Mind the gap: How to navigate the IVDD-IVDR transition - Part 2
(WorldNews Switzerland)

By Laura Nea The global trend toward more stringent regulatory control of in vitro diagnostic (IVD) medical devices is sending shock waves through the industry. Now that we have passed the halfway mark in the transition to Europe`s new In Vitro Diagnostic Regulation (IVDR 2017/746), it`s crucial that diagnostics businesses critically evaluate their entire supply chain to close any gaps and ensure IVDR-compliance can be maintained throughout the device lifecycle. An important question to ask is whether outsourcing your IVD projects will help or hinder your efforts to comply and remain competitive in this shifting regulatory landscape. In the final blog of this 2-part series, we consider the...