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Regulatory Framework of Software as Medical Device

Regulatory Framework of Software as Medical Device

Artificial intelligence (AI) and machine learning (ML) based technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day.

Medical device software is software that is intended to be used, alone or in combination, for a medical purpose as specified in the definition of a "medical device" in the medical devices regulations under concern.

  • Article 2(1) of EU MDR Regulation (EU) 2017/745
  • Section 41BD of the Therapeutic Goods Act 1989
  • Section 201(h) of the Food, Drug, and Cosmetic Act
  • Software for the following intended purposes is considered to be a medical device.
  • When Software that does not meet the definition of a medical device (i.e. software that is not SaMD) but is intended by the manufacturer to be an accessory for a medical device, falls under the scope of regulation.

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