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

TL;DR

This paper explores how to determine when software qualifies as a medical device under EU law by analyzing the role of software, its intended use, and regulatory criteria, aiding manufacturers and regulators.

Contribution

It provides a detailed framework for understanding and assessing the intention and legal requirements for software to be classified as a medical device in the EU.

Findings

Defines criteria for software to be considered a medical device

Analyzes the role of 'intention' in classification decisions

Provides guidance for compliance with EU regulations

Abstract

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.