Keyna offers non-EU manufacturers (e.g. from China) a comprehensive and legally compliant EU Authorised Representative (EU-AR) service based in Germany for Germany, specifically tailored for general consumer products such as electronic devices, toys, and household goods requiring CE marking. Our core EU Authorised Representative services include:
- Providing our EU address for product labelling and regulatory contact
- Holding and maintaining your technical documentation for at least 10 years
- Reviewing Declarations of Conformity and CE compliance documentation
- Communicating with EU market surveillance authorities on your behalf
- Supporting product recalls and corrective actions where necessary
- Clear contractual terms and limited liability, governed by German law
Whether you're launching a new CE product in Europe or need a reliable AR partner for Amazon, B2B, or distributor sales, Keyna ensures your compliance with EU regulations – efficiently, transparently, and with personal support.
- EU authorised representative for CE
- EU AR service for Chinese manufacturers
- CE compliance support Europe
Relevance of Article 4 – Regulation (EU) 2019/1020 for Non-EU Sellers
On 5 March 2021, the European Commission published practical guidelines for the implementation of Article 4 of Regulation (EU) 2019/1020, also known as the Market Surveillance Regulation. Since 16 July 2021, this article prohibits non-EU manufacturers and sellers from placing certain CE-marked products on the EU market—including toys, electrical equipment, and personal protective equipment (PPE)—unless an EU-based economic operator has been officially appointed to take over specific compliance responsibilities. This regulation is particularly important for:
- Manufacturers outside the EU selling directly to EU end users (B2B or B2C),
- Online sellers using platforms like Amazon or Alibaba, and
- Fulfilment service providers in the EU, who may automatically become the responsible party if no authorised representative is named.
Keyna can act as your designated EU Authorised Representative, ensuring your CE-marked products meet all relevant EU compliance requirements—quickly, legally, and without interruption to your supply chain.
Appoint Your EU Authorised Representative Before Selling in Europe
Under Regulation (EU) 2019/1020, it is unlawful to place certain CE-marked products on the EU market unless a responsible EU-based economic operator has been formally appointed. This applies in particular to manufacturers and exporters who sell—or intend to sell—directly to professional or consumer end users within the EU.
If you are a non-EU manufacturer or an international e-commerce seller, you must designate an EU Authorised Representative before making your products available in the European market.
Unlike many providers with long lead times, Keyna can be appointed as your official EU Authorised Representative within 24 to 48 hours.
We act as a legally recognised EU entity on behalf of non-EU manufacturers, exporters, and online sellers—ensuring full regulatory compliance so you can trade smoothly and confidently across the European Union.
Transferring Your EU Authorised Representative
According to Article 12 of the MDR and IVDR, it is possible for manufacturers to transfer their EU Authorised Representative (EU AR) to a new service provider. However, several steps and obligations must be carefully managed:
- Product labelling must be updated to reflect the new EU AR’s name and address.
- Manufacturers must document the official end date of the previous representative’s mandate and the start date of the new appointment.
- All technical and regulatory documentation should be revised accordingly.
- The previous EU AR should forward any complaints from users, patients, or healthcare professionals related to devices placed on the market before the transfer date.
- Ideally, these responsibilities are defined in a three-party agreement signed by the manufacturer, the outgoing EU AR, and the incoming EU AR.
To avoid delays and additional costs, manufacturers are advised to choose an EU AR with long-term alignment to their European market strategy from the outset.
Does the EU Authorised Representative Need to Be Listed on the Device Label?
Yes. Under both MDR and IVDR, the name and address of the EU Authorised Representative must appear directly on the product label.
- While it is not mandatory to include this information in the Instructions for Use (IFU), doing so is considered best practice for improved traceability—especially if the label or packaging is discarded by the end user.
- To avoid translation issues, the EU AR information should be placed next to the official EC REP symbol, as defined in EN ISO 15223-1:2021.
- If the device label is too small, the AR details may alternatively be printed on:
- Individual packaging, or
- Outer packaging (for multi-unit packs).
For so-called legacy devices (approved under MDD, AIMDD or IVDD), the EU AR information may appear on either the label, outer packaging, or IFU.
Additionally, the EU Authorised Representative must be named in the Declaration of Conformity and, where applicable, on the Notified Body CE Certificate.
A. Risks of Not Appointing an EU Authorised Representative (EU AR)
For manufacturers based outside the EU
According to Articles 4 and 11 of Regulation (EU) 2019/1020, certain CE-marked products may not be placed on the EU market unless a responsible economic operator — such as an EU Authorised Representative (AR) — has been officially appointed.
If no AR is appointed
- The product cannot legally be imported, sold, or distributed in the EU
- Authorities may order market withdrawals, sales bans, or issue fines
- Online marketplaces (e.g. Amazon, eBay) may suspend product listings
- Manufacturers are not contacted directly by EU authorities — products may simply be blocked or removed from the market
- Criminal liability in cases of gross negligence or intent
- Up to €100,000 under §39(2) of the German Product Safety Act (ProdSG) for serious safety violations
- Up to €50,000 for offering CE-marked telecommunications equipment without proper labelling.
For distributors, importers, and resellers
- They may be held liable as the manufacturer (“quasi-manufacturer”) under EU law
- They risk legal penalties, product seizures, or warnings due to missing CE markings or AR information
- During inspections, they must prove that an EU-based economic operator has been appointed and that technical documentation is accessible
Legal Sources & Case Law
- Bundesnetzagentur (Link)
- Regulation (EU) 2019/1020, Articles 4 & 11 → EUR-Lex Official Text
- Court of Justice of the EU (CJEU), Case C-219/15 – Brand owners may be held as manufacturers
- Higher Regional Court Frankfurt (OLG Frankfurt), Judgment 6 U 84/17 – Retailer liable for missing CE mark
Without an EU Authorised Representative, manufacturers risk losing access to the European market, and their distribution partners may face legal, financial, and operational consequences. Appointing a professional EU AR in advance is a simple but essential step toward ensuring compliance and business continuity.
B. Legal Basis for EU Authorised Representatives
Under EU Regulation (EU) 2019/1020, certain products may not be placed on the EU market unless a responsible economic operator established within the EU has been appointed. This applies particularly to manufacturers selling directly to end users—whether business customers or consumers—without involving an EU-based entity.
- The European Commission's official page on Product Compliance.
- Guidelines on CE Marking.
Keyna serves as your legally recognized EU Authorised Representative, representing non-EU manufacturers, exporters, and e-commerce sellers. We ensure that your products meet all applicable EU compliance requirements, allowing you to focus on growing your business across the European market—safely, efficiently, and in full legal conformity.
Unlike many providers who require long lead times, Keyna can be appointed and ready to represent your company within 24 to 48 hours.
1. Regulation (EU) 2019/1020 on Market Surveillance and Compliance of Products (Link)
- In force since: 16 July 2021
- Article 11 of this regulation is the key legal foundation for appointing an EU Authorised Representative when the manufacturer is based outside the European Union.
Excerpt from Article 11 (1):
"A product shall only be placed on the market if there is an economic operator established in the Union who is responsible for certain compliance tasks."
Under this regulation, the Authorised Representative must:
- Ensure that name and address appear on the packaging or product documentation
- Hold the technical documentation for at least 10 years
- Provide documentation to authorities upon request
- Support product recalls and corrective actions where required
2. Product-Specific Legal Frameworks (Selection)
Depending on the product category, various EU directives and regulations define the role and obligations of the Authorised Representative:
General Product Safety – Regulation (EU) 2023/988 (GPSR)
- Scope: All consumer products not covered by specific EU regulations
- Objective: To ensure that only safe products are placed on the EU market
- Manufacturer obligations:
- Conduct a product-specific risk assessment
- Ensure traceability throughout the supply chain
- Organize recalls or corrective actions if products are found to be unsafe
- Applicable from: 13 December 2024 across all EU Member States
- Source: Regulation (EU) 2023/988 – EUR-Lex
Machinery Directive 2006/42/EC
- Scope: Machinery and partly completed machinery placed on the EEA market
- Objective: Define essential health and safety requirements for machinery
- Manufacturer obligations:
- Perform a risk assessment
- Compile technical documentation
- Affix the CE marking
- Transition: Will be replaced by the new Machinery Regulation (EU) 2023/1230 starting 20 January 2027
- Source: Directive 2006/42/EC – EUR-Lex
Electromagnetic Compatibility (EMC) Directive 2014/30/EU
- Scope: Electrical and electronic equipment that may cause or be affected by electromagnetic disturbances
- Objective: Ensure devices do not interfere with other equipment and are themselves resilient
- Manufacturer obligations:
- Perform an EMC assessment
- Prepare technical documentation
- Affix the CE marking
- Implementation in Germany: German EMC Act (EMVG)
- Source: Directive 2014/30/EU – EUR-Lex
Low Voltage Directive 2014/35/EU (LVD)
- Scope: Electrical equipment with voltages between 50–1000 V AC or 75–1500 V DC
- Examples: Chargers, power supplies, household appliances, LED lights
- Authorised Representative obligations (Article 8):
- Keep the EU Declaration of Conformity
- Provide technical documentation upon request
- Cooperate with market surveillance authorities
- Quote (Article 8, para 3):
- "The authorised representative shall keep the EU declaration of conformity and the technical documentation at the disposal of national authorities and shall cooperate with them upon reasoned request."
- Source: Directive 2014/35/EU – EUR-Lex
Toy Safety Directive 2009/48/EC (TSD)
- Scope: Toys intended for use by children under 14
- Examples: Dolls, building blocks, toy cars, creative kits
- Authorised Representative obligations (Articles 4 & 14):
- Hold technical documentation
- Provide the Declaration of Conformity
- Support market authorities during corrective measures
- Cannot place products on the market in their own name
- Quote (Article 14, para 1):
- "The authorised representative shall, upon request, provide all information and documentation necessary to demonstrate the conformity of a toy."
- Source: Directive 2009/48/EC – EUR-Lex
Recommended Resources
- EMC Directive Guide – PDF Download
- Machinery Directive Guide (Version 2.2) – Download
- General Product Safety Regulation – Q&A (BMUV Website, DE)
- ...
C. Do I Need a Separate Authorised Representative for Each EU Country?
No — one EU Authorised Representative is sufficient for the entire European Economic Area (EEA).
What this means in practice
A single Authorised Representative covers all EU and EEA countries (including Norway, Iceland, and Liechtenstein). The representative must be properly appointed and their name and address must be clearly visible on the product, packaging, or accompanying documents.
Exceptions / Special Cases
- United Kingdom (UK): Since Brexit, a separate UK Authorised Representative (UK-REP) is required to sell products in Great Britain.
- Switzerland: A Swiss Authorised Representative (CH-REP) is mandatory for many regulated products (e.g. medical devices, measuring instruments).
Important Note
Market surveillance authorities in each EU country must be able to contact the appointed EU Authorised Representative. That’s why it is essential that your representative is reachable, reliable, and fully compliant with EU obligations.
EU, UK & Switzerland – Regional Representation Requirements
Following the United Kingdom’s withdrawal from the European Union, manufacturers are now required to appoint a separate UK Responsible Person (UKRP) in order to place products on the UK market.
Similarly, due to the expiration of the Mutual Recognition Agreement (MRA) between Switzerland and the EU for medical devices and in vitro diagnostics (IVDs), manufacturers must designate a Swiss Authorised Representative (CH-REP) for market access in Switzerland.
While one service provider may act as your EU Authorised Representative, UK Responsible Person, and CH-REP, they must have an established legal entity and physical address in each respective region.
At Keyna, we support our clients across all three regulatory areas—helping to simplify compliance and ensure consistent market access across Europe.
D. Requirements for Authorised Representatives – EU vs. UK vs. Switzerland
E. What Manufacturers Should Provide to the Authorised Representative
F. What Does the Service of an EU Authorised Representative Cost?
The cost of EU Authorised Representative (AR) services depends on various factors. Key Pricing Factors:
- Number of products / product lines
- Sales volume of the products in the EU
- Liability coverage required (e.g. €1 million, €5 million per claim)
- Scope of service (administrative only vs. full compliance involvement)
- Export destinations (EU only, or also Switzerland, Norway, UK?)
Typical Monthly Fees (net, per agreement)
In higher-risk cases, additional product liability insurance is required or priced separately (e.g. for individual product line reviews).
Typical Annual Insurance Premiums
Why More Products Mean Higher Costs:
- More product documentation must be reviewed and stored
- Greater likelihood of regulatory issues or inspections
- More administrative time in communication with authorities
- Often different directives or standards apply per product category
G. Typical Contents of an EU Authorised Representative Agreement
A formal written agreement between you (as the EU Authorised Representative) and the non-EU manufacturer (e.g. in China) should include the following key elements:
- Contracting Parties
Full name, address, company registration number, and legal representatives of both the EU Authorised Representative and the manufacturer. - Subject Matter
Confirmation that the EU Representative is appointed according to relevant EU legislation (e.g. Article 11 of Regulation (EU) 2019/1020). - Obligations of the Authorised Representative
Retention of technical documentation - Provision of documents upon request by authorities
- Communication with EU market surveillance authorities
- Assistance with product recalls or corrective actions
- Obligations of the Manufacturer
Supply of all required documentation in German or English - Timely notification of any changes or incidents
- Payment of the agreed service fees
- Liability and Insurance
The AR should maintain a suitable product liability insurance - Liability is usually limited to gross negligence or intentional misconduct
- Fees and Payment Terms
Monthly or annual flat-rate payment model, depending on service scope - Term and Termination
Minimum contract duration (e.g. 12 months) - Notice periods for ordinary termination
- Automatic renewal clauses where applicable
- Confidentiality & Jurisdiction
Mutual confidentiality agreement - Place of jurisdiction (e.g. Germany) clearly defined
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Disclaimer: This summary is provided for informational purposes only and does not constitute legal advice. For detailed risk assessments and specific legal guidance, please consult with a qualified legal professional.
