Guidance

Medical devices: software applications (apps)

Information on when software applications are considered to be a medical device and how they are regulated.

Documents

Details

Guidance on what a software application medical device is and how to comply with the legal requirements.

Read our statement on the launch of the guidance

Published 8 August 2014
Last updated 29 September 2017 + show all updates
  1. Document updated with link to new Introductory Guide to new medical device regulations.
  2. Updated guidance in attached document.
  3. Updated software guidance. Minor changes and clarification.
  4. We have updated the format of the guidance. It is now an interactive PDF.
  5. Updated links to Europa.eu pages
  6. First published.