Medical device adverse event reporting by medical device manufacturers and sponsors

Reporting form for use by medical device manufacturers and sponsors

This form is to be used by medical device manufacturers or authorised representatives for mandatory reporting of adverse events associated with a medical device.

There is a different form for use by medical device users <http://www.tga.gov.au/docs/html/forms/iris_udir.htm>, for example nurses, doctors, patients.

How to access a pdf or Microsoft Word document

• Medical device adverse event reporting form for use by medical device manufacturers and sponsors (pdf,64kb)
• Medical device adverse event reporting form for use by medical device manufacturers and sponsors (MS Word,135kb)

The act of reporting an event is not an admission of manufacturer, sponsor, user, or patient liability for the event or its consequences.

The sponsor is responsible for forwarding reports of all incidents to the manufacturer for assessment under the manufacturer's post-marketing system. It is possible that the sponsor will not have enough information to decide if the event should be reported to the TGA. In such a case, the sponsor should make reasonable efforts to obtain additional information to assist the manufacturer to make this decision. Where appropriate, the manufacturer should consult with the medical practitioners or other healthcare professionals involved, and do their utmost to retrieve the particular device. If there is any doubt about whether an incident report should be submitted, the report should be submitted. Although it is the manufacturer who must assess an incident, the sponsor will be held accountable for forwarding information concerning events to the manufacturer and then for forwarding the results of any analysis to the TGA.