Authorised Representative EU: What Non-EU Manufacturers Need to Know Before Selling into Europe

If you manufacture products outside the European Union and want to sell them in the EU market, you almost certainly need an authorised representative EU. This single requirement catches thousands of non-EU manufacturers off guard each year — either delaying market entry or, worse, resulting in products being pulled from sale.

This guide explains exactly what an EU authorised representative is, when you legally need one, how to appoint them correctly, and what mistakes to avoid. Whether you’re a manufacturer in China, the US, UK, or anywhere outside the EU, understanding this requirement is foundational to your CE marking strategy.

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What Is an EU Authorised Representative?

An authorised representative EU (often abbreviated as AR or EU AR) is a natural or legal person established within the European Union who a non-EU manufacturer formally designates to act on their behalf regarding specific regulatory obligations.

Think of it this way: EU product legislation requires someone physically present in the EU to take legal responsibility for a product’s compliance. When you’re based outside the EU, you cannot fill that role yourself. Your authorised representative steps into that position.

The AR is not a distributor, not a freight forwarder, and not just a contact address. They are a legally accountable entity whose details appear on your product documentation and, in many cases, on the product itself.

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When Is an EU Authorised Representative Required?

The requirement appears across virtually all major EU product legislation. If your product falls under any of the following directives or regulations, you will need an AR:

• Machinery Directive 2006/42/EC (and the incoming Machinery Regulation (EU) 2023/1230)
• Low Voltage Directive (LVD) 2014/35/EU
• Radio Equipment Directive (RED) 2014/53/EU
• Medical Device Regulation (MDR) (EU) 2017/745
• In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746
• General Product Safety Regulation (GPSR) (EU) 2023/988, which came into full effect in December 2024
• Toy Safety Directive 2009/48/EC
• Personal Protective Equipment Regulation (EU) 2016/425
• Pressure Equipment Directive (PED) 2014/68/EU
• Construction Products Regulation (EU) 305/2011

The General Product Safety Regulation deserves special mention here. Unlike many sector-specific directives, the GPSR has broad horizontal scope and requires non-EU manufacturers (or, where applicable, their importers) to designate a responsible person in the EU — a role that closely mirrors the traditional authorised representative requirement.

As a rule of thumb: if your product requires CE marking and you’re based outside the EU, you need an authorised representative.

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What Does an EU Authorised Representative Actually Do?

The specific duties of an AR vary slightly between directives, but the core responsibilities are consistent:

Registration and documentation tasks:

• Registering the product or manufacturer in EU databases (for example, EUDAMED for medical devices, or EPREL for energy-related products)
• Holding a copy of the Declaration of Conformity (DoC) and technical documentation for a minimum period — typically 10 years after the last product was placed on the market
• Providing technical documentation to market surveillance authorities upon request

Cooperation with authorities:

• Acting as the point of contact for national market surveillance authorities (MSAs) and customs officials
• Forwarding requests from authorities to the manufacturer and ensuring a timely response
• Notifying the manufacturer of any safety issues, complaints, or enforcement actions

Compliance oversight:

• Verifying that the CE marking and Declaration of Conformity have been correctly drawn up before products are placed on the market
• In some frameworks (particularly medical devices under MDR), the AR shares significant liability alongside the manufacturer

It is important to understand that an authorised representative does not take on responsibility for product design or manufacturing quality. Their liability centres on the regulatory and documentation obligations assigned to them under the relevant legislation.

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How to Appoint an EU Authorised Representative: Step-by-Step

Step 1: Confirm Which Directives Apply to Your Product

Before appointing anyone, identify every EU directive or regulation your product must comply with. A single product can fall under multiple frameworks simultaneously — for example, a powered industrial machine might need to comply with both the Machinery Directive 2006/42/EC and the Low Voltage Directive 2014/35/EU.

Each applicable directive may have its own AR requirements, documentation obligations, and timelines.

Step 2: Find a Qualified Authorised Representative

Your AR must be a natural or legal person established in the EU — meaning they have a registered office or place of business in an EU member state. Being established in the EEA (Norway, Iceland, Liechtenstein) does not satisfy the requirement for EU-specific legislation, though it may satisfy EEA-specific rules.

Look for an AR who:

• Has demonstrable experience with your product category
• Understands the specific directives relevant to your product
• Is registered as a business entity in an EU member state
• Can provide references or evidence of existing AR mandates
• Has clear processes for handling market surveillance authority requests

There are specialist AR service providers across the EU — particularly in Germany, the Netherlands, Ireland, and Belgium — who offer these services commercially. Costs typically range from a few hundred to several thousand euros per year depending on the product risk level and regulatory complexity.

For medical devices, the requirements are significantly more demanding. Under MDR (EU) 2017/745, the AR must register in EUDAMED and takes on a level of co-responsibility that many standard AR providers are not equipped to handle. Specialist medical device ARs are essential in this space.

Step 3: Draft and Sign a Written Mandate

The appointment must be formalised in writing. This written mandate (sometimes called an AR mandate or authorised representative agreement) should clearly specify:

• The identity of the manufacturer and the AR
• The products covered by the mandate
• The directives or regulations under which the AR is appointed
• The specific tasks and responsibilities delegated to the AR
• Obligations on the manufacturer to keep the AR informed and provide documentation
• Duration and termination conditions
• Governing law and jurisdiction

Several directives explicitly require this written mandate. For example, Article 12 of the Machinery Directive 2006/42/EC states that the authorised representative must be established by a written mandate. The MDR goes further, specifying minimum content requirements for the mandate in Article 11.

Do not rely on informal arrangements or email exchanges. A formal, signed contract protects both parties and is a document that market surveillance authorities may request to see.

Step 4: Update Your Technical Documentation and Declaration of Conformity

Once appointed, your AR’s name and EU address must appear in your technical documentation and on the Declaration of Conformity. Under many directives, these details must also appear on the product label, packaging, or in accompanying documentation.

The AR’s EU address — not the manufacturer’s non-EU address — is what must appear on the CE marking documentation. This is what gives EU customs and market surveillance authorities a legitimate point of contact within the union.

Step 5: Establish an Information Flow Between Manufacturer and AR

The AR can only do their job if they have the information they need. Establish clear processes for:

• Sending updated technical files when products change
• Notifying the AR of any safety incidents or product recalls
• Providing responses to authority inquiries within agreed timeframes
• Alerting the AR before placing new product variants on the market

This operational relationship is as important as the legal documentation. An AR who cannot access accurate, up-to-date product information is an AR who cannot properly fulfil their duties — creating compliance risk for everyone involved.

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The UK: A Common Point of Confusion

Since Brexit, the United Kingdom is no longer part of the EU. An EU authorised representative established only in the UK does not satisfy EU requirements. Conversely, the UK’s UKCA marking regime has its own UK Responsible Person requirement for non-UK manufacturers — a parallel but separate obligation.

If you sell in both the EU and the UK, you need two separate representatives: one for the EU and one for the UK. Some service providers offer combined EU AR and UK Responsible Person packages, which can simplify administration.

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Common Mistakes Non-EU Manufacturers Make

Using a Distributor or Importer as a Stand-In

Importers and distributors have their own obligations under EU law, but they are not the same as an authorised representative unless they have been formally appointed in writing with a proper mandate. An importer’s address on a product label does not automatically make them your AR.

Assuming One AR Covers All Products

An AR mandate is typically product-specific and directive-specific. If you add new products or product variants, or if a new directive applies, you may need to update your mandate or appoint an AR separately for that regulatory framework.

Failing to Update Documentation After Appointment

Appointing an AR but then continuing to circulate old versions of the Declaration of Conformity — ones that show only the manufacturer’s non-EU address — is a compliance failure. All documentation must be updated to reflect the AR’s details before products are placed on the EU market.

Choosing an AR Based on Price Alone

Cheap AR services may lack the expertise, insurance, or infrastructure to properly respond to a market surveillance inquiry. If your product is recalled or investigated and your AR cannot produce the technical documentation or respond coherently to authorities, the consequences fall on everyone involved — including potential enforcement action.

Neglecting the Mandate Renewal and Termination Process

If your relationship with an AR ends, you must appoint a new one before the old mandate expires. There cannot be a gap in AR coverage while your products are on the EU market. Similarly, when an AR mandate is terminated, the AR typically has obligations to hand over documentation to the new AR or back to the manufacturer.

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Frequently Asked Questions

Q: Can I appoint a natural person (an individual) as my EU authorised representative, rather than a company?

Yes, EU legislation permits both natural persons and legal persons to serve as ARs, provided they are established in the EU. However, using a company rather than an individual provides more stability — an individual AR who falls ill, retires, or changes circumstances creates continuity problems. Most commercial AR services are legal entities.

Q: Does my EU authorised representative need to be in the same country where I sell my products?

No. An AR established anywhere in the EU can cover you for the entire EU market. You do not need a separate AR in each member state. A single AR based in, say, the Netherlands covers your CE marking obligations across all 27 EU member states.

Q: What happens if I place products on the EU market without an authorised representative?

Market surveillance authorities in EU member states have the power to require product withdrawal, issue fines, and prohibit further sale. Customs authorities can also block imports at the border. Under the GPSR, the absence of a responsible person is explicitly identified as a compliance failure that triggers enforcement action.

Q: How long must the technical documentation be kept, and who is responsible for keeping it?

Most CE marking directives require technical documentation to be retained for 10 years from the date the last unit of the product was placed on the market (some directives specify different periods). While the manufacturer is ultimately responsible for the documentation, the AR must be able to provide it to authorities on request — meaning they need access to the full, current technical file throughout this period.

Q: Can my EU subsidiary or branch office act as my authorised representative?

Yes, if you have a subsidiary or branch that is legally established in the EU, it can act as your AR. This is common for larger manufacturers. The formal mandate must still be in place, and the subsidiary must be capable of fulfilling the regulatory obligations — it cannot simply be a sales office with no compliance capacity.

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Conclusion: Getting Your EU Authorised Representative Right from the Start

Appointing an authorised representative EU is not a bureaucratic formality to work around — it is a fundamental legal requirement that forms part of your CE marking compliance infrastructure. Getting it right means having a qualified, properly mandated representative in place before your products enter the EU market, with documentation that accurately reflects their role and EU contact details on every relevant certificate and label.

The consequences of getting it wrong — delayed shipments, market surveillance investigations, forced product withdrawals — are expensive and avoidable. The steps are clear: confirm your applicable directives, select a qualified AR, formalise the mandate in writing, update your documentation, and maintain an active information relationship with your AR.

For non-EU manufacturers who are new to CE marking, the regulatory landscape can feel overwhelming. There are multiple directives, detailed documentation requirements, specific standards to meet, and now the added layer of ensuring your AR arrangement is correctly structured.

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