Are you a seller on Amazon and have you been requested to ensure you have a Responsible Person for CE-marked products? You do not have a European Union office or subsidiary and you do not know how to fulfill this requirement from Amazon? We can help!
Alura Group’s European Union headquarters offers this service to act as your Responsible Person for CE-marked products. We can provide you with a practical solution for this requirement. This service also includes the review and verification of test reports, certificates, and other conformity documentation you received from your manufacturers. This way you can rest assured that your files are complete, your product liability is minimized, and you can continue to sell on Amazon.
Frequently Asked Questions:
The Responsible Person for CE-marked Products 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. This person is not a sales representative or distributor. S/he will also not take over your product liability. 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 uses a fulfillment service provider. Read more about the Regulation and what it means for non-EU-based manufacturers and sellers here.
Amazon does provide fulfillment services. Apparently, Amazon does not want to take the role of the person to communicate with the market surveillance authorities on product conformity issues. By requiring its non-EU-based sellers of CE-marked products to appoint a Responsible Person for CE-marked Products they avoid being held responsible by the European authorities.
No. The 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.
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. If the manufacturer is located outside of the EU and sells through Amazon directly to end-users in the EU, it is wise to appoint an authorized representative. The authorized representative can then be listed with Amazon as the Responsible Person for CE-marked Products.
How can we help you to meet the Amazon ‘Responsible Person for CE-marked Products’-requirement?
Alura Group offers a dedicated service for manufacturers and exporters that require an authorized representative for regulatory conformity matters in the European Union. The company has more than 20 years of experience offering this service. Our experts have a longstanding experience with European directives, regulations, standards, and procedures for a great variety of products. We will handle any inquiry from the authorities professionally and accurately. You do not want incorrect statements by your ‘Responsible Person for CE-marked products’ leading to blocked sales, or even recalls.
We offer our customers an electronic platform to efficiently maintain product conformity files. We also keep you informed about regulatory updates that are important for your products so that continued CE compliance will be ensured.