The Journal of mHealth Vol 1 Issue 2 (Apr 2014) | Page 56

UK's MHRA Issues Guidance on Stand-Alone Software and Apps
Continued from page 53

Systems
There is no definition of a system in the directive but there
are specific requirements for products placed on the market
that combine CE marked devices and non-CE marked products, e.g. a combination of laptop (not a medical device), software (a medical device) and heart monitoring hardware (an
accessory) is considered to be a ‘system’ if these are placed
on the market together.

Existing Guidance
In January 2012, the European Commission (EC) published
a set of guidelines in MEDDEV 2.1/6 - Guidelines on the
qualification and classification of standalone software used in
healthcare within the regulatory framework of medical devices.
These guidelines will help you decide if your software is a
medical device or an in-vitro diagnostic.
The following documents provide useful information to
help software developers understand regulations for medical
device software:
» European Commission MEDDEV 2.1/1 Definitions of
“medical devices”, “accessory” and “manufacturer”
» European Commission Manual on borderline and classification in the Community Regulatory framework for
medical devices
» Team NB FAQ on Implementation of EN 62304:2006
with respect to MDD 93/42/EEC.
» MHRA Borderlines with medical devices.

Software Applications (apps)
Mobile devices have unique qualities because they store
personal data, are generally always switched on, have a
light source and a camera that can capture high quality images and can provide information such as orientation through in-built sensors. There has been an increase
to use the software on these devices for medical purpose.
If these software applications meet the definition of a
medical device, it will be regulated by MHRA as a medical
device and will have to undergo a conformity assessment.
The words and phrases listed below are all likely to contribute
to a determination by the MHRA that the app they were associated with is a medical device:
» amplify
» analysis
» interpret
» alarms
» calculates
» controls
» converts

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April 2014

»
»
»
»

detects
diagnose
measures
monitors

There are a number of different types of apps and these
could be categorised by function such as:
» Decision-support or decision-making software that
applies some form of automated reasoning, such as a
simple calculation, a decision-support algorithm or a
more complex series of calculations, e.g. dose calculations, symptom tracking, clinicians guides. These are the
types of software most likely to fall within the scope of
the medical devices directives.
This includes software which provides personalised guidance
based on information it has about a specific individual and
makes use of data entered by them, provided by point of care
devices or obtained via health records.
» Apps acting as accessories to medical devices such as in
the measurement of temperature, heart rate, blood pressure and blood sugars could be a medical device as are
programmers for prosthetics.
» Software that monitors a patient and collects information
entered by the user, measured automatically by the app or
collected by a point of care device may qualify as a medical
device if the output affects the treatment of an individual.
» Software that provides general information but does not
provide personalised advice, although it may be targeted
to a particular user group, is unlikely to be considered a
medical device.
» Software that is used to book an appointment, request a
prescription or have a virtual consultation is also unlikely
to be considered a medical device if it only has an administrative function.
Some decision-support software may not be considered to
be a medical device if it exists only to provide information
to enable a healthcare professional to make a clinical decision
as they ultimately rely on their knowledge. However, if the
software or app performs a calculation or interprets or interpolates data and the healthcare professional does not review
the raw data, then this software may be considered a medical
device. Increasingly apps are being used by clinicians who will
rely on the outputs from this software and may not review the
source/raw data.

Telehealth and Telecare
Telehealth is the delivery of health services or information
using telecommunication technologies. It uses devices to
monitor people’s health in their own home including monitoring vital signs (blood pressure, blood oxygen levels or weight).
The data can then be transmitted to a healthcare professional
who can observe health status without the patient leaving