What is Software as a Medical Device?

Software as a Medical Device, or SaMD, is software intended to be used for one or more medical purposes without being part of a physical medical device. The term was defined by the International Medical Device Regulators Forum and is widely used by the FDA and European regulators. Examples include applications that analyse medical images, calculate drug dosing, or triage symptoms. In the EU, software that qualifies as a medical device is regulated under the MDR or IVDR and classified by the significance of the information it provides and the state of the patient. When such software uses artificial intelligence, the EU AI Act may also apply as a parallel regime. SaMD raises distinct regulatory questions around clinical evaluation, cybersecurity, change management for software updates, and post-market monitoring of real-world performance.