CECheck The reference for CE marking

Authorised Representative

Last reviewed: October 2026 · Sources listed at the end of this page.

An Authorised Representative is a natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks under EU harmonisation legislation. The role is defined in Article R1, point 4, and Article R3 of Decision No 768/2008/EC. The Authorised Representative does not assume the manufacturer's substantive conformity obligations — the manufacturer remains responsible for the design, manufacture, and conformity assessment of the product. The Representative performs procedural and contact functions on the manufacturer's behalf inside the Union.

Appointing an Authorised Representative is mandatory for non-EU manufacturers under several specific acts (e.g., Article 11 of Regulation (EU) 2017/745 for medical devices). For most acts, it is optional, but in combination with the "economic operator established in the Union" requirement of Article 4 of Regulation (EU) 2019/1020, a non-EU manufacturer that wishes to place products on the EU market without an Authorised Representative must instead rely on an EU importer or a fulfilment service provider to perform the equivalent functions. The Authorised Representative is the route the manufacturer controls directly: it is appointed by the manufacturer specifically for this purpose.

At a glance. An Authorised Representative is an EU-established person acting for a manufacturer under a written mandate. It is mandatory for non-EU manufacturers under the MDR, IVDR and the new Construction Products Regulation, and optional under most other acts, where an importer can fill the EU role instead. It does not replace a Notified Body. Key date: for products placed on the market after 9 December 2026, the new Product Liability Directive makes the representative of a non-EU manufacturer liable for defective products.

Legal basis

Tasks under Article R3

Article R3 of Decision 768/2008/EC sets out the minimum scope of the mandate. The Authorised Representative performs at least:

  1. Keep the EU Declaration of Conformity and the technical documentation at the disposal of national surveillance authorities for the retention period specified by the relevant act (commonly ten years after the product was placed on the market).
  2. Provide the documentation to authorities on reasoned request. The Representative must respond to authorities of any Member State where the product is made available.
  3. Cooperate with the competent authorities, at their request, on any action taken to eliminate the risks posed by products covered by the mandate.

Sectoral acts may extend the minimum. The Medical Devices Regulation extends the Representative's role substantially: under Article 11(3) of MDR, the Representative verifies that the Declaration of Conformity and technical documentation have been drawn up and that the appropriate conformity assessment has been carried out, and handles registration tasks; under Article 11(5), where a non-EU manufacturer has not complied with Article 10, the Representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. The MDR also requires the Representative to terminate the mandate if the manufacturer acts contrary to its obligations (Article 11(3)(h)).

The written mandate

Article R3(1) requires the mandate to be in writing, and Article R3(2) requires it to allow at least the statutory tasks. The Blue Guide (section 3.2) adds that the delegation must be explicit, defining the contents and limits of the tasks. In practice a mandate should:

The mandate must allow the Representative at minimum to perform the Article R3 statutory tasks. Some sectoral acts impose specific mandate contents — e.g., Article 11(3) of MDR lists tasks that must be in the mandate, including verifying conformity, holding documentation, and registration.

The mandate is not registered with any EU authority (with the exception of medical devices, where EUDAMED records the Representative). The Representative must, however, give a copy to market surveillance authorities on request, in a Union language they determine, and must have the appropriate means to fulfil its tasks (Regulation (EU) 2019/1020, Article 5). Where the Representative is the Article 4 operator, its name and contact details must appear on the product, its packaging, the parcel or an accompanying document (Article 4(4)), in addition to the manufacturer's own details.

What the Authorised Representative cannot do

Article R3(1) sets explicit limits. The mandate must not extend to:

The EU Declaration of Conformity is not on the excluded list. The Blue Guide (section 3.2) confirms a mandate may authorise the Representative to draw up and sign the Declaration, and Article 30(1) of Regulation (EC) No 765/2008 allows it to affix CE marking. Such a Declaration is still issued under the manufacturer's sole responsibility and must identify the manufacturer. Some sectoral acts are narrower: under the MDR, for example, drawing up the Declaration is a manufacturer obligation (Article 10(6)) and the Representative's role is to verify it (Article 11(3)). Check the applicable act and record any such authority expressly in the written mandate.

The Representative is the legal contact and procedural agent. It is not the conformity-decision-maker. The Blue Guide 2022 (§3.2) confirms that ultimate responsibility for the product's conformity remains with the manufacturer regardless of any acts the Representative performs.

When appointment is mandatory

For most acts, appointment of an Authorised Representative is optional. The non-EU manufacturer may rely on an EU importer or — for acts in the Article 4 list — a fulfilment service provider, to perform the Union-based functions. The Blue Guide (section 3.2) states the general rule that a manufacturer outside the Union is not obliged to have one. Acts that require appointment include:

Under other acts, such as the PPE Regulation (Article 9) and the Machinery Regulation (Article 12), the manufacturer may choose to appoint a Representative or to rely on an EU importer. The list is not exhaustive: check the act that applies to your product. Where there is no EU importer (for example, in direct e-commerce shipments from a non-EU seller to an EU consumer), the Article 4 obligation can only be met by appointing a Representative or, failing any other EU-established operator, through a fulfilment service provider handling the products (Article 4(2)(d) of Regulation 2019/1020).

Who may act as Authorised Representative

The Representative must be established in the Union — i.e., have a registered address in an EU Member State (or in Iceland, Liechtenstein, or Norway under the EEA Agreement, which is recognised for the purposes of acts adopted under the New Legislative Framework). A natural person or a legal entity may serve. There is no formal qualification or accreditation requirement under most acts, with the notable exception of the medical devices framework, which requires (Article 15 of MDR) that the Representative have a Person Responsible for Regulatory Compliance with specified qualifications, and (Article 15(6)) that the Representative have permanent and continuous availability of such a person.

Several commercial firms specialise in Authorised Representative services for EU market access. Common features:

An "EU address service" without a written mandate to act as Authorised Representative is not sufficient. Article R3 requires a written mandate covering the statutory tasks. A receptionist or mail-forwarding service that has not undertaken to perform Article R3 tasks does not satisfy the requirement, even if it appears on the product label.

Replacement and termination of mandate

The mandate may be terminated by either party. Article 11(3)(h) of the MDR explicitly requires the Representative to terminate the mandate if the manufacturer acts contrary to its obligations under the Regulation. Termination triggers a notification obligation in some acts — e.g., under Article 11(6) of MDR, a Representative terminating on that ground must immediately inform the competent authority of its Member State and, where applicable, the Notified Body, with the reasons; Article 12 of MDR governs a change of Representative. Agree in the mandate who takes over the documentation when the appointment ends.

The manufacturer remains responsible for products placed on the market during the period the previous Representative was in place, but a successor Representative must be in place before further products are placed on the market under acts where appointment is mandatory.

Distinction from other roles

The Authorised Representative is distinct from:

Common errors

Liability and risk

For most acts, the Authorised Representative is liable for performing its statutory tasks under Article R3 and the mandate. Failure to do so may attract national penalties. For medical devices, Article 11(5) of MDR makes the Representative of a non-compliant non-EU manufacturer jointly and severally liable for defective devices.

The position widens for all products placed on the market or put into service after 9 December 2026. Under Directive (EU) 2024/2853, Article 8(1)(c), where the manufacturer is established outside the Union the importer and the authorised representative are each liable for damage caused by a defective product, without prejudice to the manufacturer's liability. Directive 85/374/EEC continues to apply to earlier products. Commercial Representatives commonly address this in the mandate, through indemnities and insurance.

Frequently asked questions

Is an EU Authorised Representative mandatory?

Only under some acts, such as the MDR, the IVDR and the Construction Products Regulation 2024/3110, for manufacturers outside the Union. Under most other CE acts it is optional, but a product under an act listed in Article 4(5) of Regulation 2019/1020 still needs an EU-established operator, which can be an importer.

Can an Authorised Representative sign the Declaration of Conformity?

Generally yes, if the mandate says so, although the Declaration stays under the manufacturer's responsibility. Under the MDR, drawing it up cannot be delegated.

Is a GPSR responsible person the same as an Authorised Representative?

Not automatically. The GPSR role covers consumer products outside harmonised legislation and can be filled by an EU manufacturer, an importer, a mandated authorised representative or, failing those, a fulfilment service provider.

Can my EU distributor act as my Authorised Representative?

Yes, but only with an explicit written mandate. It then has to meet the representative's tasks as well as its own distributor or importer obligations.

Sources

Related on CECheck