EU's IVD sector faces regulatory upheaval, while PMA threat looms, warns EDMA
This article was originally published in Clinica
Executive Summary
The European IVD industry faces having to make big changes to comply with the anticipated new requirements of the forthcoming IVD Regulation, Jesús Rueda Rodríguez, regulatory affairs director at the European Diagnostics Manufacturers Association (EDMA), has warned in an interview with Clinica.