The International Medical Devices Regulators Forum (IMDRF) has issued guidance on when and how regulators should share information about the potential risks of certain medical devices in the postmarket setting. The system to submit such reports is currently limited to regulators in its management committee.
On 1 April, IMDRF’s National Competent Authority Report (NCAR) Exchange Program Working Group published guidance on when regulators should consider exchanging information about products that may pose serious public health risks. The guidance also outlines the procedures and forms regulators should use to share the information, as well as the requirements IMDRF members must meet to participate in the NCAR Exchange Program…
