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
  Show all updates

  1. 1 July 2023

     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. 16 May 2023

     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. 8 September 2022

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

  4. 6 September 2022

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

  5. 8 July 2021

     Changes for qualification of IVD software and intended purpose.

  6. 29 January 2021

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

  7. 4 June 2020

     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. 20 June 2018

     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. 29 September 2017

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

  10. 21 April 2017

      Updated guidance in attached document.

  11. 2 November 2016

      Updated software guidance. Minor changes and clarification.

  12. 25 August 2016

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

  13. 17 August 2016

      Updated links to Europa.eu pages

  14. 8 August 2014

      First published.

Documents

Medical device stand-alone software including apps

PDF, 1.55 MB, 43 pages

This file may not be suitable for users of assistive technology.

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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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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

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.