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 36: Medical device software market on the brink? The AI Act alarm bells are ringing - Part 3
In this final episode of our three-part mini series on the EU AI Act and its implications for manufacturers of medical devices, Marc Dautlich and Alex Denoon look in detail at Annex V of the Act.
Annex V of the EU AI Act requires, amongst other things, that a manufacturer provide the Notified Body making a conformity assessment with a statement that the high risk AI system that is being assessed and which forms part of the medical device, and which involves the processing of personal data (as many medical devices will), "complies with the GDPR".
What exactly does a statement like that look like? And how are the Notified Bodies responsible for the conformity assessment going to evaluate the inevitable qualifications and caveats to any such statement that applicants are likely to make?
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