IMDRF Provides Harmonized Definitions for When Standalone Software Is a Device

The International Medical Device Regulators Forum has issued a draft paper aimed at facilitating global regulatory convergence in the management of standalone medical software. Current regulations “do not readily translate or address the unique public health risks posed by standalone software nor assure an appropriate balance between patient/consumer protection and promoting public health by facilitating innovation,” IMDRF says.
International Medical Device Regulatory Monitor