandate cannot delegate. Your representative checks that the documents exist; it does not write them.
What extra rules apply to medical devices and machinery?
A medical device manufacturer outside the EU must appoint a single authorised representative. The representative accepts the appointment in writing and must end the mandate if the manufacturer breaches the MDR.
That follows from Article 11(1) to (3) MDR. The mandate covers at least all devices of the same generic device group. If it ends the mandate for that reason, it informs the competent authority and, where relevant, the notified body immediately (Article 11(6)). Article 12 MDR requires an agreement when the representative changes.
For machinery, the Machinery Regulation applies from 20 January 2027 (Article 54). The representative must then keep the technical documentation and the EU declaration of conformity available for at least ten years (Article 12(2)(a)). Until that date the Machinery Directive 2006/42/EC applies.
Is an EU authorised representative liable for product damage in the Netherlands?
Dutch product liability law does not currently name the authorised representative. It does treat the importer into the European Economic Area as a producer. For medical devices, the representative can be jointly and severally liable under conditions.
A producer is liable for damage caused by a defect in its product (Article 6:185 of the Dutch Civil Code, BW). Anyone who imports a product into the EEA to supply it in the course of business is treated as a producer (Article 6:187(3) BW). So is anyone who presents itself as the producer by putting its name or mark on the product (paragraph 2). If the importer cannot be identified, every supplier is treated as the producer, unless it names the importer or its own EEA supplier within a reasonable time (paragraph 4). See Book 6 of the Dutch Civil Code (in Dutch).
Under Article 11(5) MDR, the representative is jointly and severally liable with the manufacturer for defective devices if the manufacturer is outside the EU and has not complied with Article 10 MDR.
The new Product Liability Directive (EU) 2024/2853 does name the authorised representative (Article 8(1)(c)(ii)). It is not yet law in force: Member States have until 9 December 2026 to transpose it (Article 22), and it applies to products placed on the market after that date (Article 2(1)). For the current rules, see product liability under Dutch law.
What happens during an NVWA or customs check?
The Netherlands Food and Consumer Product Safety Authority (NVWA) supervises the Dutch Commodities Act and the rules based on it, including the Dutch rules implementing the GPSR. If the responsible operator’s details are missing, a shipment can be stopped at the border.
NVWA officials are charged with that supervision (Article 1 of the Aanwijzing toezichthoudende ambtenaren Voedsel en Waren Autoriteit). The Dutch decree implementing the GPSR (Warenwetbesluit uitvoering verordening algemene productveiligheid) prohibits, among other things, breaches of Article 10(2) and Article 16 GPSR in Article 2(1). Such a breach can lead to an administrative fine under Article 32a of the Commodities Act (Warenwet). Article 3 of that decree requires safety information to be available in Dutch in any case. At the border, the designated authority, such as customs, suspends release for free circulation if the operator’s name and contact details are missing (Article 26(1)(d) of Regulation 2019/1020). The Health and Youth Care Inspectorate (IGJ) supervises medical devices (Article 10 of the Dutch Medical Devices Act).
If you receive a decision, read how to handle a dispute with the NVWA. If a product has to come off the market, see product recall in the Netherlands.
What should the mandate between manufacturer and representative cover?
The mandate must be in writing and allow the statutory minimum tasks. Beyond that, the parties agree how the representative gets information, who pays for corrective action and what happens when the mandate ends.
The law requires written form and the minimum tasks (Article 4(2)(c) and Article 5(1) of Regulation 2019/1020). The table lists contractual points; only where an article is cited is it a legal requirement.
| Topic | What to agree | Statutory link |
|---|---|---|
| Scope | Which products, models and legislation the mandate covers | MDR: at least one generic device group (Art. 11(2)) |
| Technical documentation | Access or delivery within a fixed period | Must be available to the authority on request (Art. 4(3)(a)) |
| Risk information | Manufacturer’s duty to report complaints, accidents and product changes | Representative informs the authority of a risk (Art. 4(3)(c)) |
| Corrective action | Who decides, who carries it out and who pays for a recall | Duty to cooperate (Art. 4(3)(d)) |
| Indemnity and insurance | Indemnity against fines and claims, with proof of insurance | No statutory requirement |
| Term and termination | Notice period and a right to end the mandate at once if the manufacturer breaches its obligations | MDR: termination required (Art. 11(3)(h)) |
| Name on products | Until when the representative’s name may appear and what happens to stock already on the market | MDR: settle on a change (Art. 12(b)) |
| Governing law and forum | Applicable law and competent court | No statutory requirement |
How do you appoint an EU authorised representative?
Start by establishing which legislation applies and whether there is already an importer in the EU. Then record the mandate in writing and adjust the labelling.
- Identify the rules for the product: the list in Article 4(5) of Regulation 2019/1020, the GPSR, the MDR or other legislation.
- Check who places the product on the EU market and whether that party is an importer (Article 4(2)(b)).
- Confirm that the EU declaration of conformity and the technical documentation exist (Article 4(3)(a)).
- Put the mandate in writing, with the minimum tasks and the points from the table.
- For medical devices, have the representative accept the appointment in writing (Article 11(2) MDR).
- Put the representative’s name and contact details on the product, packaging, parcel or an accompanying document (Article 4(4)).
- Set up a fixed channel for complaints, accidents and questions from the authorities.
What does this look like in practice?
The request usually comes from a manufacturer without an EU establishment that sells directly to customers in the Union. Check first that the tasks are workable.
Example: a toy manufacturer from the United Kingdom sells through its own webshop to consumers in the Netherlands. It asks a Dutch wholesaler to act as its authorised representative. Toys are on the list in Article 4(5) of Regulation 2019/1020. The parties agree that the wholesaler receives the technical documentation within a fixed period and that the manufacturer indemnifies it against the costs of a recall. The wholesaler may also end the mandate at once if the manufacturer does not cooperate with an NVWA request.
Facing an NVWA request, goods held at customs or a damages claim? MAAK Advocaten assists manufacturers and representatives in dealings with the Dutch authorities and in liability disputes. Get advice on your EU authorised representative set-up. For an overview of Dutch product rules, see product compliance in the Netherlands and our page on CE marking support in the Netherlands.
Frequently asked questions about the EU authorised representative
Does the EU authorised representative have to be in the Netherlands?
No. The representative must be established in the European Union (Article 3(12) of Regulation 2019/1020), not necessarily in the Netherlands. For medical devices the location does matter: the competent authority of the representative’s Member State acts as the manufacturer’s authority (Article 11(7) MDR).
Can a UK company act as EU authorised representative?
No. The representative must be established within the Union (Article 3(12) of Regulation 2019/1020), and the United Kingdom is not a Member State. A UK group can use a subsidiary or another business established in an EU Member State, provided it has a written mandate.
What happens when the mandate ends?
The product then needs a new responsible economic operator, and new products need new labelling. Articles 4 and 5 of Regulation 2019/1020 do not say what applies to products already on the market, so agree this in the mandate. For medical devices, Article 12 MDR requires a change-over agreement.
Will the authorised representative be liable under the new Product Liability Directive?
Directive (EU) 2024/2853 names the authorised representative of a manufacturer outside the Union as a liable economic operator (Article 8(1)(c)(ii)). Transposition is due by 9 December 2026, and the Directive applies to products placed on the market after that date. Until then, and for earlier products, Articles 6:185 to 6:193 of the Dutch Civil Code apply.
