EU AI Act Legal Deep-Dive Part 1: What Can Medtech Expect, And When?

The text of the European Commission’s proposed AI Act is expected to enter the EU high-level negotiation stage within weeks, yet many questions remain as to what the final regulation will entail. Lawyers from Cooley LLP tell Medtech Insight why considerable changes to the text are possible, and what the new law is likely to mean for medtech.

Last month, members of the European Parliament voted in favor of substantial changes to the draft AI Act – a key step towards this landmark legislation being adopted in the EU.

The compromise amendments set out significant updates to the original proposal – although many of these changes are not directly relevant to medical device and IVD manufacturers.

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