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).

Sensors or other hardware components are in certain cases integral parts of general-purpose consumer electronics or wearable digital products. The interaction between the MDSW, hardware or hardware component (in particular integrated sensors) raise the question regarding the qualification and the appropriate regulatory pathway or conformity assessment of these hardware or hardware components.


MDCG 2023-4 – Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components