How The EU Needs To Address Conflicts Between AI And Medical Device Rules: Part 2

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. Royal Philips’ Koen Cobbaert explained the issues in the second part of this two-part interview piece. Part 1 was published on 28 April.

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(Shutterstock)

In this second-part of a two-part interview piece, Koen Cobbaert, senior manager, quality, standards and regulations, at Royal Philips looks in more detail at the impossible situation that notified bodies could find themselves in due to the new AI Act, at how it will impact IVDs in particular, and at the very important, but potentially compromised, issue of standards.

Koen Cobbaert

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