EU Authorized Representative: Duties, Mandate, and Labeling

A non-EU manufacturer selling most regulated products into the European Union must appoint an EU authorized representative: a person or company established inside the Union who acts under a written mandate as the regulatory point of contact with market surveillance authorities. The requirement kicks in whenever the manufacturer has no importer of its own established in the EU, and it now covers a wider slice of the consumer market than it did a year ago, because the General Product Safety Regulation took effect on December 13, 2024.

When You Need to Appoint One

Two EU regulations create the appointment requirement, and they overlap.

Regulation (EU) 2019/1020, the Market Surveillance Regulation, covers products governed by EU harmonisation legislation listed in its Annex I. That list is long: aerosol dispensers, outdoor equipment, detergents, fertilizers, in vitro diagnostic medical devices, footwear labeling, motor vehicle noise standards, and dozens more.¹ If a manufacturer covered by any of those directives has no EU-established importer, it must designate an authorized representative before placing product on the market.²

The General Product Safety Regulation (EU) 2023/988 pushes further. Article 16 says consumer products can only be placed on the EU market if a “responsible economic operator” is established in the Union to handle compliance. For a non-EU manufacturer without an EU importer, that means an authorized representative or another qualifying economic operator has to be in place.³

Medical devices and in vitro diagnostics carry a separate, stricter regime under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746, with extra qualifications and registration duties on top of the market surveillance baseline.⁴

How the Role Differs From an Importer or Fulfillment Provider

These three roles get conflated constantly, and the differences matter for who ends up legally liable.

An importer is any EU-based person or entity that places a non-EU product on the EU market. By the act of importing, the importer takes on full compliance responsibility for that product.

An authorized representative acts under a written mandate with a defined scope. The representative does not automatically inherit the importer’s obligations. If the mandate does not name a task, the representative does not have to perform it.

A fulfillment service provider is the fallback. Under Article 4(2)(d) of Regulation 2019/1020, an EU-based fulfillment service provider becomes the responsible economic operator only when no manufacturer, importer, or authorized representative is established in the Union.² The regulation defines a fulfillment service provider as a business commercially offering at least two of the following: warehousing, packaging, addressing, and dispatching products it does not own. If you route product through an EU-based fulfillment warehouse and have no other EU presence, that warehouse can be pulled into your compliance obligations without ever agreeing to them.

Who Can Serve as an Authorized Representative

The representative must be a natural or legal person actually established in the European Union.² Established means a real registered address, not a mail drop or virtual office. The representative needs enough organizational capacity and legal standing to receive formal communications from national authorities, answer information requests, and handle enforcement disputes on the manufacturer’s behalf.

Medical device manufacturers face a stricter standard. Under Article 15 of the Medical Device Regulation, the authorized representative must have permanent access to a Person Responsible for Regulatory Compliance (PRRC). The PRRC needs relevant professional experience or a university degree in a field such as law, medicine, pharmacy, or engineering.⁴ Hiring a general compliance firm without confirming PRRC availability is a common early misstep.

What the Representative Has to Do

Obligations fall into two broad buckets: keeping documentation available, and cooperating actively with authorities. Medical devices add more on top.

Documentation and Record-Keeping

The representative must keep the EU Declaration of Conformity and the technical documentation available for market surveillance authorities. Under the General Product Safety Regulation, the retention period is 10 years from the date the product is placed on the market.³ On a reasoned request from an authority, the representative must supply the information and documentation needed to demonstrate the product’s conformity, in a language the requesting authority can understand.²

Risk Notification and Cooperation

If the representative has reason to believe a product presents a risk, it must notify the relevant market surveillance authority. It must also cooperate with enforcement, including corrective action to address non-compliance or reduce risk. Under the GPSR, the responsible economic operator has an ongoing duty to regularly verify that products still match the manufacturer’s technical documentation, carry the required identification markings, and include safety information in a language consumers can understand.³

For medical devices, the representative must notify the manufacturer immediately upon receiving reports of incidents or complaints from healthcare providers and patients, and must independently verify that the manufacturer has registered the required information in the EUDAMED database.⁴ The first four EUDAMED modules, covering actor registration, device registration, notified bodies and certificates, and market surveillance, become mandatory on May 28, 2026.⁵

The Written Mandate and Technical File

The relationship starts with a written mandate. This document defines which tasks the representative will perform and the limits of its authority. A vaguely drafted mandate creates ambiguity about who is responsible when regulators arrive, so precision here pays off.

The manufacturer has to give the representative a complete technical file: design specifications, risk assessments, test reports, the EU Declaration of Conformity, and samples of product labeling and instructions.² The representative uses those materials to check that the manufacturer has met the applicable safety requirements before market entry.

Translation is a practical cost to plan for. The EU Declaration of Conformity must be translated into the language required by each member state where the product is sold.⁶ Rules vary. Germany requires German, France requires French, while countries including Denmark, Estonia, and Croatia accept English alongside the national language for medical devices.⁷ Assuming English will suffice across Europe is one of the more expensive mistakes to unwind after the fact.

Labeling With the Representative’s Details

Under Article 4(4) of Regulation 2019/1020, the name, registered trade name or trademark, and contact details of the responsible economic operator, including a postal address, must appear on the product itself, its packaging, the parcel, or an accompanying document.² Customs officials and consumers both need a way to see who is accountable inside the EU.

The GPSR adds a further layer for consumer products. The product must carry a type, batch, or serial number for identification, plus the manufacturer’s name and both postal and electronic contact information.³ Products must also include clear safety information and instructions in a language consumers in the destination country can understand, unless the product can be used safely without any documentation.

Steps to Get One in Place

Identify a person or entity established in the EU with the capacity to handle your product category. For medical devices, confirm they have access to a PRRC.
Negotiate and sign the written mandate. Both parties execute it, and the signature confirms the representative accepts the legal obligations attached to your products.
Transfer the complete technical file, EU Declaration of Conformity, and labeling and instruction samples.
Update product labeling with the representative’s name and contact details before shipping to the EU market.²
Register in any applicable databases. For medical devices, the representative registers the manufacturer’s products in EUDAMED.⁵

After registration, the representative stays actively responsible for fielding requests from customs officials and national authorities. Keep the technical file current as regulations evolve; that is a manufacturer job, not a representative job.

Switching Representatives Without a Gap

Changing representatives requires a structured handoff. Under Article 12 of the Medical Device Regulation, the transition should involve a clear agreement between the manufacturer, the incoming representative, and where practicable the outgoing representative. That agreement needs to cover:

The exact date the outgoing mandate ends and the incoming mandate begins.
How long the outgoing representative’s information may still appear on products and materials already in circulation.
How technical files, including confidential and proprietary materials, will be handed over.
The outgoing representative’s duty to forward any complaints or incident reports received after termination to the manufacturer or the incoming representative.

The risk sits in any gap between the two mandates. If the old one terminates before the new one is active, the product is on the market without a responsible economic operator, and enforcement authorities treat that the same as never having appointed anyone.

What Happens If You Skip It

Failing to appoint an authorized representative when required can result in products being stopped at customs or pulled from the EU market.² Financial penalties exist, but they are not standardized. Under Article 41(3) of Regulation 2019/1020, each member state sets its own penalties for non-compliance and notifies the European Commission, which publishes an overview.⁸ A manufacturer selling across several EU countries is exposed to several penalty regimes at once, so check with the market surveillance authority in each country where the product is sold.

The UK Is a Separate Appointment

An EU authorized representative has no standing in Great Britain, and a UK-based representative is no longer recognized in the EU. Manufacturers selling in both markets need two separate appointments. For the Great Britain market, non-UK manufacturers of medical devices must appoint a UK Responsible Person (UKRP), who registers the manufacturer’s devices with the MHRA, keeps technical documentation available for inspection, cooperates with enforcement, and ensures the manufacturer’s name and address appear on the product labeling.⁹ Former EU-authorized representative accounts that were not converted to UKRP accounts face closure if not updated by March 30, 2026.

1
UK Legislation. Regulation (EU) 2019/1020 – Annex I
2
EUR-Lex. Regulation (EU) 2019/1020 of the European Parliament and of the Council
3
GOV.UK. EU Regulation 2023/988 on General Product Safety
4
European Commission. Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and In Vitro Diagnostic Medical Devices
5
European Commission. EUDAMED Four First Modules Will Be Mandatory to Use as From 28 May 2026
6
Your Europe. Signing an EU Declaration of Conformity
7
European Commission. Medical Devices MDR – Language Requirements for Manufacturers
8
European Commission. Market Surveillance for Products
9
GOV.UK. Regulating Medical Devices in the UK