Guidance

Medical devices: software applications (apps)

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

Documents

Appendix 1 - symptom checkers

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Appendix 2 - clinical calculators

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Appendix 3 - ‘drives or influences the use of a device’

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Appendix 4 – Field Safety Warnings and End-of-Life notification

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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 8 September 2022 + show all updates
  1. Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'

  2. Appendices 1, 2 and 3 have been added to the attachments.

  3. Changes for qualification of IVD software and intended purpose.

  4. Updated as a result of the end of the Brexit transition period.

  5. New version published with updated information on clinical calculators, clarification on interpretation of direct diagnosis, addition of new indicative words, IVF products for selection of blastocysts, ECJ Case C 329/16 and Control of Conception.

  6. 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.

  7. Document updated with link to new Introductory Guide to new medical device regulations.

  8. Updated guidance in attached document.

  9. Updated software guidance. Minor changes and clarification.

  10. We have updated the format of the guidance. It is now an interactive PDF.

  11. Updated links to Europa.eu pages

  12. First published.