In July 2017, the TGA sought comments from interested parties to further align Australian and European medical device regulatory requirements to:
- up-classify surgical mesh from Class IIb (medium to high risk) to Class III (high risk); and
- require provision of medical device ID cards (patient implant cards) to patients.
On 26 October 2017, a new regulatory framework for surgical mesh devices and provision of information to the consumers for all implantable medical devices was approved by the Minister for Health.
Surgical Mesh Devices
Currently, some surgical meshes are already classified as Class III, such as meshes including medicines or materials of animal, microbial or recombinant origin.
From 1 December 2018, all new surgical mesh devices, including urogynaecological mesh devices, seeking approval from the TGA will need to meet the higher evidentiary requirements of a Class III medical device. These changes will mean that all synthetic meshes will be required to be up-classified to Class III.
The reclassification from Class IIb to Class III will mean that all implantable surgical mesh medical devices will be required to meet additional conformity assessment certification. Manufacturers will now also require design examination certification for each mesh medical device.
Additional information to be provided to patients
From 1 December 2018, manufacturers of all new permanently implantable devices (other than those exempted) will need to have a summary document about the device in the TGA approved format. These initiatives will assist consumers and doctors in the informed consent process and is aimed at overcoming the concerns from consumers about the limited information being provided to inform them about the medical device implanted during surgery.
- The TGA will work with relevant parties to co-design the format of the patient information materials so as to deliver effective and efficient information to the consumers over the lifecycle of the device.
- Manufacturers of all new permanently implantable devices will need to ensure they have a patient information leaflet in the TGA approved format by 1 December 2018.
- Existing urogynaecological devices will need to lodge a re-classification application no later than December 2020.
A summary of the changes and the transition periods can be found here.