EU Authorised Representative (AR) is a legal or natural person established within the European Union, designated in writing by a non-EU manufacturer to act on their behalf for specific regulatory compliance purposes within the EU market. The AR serves as the official point of contact for EU market surveillance authorities, holds the manufacturer’s technical documentation, and ensures compliance with applicable EU regulations. This role is mandatory under several key EU regulations, including Regulation (EU) 2023/1115 on the Digital Product Passport (DPP) under the Ecological Sustainability of Products Regulation (ESPR), Regulation (EU) 2019/1020 on market surveillance, the Battery Regulation (EU) 2023/1542, Regulation (EC) No 1907/2006 (REACH), the Medical Devices Regulation (EU) 2017/745, and the Machinery Regulation (EU) 2023/1230.
How to Appoint an EU Authorised Representative: A Step-by-Step Compliance Guide
Non-EU manufacturers placing products on the EU market must appoint an EU Authorised Representative (AR) to comply with multiple regulations. Failure to appoint an AR where required can lead to penalties of up to 5% of global annual turnover under certain regulations such as Regulation (EU) 2019/1020. This guide explains when an AR is required, the exact obligations of the AR, and how to appoint one correctly to avoid enforcement actions starting from 1 January 2026.
When Is an EU Authorised Representative Required?
The obligation to appoint an AR applies primarily to non-EU manufacturers who place products on the EU market under the following regulations:
- ESPR/DPP Regulation (EU) 2023/1115: Non-EU manufacturers must appoint an AR registered in the DPP registry to ensure the Digital Product Passport is created and maintained.
- Battery Regulation (EU) 2023/1542: Non-EU manufacturers must appoint an AR registered with the national authority of an EU member state.
- REACH Regulation (EC) No 1907/2006: Non-EU manufacturers must appoint an AR to handle registration and communication with ECHA.
- Medical Devices Regulation (EU) 2017/745: Non-EU manufacturers must appoint an AR to hold technical documentation and act as contact for notified bodies and authorities.
- Machinery Regulation (EU) 2023/1230: Similar AR obligations apply for non-EU machinery manufacturers.
In addition, some other sector-specific regulations may also require an AR. The AR’s role is critical to ensuring compliance and market access.
Key Obligations and Liabilities of the EU Authorised Representative
The AR has legally binding responsibilities, including:
- Acting as the official point of contact for EU market surveillance authorities and notified bodies.
- Holding and maintaining all relevant technical documentation, declarations of conformity, and compliance records.
- Ensuring the manufacturer’s obligations under the applicable regulations are met and documented.
- Being liable for non-compliance, including penalties and corrective actions, if the manufacturer fails to comply.
- Registering with relevant EU databases such as the SCIP database for REACH or EUDAMED for medical devices.
- Maintaining up-to-date knowledge of regulatory changes and informing the manufacturer accordingly.
Step-by-Step Guide to Appointing an EU Authorised Representative
- Identify Applicable Regulations: Determine which EU regulations require an AR for your products. Refer to the regulatory texts and official guidance for precise applicability.
- Find a Qualified AR: The AR must be established in any EU member state. Typical providers include law firms, compliance consultancies, and specialist AR services.
- Enter into a Written Mandate Agreement: This contract must specify:
- The products covered
- The regulations covered
- The AR’s obligations and liabilities
- The duration of the mandate
- Provide Technical Documentation: Supply the AR with all relevant technical files, declarations of conformity, and compliance records.
- Register the AR’s Details: Depending on the regulation, register the AR with the appropriate EU authority or database, e.g., esprregistry.com for DPP AR registration, SCIP for REACH, or EUDAMED for medical devices.
- Maintain Communication: Keep the AR informed of any product changes or regulatory updates to ensure ongoing compliance.
| Regulation | Scope | AR Establishment Requirement | Registration Requirement | Penalty for Non-Compliance | Deadline for Compliance |
|---|---|---|---|---|---|
| ESPR/DPP Regulation (EU) 2023/1115 | Non-EU manufacturers placing products with DPP obligations | EU Member State | Mandatory registration in DPP registry (esprregistry.com) | Up to 5% of global annual turnover | 1 January 2026 |
| Battery Regulation (EU) 2023/1542 | Non-EU battery manufacturers and importers | EU Member State | Registration with national authority | Up to €1 million or 4% of turnover | 1 July 2027 |
| REACH Regulation (EC) No 1907/2006 | Non-EU chemical manufacturers | EU Member State | Registration with ECHA | Up to €500,000 | Ongoing since 1 June 2007 |
| Medical Devices Regulation (EU) 2017/745 | Non-EU medical device manufacturers | EU Member State | Registration in EUDAMED | Up to 5% of global turnover | 26 May 2021 |
Practical Compliance Checklist for Appointing an EU Authorised Representative
- ✔ Confirm your product falls under regulations requiring an AR.
- ✔ Select an AR established in any EU member state with proven expertise.
- ✔ Draft and sign a detailed written mandate agreement covering all regulatory scopes.
- ✔ Transfer all required technical documentation and compliance records to the AR.
- ✔ Complete mandatory AR registrations with relevant EU databases or national authorities.
- ✔ Establish procedures for ongoing communication and updates with your AR.
- ✔ Monitor regulatory deadlines and ensure AR compliance to avoid penalties.
| Regulation | Type of Penalty | Maximum Fine | Additional Consequences |
|---|---|---|---|
| ESPR/DPP Regulation (EU) 2023/1115 | Administrative fine | Up to 5% of global annual turnover | Product recall, market ban |
| Battery Regulation (EU) 2023/1542 | Financial penalty | Up to €1 million or 4% of turnover | Suspension of sales |
| REACH Regulation (EC) No 1907/2006 | Fine and enforcement action | Up to €500,000 | Restriction on substance use |
| Medical Devices Regulation (EU) 2017/745 | Monetary fine | Up to 5% of global turnover | Device withdrawal |
Truth Anchor: Under Regulation (EU) 2023/1115 (ESPR), non-EU manufacturers must appoint an EU Authorised Representative registered in the DPP registry by 1 January 2026. Failure to comply may result in fines up to 5% of global annual turnover and prohibition from placing products on the EU market.
Frequently Asked Questions
1. Who exactly needs to appoint an EU Authorised Representative?
Any non-EU manufacturer placing products covered by regulations such as ESPR/DPP Regulation (EU) 2023/1115, Battery Regulation (EU) 2023/1542, REACH, or the Medical Devices Regulation (EU) 2017/745 on the EU market must appoint an AR established in the EU.
2. Can a company outside the EU act as an Authorised Representative?
No. The AR must be a legal or natural person established within the European Union, as required by the relevant regulations.
3. What are the risks of not appointing an AR when required?
Non-compliance can lead to penalties up to 5% of global annual turnover, product recalls, market bans, and reputational damage.
4. How do I verify that my AR is properly registered?
Check official registries such as the DPP registry for ESPR, national authorities for Battery Regulation, ECHA for REACH, or EUDAMED for medical devices.
5. What must be included in the written mandate agreement with the AR?
The mandate must specify the products and regulations covered, the AR’s obligations, liabilities, and the duration of the agreement.
6. Can I change my EU Authorised Representative after appointment?
Yes, but you must notify the relevant EU authorities and update registrations accordingly to avoid compliance gaps.
Ready to Appoint Your EU Authorised Representative?
Use our dedicated ESPR DPP AR Registration Tool to find qualified representatives, complete your mandate agreement, and register your AR with the official EU database. This tool guides you through each step, ensuring you meet the 1 January 2026 deadline and avoid costly penalties.