Products classified as medical devices must demonstrate they meet the requirements of UK Medical Devices Regulations. The purpose of these regulations is to ensure the benefits of a product outweighs the risks, so that UK citizens have access to safe and effective medical products. Demonstrating medical device safety to the MHRA requires the legal manufacturer to design, manufacture, test, and monitor their product to the “state of the art”, which includes creating documents to support this claim of safety. However, generating this safety documentation and defining “state of the art” can be complex and time-consuming. Consequently, the MHRA has this month published guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers meet their statutory obligations.
You can read the guidance in full HERE.