# Medical devices: software applications

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/e780cd0a-0379-44ac-9e35-9db83cc84419
Type: Guidance
Published: August 7, 2014
Updated: June 30, 2023

> This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the regulatory framework for software applications classified as medical devices. Rather than focusing on a specific company or individual inspection dates, this document establishes industry-wide standards for all developers seeking to enter the UK market. The framework is designed to ensure that health-related software meets strict safety, quality, and performance criteria. Main violations or regulatory issues often stem from the incorrect classification of software based on its intended medical purpose or failing to distinguish between general wellness applications and regulated medical tools. For companies developing such technology, required actions include conducting a thorough classification assessment, implementing a robust quality management system, and adhering to legal duties for CE or UKCA marking. Failure to comply with these regulations can lead to market removal or legal penalties. The guidance emphasizes that manufacturers must maintain comprehensive technical documentation and perform ongoing post-market surveillance to track software performance and safety. This document serves as a comprehensive roadmap for innovation within the digital health sector while prioritizing patient safety through rigorous oversight and clear compliance pathways for developers.

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## Content

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.

## Attachments

- [Medical device stand-alone software including apps](https://assets.publishing.service.gov.uk/media/64a7d22d7a4c230013bba33c/Medical_device_stand-alone_software_including_apps__including_IVDMDs_.pdf)
- [Appendix 1 - symptom checkers](https://assets.publishing.service.gov.uk/media/64a7d235c531eb000c650051/Appendix_1_-_symptom_checkers.pdf)
- [Appendix 2 - clinical calculators](https://assets.publishing.service.gov.uk/media/64a7d23c7a4c230013bba33e/Appendix_2_-_clinical_calculators.pdf)
- [Appendix 3 - ‘drives or influences the use of a device’](https://assets.publishing.service.gov.uk/media/64a7d247c531eb000c650053/Appendix_3_-__drives_or_influences_the_use_of_a_device_.pdf)
- [Appendix 4 – Field Safety Warnings and End-of-Life notification](https://assets.publishing.service.gov.uk/media/64a7d2507a4c230013bba33f/Appendix_4___Field_Safety_Warnings_and_End-of-Life_notification.pdf)