MDCG 2022-14 : Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs – August 2022

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.