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

02/24/2022

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by   Kaspar Rosager Ludvigsen, et al.

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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.