On 25 June, the IMDRF published their updated “In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC).” This document sets out significant revisions based on regional policy changes since the last update was published in 2019.
The table of contents is designed to support IVD regulatory submissions. IMDRF have confirmed that companion diagnostics are in scope but clinical trials are not.
The document intends to create a comprehensive submission structure that minimises regional divergences and indicates where regional variation exists. It is intended to provide guidance regarding the location of submission elements in the internationally defined structure.
