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 EU’s proposal for a new Artificial Intelligence (AI) Act is set to have a “massive impact” on medical devices and IVDs.

More work is needed to address the current misalignments between the proposed horizontal Act, which will be superimposed on many different industrial sectors, and the EU’s new device regulations, Koen Cobbaert, senior manager, quality, standards,

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