Theme Obligations of persons referred to in Article 16
Target Audience Importers and distributors
Products concerned


Documents mentioned

MDR (EU) 2017/745

IVDR (EU) 2017/746

This guide presents a series of questions and answers about the obligations of importers and distributors referred to in Article 16 of Regulations (EU) 2017/745 and 2017/746.  As a reminder, it is stipulated in this article that when a distributor, importer or other natural or legal person carries out certain activities, such as relabelling and repackaging, they are assigned the obligations of the manufacturer.

These obligations do not apply to subcontractors of the manufacturer who perform these activities on behalf of and under the control of the manufacturer.