EU In Vitro Diagnostic Regulations (IVDR)

This course describes information about the compliance of the in vitro diagnostic medical devices in accordance with the European In Vitro Diagnostic Medical Device Regulations (IVDR). Topics in this course include: Definitions, Regulatory Requirements, Conformity Assessments and Performance Studies, and EU Portal and Surveillance. After completing this course, learners will be able to recognize essential requirements and harmonized standards for in vitro diagnostic medical devices.

After this course learners will be able to recognize essential requirements and harmonized standards for in vitro diagnostic medical devices. identify significant legislative changes made to the regulations. recognize how to deal with the regulations proactively so certifications remain valid.