This page is intended for robot crawlers (which are allowed).

For the human interface, go to: glossary.

EU, EU MDR, EU IVDR, Software, Device types EU, EU MDR, EU IVDR, Software, Device types

MDSW — Medical device software

Software intended to be used, alone or in combination, for a medical purpose as set out in the definition of a medical device. Guidance distinguishes software that drives or influences a hardware device from software with an independent medical purpose, which is a device in its own right.

Reference: MDCG 2019-11

Read More
EU, EU MDR, EU IVDR, Software, Device types EU, EU MDR, EU IVDR, Software, Device types

SaMD — Software as a medical device

The international term for software intended for a medical purpose that performs that purpose without being part of a hardware medical device. Broadly parallel to medical device software in EU guidance, but the definitions are not interchangeable and the EU term should be used in EU submissions.

Reference: IMDRF SaMD WG N41

Read More