  The role of software in society has changed drastically since the start of
the 21st century. Software can now partially or fully facilitate anything from
diagnosis to treatment of a disease, regardless of whether it is psychological
or pathological, with the consequence of software being comparable to any other
type of medical equipment, and this makes discovering when software must comply
with such rules vital to both manufacturers and regulators. In lieu of the
Medical Device Regulation we expand on the idea of intention, and identify the
criteria software must fulfil to be considered medical devices within EU-law.
