This class is for medical device professionals who need get a foundation in the EU IVD Regulation. If you are an experienced auditor and need to learn how to perform audits to the EU IVDR requirements, choose our EU IVDR Auditor Training class.
The changes under Europe’s new IVD regulation are significant, including the need for Notified Body involvement, a greatly expanded definition of what is considered an IVDR, a new risk-based IVD classification system, increased clinical evidence requirements, new quality system mandates, and more rigorous postmarket scrutiny.
IVD manufacturers who conduct business in the EU must start their transition or implementation of the new regulation now in order to meet the May 26, 2022 deadline. This course is a critical first step. In this class you’ll learn about the significant new requirements found in the IVDR, their impact on manufacturers, and how to plan an effective and efficient implementation of to the IVDR.