Surgical meshes, which were previously classified as medium risk devices, or Class IIb, are now up-classified as Class III products. That is, in order to account for safety concerns, as amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 for this requirement was agreed upon, and commenced on 1 December 2018. TGA having given three years of transitional arrangements, sponsors of such devices, other than urogynaecological meshes, were allowed to demonstrate compliance with the regulatory requirements of high-risk devices prior to the implementation on 1 December 2021. The criteria of Class III medical devices are more stringent than those of Class IIb in order to ensure devices can meet the highest levels of safety, quality, and clinical performance.
The range of devices classified as surgical meshes; for example, is specified by TGA as follows:
- ● Synthetic surgical meshes used for breast implants surgeries; or
- ● Surgical meshes used to treat male stress urinary incontinence (SUI); or
- ● Surgical and non-absorbable support tape (tissue approximation, ligaments, tendons, or other soft tissues); or
- ● Surgical and non-absorbable support tape (reinforcement of the tendon).
In contrast to surgical meshes as defined above, the re-classification of urogynaecological meshes had already been implemented in 2020, and urogynaecological meshes were cancelled from the ARTG and no longer supplied in Australia, if they were not able to demonstrate and meet Class III regulatory requirements.
For Class IIb ARTG entries of surgical meshes other than urogynaecological meshes, sponsors were required to demonstrate compliance with regulatory requirements of the device by completing both actions stated below prior to 1 December 2021:
- ● To obtain the conformity assessment certificate for Class III devices, or submit an application for TGA’s conformity assessment certificate for the Class III device; or
- ● To submit an application for a Class III ARTG inclusion for the device, or the conformity assessment certificate for the Class III device being issued within six months.
However, cancellation of the ARTG Class IIb entries for surgical mesh devices have been carried out by TGA, in case both or one of the two actions above had not been completed by sponsors by 1 December 2021. The device whose ARTG entry has been cancelled is then subsequently no longer supplied in Australia, except under the Special Access Scheme (SAS) or Authorised Prescriber (AP).
A potential supply disruption for surgical mesh devices will hence happen, if the assessment and approval processes had not been completed by December 1st 2021 for those sponsors. Therefore, for practitioners/hospitals, there are a number of suggestions in case they would like to use devices that have been cancelled:
- ● Applying for the SAS or AP scheme to supply devices of non-inclusion in ARTG. This prerequisites that all other devices still included in the ARTG cannot be suitably used for the relevant conditions and patients. A justification to explain why none of the devices included in the ARTG are suitable is necessary when practitioners apply for the SAS or AP scheme to supply these kinds of devices; or
- ● Sourcing equivalent surgical mesh devices that are Class III and already included in the ARTG, or surgical meshes that are Class IIb, which yet meet the transition requirements, and remain included in the ARTG.