Standalone medical device software: The evolving regulatory framework

Abstract

The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software—sometimes referred to as ‘software as a medical device’. To aid the reader’s comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.

• Healthcare apps
• medical device
• regulations
• standalone software

Acknowledgements

We thank our colleagues Andrew Humphries, Nathaniel Mills and Dr Katherine Jeays-Ward for having provided constructive criticism and advice in the preparation of this paper.

Declaration of interest

The work of the Devices for Dignity Healthcare Technology Co-operative is funded by the UK National Institute for Health Research.