• List of European Authorised Representative Companies 2021

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    As of July 2021, non-EU companies selling products to consumers in the European Union must have a European Authorised Representative. Products shipped into the EU must also have the address of the authorised representative.

    In this article, we list companies offering European Authorised Representative services for electronics, toys, food contact materials, cosmetics, medical devices, and other products.

    Why do I need a European Authorised Representative company?

    As of July 2021, companies located outside the EU, but selling B2C to consumers in the European Union, must have an authorised representative. The role of the authorised representative can be summarized as follows:

    1. The authorised representative authorizes the non-EU company to use their address on the packaging (which is mandatory)

    2. The authorised representative holds the technical file, test report, and other relevant compliance documents

    3. The authorised representative communicates with the national authorities (e.g. market surveillance authorities) on behalf of the non-EU company

    There are a number of companies acting as European Authorised Representatives as a paid service, some of which are listed in this article. These companies normally charge a yearly fee. That said, paying a fee alone is not sufficient, as you must also provide extensive documentation:

    • Business registration documents
    • Product liability insurance
    • Compliance documents (e.g. test reports)

    In short, you need to have your act together before you can even appoint an authorised representative. Keep in mind that the customs authorities can, and will, confiscate and destroy inbound shipments without an authorised representative address.

    24hour-AR

    24hour-AR offers authorised representative services to non-EU based manufacturers, exporters, and E-commerce sellers. They claim to complete the registration process for each customer within 24 hours.

    Here is an overview of the registration process:

    • Upload your technical file
    • 24hour-AR reviews your technical file within 24 hours
    • You sign the authorised representative agreement

    According to the information displayed on the company’s official website, the annual fee is 1,490 Euro for up to 20 products (per client per year, plus VAT if applicable).

    Their service includes:

    • Verification of the EU Declaration of Conformity and technical file
    • Keeping your compliance documents for 10 years
    • Providing the legal use of an EU-based address

    For an additional fee they can also:

    • Communicate with the EU authorities on behalf of your company
    • Handle the product recalls process if needed

    Product Categories

    • Toys
    • Electronics
    • Personal protective equipment
    • Construction Products
    • Cosmetics
    • Machinery
    • Measuring equipment

    The company also offers other services, including CE Marking certification support, and technical communication.

    Company Information

    • Year of Registration: Not mentioned
    • Location: Sweden

    ProductIP

    ProductIP is a leading compliance firm with offices in Ede, in the Netherlands, Augsburg, in Germany, and Shenzhen, in China. The main goal of ProductIP is to help manufacturers, exporters, and importers to comply with the legal requirements and regulations enforced by the EU authorities, with a focus on consumer products.

    ProductIP offers comprehensive and European Authorised Representative services to companies that are looking to expand to the European Union. Their service includes the following:

    a. Helping drawing up the technical file and other relevant documentation using their own platform and standards database

    b. Maintaining the documentation on behalf of your company for 10 years, and sharing it with the authorities, upon request

    c. Cooperating and communicating with the national authority on behalf of your company, if necessary, including notification of product incidents

    d. Authorization to place their EU address in your product and packaging labeling, and in the Declaration of Conformity, when necessary

    One of the most prominent features of choosing ProductIP as the European Authorised Representative is that the company integrates all its services into its self-built system, where each customer can create its own technical files. As a matter of fact, you must have your technical file stored in their platform, in order to use their European Authorised Representative service.

    Their self-paced system allows customers to start the market accessing process by breaking the tasks into segments, using the modular structures designed by the company.

    According to the information provided by ProductIP, customers that want to purchase their EU Authorised Representative Services need to provide at least the following:

    • Valid business license/company registration document
    • Product liability insurance
    • EU AR Agreement (in the format required by the EU)

    Currently, ProductIP charges an annual fee of 2,000 Euro for its EU Authorised Representative Services.

    The company also charges 225 Euro per hour, for handling any issues related to their role as Authorised Representative, such as communicating with the authorities, when needed. You will also be required to pay a deposit of 1,800 Euro, which covers the first 8 hours of work.

    ProductIP also offers other services, including:

    a. A platform that allows you to create your own technical files and generate your own DoC – although the access to the platform is included on the European Authorised Representative service

    b. Compliance consulting, including explaining the compliance requirements to your supplier

    c. Reviewing and organizing your documentation

    d. Product labeling, packaging labeling, and user manuals checks.

    Product Categories

    Company Information

    • Year of Registration: 2008
    • Locations: Netherlands, Germany, China

    HQ Address: Rubensstraat 211, 6717 VE, Ede, The Netherlands

    Clever Compliance

    Clever Compliance is Swedish company that provides product services in accordance to the EU regulations and directives, including European Authorised Representative services.

    The European Authorised Representative package offered by Clever Compliance include the following items:

    • Providing legal name and registered address within the EU
    • Handling regulatory and administrative issues on behalf of the clients
    • Communicating with the authorities and agencies on behalf of the clients
    • Reviewing the EU declaration of conformity
    • Examining the technical documentation
    • Updating clients regulatory changes in time
    • Cloud storage of compliance documentation
    • Non-disclosure agreement (NDA)

    Customers can sign up for Authorised Representative package for 3, 12, or 12 months. Furhter, Clever Compliance has developed an online software aiming to help its clients in managing compliance for multi-products in a time-saving and cost-efficient way. This compliance tool is an integrated system that includes the following:

    • Compliance map (view product’s global compliance situation)
    • Legislation finder (finding applicable legislations)
    • Harmonised standards (finding matching EN standards)
    • Notified bodies fast search
    • Documentation requirement instructions
    • Documentation generator
    • Product compliance health estimation

    Product Categories

    • Electrical products
    • Medical devices
    • Consumer products

    Company Information

    • Year of Registration: Not mentioned
    • Locations: Sweden

    HQ Address: Drottning Kristinas väg 53, 114 28 Stockholm, Sweden

    AR Experts

    AR Experts offers its services as a European Authorised Representative for exporters who are looking to sell their products in any member state of the EU. At the present, AR Experts is headquartered in Breukelen, The Netherlands, with representative offices in the following cities:

    • Berlin, Germany
    • Shenyang, China
    • Phuket, Thailand
    • New York, United States

    AR Experts offers tailored-made solutions for traditional B2B companies and E-commerce companies in the industries of toys, electronic products, and medical devices.

    AR Experts acts as the primary contact with the relevant authorities, store the relevant documentation, and can help customers to verify that the imported products are legally allowed to bear the CE marking by scrutinizing the technical file, and other relevant documents.

    Customers need to provide information such as product specifications, test reports, usage instructions, design documents, and the declaration of conformity.

    Their services also include address registration and notified body services. More in general, they help companies in relation to product safety, labeling, quality assurance, and other requirements mandated by the applicable regulations.

    Product Categories

    • Toys
    • Electronic products
    • Radio equipment devices
    • Medical devices

    Company Information

    • Year of Registration: 1995
    • Locations: The Netherlands, Germany, China, Thailand, United States

    HQ Address: Amerlandseweg 7, 3621 ZC Breukelen, The Netherlands

    Authorised Representative Service

    Authorised Representative Service is a firm based in Dublin, Ireland, and has been offering representative services for the past two decades.

    The company acts as the responsible economic operator for non-EU-based companies that are interested to sell their product in the EU.

    Their pre-market preparation services include legal consulting, risk assessments, risk identification, risk control, EU Declaration of Conformity verification, technical documentation examination, documentation maintenance, and submission.

    Also, they will provide an EU-registered address for your company, store your documentation, and handle the communication with the relevant authorities.

    Currently, the company provides EU representative services in accordance with several regulations and directives, including the following:

    Product Categories

    • Toys
    • Household appliances
    • Low voltage electronics
    • Radio equipment
    • Personal protective equipment
    • Construction materials
    • Explosives
    • Pressure equipment
    • Machinery

    Company Information

    • Year of Registration: 1990’s
    • Locations: Ireland, United Kingdom

    HQ Address: 77 Camden Street Lower, Dublin, D02 XE80, Ireland

    Obelis Group

    Headquartered in Brussels, Belgium, Obelis Group was founded in 1988, and today specializes in offering European Authorised Representative services for customers across the globe. Over the past three decades, Obelis Group has been representing more than 3,000 manufacturers from over 60 countries. Currently, Obelis Group also owns branches in the US and Israel.

    Obelis Group’s service can be divided into four parts, which are EU registered address, EU submissions and technical documentation, legal consultation, and training.

    Specifically, the European Authorised Representative company’s services include:

    • Providing a registered address within the European Union
    • Technical file review
    • Gap analysis
    • Keeping records of technical documentation
    • Completing notifications to the European Authorities
    • Reporting incidents
    • Notifying customers of relevant regulatory updates

    Obelis Group represents clients from the industry of healthcare, medical devices, and personal care products, involving products like food supplements, aesthetic devices, and cosmetic products.

    Other than the regular European Authorised Representative services, Obelis Group also conducts clinical investigations, evaluates market prospects, translates labels, and verify GMDN Code. The company also provides additional national registration services for medical devices in France, Italy, Spain, Portugal, Greece, Slovakia, and Bulgaria.

    Product Categories

    • Cosmetics and personal care
    • Food supplements
    • Medical devices

    Company Information

    • Year of Registration: 1988
    • Locations: Belgium, Israel, United States

    HQ Address: Bd General Wahis, 53, B-1030 Brussels, Belgium

    Earn

    Earn is a legal consultant and agency from Goslar, Germany. The company specializes in offering a full package of services for companies that intend to sell battery and electronic products in the EU.

    Earn also undertakes obligations for battery and electronic companies as a European Authorised Representative, providing services like registered address, legal consulting, conformity assessments, DoC verification and examination, technical documentation review, documentation maintenance, and submission to the authorities.

    Finally, the company provides assistance and solutions to customers to ensure their products comply with the WEEE Directive and Packaging Directive, which involves registration, documentation, and recycling processes.

    Product Categories

    • Batteries
    • Electronic products

    Company Information

    • Year of Registration: 2000
    • Locations: Germany

    HQ Address: Landstraße 91, 38644 Goslar, Germany

    Emergo by UL

    Emergo by UL was founded in 1997 in the United States and is considered one of the largest Authorised Representative service providers for medical devices and in-vitro devices. According to the official website of the company, Emergo by UL has been representing more than 1,000 companies worldwide.

    Their comprehensive Authorised Representatives services cover all the member states within the EU.

    Emergo’s services are designed according to the requirements of each directive, including:

    • Registered address
    • Technical File review
    • CE Declaration of Conformity examination
    • Labeling and symbols inspection
    • Incident and Field Safety Corrective Action (FSCA) reporting assistance
    • Quality management system implementation
    • In-country representation
    • Clinical study compliance
    • Regulatory strategy
    • Regular regulatory information updates

    Emergo has set up more than 60 representative offices in 20 countries across 5 continents, including the United States, the European Union, Russia, United Kingdom, Israel, China, Japan, and many other countries.

    Product Categories

    • Health care products
    • Medical devices
    • In-vitro medical devices

    Company Information

    • Year of Registration: 1997
    • Locations: Europe, Asia, North America, South America

    HQ Address: 2500 Bee Cave Road, Building 1, Suite 300, Austin, Texas, the United States

    Eucerep

    Eucerep is headquartered in Eindhoven, providing European Authorised Representative services, product registration, testing, and industrial training services for the medical and pharmaceutical industry.

    Eucerep offers European Authorised Representative services in accordance with the requirements of the following directives and regulations:

    • Medical Devices Regulation
    • Active Implantable Medical Devices Directive
    • In-Vitro Diagnostic Medical Devices Directive

    Their service includes providing a registered address within the European Union, technical file review, maintaining the technical files and other documentation for 10 years, notifications to the European Authorities, and informing customers of the regulatory updates.

    Other than the European Authorised Representative services, Eucerep offers biomedical testing services, laboratory sanitation testing services, and packaging validation services for medical devices.

    Product Categories

    • Medical devices
    • In-vitro medical devices

    Company Information

    • Year of Registration: Not mentioned
    • Locations: The Netherlands

    HQ Address: Roald Dahllaan 33, 5629MC, Eindhoven, The Netherlands

    Qserve Group

    Qserve Group was founded in 1998 in the Netherlands. The company is an expert in providing regulatory consulting services for medical device manufacturers and exporters who are looking to open new markets in the EU, US, and China. Qserve is highly specialized in regulatory consultation, quality control, clinical trials, and educational training for the industry of medical devices.

    For customers who are looking for Authorised Representatives services in the EU, Qserve services cover the following:

    a. Authorization to use their address on the product and packaging label, and relevant documentation

    b. Assistance in communicating with the competent authorities

    c. Maintaining your technical file and make it available to the competent authorities

    d. Guidance and education of relevant legislations

    e. inspection of labeling and symbols regular updates to customers regarding regulatory changes

    Product Categories

    • Medical devices
    • In-vitro medical devices

    Company Information

    • Year of Registration: 1998
    • Locations: The Netherlands, United Kingdom, China, United States,

    HQ Address: Arnhems Business Park, Utrechtseweg 310 – Bldg B42, 6812 AR Arnhem, The Netherlands

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    • 2 Responses to “List of European Authorised Representative Companies 2021

      1. Katherine at 4:22 am

        Dear Chuiyan,
        Very interesting article, thank you!
        I have a question link to the AR. I am thinking to register a trading company in Luxembourg and distribute packaging machines to Europe, if the Chinese manufacturer agreed, can i be there AR? Do you know is there any specific requirements on my side or not?
        Thanks in advance for your reply.
        Katherine

        1. Fredrik Gronkvist at 12:52 pm

          Hi Katherine,

          If you are importing the machines to the EU under your own companythen you assume the responsibility already.

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