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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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.
A proposed revision to the European Commission’s Product Liability Directive that will extend user compensation eligibility to products such as medical smartphone apps could “needlessly disrupt” innovation in the EU, trade group MedTech Europe warns.
After some 10 years of the implementation of the EU’s Medical Device and IVD Regulations being an annual agenda item at December Council of the EU meetings, the scale of problems remains the same.