healthcare.digital July 3, 2019
When is software a medical device?
The MDR sets out clear rules on this, which are broadly similar to the previous position but provide helpful clarification.
The key test relates to the purpose of the software. The MDR states:
Example: software used for diagnosis, or predicting disease
Example: medical records software used as a storage or retrieval system
Example: apps which monitor fitness levels, diet and wellbeing
Software in its own right, when specifically intended by the manufacturer to be used for one or more medical purposes, is a medical device.
Software for a general purpose, even if used in a health care setting, is not a medical device.
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