On March 13, 2019, the Council of the European Union published two draft corrigenda to fix the errors, inconsistencies, and rectify grammatical errors in EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The regulations were effective from May 2017.
The IVDR corrigendum lists 17 corrections that will have some impact on the way Class B devices are assessed and also suggests minor changes which are analyzed in detail below. Check the analysis to see if the changes have an impact on your device(s):
DISCLAIMER – This article contains a summarised information of a regulation and is for general understanding only. For more detailed analysis or making professional judgements readers are directed towards IVDR regulations (EU) 2017/746 of the European parliament or contact us