Input data

MDCG 2019-11 lists many forms of input, from keyboard entry to documents and sensor signals. Looking at what goes in and what comes out helps decide whether software performs a medical function.

Any data provided to software in order to obtain output data after computation of this data can be considered as input data. Input data examples (non-exhaustive): - Data given through the use of a human data-input device such as a keyboard, mouse, stylus, camera or touch screen; - Data given through speech recognition; - Digital document: formatted for general purpose such as Word file or pdf file or jpeg image, formatted for medical purpose such as DICOM file or ECG records or Electronic Health Record, unformatted document. Note that digital documents have to be differentiated from software able to read such documents; - Data received from/transmitted by devices.

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