When Is Software a Medical Device? Understanding and Determining the “Intention” and Requirements for Software as a Medical Device in European Union Law

Ludvigsen, Kaspar; Nagaraja, Shishir; Daly, Angela

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.

Citation

Ludvigsen, K., Nagaraja, S., & Daly, A. (2022). When Is Software a Medical Device? Understanding and Determining the “Intention” and Requirements for Software as a Medical Device in European Union Law. European Journal of Risk Regulation, 13(1), 78-93. https://doi.org/10.1017/err.2021.45

• Journal Article Type: Article
• Acceptance Date: Sep 1, 2021
• Online Publication Date: Sep 20, 2021
• Publication Date: 2022-03
• Deposit Date: Aug 22, 2024
• Journal: European Journal of Risk Regulation
• Print ISSN: 1867-299X
• Electronic ISSN: 2190-8249
• Publisher: Cambridge University Press
• Peer Reviewed: Peer Reviewed
• Volume: 13
• Issue: 1
• Pages: 78-93
• DOI: https://doi.org/10.1017/err.2021.45
• Public URL: https://durham-repository.worktribe.com/output/2609735