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Information for medical practitioners on pending up-classification of surgical mesh devices

20 November 2020

Introduction

On 1 December 2018, amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 commenced. These amendments require surgical meshes previously classified as Class IIb medical devices to be re-classified as Class III medical devices.

The amendments respond to safety concerns relating to mesh products. They also bring the regulatory framework closer to the European Union (EU) for these devices. The Australian Government has decided to reclassify these devices ahead of the EU in order to address the serious concerns about the risks associated with the devices.

The amendments may affect the availability of some mesh devices as of 1 December 2020 and 1 December 2021. The amendments set out a transition timetable for surgical meshes already included in the Australian Register of Therapeutic Goods (ARTG) as Class IIb devices to transition into the ARTG as Class III devices:

Implementation date Type of surgical mesh

1 December 2020

Urogynaecological meshes

1 December 2021

All other surgical meshes

Sponsors of surgical meshes previously included in the ARTG as Class IIb devices must fulfil two requirements, by these dates, to transition to a Class III device:

  • have a Class III conformity assessment certificate for the device; and
  • have applied to the TGA for a Class III ARTG inclusion.

What is different about Class III requirements?

Class III medical devices must meet more stringent criteria than Class IIb medical devices to demonstrate to the TGA that the manufacture of the device meets the legislative requirements.

What are surgical meshes?

The TGA has prepared a detailed guidance document on surgical mesh, including the range of devices that constitute surgical mesh.

Availability of these devices to medical practitioners

The TGA will take steps to cancel the ARTG entries of any Class IIb surgical mesh device for which the sponsor has not made an application to include the device as a Class III device by the relevant date:

  • 1 December 2020 for urogynaecological meshes
  • 1 December 2021 for all other surgical meshes.

In addition, where the TGA does receive an application by the transition date, but concludes that those devices do not meet the requirements for inclusion in the ARTG as a Class III device, the TGA will also take steps to cancel the entries for those devices.

Following cancellation from the ARTG, practitioners:

  • can continue to use existing stock on hand;
  • source Class III devices that are included in the ARTG; or
  • apply under the Special Access Scheme (SAS) (category B) or Authorised Prescriber (AP) schemes to import or supply cancelled Class IIb devices.

Between 1 December and mid-January (when cancellation of non-transitioned ARTG entries take effect) the supply of Class IIb devices by a manufacturer or sponsor may be unlawful.

One of the key criteria for the supply of an unapproved device under SAS or Authorised Prescriber is there are no devices included in the ARTG suitable for use for the relevant condition(s) and patient(s). Practitioners applying to supply a device under SAS or AP must provide a justification to explain why none of the devices included in the ARTG are suitable.

The TGA will publish a list of surgical mesh devices in the ARTG as Class III devices by the relevant transition dates, and will update it on an ongoing basis.

Medical practitioners with inquiries about these arrangements can contact the TGA at devicesclinicaladvice@health.gov.au