On December 15, 2021, the European Parliament voted by an overwhelming majority (687 to 6) to adopt proposals by the European Commission to delay certification deadlines for the In-vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). Although steps remain before these proposals are fully formalized, it now strongly appears that IVD certification timelines will be extended beyond the IVDR formal date of application on May 26, 2022.
From IVDD to IVDR
Plans to replace the European In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) with the IVDR have been set since 2017. The IVDR initial date of application was planned for May 26, 2022.
One of the biggest changes would be a change in risk classification, which would result in about 84% of the IVDs now available in the EU requiring Notified Body certification under the IVDR–12 times as many as the current 7% under the IVDD…