RegTech entrepreneur | Reg Metrics CEO | Medical Device Regulations | MedTech SME
Do you know what classifying your medical device means? If not, Reg Metrics is here to help! It is important to have a good understanding about what classification actually is as it is a vital stage on the regulatory journey. Though it may seem confusing or daunting, we are here to reassure you that it shouldn’t have to be. So, to put it simply: #Regulations are there to make sure that your medical device is safe to use. The #classification of your device determines how much of a risk your device might be to a patient. If your medical device is class I, this means that the device is a much lower risk, whereas class III means the device is a significantly higher risk and will require more extensive testing to ensure its safety. For more information about classification, visit Reg Metrics online and view our blogs post, where we have explained classifying your device in more detail. #MDR #IVDR
