Medical device software qualification

Medical device software qualification

Medical device software qualification

Before jumping headfirst into the complexity of the Medical Device Regulation, you must be 100% sure that it is worth it. This assessment can be complex if you sell health-related software in the European Union, as the boundaries between device categories remain unclear. 

The focus is on the qualification of a device as a Medical Device Software (MDSW) or an In Vitro Diagnostic Medical Device Software (IVD MDSW), which both fall under the EU MDR or IVDR.


Can the software be considered as a medical device software ?

First of all, the software must fulfill the definition of the medical device and/or of the in Vitro medical device to be qualified as a MDSW. Moreover, it must have a medical purpose on its own and be intended to drive/influence the use of a (hardware) medical device, used alone, or in combination, for a specific purpose.

A MDSW is a software that provides informations on…

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and Annex XVI products.


An IVD MDSW is a MDSW which provides information…

  • concerning a physiological or pathological process or state (by investigation of this process or state); or
  • concerning congenital physical or mental impairments
  • concerning the predisposition to a medical condition or a disease;
  • to determine the safety and compatibility with potential recipients;
  • to predict treatment response or reactions;
  • to define or monitoring therapeutic measures.


In a former guidance, the MDCG additionally defined this term as a set of instructions that processes input data (provided through the use of a human data-input device) and creates output data (produced by a software).

Is the medical device software covered by the MDR or IVDR ?

In March 2021 the MDCG published an infographie on this topic. It describes the decision steps to assist qualification of MDSW. 

Quick overview concerning the FDA:

The term “Software as a Medical Device (SaMD)” is defined by the IMDRF as a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”. The FDA published several guidances on the requirements for the SaMD, here are some:


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