Amazon EU Responsible Person Service
An EU Responsible Person is a legally responsible entity defined under EU directives and regulations. It applies to manufacturers based outside the EU, who must appoint a legal entity within the EU as their EU Authorised Representative to act on their behalf and ensure compliance with applicable EU directives and regulations.
Under the Medical Devices Directive (MDD 93/42/EEC) or Medical Devices Regulation (MDR EU/2017/745), and the In Vitro Diagnostic Directive (IVDD 98/79/EC) or In Vitro Diagnostic Regulation (IVDR EU/2017/746), manufacturers are required to appoint an eu authorised representative to complete registration and other relevant obligations specified in the relevant legislation.
Since the entry into force of the EU General Product Safety Regulation (gpsr), nearly all product categories sold into the EU (excluding food) must have an EU Responsible Person.
Recently, the Fruugo platform issued a notice requiring sellers to remove fake EU Responsible Person information within a specified deadline and make corrections. Failure to comply will result in product removal and penalties for non-compliant listings.
Online sales also fall under the EU Responsible Person requirement:
Products sold online or via other distance-selling methods in the EU market are deemed to be placed on the EU market and are therefore subject to the same EU Responsible Person obligations.
Scope covered by the EU Responsible Person requirement
• low voltage directive (LVD) 2014/35/EU
• Radio Equipment Directive (RED) 2014/53/EU
• Electromagnetic Compatibility Directive (EMC) 2014/30/EU
• Eco-design of Energy-related Products (ErP) 2009/125/EC
• Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) 2011/65/EU
• Toy Safety Directive 2009/48/EC
• Batteries Directive 2006/66/EU
• Machinery Directive (MD) 2006/42/EC
Common products requiring an EU Responsible Person
Many sellers assume only medical devices need an EU Responsible Person, but the requirement applies to a wide range of products, such as:
1. Electronic products
• Mobile phone accessories
• Lighting products
• Batteries
• Small home appliances
2. Beauty & personal care products
• Lipsticks
• Cosmetics
• Skin care products
• Beauty devices
3. Children’s products
• Toys
• Baby products
4. Daily necessities
• Kitchenware
• Household goods
• Sports equipment
In particular:
Nearly all products requiring ce marking must appoint an EU Responsible Person.
Responsibilities of the EU Authorised Representative
1. Verify that the manufacturer follows the conformity assessment procedures set out in applicable EU directives/regulations (e.g., meeting CE certification requirements).
2. Ensure their contact details are available to the manufacturer for placement on all products they represent, acting as the main point of contact for EU authorities.
3. Notify the competent EU authorities of all significant incidents related to the products.
4. Maintain knowledge of all EU regulations applicable in EU member states and the four EFTA member states, and provide notifications of changes and amendments to directives affecting individual products.
5. Make available the product’s technical documentation, Declaration of Conformity (DoC), and other documents to competent EU authorities upon request; keep sensitive manufacturer information confidential and only disclose it to relevant authorities when necessary.
6. For medical devices: the EU Responsible Person must register the device with the competent authority before the manufacturer places it on the market to ensure legal compliance, and fulfil all other duties of an EU Authorised Representative under medical device directives/regulations.
Labelling for the EU Authorised Representative
The name, address and other details of the Authorised Representative must appear on your product label, outer packaging or Instructions for Use (IFU).
Manufacturers must also use the EU REP symbol specified in EN ISO 15223-1:2016.
How to appoint an EU Responsible Person
An EU Responsible Person must be a legal entity established within the EU.
JJR LAB can provide professional EU Responsible Person services through multiple qualified entities within the EU, helping your products meet the requirements of EU ce marking directives and regulations.
Welcome to contact us for consultation.
Services provided by JJR/LIO:
1. Sign a service agreement and provide 12-month EU Responsible Person service.
2. EU Responsible Person information can be printed on product packaging, parcels or accompanying documents.
3. After-service support, including provision of DoC templates.
4. Forwarding, handling and follow-up of customer complaints and official correspondence from the EU/UK authorities.
EU Responsible Person Service Fee
JJR LAB EU Responsible Person Service: USD 299
Processing time: 3 working days
Risks of not having an EU Responsible Person
Many sellers overlook the EU Responsible Person requirement and face the following consequences:
1. Forced delisting by platforms
Including but not limited to:
• Amazon
• Temu
• eBay
• TikTok Shop
Platforms require sellers to provide:
EU Responsible Person details
Failure to provide will result in:
Product delisting
Sales prohibition
2. Customs detention
EU customs will inspect:
• EU Responsible Person information
• Product labelling
Without valid information, goods may be detained or returned directly.
3. Product recalls
If product issues arise, EU regulatory authorities will contact the EU Responsible Person.
Without an EU Responsible Person, the seller bears greater liability and higher risks.
4. What does EU Responsible Person information typically include?
An EU Responsible Person is generally required to provide:
• Company name
• Address (within the EU)
• Contact information
Example:
EU Responsible Person
Company: XXX GmbH
Address: Germany
Email: xxxx@xxx.com
This information must usually be printed on:
• Product packaging
• User manuals
• Outer cartons
How to identify fake EU Responsible Persons
Recently, major e-commerce platforms have strengthened audits of EU Responsible Person qualifications and strictly cracked down on fake representatives. Many sellers have suffered heavy financial losses due to fraudulent qualifications and forced delistings.
In this context, it is critical for sellers to verify the authenticity and issuing authority of compliance certificates provided by agents.
Common fake EU Responsible Persons:
• Shell companies, agents or exhibition service providers
• No fixed office or stable contact within the EU
• Distributors acting as EU Responsible Persons
• Friends or relatives studying in the EU acting as EU Responsible Persons
How to identify a reliable provider:
Follow these principles: ① Check the address ② Verify qualifications ③ Evaluate capability
1. The address of the EU Authorised Representative should be a commercial office building, not a residential address or virtual address.
2. The EU Authorised Representative should have a professional EU compliance team to handle post-service issues within the scope of the agreement.
3. A reliable EU Authorised Representative should also have the financial and operational capacity to bear risks, with comprehensive response plans and strong support in case of liability claims or penalties.