Up-classification of surgical mesh devices

The Therapeutic Goods Administration (TGA) has recently up-classified implantable surgical mesh devices from Class IIb (medium-risk devices) to Class III (high-risk devices).

Class III medical devices need to meet more stringent criteria than Class IIb medical devices.

The changes affect surgical mesh and implantable medical devices available on HealthShare Victoria (HSV) contract.

Patient information requirements for implantable medical devices

From 1 December 2021, the TGA requires all implantable medical devices used by health services to have accompanying Patient Implant Card (PIC) and Patient Information Leaflet (PIL) information that can be passed on to patients prior to surgery.

This TGA requirement covers implantable medical devices and active implantable medical devices supplied from 1 December 2021.

Information and resources for health services

To support the health sector in adapting to the TGA changes, HSV has published information for health services including:

• patient information requirements for implantable medical devices
• what health services and suppliers need to do
• a link to a Medical Technology Association of Australia (MTAA) presentation for clinical staff
• how HSV is working with suppliers and health services to support this change
• further information and resources.

Please click here to view information for health services about the changes affecting surgical mesh and implantable medical devices.

If you have any concerns or questions about these changes, please contact us: HSV Helpdesk: helpdesk@healthsharevic.org.au or phone 03 9947 3900.