Authorised Representative
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 cleanest mechanism: it is appointed by the manufacturer specifically for this purpose.
Legal basis
- Decision No 768/2008/EC, Article R1(4) (definition) and Article R3 (mandate and tasks). The Decision is incorporated by every sectoral act.
- Regulation (EU) 2019/1020, Article 4 — the Authorised Representative is one of the operators that may serve as the "economic operator established in the Union" for the 18 listed acts.
- Sectoral provisions — particularly Article 11 of Regulation (EU) 2017/745 (MDR), which makes appointment of an Authorised Representative mandatory for non-EU manufacturers; equivalent provisions in Article 11 of Regulation (EU) 2017/746 (IVDR), Article 11 of Regulation (EU) 2023/1230 (Machinery), and Article 13 of Regulation (EU) 2016/425 (PPE).
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:
- 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 from the last unit placed on the market).
- Provide the documentation to authorities on reasoned request. The Representative must respond to authorities of any Member State where the product is made available.
- 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 manufacturer has drawn up the Declaration of Conformity and the technical documentation, has performed conformity assessment, and is registered in EUDAMED; under Article 11(5), the Representative is jointly and severally liable with the manufacturer for defective devices, subject to the conditions in Council Directive 85/374/EEC. The Machinery Regulation 2023/1230 requires the Representative to terminate the mandate if the manufacturer acts contrary to obligations (Article 11(4)).
The written mandate
Article R3(2) requires the mandate to be in writing. The mandate must:
- Identify the manufacturer and the Authorised Representative;
- Identify the products covered (by category, range, model, or other clear specification);
- List the tasks the Representative undertakes;
- Be signed by both parties.
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 cooperating with EUDAMED registration.
The mandate is not registered with any EU authority (with the exception of medical devices, where EUDAMED records the Representative). It must, however, be available on reasoned request to market surveillance authorities. The Representative's name and address must appear on the product or its packaging or accompanying documents (Article R3(3)), alongside or instead of the manufacturer's where the manufacturer is non-EU.
What the Authorised Representative cannot do
Article R3(4) sets explicit limits. The mandate must not extend to:
- Designing and manufacturing the product. These remain the manufacturer's responsibilities and cannot be delegated.
- Drawing up the technical documentation. The Representative holds the file but does not author it. The manufacturer compiles the file; the Representative may receive, store, and produce it on request.
- Drawing up and signing the EU Declaration of Conformity. This is the manufacturer's responsibility. (Some acts allow the Representative to sign the Declaration on the manufacturer's behalf, but only under explicit sectoral provision and within the bounds of the written mandate — for example, Article 11 of MDR does not transfer Declaration responsibility, while certain interpretations under Directive 2014/35/EU allow signature by the Representative if the mandate so provides.)
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. Acts in which appointment is mandatory in 2026:
- Medical Devices Regulation (EU) 2017/745, Article 11(1) — for non-EU manufacturers of devices made available on the EU market.
- In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, Article 11(1) — equivalent obligation.
- PPE Regulation (EU) 2016/425, Article 9 — required where a non-EU manufacturer wishes to use an Authorised Representative; not mandatory in itself but typically the practical route to EU market access.
- Construction Products Regulation (EU) 2024/3110, Article 17 — for non-EU manufacturers, formal Authorised Representative recommended but not strictly mandatory; the practical effect of Article 4 of Regulation 2019/1020 makes some form of EU-based operator essential.
- Cosmetics Regulation (EC) No 1223/2009 requires a Responsible Person inside the Union (Article 4) — analogous to but not formally the same as an Authorised Representative; cosmetics are outside the CE system.
For acts not in the above list, the manufacturer may choose to appoint a Representative or to rely on an EU importer. 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 by registering a fulfilment service provider under the GPSR.
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 11(2)(b)) 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:
- Provision of an EU contact address that appears on the product;
- Receipt and storage of technical documentation under formal mandate;
- Response to market surveillance requests on the manufacturer's behalf;
- Liaison on incident reporting where required by the act.
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(4) of the Machinery Regulation 2023/1230 explicitly requires the Representative to terminate the mandate if it finds the manufacturer is acting contrary to its obligations under the Regulation. Termination triggers a notification obligation in some acts — e.g., under Article 11(6) of MDR, the manufacturer must inform the competent authority and Notified Body of termination and the reasons. The departing Representative must transfer documentation to the manufacturer, the new Representative, or — where appropriate — directly to the competent authority.
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:
- EU Importer (importer obligations): the first economic operator to place the product on the EU market. The importer may, in principle, also be the Authorised Representative, but only if appointed in writing for that purpose. Default importer status does not confer Representative status.
- Distributor (distributor obligations): a downstream operator selling the product on the EU market. Distributors do not perform Representative functions.
- "Person responsible" under GPSR (Regulation 2023/988), Article 16 — for consumer products in GPSR's scope, the responsible person performs functions overlapping with the Authorised Representative but extending to GPSR-specific obligations (incident reporting, distance-selling traceability).
- "Person Responsible for Regulatory Compliance" under MDR, Article 15 — a qualified individual within either the manufacturer or its Representative, with specific personal duties for ensuring compliance.
Common errors
- Mail-forwarding service without a written mandate. An EU postal address printed on the product without a written mandate from the manufacturer is not an Authorised Representative within the meaning of Article R3. Authorities increasingly check for the mandate, particularly under MDR.
- Mandate not covering all products placed on the market. A mandate specifying particular product categories does not cover others not listed. Manufacturers extending their EU offering must extend the mandate.
- Authorised Representative not on the product. Article R3(3) requires the Representative's name and address to be on the product, packaging, or accompanying documents. Omission is a documentary infringement.
- Authorised Representative without access to the technical documentation. The Representative must hold the documentation or have immediate access to it. A Representative that has to ask the non-EU manufacturer to send the file when authorities request it does not satisfy Article R3(1).
- Single Representative for an unmanageable product range. Some service-provider Representatives represent thousands of products with limited capacity to perform real verification. Where the act imposes verification duties on the Representative (most clearly under MDR), this becomes a substantive deficiency.
- Confusing Authorised Representative with UK Authorised Representative. Since 1 January 2021, the UK has its own equivalent — the "UK Responsible Person" for medical devices, the "UKCA Authorised Representative" for products under the UKCA scheme. These are not interchangeable with the EU Authorised Representative.
- No Representative for Article-4-listed acts. A non-EU manufacturer that has not appointed a Representative and has no EU importer leaves the product without an EU-based responsible operator. Marketplace listings without such an operator are subject to removal under the Digital Services Act and GPSR enforcement.
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 administrative penalties. For medical devices, Article 11(5) of MDR makes the Representative jointly and severally liable with the manufacturer for defective devices, subject to product liability rules — this is the strongest form of Representative liability in EU law. Commercial Representatives typically require indemnification from manufacturers and may carry their own liability insurance.