MedTech Dive October 3, 2022
Nick Paul Taylor

Dive Brief:

  • MedTech Europe has joined with trade groups representing other manufacturing industries to warn that the Artificial Intelligence Act could have a “significant impact” on companies that are already under “regulatory strain.”
  • The trade group is concerned that “overregulation and misalignment” could create uncertainty and stop products from coming to market.
  • The organization, noting that the AI Act may impose “technical and financial burdens” and exacerbate notified body capacity constraints, is calling for changes to align the proposal with the existing New Legislative Framework (NLF).

Dive Insight:

The NLF is a cross-industry set of measures intended to improve market surveillance and the quality of conformity assessments. According to the trade groups, the AI Act modifies...

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Topics: AI (Artificial Intelligence), Medical Devices, Technology
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