Roles and Responsibilities in CE Conformity
A complete guide to the responsibilities of the Manufacturer, Importer, Distributor, and B2B Online Seller for placing compliant products on the market: conformity assessment and Technical Documentation, CE marking and EU Declaration of Conformity, document verification and storage, user instructions in the language of the destination country, proper management of storage and transport, and information obligations for online sales.
Manufacturer
Responsible for carrying out the conformity assessment and preparing the Technical Documentation to demonstrate that the product has been designed and manufactured in compliance with the applicable European directives. The manufacturer must also affix the CE marking and issue the EU Declaration of Conformity.
Importer
Responsible for verifying that products coming from non-EU countries comply with EU legislation. Must ensure that the manufacturer has carried out the conformity assessment and prepared the required Technical Documentation, keeping a copy of the Declaration of Conformity and making the necessary documents available to the competent authorities upon request.
Distributor
Must verify that the product bears the CE marking and is accompanied by the Technical Documentation and user instructions in the language of the destination country. The distributor is also responsible for ensuring that the product is stored and transported in conditions that do not compromise its conformity. Applicable directives and regulations.
B2B Online Seller
Equivalent to a distributor: must verify CE marking (where required), and ensure that instructions and mandatory information are provided in the language of the destination country, along with essential data sheets and documents before purchase. Must ensure traceability, proper management of storage and shipping, collaboration with authorities, and handling of alerts or recalls. If the seller imports directly, they also assume the responsibilities of the importer.