Updated guidance has been issued to makers of medical devices to inform them of the latest requirements for clinical investigations.
The guidance is issued by the Medicines and Healthcare Products Regulatory Agency (MHRA), and takes manufacturers through all stages of clinical investigations, from informing MHRA of the trial through to how to gain approval from the Health Research Authority (HRA).
The guidance is essential reading for any developer of medical devices or in vitro diagnostics (IVDs) seeking to run trials in the UK. MHRA says:
“You may need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device. You must inform MHRA if you are planning to do this at least 60 days before starting your investigation.”
This update clarifies how to determine if a product requires such an investigation.
Read more here.