MedTech Europe Position Paper addressed to EU Authorities advocating for ‘virtual’ IVDR/MDR audits

Posted on 01.07.2020

MedTech Europe published a position paper calling 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.

The main argument of the paper is that 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 compliance with the new Regulations at risk and even sometimes forces MDR/IVDR-ready products back under the old Directives’ regime.

 

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