Medical devices reforms: Enhancements to post-market monitoring

This project has been established to enhance the adverse event reporting processes.

The TGA reporting forms system was updated in 2019 to improve monitoring and tracking of medical device incident reports, following feedback from stakeholders. A report can be now lodged electronically, and previously reported incidents, initial reports and follow-up reports can be updated with additional information. The status of reports can be reviewed and past reports can be viewed.

To compliment these changes to the form, a guidance document for medical device incident reporting was published.

In 2021, we sought feedback on a Discussion Paper exploring the potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia. The Discussion Paper explored the following areas of interest:

• The feasibility of mandatory reporting of medical device adverse events by Australian healthcare facilities;
• The healthcare facilities and types of medical devices which should be included or excluded;
• Potential issues in enabling adverse event reporting and avoiding data duplication; and
• Accountability.

Further information is available on the Potential for Mandatory Reporting webpage.

Previously, we sought feedback on the reporting of adverse events through a consultation on proposed enhancements to adverse event reporting and improved communication with the consumers of medical devices. This consultation set out five proposals to enhance adverse event reporting:

• Proposal 1 - make changes to the current adverse event reporting exemptions
• Proposal 2 - strengthen reporting requirements for medical device adverse events
• Proposal 3 - implement a program of the TGA inspections and audits of sponsor activities and premises to validate how sponsors conduct their post market surveillance obligations
• Proposal 4 - review post-market definitions in the Medical Device Regulations
• Proposal 5 - ways to enhance communication between the TGA and consumers of medical devices. This includes making adverse event related information readily available to consumers and providing consumer information about Adverse events, accessed through a searchable Database of Adverse Event Notifications (DAEN), recall actions that can be accessed through the TGA's database System for Australian Recall Actions (SARA) and other alerts related to medical devices.

A summary of the response analysis, the industry responses and individual consumer responses of the survey have been published on the Consultation Hub.

Next steps

The survey findings indicate follow-up discussions should occur for some of the proposed options. This feedback was provided to the Minister for Health and as appropriate, will inform Australian Government policy and regulatory drafting decisions. The TGA will continue to work closely with stakeholders, including scheduling further targeted discussions, specifically seeking additional feedback from consumers, consumer representative groups, health professionals and healthcare services.

As a result of the responses to proposal 2 in the consultation, which sought feedback on strengthening reporting requirements for medical device adverse events, changes to the Therapeutic Goods (Medical Device) Regulations 2002 came into effect on 29 October 2021. Sponsors of medical devices are now required to provide a final report of an adverse event involving their device 120 days after the initial report was made. In addition, details on supply and previous complaints and adverse events are also required to be provided in these reports.

Information related to recalls actions occurring in Australia for therapeutic goods can be accessed through the TGA's SARA database. This database includes information on recalls, product defect corrections and hazard alerts, and product defect alerts undertaken in Australia since 1 July 2012.

In July 2020, enhancements were made to the SARA database's search facility to provide better access to TGA recall data. The search results summary of recall data can now be downloaded in an editable MS Excel format, in addition to the existing PDF reports. Instructions on searching the SARA database can be found at: System for Australian Recall Actions (SARA): instructions for searching.

To enhance post-market surveillance and data analytics a new database has been developed with a sponsor compliance dashboard to facilitate a transparent, efficient and secure way in which the TGA can notify sponsors of post-market reviews of medical devices, and analyse the information provided. From 19 October 2020, a new Post Market Review Compliance Dashboard was published to replace the existing process of responding to a post-market review and sending associated documentation by email to the TGA.

We are seeking feedback on the new dashboard and guidance through our online survey, available on the consultation hub.

On 20 May 2021, the Australian Register of Therapeutic Goods (ARTG) inclusion process for Class 1 in vitro diagnostic (IVD) export only devices and Class I export only medical devices was changed. This follows similar changes made on 4 December 2020 for Class 1 IVD medical devices and on 1 October 2020 for Class I medical devices.

Previously, applications for these classes of medical devices were included in the ARTG through a computer-generated decision process, with a self-declaration of compliance made by the sponsor. Some medical devices have been incorrectly included as Class I medical device or Class 1 IVDs, or applications have been found to be incomplete or inaccurate through this process.

To mitigate this the TGA made amendments to the medical device inclusion process, including publishing simplified versions of the Class I/1 Declaration of Conformity template.

More on these changes can be found at: Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices.

As a part of the Medical Devices Reforms, the Australian Government strengthened the assessment of surgical mesh devices. From 1 December 2018, all new surgical mesh devices (including urogynaecological mesh devices) will be included in the Australian Register of Therapeutic Goods (ARTG) as Class III medical devices (the highest medical device classification).

Urogynaecological mesh devices

From 1 December 2020 all existing Class IIb urogynaecological mesh devices were required to be up-classified and included in the ARTG as Class III medical devices. Devices were cancelled from the ARTG where the up-classification deadline was not met, noting a device may still be available via the Special Access Scheme.

Surgical mesh devices

All other existing surgical mesh devices are required to be up-classified as Class III medical devices by 1 December 2021. Sponsors of these devices can access transitional provisions if they submit an application for appropriate TGA conformity assessment certificate or a Class III application for inclusion in the ARTG by 1 December 2021. Devices will be cancelled from the ARTG where the up-classification deadline or transition provisions are not met, noting a device may still be available via the Special Access Scheme.

More on surgical mesh reclassification can be found at: Reclassification of surgical mesh devices.

More information for medical practitioners on reclassification of surgical mesh devices can be found at: Information for medical practitioners on pending up-classification of surgical mesh devices.

From 1 December 2018, manufacturers and sponsors of all new implantable or active implantable medical devices (other than those excluded) have been required to make available to patients, patient information leaflets with the device.

From 1 December 2020, manufacturers and sponsors of all new implantable or active implantable medical devices (other than those excluded) have been required to make available to patients, a patient implant card with the device.

A graduated transition period applies for existing medical devices. An "existing" device means one included in the ARTG because of application for inclusion was made before 1 December 2018, regardless of the date the device was actually included in the ARTG.

From 1 December 2019, manufacturers and sponsors of all existing urogynaecological mesh devices have been required to make available to patients, a patient information leaflet and a patient implant card with the device.

More on medical device patient information leaflets and implant cards can be found at: Medical device patient information leaflets and implant cards.

The time-table for transition can be found Attachment 1: Timetable for transition.

The TGA continues to undertake activities and projects to enhance post-market monitoring of medical devices.

We are improving the flow of TGA information to jurisdictions and other stakeholders. This is being achieved through:

• providing regular notifications of major device reviews already undertaken or scheduled for commencement
• identifying current and/or potential issues of interest, which are summarised and provided to jurisdictions as periodic "radar reports" to assist state/territory monitoring and collection of targeted information
• providing flexible data searching, sorting and downloading functions in the Database of Adverse Event Notifications (DAEN) (similar to that implemented for SARA) to allow jurisdictions and other stakeholders to undertake further analysis and develop summary reports of particular devices of concern/interest
• exploring other opportunities for increased data sharing from jurisdictions.

In addition, the TGA is partnering with international medical device regulators to proactively identify medical devices that may pose a risk to the health and safety of consumers. Working collaboratively to share important information related to medical device safety signals with our international counterparts, the TGA will be better placed to identify issues earlier and take action to eliminate or mitigate identified risks.

These activities promote improved safety, performance and quality of medical devices, and as a result enhance and improve health outcomes for patients who require these devices. These changes and improvements also strive to increase public confidence in the regulation of medical devices by the TGA.

Progress update: The TGA has implemented a number of changes in an effort to increase and improve post-market monitoring and surveillance of medical devices.

An update to the Medical device incident reporting guide was published in 2019.

A user guide for the post-market review compliance dashboard was published in 2020.