Responsible Person (EU)
The Responsible Person (EU) is a legal or natural person established within the European Union who is designated to act on behalf of a non-EU manufacturer for the purpose of regulatory compliance when placing products on the EU market. This role is required under specific conditions laid out in Article 4 of Directive 2014/53/EU (RED) and Article 4 of Regulation (EU) 2019/1020.
When is a Responsible Person Required?
This role applies to radio equipment placed on the EU market by manufacturers established outside the EU who do not have a physical presence in the Union. A Responsible Person must be designated to ensure regulatory accountability for:
Providing the EU Declaration of Conformity (DoC) and technical documentation to market surveillance authorities.
Cooperating with those authorities on preventive or corrective actions.
Ensuring traceability and compliance information is available and maintained.
Legal Basis
The Responsible Person is defined under:
RED Article 4(3): Requires identification of a person within the EU for radio equipment.
Regulation (EU) 2019/1020: Extends the principle to other product groups via Article 4, especially relevant in distance selling and e-commerce.
Key Requirements
The name, address, and contact details of the Responsible Person must be:
Affixed to the product packaging, label, or accompanying documents.
Clearly visible and legible for authorities and end users.
Important Distinction
The Responsible Person does not automatically assume the legal obligations of an importer or authorized representative. However, the roles can be fulfilled by the same entity, if so designated.
Acceptable Entities
The Responsible Person can be:
An importer established in the EU.
An authorized representative with a written mandate.
A fulfillment service provider (e.g. logistics platform), under certain conditions.