The International Medical Device Regulators Forum (IMDRF) has published guiding principles for artificial intelligence/good machine learning (AI/ML) practices in medical device development that are identical to a 2021 document published by US, UK, and Canadian regulators.
On 1 July, IMDRF published its 10 guiding principles for stakeholders developing ML medical products developed by its Artificial Intelligence/Machine Learning-enabled Working Group. These principles include ensuring the device’s intended use and purpose are well understood and that a range of experts are involved during the product’s lifespan to evaluate it, all of which are part of the guiding principles developed by US, UK, and Canadian regulators. (RELATED: Regulators release 10 principles for good machine learning practice, Regulatory Focus 27 October 2021)
“The 10 guiding principles for Good Machine Learning Practice (GMLP) presented in this document are a call to action to international standards organizations, international regulators, and other collaborative bodies to further advance GMLP,” said IMDRF. “Areas of collaboration include research, creating educational tools and resources, international harmonization, and consensus standards, to inform regulatory policies and regulatory guidelines.”…
