# Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19)

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/3434b101-9767-4090-8ca9-824f7bce9314
Type: Guidance
Published: June 5, 2020
Updated: December 17, 2021

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the classification of stand-alone software and applications as medical devices. Under this regulatory framework, software defined as instructions that process input data into output must obtain CE, CE UKNI, or UKCA marking if it meets the criteria for a medical device. This ensures the products are safe and function as intended by the manufacturer. Software categories likely requiring regulation include those used for diagnostic processes including artificial intelligence, chronic condition management such as diabetes or mental health, patient monitoring, and clinical decision support. Conversely, apps used strictly for recording patient details or general well-being without medical claims are generally exempt. Simple clinical calculators, like the Glasgow Coma Score, may also be exempt if their results are easily verifiable; however, complex calculators integrated into electronic health records usually require marking. Manufacturers and developers are required to assess their products against the full medical device definition and ensure compliance with marking standards. For specific inquiries, the MHRA provides a dedicated contact channel to assist with classification and safety requirements.

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## Content

We have previously published specific software guidance on medical device stand-alone software including apps. Types of software likely to be a medical device ‘Software’ is defined as a set of instructions that processes input data and creates output data. Standalone software and apps that meet the definition of a medical device are required to be CE, CE UKNI or UKCA marked in order to demonstrate that they are acceptably safe to use and perform in the way the manufacturer/developer intends them to. The following types of software are likely to be classed as medical devices: software (including artificial intelligence) and apps (either incorporated into an existing device or supplied separately) that are used for contributing to diagnostic processes software and apps for helping patients to manage their health conditions like diabetes, cancer or mental health issues software and apps for monitoring patients (including remotely) software and apps to support clinical decision making Software and apps intended only for recording patient details (such as patient diaries) or well-being apps (such as an app intended for general relaxation which may be used to treat stress) don’t usually fall under the definition of a medical device because the manufacturers do not make any medical claims for them. Manufacturers and developers should always consider the full definition of what a medical device is. Specific guidance is provided in the software guidance . Clinical calculators Many clinical calculators do meet the definition of a medical device but not all of them need to be CE , CE UKNI or UKCA marked. Calculators where the calculation/result can be easily verified, for example a Glasgow Coma Score calculator, are unlikely to be devices. However, calculators pulling data from fields in an electronic patient record are likely to be devices if the simple calculation or the data used cannot be easily verified. Further information can be obtained by emailing software@mhra.gov.uk .

## Attachments

- [Advice for members of the public and professional users: software and apps used in COVID-19 pandemic](/government/publications/regulatory-status-of-software-including-apps-used-in-the-diagnosis-treatment-and-management-of-patients-with-coronavirus-covid-19/advice-for-members-of-the-public-and-professional-users-software-and-apps-used-in-covid-19-pandemic)
- [Advice for manufacturers: software and apps used in COVID-19 pandemic](/government/publications/regulatory-status-of-software-including-apps-used-in-the-diagnosis-treatment-and-management-of-patients-with-coronavirus-covid-19/advice-for-manufacturers-software-and-apps-used-in-covid-19-pandemic)