Medical device stand-alone software including apps (including IVDMDs)
posted 8th September 2022
The MHRA has just published its latest guidance update on medical device stand-alone software including apps (including IVDMDs).
The guidance uses examples within flowcharts to show which standalone software and apps meet the definition of a medical device, an in vitro diagnostic device or active implantable medical device and are required to be UKCA marked, and those which do not.
For developers of software, including apps, it also includes information on classification, suggestions on how to address the main aspects of the UKCA marking process and responsibilities for reporting and correcting when things go wrong!