Update on standardisation efforts for the MDR and IVDR
The availability of harmonized standards is a topic that is constantly and hotly debated in the context of the MDR and IVDR. Harmonized standards can be used by manufacturers to demonstrate compliance to the Regulations’ General Safety and Performance Requirements. The process of harmonization has been slow up to now. @Mario Gabrielli Cossellu from the Commission has now published a presentation that outlines the current state of affairs and provides an outlook on the next steps that will be taken.
?You may access the corresponding presentation with additional details here: Click