EU Responsible Person:
Unlock Amazon’s European platforms

The Responsible Person for CE-marked Products or EU Responsible Person is a natural or legal person that is appointed to communicate with the market surveillance authorities of the EU Member States in which CE marked products are sold. The Responsible Person‘s role is primarily to be a single point of contact for the authorities, and to communicate on your behalf about questions related to regulatory conformity and CE compliance. For that reason, you are best served with a person that is an expert on CE marking and the CE marking regulations, standards and approval procedures.

In 2020, the European Union institutions have adopted a regulation (Regulation 2019/1020) that intends to strengthen market surveillance in the European Union. The Regulation prohibits sales from outside the European Union directly to end-users in the EU Member States. Such sales are only allowed if the exporter has a subsidiary office in the EU, works through importers, has an authorized representative or ‘Responsible Person for CE-marked products’ or ‘EU Responsible Person’.
Ever since the regulation entered into force in July of 2021, Amazon is requiring sellers to appoint an EU Responsible Person, if they are not located in the EU but sell into the EU.

No. The EU Responsible Person’s role is only to operate as a single point of contact for regulatory inquiries. It is not intended to take over communication regarding sales inquiries.

No, you will remain liable for injuries and damage caused by a defect in the products you sell in the EU. The Responsible Person is your single point of contact for the authorities.

Remember that your market access and liability are at stake. The EU Responsible Person will represent your company towards the European market surveillance authorities. You do not want to appoint just any person that disappears at the moment there are issues. You want a knowledgeable and experienced partner that will communicate professionally with authorities. A partner that answers questions, advises you, and resolves issues efficiently. You do not want incorrect statements by your ‘Responsible Person for CE-marked products’ leading to blocked sales, or even recalls.

The requirement to appoint a Responsible Person for CE-marked Products is a requirement from Amazon if you want to sell CE-marked products through their platform. It is not a legal requirement for CE marking. The CE marking regulations require the label to show the name and address of the manufacturer and importer if that is relevant.
Some EU regulations (e.g. for medical devices)require manufacturers located outside of the EU to appoint an authorized representative. The authorized representative can also be listed with Amazon as the Responsible Person for CE-marked Products. If you need an authorized representative, Alura Group can also assist you. Contact us for the details.

Alura Group offers a dedicated service for Amazon sellers that require ‘Responsible Person for CE-marked Products’. Our company has more than 25 years of experience offering regulatory representation services. Our experts have deep knowledge about the European directives, regulations, standards, and procedures for a great variety of products. We have longstanding working experience with market surveillance authorities. We will handle any inquiry from the authorities professionally and accurately.
We offer our customers an electronic platform to efficiently maintain product conformity files efficiently. We also keep you informed about regulatory updates that are important for your products so that continued CE compliance will be ensured.

The Responsible Person is required to do the following:
– Collect the product’s EU Declaration of Conformity (or Declaration of Performance) and ensure that additional documents demonstrating EU conformity of the product can be made available from the manufacturer or brand owner upon request in a language understood by an authority;
– In some cases, inform authorities of any risk posed by the product; and
– Cooperate with market surveillance authorities, including ensuring that the manufacturer or brand owner takes necessary corrective actions to remedy any non-compliance of the product.

Yes, we do. Contact us for the details.