Why Manufacturers Face A ‘Phenomenal Challenge’ In Navigating EU AI Act Regulatory Maze
The European Commission’s proposed Artificial Intelligence Act has undergone some adaptations over the past year, but concerns remain around its impact on the medtech sector. In this interview, Philips’ Koen Cobbaert outlines the current situation and challenges.
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Many computer science experts believe that the European Commission’s proposed AI Act is too legislatively heavy. In the second of a two-part interview series, Philips’ Koen Cobbaert explains what parts of the draft legislation are most troublesome for medtech.
There are serious concerns about how the EU’s proposal for a new Artificial Intelligence Act could disrupt the regulation and supply of medical devices in a few years. Royal Philips’ Koen Cobbaert, explains the challenges in detail in this first part of a two-part interview piece.
Ten medical device manufacturers will receive scientific advice from expert panels on their product clinical development strategies under a new European Medicines Agency pilot scheme. But who will it ultimately benefit and what does the scheme entail?