A medical device is defined as something used in the prevention, diagnosis or treatment of an illness or disease, or for detecting, measuring, or modifying the body for a health purpose.
Before developing your Digital Health tool, it is important to understand the different classifications, of which there are four, ranging from Class 1 [low risk] to Class 3 [high risk].
There are several considerations that go into classifying a Medical Device, including how long the device is intended to be used for continuously, as well as whether the device is surgically invasive or not.
We can give you advice on this, but we recommend you seek out further clarification to ensure you have the correct standards in place before the release of your Digital Health tool.
The MHRA defines the four classifications as;
- Class 1 - ‘Low-risk’ devices.
- Class 2A – Devices that are intended to directly diagnose a user or monitor vital signs.
- Class 2B – Devices that administer ‘energy’ that could be potentially hazardous to a user.
- Class 3 – Devices that are surgically invasive or have direct contact with the human central nervous system.
How Can Evolyst Help?
If you are unsure which category your device falls under or if you have any other medical device related questions, we can assist you.
We work alongside medical professionals to achieve the best results for the software and highlight the most effective routes to take to ensure the device is correctly classified.
If you want to know more about how we can support you, take a look at our FREE guide, ‘How to develop a Digital Health tool’.