Guidance: Medical device stand-alone software including apps (including IVDMDs) v1.06
Investigation, replacement or modification Investigation, replacement or modification of the anatomy or of a physiological process includes devices that claim to be able to investigate, replace or modify the anatomy or a physiological process. Examples that are unlikely to be devices include: • Educational anatomy and physiology apps and software.
Indicative words and phrases:
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Introduction
Device decision flow chart
Medical purpose flow chart
Medical devices
In vitro diagnostic medical devices
Active implantable medical devices
Non medical devices
Index
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