Clinical Investigations of Medical Devices: Guidance for Investigators
Report
Free
It is often necessary for device manufacturers to provide clinical data to back up claims made for their devices.
This report produced by the Medicines and Healthcare products Regulatory Agency (MHRA) aims to help researchers and innovators by highlighting a number of specific requirements that arise in relation to the clinical investigation of non-UKCA/CE/CE UKNI marked medical devices.
This report was published in May 2021.
Added on: 09 October 2024