Medical device software market on the brink? The AI Act alarm bells are ringing - Part 1

Team-NB, representing the majority of Notified Bodies for EU MDR and IVDR medical devices, has issued a stark warning: the implementation of the EU AI Act carries a significant risk of major disruption to the medical device software sector.Their recently published Position Paper doesn't hold back, highlighting critical shortcomings in the implementation framework and emphasising the dwindling time left to address them. Team-NB is urgently calling for swift action to prevent widespread issues.To unpack this crucial situation, our specialists Marc Dautlich and Alex Denoon offer their expert analysis of the Team-NB findings – and an additional key consideration – from the vantage points of data protection and product regulatory in the three part series.