Urgent solutions needed to ensure a successful transition to the new IVD Regulation in light of COVID-19

Posted on 09.09.2020

MedTech Europe has published a position paper on the impact of the ongoing COVID-19 crisis on the implementation efforts of the IVD Regulation, set to be fully implemented in May 2022.

Since at least January 2020, in vitro diagnostic (IVD) manufacturers have faced unprecedented worldwide demand from healthcare systems for tests needed to combat COVID-19. The circumstances of the COVID-19 outbreak have derailed the IVDR implementation process, as the European Commission and Member States, as well as manufacturers, have needed to redirect significant resources towards combating the COVID-19 outbreak. Nevertheless, Europe still needs a well-functioning and predictable regulatory framework for diagnostics, and the paper outlines the concerns that the IVD industry has identified in the implementation of the IVDR.

Because of these concerns, MedTech Europe requests urgent solutions from authorities to address these concerns and to ensure that existing and new diagnostic tests will be available for patients and healthcare systems.