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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Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.
Medtech companies will soon be able to reference an updated European version of the international risk management standard when proving compliance with the EU Medical Device Regulation.