A deep analysis of the IVD Regulation

Petra Zoellner, Director IVDR-MDR, discusses the transition to the IVD Regulation and its implications for the sector.

In October 2022, MedTech Europe ran its latest survey to gather data from IVD manufacturers on the state of the IVDR regulatory infrastructure. The survey represents an estimated 75% market revenue coverage, and the full report and its annex with visuals of the results may be read here.