Consortium Calls for Comment on Real-World Evidence Framework for IVDs

The Medical Device Innovation Consortium (MDIC) has invited comments on its new framework for using real-world evidence (RWE) in the development and regulatory clearance of in-vitro diagnostics (IVDs).

The framework outlines how to generate RWE to support regulatory submissions, including ways to address data quality issues.

The consortium aims to develop best practices for appraising IVD data from routine clinical practice.