Standalone Software & Apps as a Medical Device – Guidance

Are standalone software and apps considered as medical devices?

The exact regulatory status of medical device software has been a vexed issue for several years now. 

And it's an issue that's frequently discussed with Notified Bodies and Certification Bodies in relation to ISO 13485 Certification. Questions of whether standalone software is a medical device or not, or whether an App was a disseminator of information or, in fact, a medical device, are typical.

What UK's MHRA Says About Standalone Software and Apps

The UKs MHRA has published a very useful guide, ‘Medical device stand-alone software including apps (including IVDMDs)’ that clarifies matters.  This guidance is intended to be used in addition to MEDDEV 2.1/6 and is the UK’s interpretation of the guidance.

Note that in the UK and throughout Europe, standalone software and apps that meet the definition of a medical device are required by regulations to be CE marked.

In ISO 13485 implementation you'll need to address this very early on in the process.  It may help you decide whether the services of a Notified Body (dearer) are required or whether a Certification Body (cheaper) can fulfill your needs. While what's given here is valid for the UK Regulatory Area on the date of publication, you'll also need to monitor the MHRA website to identify revised regulations and the adoption of the UKCA Marking.

The flowchart below, taken from the Guidelines, shows how easy it is to follow the guidance.

Flowchart on How to Determine if Software Can be Considered "Software as a Medical Device"

Further Reading

See Medical devices: software applications for the detailed guidelines or head on to our ISO 13485 course overview page to learn more about our ISO 13485 Auditor Training Courses.

Note: First published in June 2018; revised and updated in Aug 2021.

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