Consultation: Medical Devices Essential Principles - Part 2: Proposed alignment with the European Regulation

This consultation closed on 13 November 2024.

We invited stakeholders to provide feedback on proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles), to provide further clarity and align with changes being implemented in the European General Safety and Performance Requirements (GSPR). Moreover, our aim was to ensure that the Essential Principles remain current and relevant, while identifying opportunities to further strengthen the regulatory requirements. 

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

This was the second consultation paper (Part 2) which proposed some changes to the Essential Principles.

Outcome of the consultation

We received 41 responses from stakeholders, including medical device sponsors, manufacturers, medical device industry organisations or peak bodies, hospitals and health professionals or their representative bodies, and regulatory affairs consultants. 

A summary of responses and individual responses in accordance with the respondent’s consent has been published on the TGA Consultation Hub. 

Next steps

We are reviewing the feedback received and working to finalise a recommendation for Government consideration. Stakeholders will be informed about the next steps accordingly. 

Enquiries

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