The MHRA is an executive agency of the Department of Health. The cornerstone of the medical device regulations within the UK, responsible for determining a device’s medical purpose. They also play the part of ensuring the safety of patients when using the device and that its intended purpose is fulfilled. This is important to follow the guidelines as a device classification will then determine the level of additional regulatory requirements needed to meet the Medical Device Regulations. We are a class 1 medical device, allowing us to display the CE marking for quality.