MHRA update to the guidance on the regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with COVID-19

The Medicines and Healthcare products Regulatory Agency (MHRA) is the standalone regulator for medicines and medical devices in the UK. In January 2021, the MHRA has updated its guidance on medical device standalone software, including apps, to ensure that software and apps used in response to the COVID-19 pandemic – and qualified as medical devices – can be promptly identified and regulated.

The update gives an insight into the MHRA approach to the different types of software and apps used in the healthcare and wellness sectors, including assistance software, symptoms checkers, clinical calculators and accessories.

Is your software a medical device?

According to the MHRA guidance (2021), software is “a set of instructions that processes input data and creates output data”. To determine when software becomes medical devices, the MHRA relies on EU guidelines (MEDDEV 2.1/6), which emphasize the intended medical purpose:

“Software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Standalone software for general purposes when used in a healthcare setting is not a medical device” (Recital 6 of the Directive 2007/47/EC).

As an example, software with library functions used for the retrieval of medical records cannot be qualified as a medical device. On the other hand, software used to analyse, create and modify medical information, may fall under the definition of medical device, depending on its intended use.

Standalone software and healthcare apps with an intended medical purpose can be qualified as medical devices, but need to be CE, CE UKNI or UKCA marked. This is to ensure that they are acceptably safe to use and perform, according to the manufacturer’s intended use. The UKCA or CE mark should be clearly visible on the app, as displayed in the app store, and on the page describing the functions of the application (landing page). Software most likely to be qualified as a medical device is:

  • Software and apps contributing to diagnostic processes;
  • Software and apps intended for monitoring patients, and those that help patients manage their diabetes or cancer;
  • Software and apps supporting clinical decision making;

Exemptions due to the COVID-19 pandemic

Manufacturers developing new software and apps in response to the COVID-19 outbreak -and likely to be classified as medical devices – can apply for an exceptional use authorization or

derogation exemption, in order to place their devices on the market before completing the UKCA or CE UKNI marking process.

If the software or app is already CE, CE UKNI or UKCA marked, but not for the purpose of responding to the COVID-19 pandemic, it may still be possible to benefit from regulatory flexibilities and perform expedited clinical investigations. In order to add COVID-19 as a new indication, manufacturers need to provide sufficient clinical evidence to support the new claim.

If the change to the intended purpose is minimal, there is no need to apply for an exemption, but a risk assessment should be performed.

Giorgia de Stefano

Regulatory Affairs Department

25.05.2021

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References:

  • MHRA. (2021). Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19). Retrieved on 25.05.2021 from: https://www.gov.uk/government/publications/regulatory-status-of-software-including-apps-used-in-the-diagnosis-treatment-and-management-of-patients-with-coronavirus-covid-19?utm_source=govdelivery&utm_medium=email&utm_campaign=MHRA_COVID_19_updates&utm_content=IND37
  • European Commission. (2016). MEDDEV 2.1/6 (2016). Retrieved on 25.05.2021 from: DocsRoom – European Commission (europa.eu)
  • MHRA. (2021). Guidance: Medical device stand-alone software including apps (including IVDMDs). Retrieved on 25.05.2021 from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/957090/Software_flow_chart_Ed_1-07b-UKCA__002__FINAL.pdf
  • MHRA. (2021). How to tell if an app is a medical device. Retrieved on 25.05.2021 from: https://www.gov.uk/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
  • MHRA. (2021). Advice for manufacturers: software and apps used in COVID-19 pandemic. Retrieved on 25.05.2021 from: https://www.gov.uk/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

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