The MHRA has released regulatory guidelines for members of the public, manufacturers and professional users working with COVID-19 that include software and apps.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
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 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.
Many clinical calculators do meet the definition of a medical device but not all of them need to be CE 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 the NIHR: firstname.lastname@example.org.