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

When is Software a Medical Device? Understanding and Determining the 'Intention' and Requirements for Software as a Medical device in EU law