https://www.iso.org/standard/83968.html
A new version of ISO14155 is currently under development, and on 20-JUN-2024 ISO/DIS 14155, replacing ISO14155:2020 when ready, entered the voting phase that terminates on 12-SEP-2024.
A couple of interesting elements are in (potentially) impacting riskmanagement and safety for medical device clinical investigations (note the scope seems to have widened no longer excluding IVDs), such as a clarification on the difference between risks related to the investigational device and those related to the study procedures, an updated definition of adverse event (taking out the confusion term “procedures involved”), and an updated adverse events categorization in the F1 flowchart.