Regulating companion diagnostics: is it time for a major change?
This article was originally published in SRA
Executive Summary
Should the EU wait for the introduction of the forthcoming EU IVD Regulation (IVDR) to regulate companion diagnostics or should it create an entirely new and separate regulation for this product group? And if it does this now, could a new regulatory vehicle help to fast-track the IVDR and the Medical Device Regulation (MDR) that is also wending its way through the EU legislative process?