Medical device patient information leaflets and implant cards (including acceptance of Implementation Plans) v1.9

This document aims to help manufacturers and sponsors understand the legislative requirements for patient information materials, such as patient implant cards and patient information leaflets, and how to comply with these requirements.

Main sections:

· Patient information materials

· Patient information leaflets

· Patient implant cards

· Review by the TGA

· Reporting adverse events

· Attachment 1: Timetable for transition

· Attachment 2: Implantable medical devices exempted from requirements

· Attachment 3: Best practice for patient information leaflets and patient implant cards

· Attachment 4: Breast Implants – specific information to be included about adverse events

· Attachment 5: Urogynaecological meshes – specific information to be included about adverse events