The UK’s Medicines and Healthcare products Regulatory Agency is switching to a new application form for medical device trials beginning April 18 and has announced changes that devicemakers should implement immediately.
Manufacturers must inform the MHRA at least 60 days before starting a clinical trial. Those planning to submit an integrated research application system (IRAS) notice should submit it before April 18. If a final form is not completed before that date, a new MHRA form will need to be filed to ensure that the data has been transferred into the new system.
The new form requires significantly more detail about the investigational device and about the study. It also requires electronic sign off rather than printing and signing.