Surgical Meshes Reclassified to High-Risk Medical Devices

Overview

Surgical meshes, previously classified as medium risk devices (Class IIb), have been reclassified as Class III products to address safety concerns. This change is part of the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, effective from December 1, 2018. The Therapeutic Goods Administration (TGA) provided a three-year transitional arrangement, allowing sponsors of these devices (excluding urogynaecological meshes) to demonstrate compliance with the regulatory requirements for high-risk devices before the implementation date of December 1, 2021.

Understanding Class II Medical Devices

Class II medical devices have more stringent criteria compared to Class IIb, ensuring that products meet the highest standards of safety, quality, and clinical performance.

Classifications of Surgical Meshes

The TGA specifies the following types of surgical meshes:

• Synthetic surgical meshes used for breast implant surgeries;
• Surgical meshes used to treat male stress urinary incontinence (SUI);
• Surgical and non-absorbable support tape for tissue approximation, ligaments, tendons, or other soft tissues;
• Surgical and non-absorbable support tape for tendon reinforcement.

Urogynaecological Meshes

In contrast, the reclassification of urogynaecological meshes was implemented in 2020. These meshes were canceled from the Australian Register of Therapeutic Goods (ARTG) and are no longer supplied in Australia if they do not meet Class III regulatory requirements.

Compliance Requirements

For Class IIb ARTG entries of surgical meshes (excluding urogynaecological meshes), sponsors must demonstrate compliance with regulatory requirements by completing one of the following actions by December 1, 2021:

• Obtain a conformity assessment certificate for Class III devices or submit an application for TGA's conformity assessment certificate for a Class III device; or
• Submit an application for Class II ARTG inclusion for the device, or a conformity assessment certificate for a Class II device issued within six months.

Failure to complete these actions results in the cancellation of the ARTG Class IIb entries for surgical mesh devices by the TGA. Consequently, devices with canceled ARTG entries are no longer supplied in Australia, except under the Special Access Scheme (SAS) or Authorised Prescriber (AP).

Potential Impact on Supply

A potential disruption in the supply of surgical mesh devices may occur if the assessment and approval processes are not completed by December 1, 2021. For practitioners and hospitals wishing to use canceled devices, it is recommended to:

• Apply for the SAS or AP scheme to supply devices that are not included in the ARTG. It's crucial to justify why none of the included ARTG devices are suitable for the patients and conditions at hand.
• Source equivalent surgical mesh devices that are Class II and currently included in the ARTG, or surgical meshes classified as Class IIb that meet transition requirements and remain included in the ARTG.

Additional Information

New Link: TGA Surgical Mesh Classification Information - https://www.tga.gov.au/information-medical-practitioners-classification-surgical-mesh-devices#purpose

Regulatory Impact

Type Approval impacted: Medical
Approval Process impact: Yes
Importation process impact: N.A
Type of product impacted: Surgical devices
Country: Australia