With European legislation on how to regulate the integration of artificial intelligence (AI) into daily life on the horizon, it’s time to consider how its use will impact the medical device industry, experts said at the 2023 RAPS European Clinical and Risk Management Conference.
The clinical evaluation of medical devices with AI is an “ever-changing landscape” that regulators will increasingly receive applications for, observed Rachel Mead, clinical regulatory lead at BSI Group. “This is a rapidly expanding field. We’re hearing more and more about how it can bring about transformation in the medical device field in terms of disease prevention, detection and diagnosis,” she added.
“What we need to think about is what the impact is on the regulatory framework; how we actually manage these sorts of devices moving forward from a compliance point of view,” Mead said, adding that the aim of the pending EU AI Act is not to stifle innovation as AI-linked systems hold a lot of promise for being able to adapt treatment protocols to meet individual patient needs. The problem is showing how research results translate into clinical practice and how they might provide a benefit in the long term…
