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MDR stands for the Medical Device Regulation (specifically EU MDR 2017/745).

  • What it means: It is a set of regulations that governs the production and distribution of medical devices in Europe.
  • Significance: If a software platform has an MDR designation (often as “Software as a Medical Device” or SaMD), it has been certified to meet stringent safety, performance, and clinical evaluation standards. It isn’t just “tech”; it is legally a medical tool.

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