Software as a Medical Device (SaMD) refers to software intended for medical purposes that performs these functions without being part of a hardware medical device.
Under the EU MDR (Regulation 2017/745), it’s officially termed Medical Device Software (MDSW).
Key Definitions
MDSW under EU MDR aligns closely with the global SaMD concept defined by IMDRF.
A software must have a clearly defined intended medical purpose such as diagnosis, treatment, prevention, or monitoring of a condition.
Examples of SaMD/MDSW
– AI-based radiology tools
– Depression treatment apps
– Software for detecting pneumonia in chest X-rays
Regulatory Trigger: Intended Use
Your declared intended use is the most critical driver of classification. Even minor “call-to-action” features (e.g., “contact your doctor”) can elevate a wellness app into a regulated medical device.
Resources
This post is part of SaMD Europe Launch Guide.
This content has been enhanced by GenAI tools.