Software has become an increasingly important part of the medical device landscape. It is
estimated that one in four medical devices either incorporate medical device software
(MDSW)1 or are MDSW in their own right. With the broad public use of smart phones and
wearable digital products, certain MDSW make use of a broad range of technologies in order
to fulfil their intended purpose. This use has enabled patients and clinicians to engage with
health information in an unprecedented manner.
In many cases, MDSW can only achieve its intended purpose when it is used in combination
with a hardware2 or hardware component (e.g., sensor) generating or providing input data. For
example, MDSW downloaded or available on wearables (e.g. bracelets, smartwatches,
virtual/augmented reality goggles) to prevent, predict or manage a disease, achieve their
intended purpose by receiving and analysing data provided by a hardware or hardware
component. In these cases, relevant hardware often incorporate components such as sensors
and cameras, the information from which may be used in a variety of MDSW, including socalled medical device applications (MDSW apps)…
