In This Article
- EU Authorised Representatives must be based in the European Union and mandated by non-EU manufacturers.
- Importers bear legal responsibility for ensuring conformity and correct documentation upon entry into the EU.
- Both roles have distinct obligations but must collaborate effectively to meet regulatory requirements.
- Proper labelling and traceability are mandatory for market access under CE and GPSR regulations.
- Choosing the right compliance model is essential to minimise liability and ensure smooth operations.
Understanding the EU Authorised Representative Role
Who are EU Authorised Representatives?
An EU Authorised Representative is a natural or legal person established within the European Union who has received a written mandate from a non-EU manufacturer to act on their behalf regarding specific tasks under EU product legislation. This is a mandatory compliance function for manufacturers based outside the EU intending to market certain regulated products—including medical devices, machinery, and electronics—within the internal market. The role ensures that these products fulfil all relevant EU regulatory requirements, even in the absence of the non-EU manufacturer.
The Role of Importers in EU Compliance
How Importers Differ from Authorised Representatives
Importers serve an entirely different function from that of an EU Authorised Representative. While the authorised representative is a delegate of the non-EU manufacturer, the importer brings products into the EU economic zone and takes legal ownership of the goods. Consequently, importers are responsible for ensuring that the products comply with EU legislation and hold the correct conformity documentation, including the EU Declaration of Conformity and technical files. Notably, importers must also ensure that the name and address of the EU Authorised Representative are clearly indicated on the product or its packaging.
“Understanding who holds what responsibility—between the EU Authorised Representative and the importer—can protect your business from regulatory fines and product re-calls.”
Compliance Layers in the EU Market
To navigate the European Union’s multifaceted regulatory framework effectively, it’s crucial to understand the layered nature of compliance. All economic operators—including manufacturers, EU Authorised Representatives, importers, and distributors—have specific roles. These roles are clearly outlined in several core EU regulations, such as the General Product Safety Regulation (GPSR), the Medical Device Regulation (MDR), and the Machinery Directive.
The authorised representative and importer must operate in tandem, although their duties do not overlap. For example, the EU Authorised Representative ensures that the manufacturer’s technical documentation is available and responds to requests from national competent authorities. Meanwhile, the importer conducts due diligence, confirms proper labelling, and retains transport documentation for inspection.
How GPSR and CE Marking Apply to Importers and ARs
The General Product Safety Regulation (GPSR) ensures that only safe products enter the EU market. When it comes to compliance with this regulation, both importers and EU Authorised Representatives have key but distinct responsibilities. The importer must verify that products are safe and complaint prior to import and that each carries the correct CE marking where applicable.
EU Authorised Representatives, on the other hand, do not physically handle the products but must ensure that conformity assessments have been conducted appropriately. Essentially, while importers are responsible for the physical entry and ensuring the availability of regulatory markings, the authorised representative holds a more regulatory oversight role.
Differences Under the MDR Framework
Under the Medical Device Regulation (EU) 2017/745, which came into force in May 2021, the distinction between importers and EU Authorised Representatives becomes even more pronounced. The MDR imposes specific, formal obligations on both parties. The EU Authorised Representative, for instance, must verify that the Declaration of Conformity and the technical documentation have been drawn up, and that the manufacturer has complied with the registration obligations.
Additionally, the authorised representative acts as the contact point for authorities and must be prepared to participate in post-market surveillance and vigilance activities. Importers, alternately, must ensure that each device they import is compliant and that the necessary documentation and labelling is present. This dual approach is part of broader regulatory objectives aimed at enhancing traceability and reinforcing the accountability of all economic operators.
Labelling & Traceability Responsibilities
Product labelling and traceability form core aspects of EU regulatory compliance. Importers are legally obligated to include their name, address, and contact details on the product packaging. Moreover, any EU Authorised Representative associated with the product must also be clearly identified on the packaging or user manual, particularly for regulated sectors like medical devices and radio equipment.
The EU Authorised Representative is not usually responsible for physical labelling; however, they need to verify that proper labelling exists and is maintained. In event of non-compliance, the authorised representative may be required to cooperate with regulatory bodies to manage recalls, initiate corrective actions, or halt sales. Regulatory authorities rely on the representative to access crucial documentation promptly.
When to Appoint an Authorised Representative
Non-EU manufacturers are required to appoint an EU Authorised Representative if their product falls under one of many CE-marked categories, including medical devices, machinery, PPE, and construction products. This requirement is non-negotiable; without an appointed authorised representative based within the EU, products cannot legally enter the market under most regulatory frameworks. Learn more about EU Product Compliance & Responsible Person Roles
The appointment should be formalised in a clearly defined “mandate” detailing the responsibilities transferred to the EU Authorised Representative. This document forms a legal basis for responsibility sharing and needs to survive regulatory scrutiny. Moreover, the choice must not be taken lightly, as the actions of the AR can legally impact the manufacturer.
Importer Duties Under New Safety Regulations
In recent years, regulatory reforms such as the updated GPSR and Ecodesign for Sustainable Products Regulation (ESPR) have elevated the duties of importers. Now, importers are not only required to verify product conformity but also expected to monitor compliance over time. They may be held accountable for placing non-compliant products on the market—even where the fault lies with the original manufacturer.
Given this increased responsibility, importers must implement rigorous internal controls and compliance processes. This includes maintaining robust documentation systems, performing random sampling where applicable, and cooperating with surveillance activities. The integration of digital product passports may eventually become mandatory, necessitating deeper collaboration between importers, EU Authorised Representatives, and authorities. Official EU guidance on Authorised Representatives & Importers
Common Myths Between ARs and Importers
A persistent myth is that an importer can also serve as the EU Authorised Representative without any conflict of interest. While it’s legally possible, it is often not advisable due to potential liability overlaps. Holding both roles could create risks in maintaining objectivity or result in operational confusion regarding who is answerable for what.
Another common misconception is that the AR is accountable for product defects or malfunctions. In reality, unless they have taken additional responsibilities beyond regulatory liaison, that liability remains with the manufacturer. It is essential to understand that both roles are not interchangeable—they are complementary and should be treated as distinct entities within a compliance framework.
Choosing the Right Compliance Strategy for Your Product
Effective compliance begins with a clear understanding of your product’s regulatory classification. Once classification is determined, businesses must evaluate their distribution model and select a competent EU Authorised Representative that can engage fluently with regulators and supply necessary documentation on demand.
It’s equally important to vet importers properly. They should have a transparent record-keeping system, familiarity with EU laws, and the capacity to carry out post-market obligations. Collaborative relationships and shared compliance platforms can optimise workflows and minimise legal exposure. Engaging a compliance consultancy or digital platform might further enhance accountability. Read a related article
Conclusion: Navigating Responsibility
In conclusion, while both the importer and EU Authorised Representative are vital to placing and maintaining compliant products within the EU market, the roles are technically and legally distinct. The importer is primarily concerned with physical logistics, documentation, and immediate conformity assessments. Conversely, the EU Authorised Representative liaises directly with EU regulatory bodies on behalf of the non-EU manufacturer and maintains records and declarations for inspection. Navigating this shared landscape of responsibility demands an expert-led, strategic approach. Aligning all actors with their specific compliance obligations is the safest and most effective way to ensure product success within the EU.
Great guide on what-is-the-difference-between-an-authorised-representative-and-an-importer-interactive-compares-the-roles-of-eu-authorised-representatives-and-importers-outlining-responsibility-layers-in-produc – Community Feedback
What is an Authorised representative in the EU?
A European Authorised Representative (E.A.R.) acts as a legal entity appointed by non-EU manufacturers to represent them and ensure compliance with relevant EU Directives. This representative facilitates communication with authorities and manages regulatory documentation.
What is the difference between distributor and importer in EU MDR?
An importer is the first entity bringing a product from a non-EU country into the EU market, while a distributor further supplies the product within the EU after this action has occurred. The role is determined for each individual device and not by product type.
What is the role of Authorised representative?
An Authorised Representative is responsible for ensuring and declaring product compliance with EU requirements, affixing the CE marking, and acting as a liaison point with EU authorities. Their duties can vary depending on the specific directive or regulation.
What is the EU Authorised representative label?
The label indicates the appointed EU Authorised Representative’s details, serving as a point of contact for regulatory authorities. It is required on product labeling across Europe and ensures transparency in regulatory responsibility.
