Importers and Distributors: Pivital roles in MDR and IVDR Compliance
There is a common misconception that only manufacturers need to comply with the Medical Device Regulation (MDR) 2017/745 and/or the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) . However, MDR/IVDR defines the roles and the responsibilities of “Economic Operators” which includes Importers, Distributors, Authorized Representatives and Manufacturers. An Importer means any natural or […]