About the Event
Medical devices are electro-mechanical or mechanical devices that may potentially result in incidents of failure, potential failure or perceived failure. The conditions of approval of placing such devices in the market by their inclusion in the Australian Registry of Therapeutic Goods (ARTG) mandates that the sponsor of these devices should have processes to ensure adequate handling of incidents that they become aware of such that their clinical benefit continues to outweigh the risks. Where a reported incident constitutes an adverse event or potential adverse event, the sponsor is required to report the incident to the TGA resulting in a DIR. The Australian regulatory framework allows for incidents of alleged failures to be reported directly to the TGA with or without the knowledge of the sponsor, resulting in a DIR as well. The sponsor, while responsible for the regulatory requirements and user communications, relies on the manufacturer for investigation of the incident.