Document paper COVID19 COVID19 acute Notified Bodies

The need for ‘virtual audits’ under the Medical Device and In Vitro Diagnostic Regulations in the context of a pandemic, such as COVID-19

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 the market which could help in the fight against COVID-19. Equally it puts at risk compliance with the new Regulations and even sometimes forces MDR/IVDR-ready products back under the old Directives regime.

In its position paper, MedTech Europe urgently calls upon the European Commission and Member States to publish guidance clarifying that in place of on-site audits, Notified Bodies may conduct audits under MDR and IVDR in a ‘virtual’ mode. These virtual audits should not only be limited to COVID-19 related products.

Posted on 10.06.2020

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