Bristows' Podcast
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Bristows' Podcast
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?