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

For full functionality, this document is best viewed in Acrobat reader.

Published 8 August 2014
Last updated 20 June 2018 + show all updates
  1. Uploaded a new version of the guidance. This includes a new appendix on symptom checkers, and edits to the introduction (page 4), diagnosis (page 19) and new links related to GDPR.
  2. Document updated with link to new Introductory Guide to new medical device regulations.
  3. Updated guidance in attached document.
  4. Updated software guidance. Minor changes and clarification.
  5. We have updated the format of the guidance. It is now an interactive PDF.
  6. Updated links to Europa.eu pages
  7. First published.