When Is Software a Medical Device? Understanding and Determining the "Intention" and Requirements for Software as a Medical Device in European Union Law. (20th March 2022)

• Record Type: Journal Article
• Authors: LUDVIGSEN, Kaspar; NAGARAJA, Shishir; DALY, Angela
• Is Part Of: European journal of risk regulation. Volume 13:Number 1(2022)
• Page Start: 78
• Page End: 93
• Publication Date: 2022-03-20
• Subjects: Risk management -- Periodicals; Risk management -- Europe -- Periodicals; Periodicals; 363.102
• DOI: 10.1017/err.2021.45
• Languages: English
• ISSNs: 1867-299X

Abstract

Abstract : The role of software in society has changed drastically since the start of the twenty-first century. Software can now partially or fully facilitate diagnosis and treatment of a disease, regardless of whether it is psychological or pathological. Consequently, software plays a role comparable to medical equipment with a physical footprint. Understanding when software as a medical device must comply with applicable rules is vital for both manufacturers and regulators. We therefore examine the Medical Device Regulation to expand on the notion of intention, as this is the key basis for the classification of medical devices. Finally, we develop objective criteria that software must fulfil to be considered a medical device under European Union law.