IVDR requirements for SOFTWARE
Software fulfilling the definition of an in vitro diagnostic medical device falls under the in vitro diagnostic medical devices regulation (EU) 2017/746 (IVDR). In the past, several of these are self-certified or not covered under IVDD. Provided that MDSW is intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable it to be used in accordance with its intended purpose, this MDSW falls under the scope of the in vitro diagnostic medical devices regulation and shall be treated as an In Vitro Diagnostic MDSW (IVD MDSW) in its own right.
Functions of In vitro diagnostic medical device software