Importance of Importers in the MDR/IVDR
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), an importer is defined as any natural or legal person established within the European Union who places a medical device from a third country onto the EU market. The key criteria for an importer, as specified in the regulations, are: Obligations of Importers The obligations ...
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Although the MDR and IVDR define the terms importer and distributer and specify their respective obligations, certain aspects still remain unclear. In light of this, the MDCG has published a question and answer regarding Article 13 & 14 of the MDR and IVDR respectively, entitled MDCG 2021-27 with the aim of clarifying these aspects. The ...
