In This Article
- Verify the specific EU regulation applying to your product type.
- Determine whether you need an EU Responsible Person, Authorised Rep, or both.
- Draft clear and comprehensive mandate agreements for each role.
- Ensure that your labelling includes the correct contact details for your appointed representative.
- Maintain up-to-date technical documentation accessible within the EU.
- Periodically review your compliance mechanisms in light of changing regulations.
- Choose representation partners with industry experience and proven track records.
What Is an EU Responsible Person?
Definition and Regulatory Role
The term EU Responsible Person refers to a legal entity or individual established within the European Union who is designated by the manufacturer to carry out specific legal tasks associated with product compliance. This role, now mandatory under several directives and regulations—particularly in sectors such as cosmetics, medical devices, and general product safety—acts as the primary liaison between non-EU manufacturers and European regulatory bodies.
An EU Responsible Person ensures that a product placed on the European market complies with all the relevant legislation, such as the General Product Safety Regulation (GPSR), REACH Regulation, and various product-specific directives. Responsibilities include keeping technical documentation available, verifying product conformity, managing safety issues, and cooperating with market surveillance authorities upon request. Most importantly, the EU Responsible Person enables non-EU entities to maintain regulatory accountability within the EU’s jurisdiction.
Since Brexit, UK-based companies targeting EU markets must now appoint an EU Responsible Person based in an EU member state. This shift has led to increased awareness and demand for such services among global exporters. The role is not optional where required—it is a legal necessity designed to protect consumer safety and foster market fairness.
What Is an EU Authorised Representative?
Functions and Mandate Details
An EU Authorised Representative is another critical regulatory figure, especially in cases where non-EU manufacturers are required by legislation to appoint a legal representative within the EU. This mandate is explicitly mentioned in directives such as the Medical Device Regulation (MDR) and the Machinery Directive. The Authorised Representative (often abbreviated as AR) operates as a formal agent empowered to act on behalf of the manufacturer, working in compliance with EU requirements.
The scope of an Authorised Representative’s duties may overlap with that of an EU Responsible Person, but there are key distinctions. The Authorised Rep is typically more involved with notification procedures, CE marking declarations, keeping registration documents updated, and acting as the first point of contact for EU authorities and customers. Importantly, they must be formally designated in writing—a contractual agreement often referred to as a mandate—and their name and address must appear on the product labelling, packaging, or accompanying documentation.
Because European legislation tends to be nuanced and sector-specific, it’s vital to clearly understand what role your business needs to appoint. Failure to do so can lead to legal penalties, product recalls, or inability to access the EU market altogether.
“Choosing the right compliance pathway—including the appropriate representative—can be the deciding factor between market access and regulatory failure.”
Legal Differences Between the Two Roles
While both the EU Responsible Person and EU Authorised Representative serve as regulatory intermediaries for non-EU manufacturers, their legal status, scope of responsibilities, and sector of relevance differ significantly. The Responsible Person is typically product-specific—for example, required under the Cosmetic Products Regulation for cosmetics—but not applicable to all industries. Conversely, the Authorised Representative is mandated across multiple directives and is more broadly used in regulated product categories such as electronics, PPE, and medical devices.
From a legal standpoint, one of the biggest differences lies in liability. While both roles carry responsibility for non-compliance, the Authorised Representative often has more direct legal accountability, particularly in highly regulated sectors. In contrast, the Responsible Person focuses on conformity oversight and technical obligations without formally being the manufacturer’s legal agent.
How GPSR Impacts Responsible Person and Authorised Rep Status
The introduction of the new General Product Safety Regulation (GPSR), replacing the outdated General Product Safety Directive (GPSD), has substantially affected both roles. The GPSR explicitly reinforces the need for a Responsible Person across a wider product range, including many general consumer products that previously had no such requirement.
Under the GPSR, the economic operator—be it an EU Responsible Person, manufacturer, or importer—must ensure safety verification, compliance documentation, and market traceability. This change signifies an increased compliance threshold, placing greater importance on choosing a knowledgeable EU Responsible Person for businesses previously unaffected.
Simultaneously, the GPSR reiterates the necessity of clearly identifying the authorised representative when required by directives. Failure to do so may result in customs seizure or denial of market access. This updated regulation underscores the converging yet distinct roles of both representatives in protecting consumer safety.
When You Need One vs When You Need Both
The complexity of EU regulations often means that manufacturers are required to appoint either an EU Responsible Person, an EU Authorised Representative, or sometimes both—depending on the product category and legal obligations. For example, cosmetic manufacturers selling in the EU must have a Responsible Person but not necessarily an Authorised Rep. On the other hand, manufacturers of Class I medical devices must appoint an Authorised Representative but not a Responsible Person.
In rarer instances—such as multifunctional products that fall under multiple legal frameworks—a product may simultaneously require both roles. When this occurs, it is critical to delineate responsibilities in separate mandates to avoid conflicts and misinterpretation.
Consulting an expert or third-party consultancy can reduce these regulatory burdens and ensure that your commercial documentation, labelling, and compliance pathways are fully aligned. Learn more about EU Product Compliance & Representation
Case Study: Amazon Sellers Navigating EU Compliance
Amazon sellers targeting the EU are increasingly required to comply with updated safety directives and consumer protection regulations. Many merchants, especially those based outside the EU, find themselves needing to appoint an EU Responsible Person to list and ship their products. Platforms like Amazon now demand valid proof of such representation as a prerequisite for product listing in electronics, beauty, and toy categories.
Case in point: A Canadian seller of LED beauty devices aiming to enter the German market had to appoint both an Authorised Representative—due to the electrical components—and an EU Responsible Person as per the Cosmetic Regulation. The seller’s market access was denied until both mandates were fully documented and linked to the seller account via Amazon’s compliance portal.
This case highlights how e-commerce platforms are tightening regulatory filters and making third-party representation a baseline requirement. Sellers ignorant of these requirements risk delisting or account suspension. Read a related article
Documentation Requirements and Labelling Obligations
When appointing an EU Responsible Person or Authorised Representative, it is essential to understand the associated documentation. This includes the Declaration of Conformity (DoC), technical files, risk assessments, safety data sheets, and labelling proof. The RP or AR must maintain access to these documents and provide them upon request to the authorities.
Labelling requirements differ based on the role. For example, the EU Responsible Person’s name and address must appear on cosmetic or general product labels, while the Authorised Representative’s details are included on the CE marking or package inserts of medical devices. This transparency ensures traceability and accountability from producer to end-user.
Ongoing maintenance of compliance documents is also mandatory. This includes updating safety standards, renewing expired declarations, and adjusting information based on product changes or regulatory shifts.
Costs: Responsible Person vs Authorised Rep Services
The cost of engaging an EU Responsible Person or Authorised Representative can vary significantly depending on product type, risk category, and documentation complexity. On average, appointing a Responsible Person for cosmetics products may cost between €800–€1,500 per year. This fee typically includes safety assessments, label reviews, and technical file hosting.
An Authorised Representative’s annual fee could range from €1,500 to €5,000 or more, especially for medical devices or electronics. The higher cost reflects intricate responsibilities around CE conformity, vigilance report handling, and legal liability. Costs may rise if real-time support or multilingual communication is required.
Some service providers offer dual-role support at a discounted rate. Nonetheless, businesses must evaluate not only cost but also credibility, sector expertise, and regulatory updates capacity. Understanding the role of a European Authorised Representative
Choosing the Right EU Compliance Partner
Selecting a qualified EU Responsible Person or Authorised Representative is a critical decision with long-term implications. When choosing a provider, consider their industry experience, ability to support multilingual documentation, in-house regulatory experts, and responsiveness to market surveillance inquiries.
Request proof of past client success, sample technical documentation reports, and platform integration capabilities (e.g., for Amazon or eBay sellers). Insist on a written mandate that clearly defines the scope of representation, liability limitations, and service-level expectations.
Favour partners with ISO 9001 or similar quality certifications. These indicators suggest a structured and repeatable approach to compliance management—essential in a rapidly evolving EU regulatory environment.
Common Misconceptions and Mistakes to Avoid
Many businesses mistakenly believe that the roles of EU Responsible Person and Authorised Representative are interchangeable. In fact, appointing the wrong type can lead to compliance gaps. Another frequent oversight is failing to properly document the mandate, leaving unclear liability in case of inspection or recall.
Other errors include using PO boxes instead of physical EU addresses, omitting the required labelling, and relying on distributors or importers to shoulder legal responsibilities they are not obligated—or qualified—to perform. Proactive training and expert consultation can eliminate these missteps.
Final Checklist for Compliance Success
Conclusion: Make an Informed Decision
Whether launching a new product or scaling sales across the European Union, understanding the role and necessity of an EU Responsible Person and Authorised Representative is fundamental. These legal designations are not redundant bureaucracies but pivotal safeguards that protect consumers, prevent recalls, and enable global market participation. By aligning your business with qualified compliance partners and meticulously fulfilling EU requirements, you transform regulatory complexity into a competitive advantage. Take steps today to secure proper representation—and ensure that your journey into the European marketplace is legally sound, sustainable, and successful.
Great guide on eu-responsible-person-vs-authorised-rep-whats-the-difference-interactive-understand-whether-your-product-needs-an-eu-responsible-person-an-authorised-representative-or-both-avoid-major-complia – Community Feedback
What is a responsible person in the EU?
An EU Responsible Person (EURP) acts as a point of contact for product safety concerns within the EU and must be based in the EU, often appointed by businesses outside the EU to ensure compliance.
What is an authorized representative in the EU?
An EU Authorized Representative serves as a liaison between manufacturers and national Competent Authorities, helping with registrations and compliance, especially for medical devices and certain categories.
Who is an Authorised person in GPSR?
An Authorised Representative under GPSR can be an individual or a business based in the EU who is given a written mandate by the manufacturer to carry out specific compliance tasks.
What is a European Authorised Representative EC rep?
A European Authorised Representative (EC REP) is the designated liaison between a manufacturer and national authorities, with their details appearing on product labelling throughout the EU.
