Medical device software (MDSW)

MDSW can run on its own or drive hardware, and whether software qualifies depends on what the manufacturer claims it does. MDCG 2019-11 explains how to decide whether software is MDSW and which classification rule applies, with Rule 11 central for software under the MDR.

SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE NOTE This includes a MEDICAL DEVICE software product, which then is a MEDICAL DEVICE in its own right.

IEC 62304:2006+AMD1:2015, clause 3.12

Medical device software (MDSW) is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the Medical Devices Regulation or In Vitro Diagnostic Medical Devices Regulation.

MDCG 2020-16 Rev.5, Section 3.2.3, Software

MDSW is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the medical devices regulation or in vitro diagnostic medical devices regulation.

MDCG 2019-11 Rev.1, Section 2, Definitions and abbreviations