On Medical Device Software CE Compliance and Conformity Assessment

TL;DR

This paper discusses the regulatory challenges faced by developers of standalone medical device software, highlighting mismatches between software and physical device regulations based on industry experiences.

Contribution

It identifies specific regulatory requirement mismatches for standalone medical software and provides insights from industry practices and development processes.

Findings

Regulatory requirements often do not differentiate between physical devices and software.

Developers face unique challenges due to regulatory mismatches.

Industry experiences reveal the need for tailored compliance strategies.

Abstract

Manufacturing of medical devices is strictly controlled by authorities, and manufacturers must conform to the regulatory requirements of the region in which a medical device is being marketed for use. In general, these requirements make no difference between the physical device, embedded software running inside a physical device, or software that constitutes the device in itself. As a result, standalone software with intended medical use is considered to be a medical device. Consequently, its development must meet the same requirements as the physical medical device manufacturing. This practice creates a unique challenge for organizations developing medical software. In this paper, we pinpoint a number of regulatory requirement mismatches between physical medical devices and standalone medical device software. The view is based on experiences from industry, from the development of all-software medical devices as well as from defining the manufacturing process so that it meets the regulatory requirements.