International – IMDRF finalizes good machine learning practice, software risk documents

The International Medical Device Regulators Forum (IMDRF) on Wednesday finalized two highly anticipated technical documents detailing guiding principles for good machine learning practices (GMLP) and risk characterization for medical device software.

GMPL principles

The final IMDRF document lists ten guiding principles for good machine learning practices. They are practically identical to principles presented by the US, UK, and Canada, which are IMDRF members, in 2021. (RELATED: Regulators release 10 principles for good machine learning practiceRegulatory Focus 27 October 2021)

The principles include understanding the product’s intended use; implementing good software, design, and security practices; using population-representative datasets during clinical evaluation; and training the datasets independently of test sets…