|Theme||Transition to the MDR and IVDR|
|Target Audience||Notified Bodies (NB), Manufacturers|
|Products concerned||MD & IVD|
Regulation (EU) 2017/745
Regulation (EU) 2017/746
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.