The IVD industry welcomes the new in vitro Diagnostic Regulation (IVDR) and is fully committed to playing its part to transition to the new CE marking system.

The implementation and success of this significant system change require the deployment of necessary resources from all parties involved.

However, the COVID-19 outbreak has put the EU’s IVDR implementation progress to a halt, in particular to the running operations of Notified Bodies, Member State authorities and manufacturers, critical elements of the new regulatory system that did not exist even before the beginning of the pandemic, making it challenging for all actors to transition to the new Regulation. This directly threatens the timely establishment of the new regulatory system and the issuing of CE-marking certificates under the IVDR.

In this paper, MedTech Europe outlines the concerns that the IVD industry identified in the implementation of the IVDR. Because of these concerns, MedTech Europe requests for urgent solutions from authorities to address these concerns in order to ensure that existing and new diagnostic tests will be available for patients and healthcare systems.