Description: The Medical Device Regulation (MDR) and In Vitro Diagnostics Regulations (IVDR) introduced a “new” Economic Operator; the Importer. The role of this importer has become essential for medical devices regarding regulations and device placement within the EU but also the UK, and Swiss markets. In this presentation, we will discuss how an importer can navigate market placement efficiently while ensuring regulatory requirements are met and how legal manufacturers can ensure compliance in the distribution chain related to this topic.
Learning Objectives:
The responsibilities of a regulatory importer
How obligations of an importer can be met
Who can act as a regulatory importer
How to ensure compliance of partners acting as regulatory importer
The importance of ongoing compliance with EU, UK, or Swiss regulations
