EU Responsible Person on Amazon

What is an EU Responsible Person

An EU Responsible Person (european authorized representative / European Authorised Representative) refers to a legal or natural person explicitly designated by a manufacturer located outside the European Economic Area (EEA).

This legal or natural person may represent the non-EEA manufacturer in performing specific duties required of the manufacturer under relevant EU laws and directives.

Usage of Chinese Translations for EU Responsible Person

In the English versions of EU product directives, the standard term (British English) is European Authorised Representative.

Manufacturers based in the United States typically use American English and write it as European Authorized Representative.

In Chinese translations, European Authorized Representative and European Authorised Representative are generally rendered as:

Ōuméng Shòuquán Dàibiǎo

Alternative translations include:

European Authorized Representative, EU Authorized Agent, European Authorized Agent, EU Agent, European Agent, european representative.

In China, it is more commonly abbreviated as:

EU Representative or EU Responsible Person.

Core Functions of an EU Responsible Person

• The manufacturer must submit a complete set of technical documentation to the EU Responsible Person for inspection by competent authorities.

• With an EU Responsible Person, the manufacturer may register the product with the Ministry of Health in the country where the EU Responsible Person is located, similar to registering medical devices with China’s NMPA to obtain a medical device registration certificate.

Application Requirements & Qualifications for an EU Responsible Person

A qualified EAR (eu authorized representative) shall meet the following criteria:

• Be familiar with MDR regulations and assist manufacturers in complying with the latest EU regulatory requirements.

• Possess strong technical capabilities to support enterprises in compiling and reviewing technical documentation, reducing quality risks.

• Efficiently and compliantly assist manufacturers in completing EU Responsible Person registration and other relevant device/equipment registrations within the EU.

• Have extensive experience in EU Responsible Person registration and inspection, enabling effective communication with relevant EU authorities to resolve issues on behalf of manufacturers.

Technical Documentation Requirements for EU Responsible Person Registration (Taking Disposable Medical Masks as an Example)

EU Responsible Person registration for masks requires not only an EU Authorized Representative but also a full set of product-specific technical documentation.

Technical documentation for disposable medical mask test reports shall include:

• Product description and specifications, including product name, classification, raw materials, composition, intended purpose, technical specifications, etc.

• Product labels and instructions; information related to product design and manufacturing.

• Compliance with essential safety and general performance requirements.

• Product verification and validation, including pre-clinical testing and evaluation data.

• Benefit-risk analysis and risk management documentation.

• Post-market surveillance plan.

Requirements for the Declaration of Conformity (DOC)

In addition to product technical documentation, the manufacturer must draft and sign a Declaration of Conformity (DOC).

According to MDR requirements, the Declaration of Conformity shall include:

• Product name, classification, and specifications/models.

• Manufacturer’s name and address.

• Name and address of the EU Authorized Representative.

• A statement that the product complies with MDR and relevant regulatory requirements (e.g., compliance with Directive 93/42/EEC and applicable associated regulations).

• ce certificate number (if applicable).

• Date and place of signature.