The Therapeutic Goods Administration (TGA) is seeking industry feedback on proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles), to align with new European regulations.
Industry feedback is being sought on proposed changes to the Essential Principles, to align with changes being implemented in the European General Safety and Performance Requirements (GSPR).
The TGA is aiming to ensure the Essential Principles remain relevant and to identify opportunities for potential strengthening to improve safety and performance of medical devices. It is seeking industry input on proposed alignment with the European GSPR from both the:
- European Regulations 2017/745 on medical devices (MDR)
- European Regulations 2017/746 for in vitro diagnostic medical devices (IVDR).
The Australian (AUS) Essential Principles set out the safety and performance characteristics of medical devices in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002. There are currently no Australia Essential Principles that align with the intent of the EU GSPRs, except for IVDR GSPR 19, which partly aligns with requirements of Essential Principle 15.
The TGA has been systematically reviewing the regulations and guidance materials relating to medical devices, with progress published on the TGA website.
As stated in the Consultation document, “The regulatory reforms in this consultation are based on the Government policy as agreed in 2016 in response to the Review of Medicine and Medical Devices Regulation[1].
“It was agreed that the Australian Medical Device Framework be aligned, wherever possible, with the European Union Medical Device Framework. Of note was the existing alignment already between the two frameworks.”
The TGA conducted its first consultation (Part 1) on proposed changes to the Essential Principles in 20219, which indicated strong support for alignment with the GSPR for medical devices and in vitro diagnostic devices.
This consultation focuses on Part 2 of reviewing the Australian (AUS) Essential Principles for Safety and Performance of medical devices to ensure they remain relevant and robust.
Industry is invited to respond to the survey and make a submission via the TGA consultation hub. The consultation paper and attachment can be found on the TGA Consultation Hub.
The consultation closes on 16 October 2024.
[1] Australian Government response to the Review of Medicines and Medical Devices Regulation: https://www.tga.gov.au/news/news/australian-government-response-review-medicines-and-medical-devices-regulation#devices