Software Applications (Apps) are significantly changing our way of living, helping in various
aspects of our daily lives, including healthcare. Medical device software (MDSW) Apps cover
an extensive variety of uses such as those intended to drive insulin pumps, detect and
diagnose skin cancers (e.g. melanoma) etc.
These apps are directly available on app platforms for download and use by patients. Their
safety and compliance with the safety and performance requirements of the Medical Devices
Regulations1 is paramount. It is therefore of crucial importance that app platform providers
enable manufacturers of MDSW to fulfil their requirements including but not limited to the
transparency requirements set out in the MDR/IVDR…
