Guidance

Advice for members of the public and professional users: software and apps used in COVID-19 pandemic

Updated 17 December 2021

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This publication is available at 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

How to tell if an app is a medical device

If the software or app you are using has a medical purpose it is important that it is either CE, CE UKNI or UKCA marked.

A CE, CE UKNI or UKCA mark is a logo that is placed on medical devices to show they conform to the regulatory requirements. It shows that the device is fit for its intended purpose and meets legislation relating to safety.

The app must be labelled with a CE, CE UKNI or UKCA mark and regulatory information such as details of the manufacturer. This may also be listed in the app store listing. If you cannot find a CE, CE UKNI or UKCA marking and you think it should have one, you can report this to MHRA.

There is a legal definition of a medical device. To illustrate through some practical examples, the app is likely to be a medical device if:

  • you enter certain information about yourself and that information is used to calculate medicine doses for you to take/inject
  • it tells you that you have a medical condition or disease or gives you an individual percentage risk score of having one
  • it helps you manage or monitor your symptoms

If the app is giving you significant health information, then be sure that you understand the result and you know what you need to do when you get it.

Some software or apps may not have a CE, CE UKNI or UKCA mark if they have been given an exception for use in managing the COVID-19 pandemic.

Actions to take if you’re worried the app is giving you the wrong advice or isn’t working

If you are in doubt about the information that the app has given you or you are concerned about your health then you should consult a healthcare professional (a pharmacist, health visitor, practice nurse, GP or through the NHS 111 service.)

You should report the issue to the MHRA if you have any problems with the app not working as stated such as:

  • if the instructions aren’t clear, or the app is difficult to use, or
  • if you have concerns over the safety of the app or the information that it provides

There is now a dedicated Yellow Card reporting coronavirus website for reporting any incidents involving medical devices related to COVID-19 treatment

You should also contact the developer/owner of the app to tell them, through the app store or the supplier’s website.

Further information

MHRA guidance on coronavirus (COVID-19)

In vitro diagnostic medical devices: guidance on legislation

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