Guidance

Medical devices: software applications

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

From:
Medicines and Healthcare products Regulatory Agency
Published
8 August 2014
Last updated
1 July 2023 — See all updates

Documents

Medical device stand-alone software including apps

PDF, 1.49 MB, 43 pages

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Appendix 1 - symptom checkers

PDF, 110 KB, 1 page

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Appendix 2 - clinical calculators

PDF, 124 KB, 1 page

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

PDF, 105 KB, 1 page

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

PDF, 128 KB, 1 page

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Details

This guidance explains when a software application is considered a medical device and how the MHRA regulates such applications.

You can also find out how to ensure you to fulfil your legal duties if you are placing an application on the UK market.

For full functionality, the PDF documents are best viewed in Acrobat reader.

Updates to this page

Published 8 August 2014
Last updated 1 July 2023 + show all updates

  1. Updated file 'Medical device stand-alone software including apps (including IVDMDs)' to reflect that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

  2. Updated file 'Medical device stand-alone software including apps' to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.

  3. Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'

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

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

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

  7. 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.

  8. 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.

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

  10. Updated guidance in attached document.

  11. Updated software guidance. Minor changes and clarification.

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

  13. Updated links to Europa.eu pages

  14. First published.

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