Artificial Intelligence Medical Devices
The Charter of the Artificial Intelligence Medical Devices working group is to achieve an aligned approach to the management of artificial intelligence (AI) based-medical devices.
The first project of the working group will cover machine learning-based medical devices representing AI technology applied to medical devices and further standardize terminology for machine learning-based medical devices among member jurisdictions.
The working group has developed a document for terminology and is having the public consultation for the document below:
- IMDRF/AIMD WG (PD1)/N67:2021 Machine Learning-enabled Medical Devices—A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions