Guidance: Medical device stand-alone software including apps (including IVDMDs) v1.06
Compensation Compensation - includes software that the manufacturer claims can compensate for an injury or handicap or claims that the sensors and output from the physical device can be used for this purpose. It doesn’t include those products that are intended for general use but can be used to compensate for an injury or handicap.
There needs to be a link to a specific injury or handicap.
Examples that may be devices include: • Apps and software that are intended to magnify text specifically for people with visual impairment. • Apps and software that are intended to amplify sounds for people with reduced hearing. Examples that are unlikely to be devices include: • Apps and software that are intended to magnify text but there is no mention of visual impairment in the manufacturer’s claims. • Apps and software that are intended to amplify sounds but the manufacture’s claims do not mention reduced hearing ability.
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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