How The EU Needs To Address Conflicts Between AI And Medical Device Rules: Part 1
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.
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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.
The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.
A review of expert panel opinions related to high-risk medical devices shows no challenges yet by notified bodies to their findings.