In relation to a topic of interest for our sector – virtual audits – I hereby send you enclosed, for your information, the MedTech Europe Position Paper addressed to EU Authorities advocating for ‘virtual’ IVDR/MDR audits published in July.
The main argument of the paper is that COVID-19 related travel restrictions and quarantine orders around the world make it 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 the market which could help in the fight against COVID-19. Equally, it puts compliance with the new Regulations at risk and even sometimes forces MDR/IVDR-ready products back under the old Directives’ regime.
