MHRA has published guidance detailing the extra information sponsors must provide when notifying the agency of plans to conduct clinical investigations on electrically powered medical devices. This guidance applies to anyone undertaking such investigations and specifies additional documentation or data requirements beyond standard clinical investigation notification procedures.

Sponsors and clinical investigators planning to conduct clinical investigations of electrically powered medical devices in the UK should review this guidance before submitting their notification to MHRA. They must ensure their applications include the additional information specified in the guidance to avoid delays or rejection of their notification.