The Journal of mHealth Vol 1 Issue 2 (Apr 2014) | Page 58

UK's MHRA Issues Guidance on Stand-Alone Software and Apps
Continued from page 55

products that have been “placed on the market” rather
than sold.

Viruses and Antivirus Protection
Currently only a small number of smart phones are protected
by security software. Any virus that attacks the mobile phone
operating systems may also affect the medical device app and
this may not work as the manufacturer intended and the user
may be unaware of this. Incorrect use of antivirus software is
also known to affect performance of medical devices.

Software that Makes Recommendations Based
on Patient Entered Data
Software intended to carry out further calculations, enhancements or interpretations of patient images or data, is a medical device. It’s also a medical device if it carries out complex
calculations, which replaces the clinician’s own calculation.

Software that Replaces Existing Paper Charts

Software which Uses A Physical Accessory
If the app has a medical purpose and relies on a physical
accessory to obtain data to function, e.g. a device to position
a smartphone’s camera, it will be a medical device and the
device that positions the camera could be viewed as an accessory to the software. Accessories are classified in their own
right separately from the device with which they are used.

Software that Utilises A Patient’s Genetic
Information Together with Other Data from A
Patient Record for A Medical Purpose
The guidance document MEDDEV 2.1/6 gives the example
of “software that integrates genotype of multiple genes to
predict risk of developing a disease or medical condition” and
considers the software to be an in-vitro diagnostic.

These are not usually considered to be a medical device; however, the addition of complex functions to the product can
make it a medical device.

Software for in-House Use Only

Software Combined with Non-Medical Products

Disclaimers

A system can comprise medical devices that need
to be CE marked for a medical purpose as well as
other devices that could be used in a social care context but will not be regulated as a medical device.
In cases where the system incorporates devices which do
not bear a CE marking or where the chosen combination of
devices is not compatible in view of their original intended
use, the system will be treated as a device in its own right and
as such be subjected to the relevant conformity assessment.
The MDD requires the whole system to be safe. This is particularly pertinent to stand alone software, where the manufacturer must demonstrate compatibility with the recommended hardwar