The Roadmap
Welcome to The Roadmap, the technology law podcast series from Bristows. In this podcast, our technology lawyers dive into the digital transformation trends that are re-shaping modern businesses, even entire industries. In each episode, we will unpack a particular technology or trend – whether a type of transformational project, the latest market practice or a regulatory change – and explain what our clients need to understand in order to add value to their business. If you have any feedback, questions or comments, please email us at theroadmap@bristows.com - we'd love to hear from you. Also, find all the latest episodes on our tech focused site, The Cookie Jar, for views on matters shaping technology: https://www.bristows.com/the-cookie-jar-podcast-videos/
The Roadmap
Ep 34: 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 this three part series.
Learn more about our Data Protection Top 10 event here.
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