Regulating medical device apps

The Medicines & Healthcare products Regulatory Agency (MHRA) has produced new guidance to ensure that health apps which qualify as medical devices are being identified and comply with safety regulation. Valerie Field, interim group manager in the MHRA devices division, explores the situation

We live in an increasingly digital world. Healthcare professionals, patients and the public are using software and stand-alone applications (apps) to aid diagnosis and monitor health, with many manufacturers, software developers, academics, clinicians, patients and organisations use software apps for both healthcare and social care needs.

From counting steps to helping healthcare professionals diagnose burns treatment, healthcare apps and standalone software are a part of everyday life. We are all so familiar with apps that you might not realise depending on an unregulated app to provide a diagnosis or recommend treatment could have life threatening consequences.

Some apps, which are used on smart phones and computers, can be considered a medical device in their own right if they have a medical purpose. These can be called stand-alone software or stand-alone medical devices. This doesn’t include software that is part of an existing medical device such as software that controls a CT scanner as it is seen to be part of the device already and not stand-alone in its own right.

The regulations
Many apps and pieces of standalone software currently on the market are classified as medical devices. These are apps which gather data from the user, such as diet, exercise, or heartbeat and then analyse and interpret the data to make a diagnosis, prescribe a medicine, or recommend treatment.

It is important that apps which are medical devices comply with medical device regulation to make sure they are not providing an incorrect diagnosis which may have severe, potentially life-threatening consequences for the user.

Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.

As well as medical device apps becoming a growth area in healthcare management in hospital and in the community settings, the role of apps used as part of fitness regimes and for social care situations is also expanding. However, in the UK and throughout Europe, standalone software and apps that meet the definition of a medical device are still required to be CE marked in line with the EU medical device directives in order to ensure they are regulated and acceptably safe to use and also perform in the way the manufacturer/ developer intends them to.

New guidance
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance to help identify the health apps which are medical devices and make sure they comply with regulations. This will make help to make sure the health apps which meet the classification of medical devices are being identified and comply with regulations for safety and consistency.

The guidance is presented as a step-by-step interactive PDF and will help software and app developers identify if their product is a medical device. It will also help developers navigate the regulatory system so they are aware what procedures they need to have in place with regard to CE marking and post-market surveillance.

It also has information on the need to register as a manufacturer / developer and to self- certify that their app meets the regulatory requirements. This guidance uses examples within flowcharts to show which standalone software and apps meet the definition of a medical device, an in vitro diagnostic device or active implantable medical device and therefore required to be CE marked, and those which do not.

For developers of software, including apps, we have also including information on classification, suggestions on how to address the main aspects of the CE marking process and responsibilities for reporting and correcting when things go wrong.

Is it the right app for me?
For users we offer a few tips on how to decide if the app or software device you are using is a medical device and if so how to ensure it is CE marked along with how to report problems. You should think about what you will do with the results and the information that the app is giving you. If the app is giving you significant health information then be sure you will understand the result and you know what you need to do when you get the result.

When an app developer applies a ‘CE mark’ they are claiming that the app is fit for the purpose it claims and it is acceptably safe to use. The CE mark should be visible on the app when you are looking at it in the app store or on the further information or ‘landing’ page.

This information should also tell you what the app can be used for and how to use it. If you can’t see these details or are unsure we suggest you contact the developer to ask and in the meantime that you don’t use it. Please use only medical device apps that are CE marked. If you see a medical device app that does not have a CE mark, then you can report it to MHRA through our Yellow Card Scheme.

Once you are sure the app is right for you and it is CE marked then you should follow the instructions carefully. Be honest with the information you put into the app. If you enter wrong information about yourself, the app may not give you the right result. Ensure that you always update the app to the newest compatible version.

Tell MHRA if you have any problems with the app not working as stated through our Yellow Card Scheme. This could be: if the instructions are not clear or the app is difficult to use; if the app isn’t giving you the results you expected; or if you have any concerns over the safety of the app or the information that it provides.You should also contact the developer of the app to tell them.

Personal data
It is important that you have read the small print to understand what personal data you may have agreed to share with the developer by signing up to the app and how they might store or use your data. This includes information about you such as your name, address, date of birth and information about your health.

If you are in any doubt about the information that the app has given you or you are concerned about your health you should consult a healthcare professional such as a doctor or pharmacist.

Manufacturers have a responsibility to implement an effective post-market surveillance system to ensure that any problems or risks associated with the use of their device are identified early, reported to the relevant authorities, and acted upon.

Further Information:

Supplier Profiles