Theme Transition to the MDR and IVDR
Target Audience Notified Bodies (NB), Manufacturers
Products concerned MD & IVD
Documents mentioned

Regulation (EU) 2017/745

Regulation (EU) 2017/746

MDCG 2019-6

MDCG 2020-12

MDCG 2022-4

MDCG 2022-11


This document, published in August 2022, outlines actions to improve the efficiency of the implementation of regulatory requirements to avoid disruption of supply of IVD and MD. Actions are proposed to address 3 major challenges: increasing NB capacity, improving access to NB, and improving manufacturer preparedness.