If a non-EU manufacturer does not have an official representative in the EU, can we accept an EU declaration of conformity prepared by the importer?
If the manufacturer is not in the EU and does not have an EU representative, the importer may take over certain responsibilities - however, this does not automatically mean that the declaration prepared by the importer is equivalent to the declaration prepared by the manufacturer or the EU representative.
If the declaration is prepared on behalf of the importer, the importer must be properly identified, clearly assume responsibility (which is usually not provided for in the declaration when the document is prepared by the manufacturer) and must contain all necessary provisions - whether he performs the functions of the manufacturer (e.g., the first to place the product on the market).
From the risk perspective of your organization - the importer must ensure that he has all the technical documentation, that he can answer market surveillance questions and identify the product and the manufacturer.
The Sertika team can help you assess whether the technical documentation of the product has been properly prepared, whether the declaration is written correctly (GAP analysis), we look forward to your questions.
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