Medical Innovation Exchange

Software and Artificial Intelligence as a Medical Device



Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.”

The guidance brings together current guidances, advice and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD), and covers:

  • Classification of software as a general medical device or IVD, including when software applications are considered to be a medical device and how they are regulated
  • UK Regulatory Framework for Software as a Medical Device
  • Software and AI as a Medical Device: The Change Programme Roadmap
  • Qualification and Classification, including how to create an intended use statement that defines the intended purpose for your SaMD
  • Post-Market and Vigilance, covering reporting of adverse events for manufacturers and healthcare professionals and field safety corrective action requirements
  • Artificial Intelligence, a review of the 10 guiding principles for Good Machine Learning developed by MHRA, FDA and Health Canada.

The document was developed by the MHRA Software Group in collaboration with international regulators, academic groups, and UK health organizations with the goal of advancing software and AI medical device regulation.

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