Software as a Medical Device (SaMD) Regulations
In 2021, the NIHR Trauma MIC were successful in leveraging funding to add mental health as a workstream. This provided funding for a piece of work which aims to clearly outline the regulations for Software as a Medical Device (SaMD), particularly software focussing on mental health.
The document outlining the SaMD regulations can be found below in addition to the webinar recording from July 2023.
SaMD Regulatory Pathway Document
V2.0_MentalHealthRegulatoryWork by Emily Brush
SaMD Regulatory Pathway Webinar Recording
