Whereas in the pharmaceutical business software plays a role in the manufacture of products, it can also act as two parts in the medical device business - one in the manufacture of a device and one as a medical device as such - i.e. software as a medical device. The British Health Authority - MHRA - has published a current guidance on software as a medical device, also called stand-alone software, intended for developers of such software. This guidance also addresses the increasingly encountered topic "apps". The text doesn't cover software that is part of a medical device, e.g. software that controls a CT scanner.
The guidance itself is very short and divided into 6 main chapters:
Key points and existing guidance
Software applications (apps)
Telehealth and telecare
Specific software considerations
The topic software application (apps) is extensively described. If apps fulfil the definitions of a medical device, MHRA regulations will apply and they will undergo a conformity assessment. The following keywords should help the MHRA determinate whether the apps are a medical device or not:
Furthermore, the guidance provides some support on which apps can be basically categorised as medical devices and which not:
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
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.
In addition, the guidance refers to a range of other documents and European Guidelines on medical devices which provide other important information.