Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · EU medical devices: MDR

Medical device software (MDSW)

Also known as: MDSW, Medical device software (MDR and IVDR)

Under the EU Medical Device Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746, medical device software (MDSW) is software intended by its manufacturer to be used, alone or in combination, for a purpose that falls within the definition of a medical device or an in vitro diagnostic medical device. The term is used in MDCG 2019-11, the guidance on qualification and classification of software.

  • EU
  • MDR
  • IVDR

In one sentence

Medical device software (MDSW) is software whose intended purpose meets the MDR or IVDR device definition, whether standalone or part of a device.

Example

An app that calculates insulin doses from glucose readings and the patient’s weight is MDSW; an app that only stores appointment dates is not, because it has no medical purpose.

How it applies

  • Qualification first: Software qualifies as a device only if its intended purpose is medical, for the benefit of individual patients. Software for general wellbeing, simple storage or communication is not MDSW.
  • MDR or IVDR: MDSW that provides information derived from in vitro examination of specimens falls under the IVDR; other MDSW falls under the MDR. MDCG 2019-11 describes how to decide.
  • Standalone or embedded: MDSW can run on general-purpose hardware such as a phone or a server. Software that drives or influences the use of a hardware device is assessed together with that device; MDCG 2019-11 explains when it is qualified in its own right.
  • Classification: Under the MDR, Rule 11 applies; under the IVDR, the IVD rules apply.
  • Lifecycle standards: Development typically follows IEC 62304, usability IEC 62366-1 and security IEC 81001-5-1; these are means to show GSPR conformity, not the requirements themselves.
  • Technical documentation: Each software version needs a traceable link from intended purpose to requirements, architecture, verification and validation, and release notes; version changes are checked for significance before release.

MDSW vs. software as a medical device (SaMD)

Software as a medical device (SaMD) is the IMDRF term for software that performs a medical purpose without being part of a hardware medical device. MDSW is the EU term used in MDCG 2019-11 and is framed by the MDR and IVDR definitions rather than by the IMDRF one. The terms overlap for standalone software but are not formal synonyms; cite MDSW in EU documentation.