Output data

MDCG 2019-11 uses output data when deciding whether software is medical device software. What matters is whether the software acts on data in a way that goes beyond storing, archiving, communicating or simple search, for the benefit of individual patients.

Any data produced by a software can be considered as an output data. Output data examples (non-exhaustive): - Screen display data (such as layout with number, characters, picture, graphics, etc.); - Print data (such as layout with number, characters, picture, graphics, etc.); - Audio data; - Digital document (formatted for a general purpose such as Word file or pdf file or jpeg image, or formatted for medical purpose such as DICOM file or ECG records or Electronic Health Record, unformatted document); - Haptic buzzing as an alternative to audio sound; - Alarms (Haptic buzzing as an alternative to audio sound or a warning in a free text form); - Digital or analogue signal controlling another medical device.

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