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UK's MHRA Guidance: Software & AI as a Medical Device Change Programme

The Medicines and Healthcare Products Regulatory Agency (MHRA) has begun reforming medical device regulation to ensure software, including artificial intelligence (AI), is compliant. As a part of this initiative, the MHRA updated its guidance on the "Software and AI as a Medical Device Change Programme" earlier today (17-Oct-2022).

The role of software (and AI in particular) in healthcare systems is becoming increasingly prominent. For this reason, medical device regulation must be fit for the purpose to ensure the best use of medical technology for patients, the public, and healthcare professionals.


By implementing the Change Programme, a robust regulatory framework will be created that protects patients and the general public. In addition, it ensures that the UK is recognized globally as a center for innovative medical device software.


The major work packages in the Software and AI as a Medical Device Change Programme are set out in this guidance and the work packages have one primary aim: to protect patients and the public whilst ensuring that we accelerate responsible innovation.


Click this LINK to know more about this guidance.



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