Amending legislation published to extend the transition of legacy IVDs and roll out EUDAMED
Regulation 2024/1860 was officially released to extend the transition time for legacy IVDs, roll out EUDAMED, and require data on disruption in supply as Article 10a Medical Devices Regulation (2017/745, MDR) and the In Vitro Diagnostics Devices Regulation (2017/746, IVDR). This was long awaited and formalized aspects that were discussed for over six months. Discussions related to Article 10a are still ongoing.
In the table below, we present the impending deadlines for legacy IVDs. One legacy element is that the IVD was placed on the market before the IVDR Date of Application (DoA), May 26, 2022…
