Understanding the Role of
EU MDR & IVDR Importer
What is an EU MDR/IVDR Importer and Why is One Required?
In May 2021 the new European Medical Device Regulation (MDR) became effective, as will the In Vitro Diagnostic Regulation (IVDR) in May 2022. Article 13 in both regulations defines the expanded role and responsibilities of the importer. Despite the moniker, an EU importer (in the context of the MDR and IVDR) is a compliance role, similar to an Authorized Representative. They are generally not involved in product handling or logistics. Device companies with no legal entity in Europe must define who will take on the importer responsibilities and we explain how this works in this short video.