Consultation: Medical Devices - Essential Principles for Safety and Performance

While the consultation is open you can make a submission at our TGA consultation hub.

About this consultation

This consultation seeks feedback on proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles), to align with changes being implemented in the European General Safety and Performance Requirements (GSPR).

In 2019, we conducted our first consultation (Part 1) on proposed changes to the Essential Principles, this consultation indicated strong support for alignment with the GSPR for medical devices and in vitro diagnostic devices. 

This second consultation paper (Part 2) details the remaining proposed changes to the Essential Principles. 

We are aiming to ensure the Essential Principles remain relevant and to identify opportunities for potential strengthening to improve safety and performance of medical devices. We are seeking your 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).

For more details, read the consultation paper and attachment available on the TGA Consultation Hub and provide your feedback by answering the survey questions. The consultation will be open for feedback from 7 August to 13 November 2024.

Next steps

We will review the feedback received and determine whether to proceed with any legislative changes accordingly.

Enquiries

For enquiries relating to the consultation or next steps, email devicereforms@tga.gov.au.