The MHRA has put a new process in place for medical device and IVD vigilance reporting. The process is outlined: HERE
After 31 August 2023, manufacturers must have an account in the new version of the MHRA vigilance reporting platform MORE, to report adverse incidents or initiate field safety corrective actions (FSCAs).
We reviewed the MHRA’s 43-page user guide and outlined the key steps to create a new account.