UK guidance on stand-alone medical device software including apps issued

UK regulator publishes updated guidance

The use of medical device applications (apps) is growing for healthcare management in hospitals and the community, in social care settings and as an element of personal wellness and fitness monitoring. Standalone software and apps that meet the definition of a medical device are required to be CE marked in accordance with the EU regulatory requirements in order to ensure they are safe to use and perform in the intended manner.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance to help identify the health apps which are medical devices. The guidance is intended to help developers of software and apps in navigating the regulatory system so they are aware of the procedures that they need to follow in order to affix a CE mark. It also provides guidance on the likely classification of the device. It should be remembered that other jurisdictions also have guidance on medical apps, such as the US FDA Policy for device software functions and mobile medical applications.

The MHRA guidance is intended to be used together with the European guidance in MEDDEV 2.1/6, Scope, field of application, definition - Qualification and Classification of standalone software. The MHRA guidance provides the UK interpretation of this MEDDEV document.

The guidance document provides interactive flow charts to guide decision making on whether the software or app:

• has an intended medical purpose;
• is a medical device or in vitro diagnostic medical device.

The updated guidance provides new or expanded guidance on some specific types of software including prescribing assistance software, clinical calculators or symptom checkers and the classification of third-party software intended to be used together with medical devices from other manufacturers.

In regards to prescribing assistance software, the guidance points to a European Court of Justice ruling that software that makes it possible to use patient-specific data to detect contraindications, drug interactions and excessive doses, is a medical device, even if that software does not act directly in or on the human body.

Symptom checkers are independent software intended for use by lay persons, who manually enter details or symptoms and the software matches these with conditions. The guidance lists examples of such software that could be a medical device as including software that indicate:

• a subset of medical conditions that match the symptoms;
• the likelihood of a match with a medical condition;
• treatment recommendations for listed conditions;
• an indication of seriousness of potential conditions.

In terms of medical calculators, if the calculation cannot be easily verified by the intended user then it is likely to be a device, for example if it uses linked data that is not displayed.

The classification rules indicate that software that drives a device or influences the use of a device, falls automatically in the same class as the device itself. The guidance indicates that driving or influencing the use of a device can range from direct control of the device to just selecting a device. The guidance provides examples of software influencing the use of the device outside its intended purpose or outside the use described in the instructions for use.

This updated advice gives insight into the MHRA approach to various types of health software and apps. It will be helpful in distinguishing software and apps that fall within and outside the regulatory  requirements for medical devices in Europe. As such, it will be of interest to medical device manufacturers and technology companies working on software and apps in the health and wellness fields.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development