Software, apps and Artificial Intelligence (AI) reporting

You can report any safety concerns involving software and artificial intelligence (AI) also known as software as a medical device (SaMD) or AI as a medical device (AIaMD) to our Yellow Card scheme. If you have a safety concern, we advise that you complete a Yellow Card report as soon as possible and keep all references to the software you used, as a further review might be needed from us or the manufacturer.

What is a ‘software as a medical device (SaMD) or AI as a medical device (AIaMD)?

Software including AI plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices.

If the software or app you are using has a medical purpose and sufficient functionality it is important that it is UKCA or CE accredited.

There is a legal definition of a medical device but here are some practical examples;

Apps or devices which calculate medicine doses for you to take or inject, such as the software used to calculate an insulin dosage or the pump used to administer it.
Apps or devices that tell you that you have a medical condition or disease or give you an individual percentage risk score of having one.
They can be used for the diagnosis, prevention, monitoring, or treatment or alleviation of illness. The products you can report to the Yellow Card scheme as medical devices will have a CE or UKCA mark on them, or their packaging/associated leaflet.

Before you choose a medical device app - is it the right app for me?

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 demonstrates ‘UKCA or CE conformity’ they are claiming that the app is fit for the purpose it claims, and it is acceptably safe to use. The UKCA or CE accreditation 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 UKCA or CE accredited. If you see a medical device app that does not have a UKCA or CE accreditation, then you can report it to MHRA.

Once you have started using the medical device app

Once you are sure the app is right for you, and it is UKCA or CE accredited 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.

After using the medical device app 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 or GP).

If you have any problems with the app not working as stated e.g. if

the instructions aren’t clear or the app is difficult to use
the app isn’t giving you the results that you expected
you have concerns over the safety of the app or the information that it provides

Tell the MHRA about these problems using the Yellow Card reporting page on the website. You should also contact the developer/owner of the app to tell them.

Personal data and security

It is very 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 or share your information with third parties. This includes information about you such as your name, address, date of birth and information about your health.

An adverse incident in relation to a medical device, is an event that caused (or almost caused) an injury to someone or affected the treatment or diagnosis one could receive.

Practical examples of problems with software include:

imprecise results
inadequate quality controls
inadequate calibration
false positive or
false negative results.

For self-testing devices, a medical decision may be made by the user of the device who is also the patient. This also includes devices where an indicative diagnosis may be given to a user who may go on to seek, or otherwise not seek, additional medical advice because of the device output. This may be of particular relevance to symptom checkers and transdiagnostic assessment tools for mental health conditions.

Medical devices including software can be found to be defective or have inherently unsafe design. If any of these could cause an adverse incident or have a safety concern, these can all be reported through the Yellow Card scheme.

Medical devices reporting in Scotland by healthcare professionals

In England, Wales and Northern Ireland, healthcare professionals should report adverse incidents involving medical devices to the Yellow Card scheme; in accordance with your organisations medical device policies and procedures.

We work closely together with Scotland, who have their own reporting systems for healthcare professionals to report medical devices.

In Scotland, incidents should be reported to the Incident Reporting & Investigation Centre (IRIC) and the local incident recording system.

Medical device reporting from manufacturers, suppliers, and their representatives

The Manufacturer's Online Reporting Environment (MORE) is the system for device manufacturers or suppliers and their authorised representatives to report adverse medical incidents and provide responses to MHRA incident investigations.

Why report side effects to the Yellow Card scheme?

Everyone is different and therefore it is very difficult to predict whether an individual will experience a side effect from the use of software or AI. Whether you are a healthcare professional or a member of the public, you can help others by reporting side effects which you or your patients experience to the MHRA Yellow Card scheme. Reports help us gain a better understanding of the safety of medicines and help to ensure medical devices are acceptably safe and function as intended, thereby protecting patients and public and users through vigilant monitoring.

Further information

Medicines and medical devices: product-specific information

Find out more about the Yellow Card scheme, including how to report.