Open Internet by MindsNet

MDR/IVDR Notified Body Capacity Bottleneck

The MDR/IVDR transition is facing a bottleneck due to limited notified body capacity, leading to extended review timelines and potential logjams before the 2027/2028 deadlines. This is causing concerns for manufacturers, especially SMEs, who are struggling to meet the transitional requirements. The bottleneck is attributed to incomplete submissions and limited notified body resources.

Engineering, Core Engineering, Electrical Engineering