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

17 June 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has produced some specific guidance on medical device apps and software which might be used as part of the response to COVID-19.

If the software or app that you are using has a medical purpose it is important that it is CE marked. A CE 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 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 marking and you think it should have one, you can report this to MHRA.

Please note, some software or apps may not have a CE mark if they have been given an exception for use in managing the coronavirus (COVID-19) epidemic.

Please see the MHRA website for further information.

ENDS