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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

Registration for IVDR requirements for SOFTWARE

Software normally supports the following functions:

  • Ordering of laboratory tests, samples with labels and sorting.
  • Technical and clinical validation, connection to analytic instruments.
  • Laboratory results and reports on paper fax or electronic records that can be directly returned the ordering clinic’s patient record.
  • Analytical instruments can be interfaced with Hospital Information Systems (HIS), Electronic Patient Record Systems, Infectious control databases, etc.

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