Can I read IVDR Compliance Guide for IVDs on EtoBox?

IVDR Compliance Guide for IVDs by Steven King is a document available to read on EtoBox.

What is IVDR Compliance Guide for IVDs about?

The document provides an overview of the new In Vitro Diagnostic Regulation (IVDR) that replaces the In Vitro Diagnostic Directive. The IVDR introduces stricter requirements for IVD devices, including a new risk-based classification system, increased clinical evidence requirements, and more stringent oversight of notified bodies and manufacturers. It has a transition period until 2022 when full compliance will be required. The IVDR aims to improve regulation of IVD devices to better protect public health in

Author

Steven King

Language

EN