News New medtech regulations Newsletter

Second Corrigenda to the MDR and IVDR

Posted on 06.02.2020

On 27 December, the second wave of Corrigenda was published in the EU Official Journal: click here for the IVDR text and here for the MDR text. The MDR Corrigendum, in particular, is especially relevant because it makes important clarifications regarding the range of medical devices eligible for the MDR ‘grace period,’ which extends beyond the 26 May 2020 date of application and until 26 May 2024.