New Guidance on Good Machine Learning Practice for Medical Devices: Top 5 Takeaways

Lexology November 9, 2021
Baker McKenzie

Last month, medical device regulators in the US, Canada and the UK issued 10 key guiding principles to facilitate the development of effective, safe and high quality artificial intelligence/machine learning (AI/ML) enabled medical devices. The project involves the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in collaboration with the US Food and Drug Administration (FDA) and Health Canada (the Regulators).

We’ve set out our top 5 takeaways from the guidance below.

1. Aims to ensure that the medical devices produced are effective, safe and of high-quality: Developments in AI/ML have shown potential to radically expand and transform this sector. However, the complexities in this field (as well as the pace of innovation) necessitate a strong message of Good Machine...

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