The COVID-19 related travel restrictions and quarantine orders around the world, make it neither possible nor safe for physical (on-site) Notified Body audits to happen in the foreseeable future. This has major implications on the MDR/IVDR conformity assessment procedures which in many cases are put on hold, thereby threatening industry’s efforts to place products on … Continue reading The need for ‘virtual audits’ under the Medical Device and In Vitro Diagnostic Regulations in the context of a pandemic, such as COVID-19